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Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 1 of 46 PAGEID #: 60365 EXHIBIT E Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 2 of 46 PAGEID #: 60366 IN THE UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF OHIO EASTERN DIVISION IN RE: E I. DU PONT DE NEMOURS AND COMPANY C-8 PERSONAL INJURY LITIGATION CASE NO. 2:13-MD-2433 JUDGE EDMUND A. SARGUS, JR. MAGISTRATE JUDGE ELIZABETH P. DEAVERS This document relates to: Carla Marie Bartlett v. E. I. du Pont de Nemours and Company, Case No. 2:13-cv-170. DECLARATION OF VITALY MARGULIS, MD, F.A.C.S. I, Vitaly Margulis, declare and state as follows: 1. I prepared the Expert Report of Vitaly Margulis, dated December 8, 2014 ("Expert Report") and a true and accurate copy is attached as Exhibit 1. 2. Each of the opinions in the Expert Report is stated to a reasonable degree of medical certainty, and was arrived at using reliable methods. 3. If called as a witness, I would testify competently to the matters stated in the Expert Report. 4. I declare under penalty of perjury under the laws of the United States of America that the foregoing is true and correct. Dated: May 8, 2015 Vitaly Margulis, MD, F.A.C.S Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 3 of 46 PAGEID #: 60367 EXHIBIT 1 EXPERT REPORT IN Carla Bartlett v. E. I. du Pont de Nemours and Company, Case No. 2:13-cv-170 (S.D. Ohio) Vitaly Margulis, MD, F.A.C.S. Prepared for: Plaintiffs' Steering Committee In re: E. I. du Pont de Nemours & Co. C-8 Personal Injury Litigation, MDL 2433 Case No. 2:13-md-2433 (S.D. Ohio) CONFIDENTIAL SUBJECT TO MDL PROTECTIVE ORDER Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 4 of 46 PAGEID #: 60368 THE UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF OHIO EASTERN DIVISION IN RE: E. I. DU PONT DE NEMOURS AND COMPANY C-8 PERSONAL INJURY LITIGATION CASE NO. 2:13-md-2433 JUDGE EDMUND A. SARGUS, JR. MAGISTRATE JUDGE ELIZABETH P. DEAVERS This document relates to: Bartlett et al. v. E. I. du Pont de Nemours and Company, Case No. 2:13-cv-0170 Case-Specific Expert Opinion Report of Vitaly Margulis, M.D., F.A.C.S. Date: December 8, 2014 RE: Carla Bartlett DOB: 1/30/1956 Background & Qualifications I am board certified in urology and an Assistant Professor of Urology at the University of Texas, Southwestern Medical Center. I am the Fellowship Director of the Society of Urologic Oncology and the Chief of Urology at Parkland Memorial Hospital. My complete curriculum vitae is attached to this report as Appendix A. Prior Testimony: A list of all other cases in which I have testified as an expert at trial or deposition during the last four years will be supplemented under separate cover and incorporated as Appendix B to this report. Compensation: My current fees include $600.00 per hour for record review and report preparation; $850.00 per hour for deposition testimony; $1,250.00 per hour for trial testimony; and $4,000.00 a day for a full day away from the office. My current fee schedule is attached as Appendix C. 2 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 5 of 46 PAGEID #: 60369 Basis for Opinions and Methodology Employed I was asked to opine as to whether Ms. Bartlett's exposure to perfluorooctanoic acid (hereinafter referred to as "C-8" a/k/a PFOA) was a substantial contributing factor to the development of her renal cell carcinoma ("RCC"). To answer this question, I reviewed the materials listed in Appendix D to this report, including Ms. Bartlett's relevant medical records, and also conducted a physical examination of Ms. Bartlett. In forming my opinions, I utilized the standard methodology of my practice as a urologic oncologist, which includes conducting a differential diagnosis. In addition, I have relied on the work of other experts in various fields in forming my differential diagnosis, which is common practice in the ordinary course of my work. Finally, all of the opinions that are set forth in this report are stated to a reasonable degree of medical certainty. Summary of Opinions: Ms. Bartlett was diagnosed with RCC, Stage 2. At the time of her diagnosis, Ms. Bartlett only had two risk factors for RCC, which included obesity and exposure to C-8. Based on my review of the relevant medical records, the C-8 Science Panel probable link report, the expert report of Dr. David MacIntosh, in addition to the materials/documents listed in Appendix D, Ms. Bartlett's exposure to C-8 was a substantial contributing factor to her development of RCC, her resulting follow up care and related sequalae. As a result of her RCC, Ms. Bartlett underwent surgery and related follow up care, and subsequently endured severe pain and suffering as well as emotional distress. As a result of her RCC, Ms. Bartlett remains at an increased risk for developing RCC as well as other cancers, and will continue to need CT scans and/or MRIs throughout her life to ensure her cancer remains in remission. History of Present Illness, i.e., Renal Cell Carcinoma Carla Bartlett was a 40-year old Caucasian female who had no prior urologic history, when in 1996, she was evaluated with an ultrasound for abdominal pain. Subsequent to the ultrasound, she was diagnosed with cholelithiasis and a cystic left renal mass of unclear malignant potential. A laparoscopic cholecystectomy was performed in 1996, and additional renal imaging with CT was obtained in 1997. Due to presence of concerning radiologic features in the left renal lesion, a urologic consultation with her treating oncologist, Dr. Bahnson (Ohio State University), was obtained and left renal exploration with excision of the tumor was recommended. A left renal 3 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 6 of 46 PAGEID #: 60370 exploration with a left partial nephrectomy was performed in June of 1997 without any recorded complications. Following her partial nephrectomy, a final pathologic evaluation revealed pT1pNxcM0 cystic renal cell cancer, Fuhrman nuclear grade I, negative margins. Following this surgery, Ms. Bartlett underwent yearly follow up appointments with cross sectional imaging of the abdomen and chest through 2011. Prior Medical History Prior to her RCC diagnosis, Ms. Bartlett's surgical history included the placement of a metal plate in her head and ear surgery, which occurred in the 1980s. In addition, following these two procedures, she underwent a cholecystectomy, removal of uterine fibroids and a caesarean section. Following her kidney cancer diagnosis, in addition to the partial nephrectomy she underwent as a result of the kidney cancer diagnosis, her surgical history included, a cystourethroscopy with repair of a vesicovaginal fistula, a hysterectomy and back surgery. With respect to her medical history, prior to her RCC diagnosis, Ms. Bartlett's medical history was limited to obesity. Following her RCC diagnosis, Ms. Bartlett's medical history includes depressive disorder, hypertension, diabetes, high cholesterol, obesity, hyperlipidemia and high blood pressure. Social History Ms. Bartlett lives in Guysville, Ohio and has been at this residence since 1990. She is employed as a secretary/rental agent for Good Incorporated, which rents apartments to local college students. She has held this position since 1986, with the exception of late 1995 to late 1997, during which time she took approximately two years off of work to care for her newborn son, who was born via caesarean section in November 1995. Ms. Bartlett has been married for thirteen years and has two sons, one biological son and one stepson. Her husband is a truck driver. As noted in further detail below, Ms. Bartlett has no history of smoking and does not, and has never, consumed alcohol regularly. Further, Ms. Bartlett does not, and has never, used recreational drugs. She exercises by walking daily. Family History: Non-contributory. Ms. Bartlett has no family history of RCC. A review of the death certificate of Ms. Bartlett's father, Carl L. Clem, makes clear that he suffered from transitional cell carcinoma of the left kidney (urothelial cell cancer) as well as prostate cancer. This is not renal cell cancer carcinoma, and thus cannot be considered a family history of the disease. 4 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 7 of 46 PAGEID #: 60371 Moreover, there is also no family history of either renal failure or renal cystic disease. Clinical Kidney Cancer Course Ms. Bartlett was diagnosed with RCC in June 1997 after a left renal mass was identified during work up of right abdominal pain in 1996. Following her RCC diagnosis, Ms. Bartlett underwent a left partial nephrectomy performed by Dr. Bahnson in June of 1997, without apparent complications. Following this procedure, Ms. Bartlett was required to undergo 10 years of annual scans with Dr. Bahnson. Moreover, according to the documents reviewed, at the conclusion of this ten year period, Ms. Bartlett was also instructed by Dr. Bahnson to have an ultrasound every two years with her family doctor, and the occasional chest x-ray in order to confirm that her cancer remains in remission. Pathology from the resected tumor is consistent with pT1pNxcM0 cystic renal cell cancer, Fuhrman grade 1, negative margins. While Ms. Bartlett's pathologic findings at the time of diagnosis suggest that the chances of maintaining remission are high, she will continue to require monitoring, and will remain at an increased risk for kidney cancer by virtue both of her prior cancer diagnosis as well as her exposure to continued CT scans. Moreover, the records reviewed also indicate that Ms. Bartlett experienced both depression (for which she is treated with Lexapro by her primary care physician) as well as weight gain as a result of her RCC and the subsequent clinical course. Physical Examination: BP 164/93 | Pulse 90 | Temp 36.7 C (98.1 F) (Tympanic) | Resp 16 | Ht 5' 7" (1.70 m) | Wt 265 lb 8 oz (120.2 kg) | BMI 41.6 kg/m2 General appearance: healthy, alert, well developed, well nourished, no distress Skin: negative - no abnormal appearing lesions on exposed areas Head: Normocephalic. No masses, lesions, tenderness or abnormalities. Neurologic: cranial nerves intact. Distal sensation and motor function intact and symmetric Eyes: Pupils equal and reactive to light and extraocular movements are intact Oropharynx: Lips, mucosa and tongue normal. Teeth and gums normal. Neck: Neck supple, no adenopathy. Thyroid symmetric, normal size. Lungs: normal effort and clear to auscultation and percussion Heart: regular rate and rhythm and no murmurs, clicks, or gallops Abdomen: Abdomen soft, nontender. Bowel sounds normal. No masses or organomegaly. No distention. Well healed left flank incision without hernia. Well healed lower abdominal incision. Back: Back symmetric, normal lumbar and thoracic curvatures, No CVA tenderness 5 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 8 of 46 PAGEID #: 60372 Musculoskeletal: Muscular strength intact, normal gait Extremities: No deformities, edema, or skin discolorations. Vascular: equal and symmetric pulses proximally and distally upper and lower extremities. Differential Diagnosis: With respect to the cause of Ms. Bartlett's RCC, according to the American Cancer Society, the risk factors for development of RCC include smoking, workplace chemical exposures (e.g., cadmium, herbicides, organic solvents), obesity, family history, genetic and hereditary risk factors (VHL, Birt-Hogg-Dube etc.), hypertension, race (African-Americans are at a slightly greater risk than Caucasians), gender (men are at a two-fold greater risk than women to develop kidney cancer), certain medications and advanced kidney disease. (See http://www.cancer. org/cancer/kidneycancer/detailedguide/kidney-cancer-adult-risk-factors). In addition, advanced age is also an accepted risk factor for the development of RCC. (See http://seer.cancer.gov/statfacts/html/kidrp.html). Based on my physical examination of Ms. Bartlett, a review of the documents and materials identified above and/or the materials identified on Appendix D, I was able to rule out each of the following potential risk factors as the cause of Ms. Bartlett's RCC: Smoking history: according to the records I reviewed, she was never a smoker and thus I was able to rule out this factor as a cause of her RCC; Workplace chemical exposure: according to the records I reviewed, she has never been exposed to chemicals in the workplace and thus I was able to rule out this factor as a cause of her RCC; Hereditary risk factors: based on a review of her records as well as a taking of her medical and family history during my physical examination, Ms. Bartlett does not have a history of hereditary factors that would predispose her to RCC and thus I was able to rule out this factor as the cause of her RCC; Hypertension: based on a review of her records and as well as a taking of her medical and family history during my physical exam, Ms. Bartlett did not have hypertension at the time of her RCC diagnosis and thus I was able to rule out this factor as a cause of her RCC; Race: Ms. Bartlett is Caucasian and thus I was able to rule out this risk factor as a cause of her RCC; Gender: Ms. Bartlett is female and thus I was able to rule out this risk factor as a cause of her RCC; Medical renal disease: based on a review of her records as well as a taking of her medical during my physical examination, Ms. Bartlett does not have a history of medical renal disease and thus I was able to rule out this risk factor as a cause of her RCC; 6 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 9 of 46 PAGEID #: 60373 Family history: based on a review of her records, and a review of her father's death certificate, Ms. Bartlett does not have a family history of RCC and thus I was able to rule out this risk factor as a cause of her RCC; Kidney failure: based on a review of her records as well as a taking of her medical history during my physical examination, Ms. Bartlett does not have kidney failure and thus I was able to rule out this risk factor as a cause of her RCC; Kidney transplant: based on a review of her records as well as a taking of her medical history during my physical examination, Ms. Bartlett has not undergone a kidney transplant and thus I was able to rule out this risk factor as a cause of her RCC; Advanced age: Ms. Bartlett was only 41 years old at the time of her RCC diagnosis and thus I was able to rule out this risk factor as a cause of her RCC; and Medications: based on a review of her records as well as a taking of her medical history during my physical examination, Ms. Bartlett is not prescribed medications associated with an increased risk of RCC, and thus I was able to rule out this risk factor as a cause of her RCC. Conversely, and as noted above, Ms. Bartlett did have exposure to perfluorooctanoic acid. For the purposes of this case, I understand that C-8 exposure is a cause of kidney cancer "among Class Members." (C-8 Science Panel Probable Link Report). I have reviewed the expert report of Dr. David MacIntosh who opines that Ms. Bartlett is a Class Member. It is standard medical practice to rely on other experts in forming a differential diagnosis. Moreover, although obese at the time of her RCC diagnosis, obesity is generally not considered a major risk factor for RCC, and thus I am able to rule it out as the predominant cause of Ms. Bartlett's RCC.1 However, even assuming Ms. Bartlett's obesity did predispose her to RCC, or acted synergistically with C-8, my opinion remains unchanged; as set forth below, it is my opinion to a reasonable degree of medical certainty that C-8 was a substantial contributing factor in causing Ms. Bartlett's RCC. In sum, I conclude to a reasonable degree of medical certainty that C-8 was a substantial contributing factor in causing Ms. Bartlett's RCC, which caused her both pain and suffering as well as emotional distress. Moreover, I further conclude to a reasonable degree of medical certainty that as a result of her kidney cancer, Ms. Bartlett will continue to require monitoring, will remain at an increased risk for cancer for the remainder of her life as a result of her prior cancer diagnosis as well as her continued monitoring, and has suffered from both depression and weight gain since her RCC diagnosis, both of which she attributes to her RCC. 1 The evidence with respect to obesity is conflicting and merely observational at best with no evidence o f a causal link. 7 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 10 of 46 PAGEID #: 60374 Please note that I reserve my right to supplement this report in the event that new information becomes available to me. /s/__________________ Dated: December 8, 2014 8 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 11 of 46 PAGEID #: 60375 APPENDIX A Curriculum Vitae Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 12 of 46 PAGEID #: 60376 Date Prepared: Curriculum vitae October 13, 2014 Name: Office Address: Work Phone: Work E-Mail: Work Fax: Place of Birth: Vitaly Margulis, M.D. 5323 Harry Hines Blvd. Dallas, TX 75390-9110 (214) 648-0567 vitaly.margulis@utsouthwestern.edu (214) 648-8786 Ukraine Education Year 1993 - 1997 1997 - 2001 Degree (Honors) Bachelor of Science Doctor of Medicine Field of Study (Thesis advisor for PhDs) Biology, Biochemistry Postdoctoral Training Year(s) Titles 2001 - 2006 Residency Specialty/Discipline (Lab PI for postdoc research) Urology 2006 - 2008 Fellowship Urologic Oncology Faculty Academic Appointments Year(s) 2008 - 2009 Academic Title Clinical Specialist Department Urologic Oncology 2009 - Present Assistant Professor Urology Institution University of Texas University of Texas Southwestern Medical School Institution University of Texas Southwestern Medical Center University of Texas MD Anderson Cancer Center Academic Institution University of Texas M.D. Anderson Cancer Center Houston, Texas University of Texas Southwestern Medical Center 1 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 13 of 46 PAGEID #: 60377 Current Licensure and Certification Licensure 2002 - Present 2002 - Present 2002 - Present 2010 - Present Texas Board of Medical Examiners Texas Department of Public Safety DEA Controlled Substances National Provider Identification Board and Other Certification 2007 American Board of Urology Honors and Awards Year Name of Honor/Award Awarding Organization 1993 - 1997 1997 2001 2004 2004 - 2005 2005 2005 2006 - 2008 2006 - 2007 2007 2007 - 2011 2008, 2013 2009 2010, 2013 2009 - 2011 Presidential Full Tuition Merit Scholarship Summa Cum Laude Alpha Omega Alpha Travel Grant Excellence in Urologic Pathology Award Travel Grant Travel Grant American Urologic Association Foundation Research Scholar Award, (AFUD) Ruth L. Kirschstein National Research Service Award Travel Grant NIH Clinical Research Staff LRP Award Merit Award University of Texas University of Texas University of Texas Southwestern Medical Center American Geriatric Society Meeting University of Texas Southwestern Medical Center Cleveland Clinic Foundation Endourologic Workshop Northwestern University Visiting Resident American Urological Association University of Texas M.D. Anderson Cancer Center Best of American Society of Clinical Oncology National Institute of Health American Society of Clinical Oncology Best Poster Award Faculty Teaching Award NIH Clinical Research Scientist LRP Award Society of Urologic Oncology University of Texas Southwestern Medical Center National Institute of Health 2 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 14 of 46 PAGEID #: 60378 2012 2012 2012 2014 2014 2014 American Urological Association / Japanese Urologie Association Academic Exchange Scholar Texas Rising Stars Best Reviewer Castle Connolly Top Doctor - Urology Best Doctors in Dallas Texas Super Doctors American Urological Association Super Doctors The Journal of Urology Castle Connolly Medical LTD. D Magazine - Urology category Texas Monthly Appointments at Hospitals/Affiliated Institutions Past Year(s) 2008 -2009 Position Title Department/Division Clinical Specialist Urologic Oncology Institution University of Texas M.D. Anderson Cancer Center Current Year(s) 2009 - Present Position Title Assistant Professor Department/Division Urology 2006 - Present 2006 - Present 2006 - Present Active Attending Chief of Urology Active Attending Urology Urology Urology 2006 - Present Active Attending Urology Institution University of Texas Southwestern Medical Center VA North Texas Parkland Memorial Hospital Zale-Lipshy University Hospital Children's Medical Center Major Administrative/Leadership Positions Year(s) Position Title 2013 - Present Fellowship Director 2013 - Present Chief of Urology Institution Society of Urologic Oncology Parkland Memorial Hospital Committee Service Year(s) UTSW 2009 - Present Name of Committee Annual Paul C. Peters Urologic Symposium Organizing Committee Institution/Organization University of Texas Southwestern Medical Center and Affiliated Hospitals 3 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 15 of 46 PAGEID #: 60379 2010 - Present Applicant Interviewer Medical School Admissions 2011 - Present Surgical Services Executive Committee 2012- Present Applicant Interviewer Medical School Admissions 2012 - Present STARS Summer Research Program Mentor University of Texas Southwestern Medical Center and Affiliated Hospitals University of Texas Southwestern Medical Center and Affiliated Hospitals University of Texas Southwestern Medical Center and Affiliated Hospitals University of Texas Southwestern Medical Center and Affiliated Hospitals Hospital 2011 - Present Operation Room Committee 2012 - Present Surgical Chiefs Committee Parkland Health and Hospital System Parkland Health and Hospital System N ati onal/Internati onal 2011 - Present Annual Congress Content Reviewer 2013 Co-Director American Urologie Association Course on Locally Advanced Renal Cell Cancer American Urological Association American Urological Association Professional Societies Dates 2013 Fellowships Society of Urological Oncology, Member American Association for Cancer Research, Member American College of Surgeons, Member Endourologic Society, Member American Urological Association, Member American Medical Association, Member Texas Medical Association, Member Dallas County Medical Society, Member Harris County Medical Society, Member Editorial Activities 2014 Minerva Urologic e Nefrolica, Editorial Board Editor/Associate Editor 2014 BMC Urology, BioMed Central, Associate Editor Ad Hoc Reviewer 4 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 16 of 46 PAGEID #: 60380 Urologic Oncology Clinical Cancer Research Journal of Clinical Oncology European Journal of Cancer Expert Reviews in Oncology Oncogene Cancer Epidemiology Biomarkers and Prevention Urology International Journal of Cancer International Journal of Urology Expert Reviews in Anticancer Therapy Molecular Cancer Therapeutics Brazilian Journal of Urology Indian Journal of Urology The Prostate World Journal of Urology Journal of Urology British Journal of Urology European Urology Invited Lectures Year(s) International 2010 2011 2012 2014 National 2008 2010 2012 Title Location Genetic basis in renal cell cancer Minimally invasive options for management of localized kidney cancer Integration of surgery and systemic therapy for management of advanced renal cell cancer Society of Translational and Clinical Oncology, Chiclayo, Peru. Jikey University Grand Rounds, Tokyo, Japan Spanish Oncology Genitourinary Group, Madrid, Spain 29th Annual EAU Congress, Stockholm, Sweden Locally advanced renal cell cancer: resecting the unresectable Targeted systemic therapy in management of advanced renal cell cancer Management of small renal mass in the modern era Seventh International Kidney Cancer Symposium, University of Chicago, Chicago Illinois American Urologic Association Annual Meeting, San Francisco, California. Society of Urologic Nurses and Associates, Washington, D.C. 5 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 17 of 46 PAGEID #: 60381 2013 2013 2014 Management of lymph nodes in renal cell carcinoma Locally advanced renal cell cancer course Regional/Local 2007 Surveillance after surgical management of renal cell carcinoma and observation of small renal masses 2009 Surveillance for recurrent disease: how often should I be seen and what tests should be ordered Kidney Cancer Association, Chicago, IL American Urologic Association Annual Meeting, San Diego, CA American Urologic Association Annual Meeting, Orlando, FL Kidney Cancer Association Patient Advocacy Meeting. University of Texas M.D. Anderson Cancer Center, Houston, Texas Kidney Cancer Association Patient Advocacy Meeting. University of Texas M.D. Anderson Cancer Center, Houston, Texas 2009 2009 2010 2010 2010 2010 2011 2011 2011 2011 2011 2013 2013 2014 PSA and prostate puzzle Advances in prostate cancer management Chemoradiation in management of bladder cancer Active surveillance for small renal masses Penile cancer in 2010 Renal cell cancer Multimodality management of upper urinary tract cancer Perioperative systemic therapy for advanced renal cancer Current state of adjuvant therapy in prostate cancer Partial nephrectomy: current status Epithelial to mesenchymal transition in renal cancer Risk assessment and integration of systemic therapy in upper tract urothelial cancer Upper tract urothelial cancer updates Clinical cases in Urologic Oncology University of Texas Southwestern Medical Center Continued Education, Dallas Presbyterian Hospital Group Grand Rounds Annual Paul C. Peters Urologic Symposium, Dallas Annual Paul C. Peters Urologic Symposium, Dallas Texas Urologic Society, San Antonio Texas Academy of Physician Assistants, Fort Worth Annual Paul C. Peters Urologic Symposium, Dallas Annual Paul C. Peters Urologic Symposium, Dallas Annual Paul C. Peters Urologic Symposium, Dallas Texas Urologic Society, San Antonio Renal Cell Carcinoma Task Force, M.D. Anderson Cancer Center The 50th Annual Harry M. Spence Visiting Professor Conference, Dallas Annual Paul C. Peters Urologic Symposium, Dallas Urology Update 2013, Dallas 6 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 18 of 46 PAGEID #: 60382 Bibliography Peer-Reviewed Publications Original Research Articles 1. Margulis V, Lemack GE, Molberg K, Saboorian MH. Bladder "Mullerianosis" in a woman with lower urinary tract symptoms and hematuria. J Urol 2001 Jun; 165(6 Pt 1): 1996-7. PMID: 11371906. 2. Lemack GE, Blander DS, Margulis V, Zimmern PE. Vaginal vault fixation and prevention of enterocele recurrence by high midline levator myorraphy: physical examination and questionnaire-based follow-up. Eur Urol 2001 Dec; 40(6): 648-51. PMID: 11805411. 3. Wai CY, Margulis V, Baugh BR, Schaffer JI. Multiple vesical calculi and complete vaginal vault prolapse. Am J Obstet Gynecol 2003 Sep; 189(3):884-5. PMID: 14526336. 4. Margulis V, Defreitas G, Zimmern PE. Urinary retention after tension-free vaginal tape procedure: from incision to excision...to complete urethrolysis. Urology 2004 Sep; 64(3): 590. PMID: 15351609. 5. Margulis V, Matsumoto ED, Lindberg G, Tunc L, Taylor G, Sagalowsky AI, Cadeddu JA. Acute histologic effects of temperature-based radiofrequency ablation on renal tumor pathologic interpretation. Urology 2004 Oct; 64(4): 660-3. PMID: 15491694. 6. Matsumoto ED, Johnson DB, Ogan K, Trimmer C, Sagalowsky A, Margulis V, Cadeddu JA. Short-term efficacy of temperature-based radiofrequency ablation of small renal tumors. Urology 2005 May; 65(5): 877-81. PMID: 15882715. 7. Margulis V, Matsumoto ED, Taylor G, Shaffer S, Kabbani W, Cadeddu JA. Retrograde renal cooling during radio frequency ablation to protect from renal collecting system injury. J Urol 2005 Jul; 174(1) 350-2. PMID: 15947688. 8. Margulis V, Matsumoto ED, Svatek R, Kabbani W, Cadeddu JA, Lotan Y. Application of novel hemostatic agent during laparoscopic partial nephrectomy. J Urol 2005 Aug; 174(2): 761-4. PMID: 16006972. 9. Margulis V, Matsumoto ED, Tunc L, Taylor G, Duchenne D, Cadeddu JA. Effect of warmed, humidified insufflation gas and anti-inflammatory agents on cytokine response to laparoscopic nephrectomy: porcine model. J Urol 2005 Oct; 174(4 Pt 1): 1452-6. PMID: 16145469. 10. Malaeb BS, Gardner TA, Margulis V, Yang L, Gillenwater JY, Chung LW, Macik G, Koeneman KS. Elevated activated partial thromboplastin time during administration of first generation adenoviral vectors for gene therapy for prostate cancer: identification of lupus anticoagulants. Urology 2005 Oct; 66(4): 830-4. PMID: 16230147. 11. Matsumoto ED, Margulis V, Tunc L, Taylor GD, Duchene D, Johnson DB, Pearle MS, Cadeddu JA. Cytokine response to surgical stress: comparison of pure laparoscopic, handassisted laparoscopic, and open nephrectomy. J Endourol 2005 Nov; 19(9): 1140-5. PMID: 7 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 19 of 46 PAGEID #: 60383 16283854. 12. Matsumoto ED, Margulis V, Tunc L, Taylor GD, Duchene D, Johnson DB, Pearle MS, Cadeddu JA. Cytokin response to surgical stress: Comparison of pure laparoscopic, handassisted laparoscopic, and open nephrectomy. 2005 J Endourol 19(9): 1140-45. 13. Abdel-Aziz KF, Anderson JK, Svatek R, Margulis V, Sagalowsky AI, Cadeddu JA. Laparoscopic and open retroperitoneal lymph-node dissection for clinical stage I nonseminomatous germ-cell testis tumors. J Endourol 2006 Sep; 20(9): 627-31. PMID: 16999613. 14. Knudsen BE, Matsumoto ED, Chew BH, Johnson B, Margulis V, Cadeddu JA, Pearle MS, Pautler SE, Denstedt JD. A randomized, controlled, prospective study validating the acquisition of percutaneous renal collecting system access skills using a computer based hybrid virtual reality surgical simulator: phase I. J Urol 2006 Nov; 176(5): 2173-8. PMID: 17070287. 15. Margulis V, Shariat SF, Ashfaq R, Sagalowsky AI, Lotan Y. Ki-67 is an independent predictor of bladder cancer outcome in patients treated with radical cystectomy for organconfined disease. Clin Cancer Res 2006 Dec 15; 12(24): 7369-73. PMID: 17189409. 16. Margulis V, Shariat SF, Ashfaq R, Sagalowsky AI, Lotan Y. Ki-67 is an independent predictor of bladder cancer outcome in patients treated with radical cystectomy for organconfined disease. Clin Cancer Res 2006 Dec 15; 12(24): 7369-73. PMID: 17189409. 17. Svatek RS, Karam JA, Rogers TE, Shulman MJ, Margulis V, Benaim EA. Intraluminal crystalloids are highly associated with prostatic adenocarcinoma on concurrent biopsy specimens. Prostate Cancer Prostatic Dis 2007; 10(3): 279-82. Epub 2007 Feb 27. PMID: 17325718. 18. Margulis V, Snchez-Ortiz RD, Tamboli P, Cohen DD, Swanson DA, Wood CG. Renal cell carcinoma clinically involving adjacent organs: experience with aggressive surgical management. Cancer 2007 May 15; 109(10): 2025-30. PMID: 17420980. 19. Margulis V, Tamboli P, Matin SF, Meisner M, Swanson DA, Wood CG. Redefining pT3 renal cell carcinoma in the modern era: a proposal for a revision of the current TNM primary tumor classification system. Cancer 2007 Jun 15; 109(12): 2439-44. PMID: 17487856. 20. Margulis V, Wood CG. Update on staging controversies for locally advanced renal cell carcinoma. Expert Rev Anticancer Ther 2007 Jul; 7(7): 909-14. PMID: 17627450. 21. Margulis V, Tamboli P, Matin SF, Meisner M, Swanson DA, Wood CG. Location of external tumor extension does not impact survival of patients with pT3a renal cell carcinoma. J Urol 2007 Nov; 178(5): 1878-82. Epub 2007 Sep 17. PMID: 17868733. 22. Margulis V, Shariat SF, Ashfaq R, Thompson M, Sagalowsky AI, Hsieh J-T, Lotan Y. Expression of cyclooxygenase-2 in normal urothelium, and superficial and advanced transitional cell carcinoma of the bladder. 2007 J Urol 177(3): 1163-68. 23. Shariat SF, Karam JA, Margulis V, Karakiewicz PI. New blood-based biomarkers for the diagnosis, staging and prognosis of prostate cancer. BJU Int 2008 Mar; 101(6):675-83. Epub 2007 Oct 17. PMID: 17941930. 24. Margulis V, Lotan Y, Shariat SF. Survivin: a promising biomarker for detection and prognosis of bladder cancer. World J Urol 2008 Feb; 26(1): 59-65. Epub2007 Oct 26. PMID: 17962949. 25. Margulis V, Tamboli P, Jacobsohn KM, Swanson DA, Wood CG. Oncological efficacy and safety of nephron-sparing surgery for selected patients with locally advanced renal cell carcinoma. BJU Int 2007 Dec; 100(6): 1235-9. PMID: 17979923. 26. Margulis V, Wood CG. Cytoreductive nephrectomy in the era of targeted molecular agents: is it time to consider presurgical systemic therapy? Eur Urol 2008 Sep; 54(3): 489-92. Epub 8 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 20 of 46 PAGEID #: 60384 2008 Jan 11. PMID: 18206292. 27. Shariat SF, Margulis V, Lotan Y, Montorsi F, Karakiewicz PI. Nomograms for bladder cancer. Eur Urol 2008 Jul; 54(1): 41-53. Epub 2008 Jan 15. PMID: 18207314. 28. Margulis V, Tamboli P, Matin SF, Swanson DA, Wood CG. Analysis of clinicopathologic predictors of oncologic outcome provides insight into the natural history of surgically managed papillary renal cell carcinoma. Cancer 2008 Apr 1; 112(7): 1480-8. PMID: 18240184. 29. Margulis V, Lotan Y, Montorsi F, Shariat SF. Predicting survival after radical cystectomy for bladder cancer. BJU Int 2008 Jul; 102(1): 15-22. Epub 2008 Mar 5. PMID: 18325050. 30. Shariat SF, Karakiewicz PI, Margulis V, Kattan MW. Inventory of prostate cancer predictive tools. Curr Opin Urol 2008 May; 18(3): 279-96. PMID; 18382238. 31. Svatek RS, Shulman MJ, Benaim EA, Rogers TE, Margulis V. Change in prostate specific antigen following androgen stimulation is an independent predictor of prostate cancer diagnosis. J Urol 2008 Jun; 179(6): 2192-5; discussion 2195-6. Epub 2008 Apr 18. PMID: 18423746. 32. Margulis V, Matin SF, Tannir N, Tamboli P, Swanson DA, Jonasch E, Wood CG. Surgical morbidity associated with administration of targeted molecular therapies before cytoreductive nephrectomy or resection of locally recurrent renal cell carcinoma. J Urol 2008 Jul; 180(1): 94-8. Epub 2008 May 15. PMID: 18485389. 33. Karam JA, Margulis V, Montorsi F, Karakiewicz PI, Lotan Y, Kikuchi E, Weizer A, Zigeuner R, Bolenz C, Shariat SF. Carcinoma in situ of the upper urinary tract treated with radical nephroureterectomy--results from a multicenter study. Eur Urol 2008 Oct; 54(4): 961-3. Epub 2008 May 8. PMID: 18485573. 34. Shariat SF, Karam JA, Walz J, Roehrborn CG, Montorsi F, Margulis V, Saad F, Slawin KM, Karakiewicz PI. Improved prediction of disease relapse after radical prostatectomy through a panel of preoperative blood-based biomarkers. Clin Caner Res 2008 Jun 15; 14(12): 3785-91. PMID: 18559597. 35. Margulis V, Matin SF, Wood CG. Cytoreductive nephrectomy in metastatic renal cell carcinoma.Curr Opin Urol 2008 Sep; 18(5): 474-80. PMID: 18670270. 36. Raman JD, Ng CK, Shariat SF, Margulis V, Montorsi F, Karakiewicz P; Upper-Tract Urothelial Carcinoma Collaboration. BJU Int 2009 Jan; 103(1): 3-4. Epub 2008 Aug 18. PMID: 18717670. 37. Margulis V, Wood CG, Jonasch E, Matin SF. Current status of debulking nephrectomy in the era of tyrosine kinase inhibitors. Curr Oncol Rep 2008 May; 10(3): 253-8. PMID: 18765156. 38. Margulis V, Lin J, Yang H, Wang W, Wood CG, Wu X. Genetic susceptibility to renal cell carcinoma: the role of DNA double-strand break repair pathway. Cancer Epidemiol Biomarkers Pre 2008 Sep; 17(9): 2366-73. PMID: 18768505. 39. Margulis V, Maity T, Zhang XY, Cooper SJ, Copland JA, Wood CG. Type III transforming growth factor-beta (TGF-beta) receptor mediates apoptosis in renal cell carcinoma independent of the canonical TGF-beta signaling pathway. Clin Cancer Res 2008 Sep 15; 14(18): 5722-30. PMID: 18794080. 40. Margulis V, Wood CG. The role of lymph node dissection in renal cell carcinoma: the pendulum swings back. Cancer J 2008 Sep-Oct; 14(5): 308-14. PMID: 18836335. 41. Fernndez MI, Shariat SF, Margulis V, Bolenz C, Montorsi F, Suardi N, Remzi M. Wood CG, Roscigno M, Kikuchi E, Oya M, Zigeuner R, Langner C, Weizer A, Lotan Y, Koppie TM, Raman JD, Karakiewicz P, Bensalah K, Schultz M, Bernier P. Evidence-based sexrelated outcomes after radical nephroureterectomy for upper tract urothelial carcinoma: 9 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 21 of 46 PAGEID #: 60385 results of large multicenter study. Urology 2009 Jan; 73(1): 142-6. Epub 2008 Oct 8. Erratum in Urology 2010 May; 75(5): 1243. Karakiewicz, Pierre. PM1D: 18845322. 42. Karam JA, Margulis V, Montorsi F, Karakiewicz PI, Lotan Y, Kikuchi E, Weizer A, Zigeuner R, Bolenz C, Shariat SF. Carcinoma in site of the Upper Urinary Tract Treated with Radical Nephroureterectomy - Results from a Multicenter Study. 2008 European Urol 54(4): 961-63. 43. Margulis V, Wood CG. Cytoreductive nephrectomy in the era of targeted molecular agents: Is it time to consider presurgical sysemtic therapy? 2008 Eur Urol 54(3): 489-92. 44. Margulis V, Matin SF, Wood CG. Cytoreductive nephrectomy in metastatic renal cell carcinoma. 2008 Curr Opin in Urol 18(5): 474-80. 45. Margulis V, Matin SF, Tannir N, Tamboli P, Shen Y, Lozano M, Swanson DA, Jonasch E, Wood CG. Randomized trial of adjuvant thalidomide versus observation in patients with completely resected high-risk renal cell carcinoma. Urology 2009 Feb; 73(2): 337-41. Epub 2008 Oct 31. PMID: 18950837. 46. Remzi M, Haitel A, Margulis V, Karakiewicz P, Montorsi F, Kikuchi E, Zigeuner R, Weizer A, Bolenz C, Bensalah K, Suardi N, Raman JD, Lotan Y, Waldert M, Ng CK, Fernndez M, Koppie TM, Strobel P, Kabbani W, Murai M, Langner C, Roscigno M, Wheat J, Guo CC, Wood CG, Shariat SF. Tumor architecture is an independent predictor of outcomes after nephroureterectomy: a multi-institutional analysis of 1363 patients. BJU Int 2009 Feb; 103(3): 307-11. Epub 2008 Oct 16. Erratum in: BJU Int 2009 Aug; 104(4): 574. Karakiewicz, P. PMID: 18990163. 47. Bolenz C, Shariat SF, Fernndez MI, Margulis V, Lotan Y, Karakiewicz P, Remzi M, Kikuchi E. Zigeuner R, Weizer A, Montorsi F, Bensalah K, Wood CG, Roscigno M, Langner C, Koppie TM, Raman JD, Mikami S, Michel MS, Strobel P. Risk stratification of patients with nodal involvement in upper tract urothelial carcinoma: value of lymph-node density. BJU Int 2009 Feb; 103(3): 302-6. Epub 2008 Oct 16. PMID: 18990164. 48. Margulis V, Wood CG. Pre-surgical targeted molecular therapy in renal cell carcinoma. BJU Int 2009 Jan; 103(2): 150-3. Epub 2008 Nov 4. PMID: 19007359. 49. Kikuchi E, Margulis V, Karakiewicz PI, Roscigno M, Mikami S, Lotan Y, Remzi M, Bolenz C, Langner C, Weizer A, Montorsi F, Bensalah K, Koppie TM, Fernndez MI, Raman JD, Kassouf W, Wood CG, Suardi N, Oya M, Shariat SF. Lymphovascular invasion predicts clinical outcomes in patients with node-negative upper tract urothelial carcinoma. J Clin Oncol 2009 Feb 1; 27(4): 612-8. Epub 2008 Dec 15. PMID: 19075275. 50. Margulis V, Lotan Y, Karakiewicz PI, Fradet Y, Ashfaq R, Capitanio U, Montorsi F, Bastian PJ, Nielsen ME, Mller SC, Rigaud J, Heukamp LC, Netto G, Lerner SP, Sagalowsky AI, Shariat SF. Multi-institutional validation of the predictive value of Ki-67 labeling index in patients with urinary bladder cancer. J Natl Cancer Inst 2009 Jan 21; 101(2); 114-9. Epub 2009 Jan 13. PMID: 19141773. 51. Margulis V, Shariat SF, Matin SF, Kamat AM, Zigeuner R, Kikuchi E, Lotan Y, Weizer A, Raman JD, Wood CG; Upper Tract Urothelial Carcinoma Collaboration The Upper Tract Urothelial Carcinoma Collaboration. Outcomes of radical nephroureterectomy: a series from the Upper Tract Urothelial Carcinoma Collaboration. Cancer 2009 Mar 15; 115(6): 1224-33. PMID: 19156917. 52. Margulis V, McDonald M, Tamboli P, Swanson DA, Wood CG. Predictors of oncological outcome after resection of locally recurrent renal cell carcinoma. J Urol 2009 May; 181(5): 2044-51. Epub 2009 Mar 14. PMID: 19286220. 53. Capitanio U, Shariat SF, Isbarn H, Weizer A, Remzi M, Roscigno M, Kikuchi E, Raman JD, Bolenz C, Bensalah K, Koppie TM, Kassouf W, Fernndez MI, Strobel P, Wheat J, Zigeuner 10 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 22 of 46 PAGEID #: 60386 R, Langner C, Waldert M, Oya M, Guo CC, Ng C, Montorsi F, Wood CG, Margulis V, Karakiewicz PI. Comparison of oncologic outcomes for open and laparoscopic nephroureterectomy: a multi-institutional analysis of 1249 cases. Eur Urol 2009 Jul; 56(1): 1 9. Epub 2009 Apr 3. PMID: 19361911. 54. Roscigno M, Shariat SF, Margulis V, Karakiewicz P, Remzi M, Kikuchi E, Langner C, Lotan Y, Weizer A, Bensalah K, Raman JD, Bolenz Z, Guo CC, Wood CG, Zigeuner R, Wheat J, Kabbani W, Koppie TM, Ng CK, Suardi N, Bertini R, Fernndez MI, Mikami S, Isida M, Michel MS, Montorsi F. Impact of lymph node dissection on cancer specific survival in patients with upper tract urothelial carcinoma treated with radical nephroureterectomy. J Urol 2009 Jun; 181(6): 2482-9. Epub 2009 Apr 16. PMID: 19371878. 55. Wood CG, Margulis V. Neoadjuvant (presurgical) therapy for renal cell carcinoma: a new treatment paradigm for locally advanced and metastatic disease. Cancer 2009 May 15; 115(10 Suppl): 2355-60. PMID: 19402066. 56. Roscigno M, Shariat SF, Margulis V, Karakiewicz P, Remzi M, Kikuchi E, Zigeuner R, Weizer A, Sagalowsky A, Bensalah K, Raman JD, Bolenz C, Kassouf W, Koppie TM, Wood CG, Wheat J, Langner C, Ng CK, Capitanio U, Bertini R, Fernndez MI, Mikami S, Isida M, Strobel P, Montorsi F. The extent of lymphadenectomy seems to be associated with better survival in patients with nonmetastatic upper-tract urothelial carcinoma: how many lymph nodes should be removed? Eur Urol 2009 Sep; 56(3): 512-8. Epub 2009 Jun 18. PMIC: 19559518. 57. Shah JB, Margulis V. Clinical trials: nationally representative data in urology. Nat Rev Urol 2009 Jul; 6(7): 354-5. PMID: 19578349. 58. Hellenthal NJ, Shariat SF, Margulis V, Karakiewicz PI, Roscigno M, Bolenz C, Remzi M, Weizer A, Zigeuner R, Bensalah K, Ng CK, Raman JD, Kikuchi E, Montorsi F, Oya M, Wood CG, Fernndez M, Evans CP, Koppie TM. Adjuvant chemotherapy for high risk upper tract urothelial carcinoma: results from the Upper Tract Urothelial Carcinoma Collaboration. J Urol 2009 Sep; 182(3): 900-6. Epub 2009 Jul 17. PMID: 19616245. 59. Raman JD, Ng CK, Scherr DS, Margulis V, Lotan Y, Bensalah K, Patard JJ, Kikuchi E, Montorsi F, Zigeuner R, Weizer A, Bolenz C, Koppie TM, Isbarn H, Jeldres C, Kabbani W, Remzi M, Waldert M, Wood CG, Roscigno M, Oya M, Langner C, Wolf JS, Strobel P, Fernndez M, Karakiewicz P, Shariat SF. Impact of tumor location on prognosis for patients with upper tract urothelial carcinoma managed by radical nephroureterectomy. Eur Urol 2010 Jun; 57(6): 1072-9. Epub 2009 Jul 15. PMID: 19619934. 60. Chiong E, Wood CG, Margulis V. Role of cytoreductive nephrectomy in renal cell carcinoma. Future Oncol 2009 Aug; 5(6): 859-69. PMID: 19663735. 61. Roscigno M, Shariat SF, Freschi M, Margulis V, Karakiewicz P, Suardi N, Remzi M, Zigeuner R, Bolenz C, Kikuchi E, Weizer A, Bensalah K, Sagalowsky A, Koppie TM, Raman J, Fernndez M, Strobel P, Kabbani W, Langner C, Wheat J, Guo CC, Kassouf W, Haitel A, Wood CG, Montorsi F. Assessment of the minimum number of lymph nodes needed to detect lymph node invasion at radical nephroureterectomy in patients with upper tract urothelial cancer. Urology 2009 Nov; 74(5): 1070-4. PMID: 19883824. 62. Shariat SF, Godoy G, Lotan Y, Droller M, Karakiewicz PI, Raman JD, Isbarn H, Weizer A, Remzi M, Roscigno M, Kikuchi E, Bolenz C, Bensalah K, Koppie TM, Kassouf W, Wheat JC, Zigeuner R, Langner C, Wood CG, Margulis V. Advanced patient age is associated with inferior cancer-specific survival after radical nephroureterectomy. BJU Int 2010 Jun; 105(12): 1672-7. Epub 2009 Nov 13. PMID: 19912201. 63. Zigeuner R, Shariat SF, Margulis V, Karakiewicz PI, Roscigno M, Weizer A, Kikuchi E, Remzi M, Raman JD, Bolenz C, Bensalah K, Capitanio U, Koppie TM, Kassouf W, Sircar K, 11 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 23 of 46 PAGEID #: 60387 Patard JJ, Fernndez MI, Wood CG, Montorsi F, Strobel P, Wheat JC, Haitel A, Oya M, Guo CC, Ng C, Chade DC, Sagalowsky A, Langner C. Tumour necrosis is an indicator of aggressive biology in patients with urothelial carcinoma of the upper urinary tract. Eur Urol 2010 Apr; 57(4): 575-81. Epub 2009 Nov 25. PMID: 19959276. 64. Hulick P, Zimmer M, Margulis V, Skates S, Hamel M, Dahl DM, Michaelson DM, Liebermann T, Signoretti S, Carney W, Wood C, Iliopoulos O. Blood levels of carbonic anhydrase 9 correlate with clear cell renal cell carcinoma activity. 2009 Clinical Proteomics 5(1): 37-45. 65. Myers RP, Seki N, Gotoh M, Chai TC, Kaplan SA, Inoue K, Trachtenberg J, Kikuchi E, Nishiyama H., Chang SS, Lee C. Muto S, Ito K, Andriole GL, Eto M, Sumitomo M, Kamba T, Wood CG, Margulis V, Naito S, Egawa S. Fifth joint meeting of the American Urological Association and the Japanese Urological Association International affiliate society meeting at the 105th annual meeting of the American urological association. Int J Urol 2010 17(8): 743 752. 66. Raman JD, Shariat SF, Karakiewicz PI, Lotan Y, Sagalowsky AI, Roscigno M, Montorsi F, Bolenz C, Weizer AZ, Wheat JD, Ng CK, Scherr DS, Remzi M, Waldert M, Wood CG, Margulis V; Upper-Tract Urothelial Carcinoma Collaborative Group. Does preoperative symptom classification impact prognosis in patients with clinically localized upper-tract urothelial carcinoma managed by radical nephroureterectomy? Urol Oncol 2011 Nov-Dec; 29(6): 716-23. Epub 2010 Jan 6. PMID: 20056458. 67. Cooper SJ, Zou H, Legrand SN, Marlow LA, von Roemeling CA, Radisky DC, Wu KJ, Hempel N, Margulis V, Tun HW, Blobe GC, Wood CG, Copland JA. Loss of type III transforming growth factor-beta receptor expression is due to methylation silencing of the transcription factor GATA3 in renal cell carcinoma. Oncogene 2010 May 20; 29(20): 2905 15. Epub 2010 Mar 8. PMID: 20208565. 68. Wheat JC, Weizer AZ, Wolf JS Jr, Lotan Y, Remzi M, Margulis V, Wood CG, Montorsi F, Roscigno M, Kikuchi E, Zigeuner R, Langner C, Bolenz C, Koppie TM, Raman JD, Fernndez M, Karakiewicz P, Capitanio U, Bensalah K, Patard JJ, Shariat SF. Concomitant carcinoma in situ is a feature of aggressive disease in patients with organ confined urothelial carcinoma following radical nephroureterectomy. Urol Oncol 2012 May-Jun; 30(3): 252-8. Epub 2010 May 6. PMID: 20451416. 69. Shah JB, Margulis V. In search of a better crystal ball: recent advances in prognostic markers for clear-cell renal cell carcinoma. Expert Rev Anticancer Ther 2010 Jun; 10(6): 837-42. PMID: 20553209. 70. Culp SH, Tannir NM, Abel EJ, Margulis V, Tamboli P, Matin SF, Wood CG. Can we better select patients with metastatic renal cell carcinoma for cytoreductive nephrectomy? Cancer 2010 Jul 15; 116(14): 3378-88. PMID: 20564061. 71. Matin SF, Margulis V, Kamat A, Wood CG, Grossman HB, Brown GA, Dinney CP, Millikan R, Siefker-Radtke AO. Incidence of downstaging and complete remission after neoadjuvant chemotherapy for high-risk upper tract transitional cell carcinoma. Cancer 2010 Jul 1; 116(13): 3127-34. PMID: 20564621. 72. Margulis V, Youssef RF, Karakiewicz PI, Lotan Y, Wood CG, Zigeuner R, Kikuchi E, Weizer A, Raman JD, Remzi M, Roscigno M, Montorsi F, Bolenz C, Kassouf W, Shariat SF; Upper Tract Urothelial Carcinoma Collaborative Group. Preoperative multivariable prognostic model for prediction of nonorgan confined urothelial carcinoma of the upper urinary tract. J Urol 2010 Aug; 184(2): 453-8. Epub 2010 Jun 17. PMID: 20620397. 73. Margulis V, Youssef RF, Karakiewicz PI, Lotan Y, Wood CG, Zigeuner R, Kikuchi E, Weizer A, Raman JD, Remzi M, Roscigno M, Montorsi F, Bolenz C, Kassouf W, Shariat SF; 12 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 24 of 46 PAGEID #: 60388 Upper Tract Urothelial Carcinoma Collaborative Group. Preoperative multivariable prognostic model for prediction of nonorgan confined urothelial carcinoma of the upper urinary tract. J Urol 2010 Aug; 184(2): 453-8. Epub 2010 Jun 17. PMID: 20620397. 74. Margulis V, Sagalowsky AI. Penile cancer: management of regional lymphatic drainage. Urol Clin North Am 2010 Aug; 37(3): 411-9. Epub 2010 Jun 17. PMID: 20674696. 75. Sundi D, Svatek RS, Margulis V, Wood CG, Matin SF, Dinney CP, Kamat AM. Upper tract urothelial carcinoma: impact of time to surgery. Urol Oncol 2012 May-Jun; 30(3): 266-72. Epub 2010 Sep 25. PMID: 20869888. 76. Margulis V, Sagalowsky AI. Assessment of hematuria. Med Clin North Am 2011 Jan; 95(1): 153-9. PMID: 21095418. 77. Youssef RF, Shariat SF, Lotan Y, Wood CG, Sagalowsky AI, Zigeuner R, Langner C, Montorsi F, Bolenz C, Margulis V. Prognostic effect of urinary bladder carcinoma in situ on clinical outcome of subsequent upper tract urothelial carcinoma. Urology 2011 Apr; 77(4): 861-6. Epub 2010 Dec 16. PMID: 21167566. 78. Karam JA, Zhang XY, Tamboli P, Margulis V, Wang H, Abel EJ, Culp SH, Wood CG. Development and characterization of clinically relevant tumor models from patients with renal cell carcinoma. Eur Urol 2011 Apr; 59(4): 619-28. Epub 2010 Dec 8. PMPD: 21167632. 79. Youssef RF, Shariat SF, Lotan Y, Wood CG, Sagalowsky AI, Zigeuner R, Kikuchi E, Weizer A, Raman JD, Remzi M, Kabbani W, Langner C, Guo CC, Roscigno M, Montorsi F, Bolenz C, Kassouf W, Margulis V. Upper urinary tract urothelial carcinoma with loco-regional nodal metastases: insights from the Upper Tract Urothelial Carcinoma Collaboration. BJU Int 2011 Oct; 108(8): 1286-91. Epub 2011 Feb 18. PMID: 21332905. 80. Cost NG, Delacroix SE Jr, Sleeper JP, Smith PJ, Youssef RF, Chapin BF, Karam JA, Culp S, Abel EJ, Brugarolas J, Raj GV, Sagalowsky AI, Wood CG, Margulis V. The impact of targeted molecular therapies on the level of renal cell carcinoma vena caval tumor thrombus. Eur Urol 2011 Jun; 59(6): 912-8. Epub 2011 Feb 23. PMID: 21367518. 81. Gurbuz C, Youssef RF, Shariat SF, Lotan Y, Wood CG, Sagalowsky AI, Zigeuner R, Kikuchi E, Weizer A, Raman JD, Remzi M, Roscigno M, Montorsi F, Bolenz C, Kassouf W, Margulis V. The impact of previous ureteroscopic tumor ablation on oncologic outcomes after radical nephroureterectomy for upper urinary tract urothelial carcinoma. J Endourol 2011 May; 25(5): 775-9. Epub 2011 Mar 9. PMID: 21388245. 82. Matsumoto K, Novara G, Gupta A, Margulis V, Walton TJ, Roscigno M, Ng C, Kikuchi E, Zigeuner R, Kassouf W, Fritsche HM, Ficarra V, Martignoni G, Tritschler S, Rodriguez JC, Seitz C, Weizer A, Remzi M, Raman JD, Bolenz C, Bensalah K, Koppie TM, Karakiewicz PI, Wood CG, Montorsi F, Iwamura M, Shariat SF. Racial differences in the outcome of patients with urothelial carcinoma of the upper urinary tract: an international study. BJU Int 2011 Oct; 108(8 Pt 2):E304-9. Epub 2011 Apr 20. PMID: 21507184. 83. Ehdaie B, Chromecki TF, Lee RK, Lotan Y, Margulis V, Karakiewicz PI, Novara G, Raman JD, Ng C, Lowrance WT, Scherr DS, Shariat SF. Obesity adversely impacts disease specific outcomes in patients with upper tract urothelial carcinoma. J Urol 2011 Jul; 186(1): 66-72. Epub 2011 May 14. PMID: 21571333. 84. Verhoest G, Shariat SF, Chromecki TF, Raman JD, Margulis V, Novara G, Seitz C, Remzi M, Roupret M, Scherr DS, Bensalah K. Predictive factors of recurrence and survival of upper tract urothelial carcinomas. World J Urol 2011 Aug; 29(4): 495-501. Epub 2011 Jun 17. PMID: 21681525. 85. Youssef RF, Shariat SF, Lotan Y, Cost N, Wood CG, Sagalowsky AI, Zigeuner R, Langner C, Chromecki TF, Montorsi F, Bolenz C, Margulis V. Urothelial carcinoma at the uretero- 13 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 25 of 46 PAGEID #: 60389 enteric junction: Multi-center evaluation of oncologic outcomes after radical nephroureterectomy. Urol Oncol 2013 Jul; 31(5): 676-681. Epub 2011 Jun 25. PMID: 21704538. 86. Cost NG, Lubahn JD, Granberg CF, Schlomer BJ, Wickiser JE, Rakheja D, Gargollo PC, Leonard D, Raj GV, Baker LA, Margulis V. Oncologic outcomes of partial versus radical nephrectomy for unilateral Wilms tumor. Pediatr Blood Cancer. 2012 Jun; 58(6): 898-904. Epub 2011 Jul 9. PMID: 21744482. 87. Margulis V, Master VA, Cost NG, Leibovich BC, Joniau S, Kuczyk M, Mulders PF, Kirkali Z, Wirth MP, Hirao Y, Rawal S, Chong TW, Wood CG. International consultation on urologic diseases and the European Association of Urology International consultation on locally advanced renal cell carcinoma. Eur Urol 2011 Oct; 60(4): 673-83. Epub 2011 Jun 29. PMID: 21752533. 88. Roscigno M Brausi M, Heidenreich A, Lotan Y, Margulis V, Shariat SF, Van Poppel H, Zigeuner R. Lymphadenectomy at the time of nephroureterectomy for upper tract urothelial cancer. Eur Urol 2011 Oct; 60(4): 776-83. Epub 2011 July 14. PMID: 21798659. 89. Chromecki TF, Cha EK, Fajkovic H, Margulis V, Novara G, Scherr DS, Lotan Y, Raman JD, Kassouf W, Bensalah K, Weizer A, Kikuchi E, Roscigno M, Remzi M, Matsumoto K, Walton TJ, Pycha A, Ficarra V, Karakiewicz PI, Zigeuner R, Pummer K, Shariat SF. The impact of tumor multifocality on outcomes in patients treated with radical nephroureterectomy. Eur Urol 2012 Feb; 61(2): 245-53. Epub 2011 Sep 28. PMID: 21975249. 90. Rink M, Chun FK, Robinson B, Sun M, Karakiewicz PI, Bensalah K, Fisch M, Scherr DS, Lee RK, Margulis V, Shariat SF. Tissue-based molecular markers for renal cell carcinoma. Minvera Urol Nefrol 2011 Dec; 63(4): 293-308. PMID: 21996985. 91. Youssef RF, Shariat SF, Lotan Y, Wood CG, Sagalowsky AI, Zigeuner R, Kikuchi E, Weizer A, Raman JD, Remzi M, Kabbani W. Langner C, Guo CC, Roscigno M, Montorsi F, Bolenz C, Kassouf W, Margulis V. Upper urinary tract urothelial carcinoma with loco-regional nodal metastases: Insights from the upper tract urothelial carcinoma collaboration. J Urol 2011 186(2): 454. 92. Gurbuz C, Youssef RF, Shariat SF, Lotan Y, Wood CG, Sagalowsky AI, Zigeuner R, Kikuchi E, Weizer A, Raman JD, Remzi M, Roscigno M, Montorsi F, Bolenz C, Kassouf W, Margulis V. The impact of previous ureteroscopic tumor ablation on oncologic outcomes after radical nephroureterectomy for upper urinary tract urothelial carcinoma. J Urol 2011 186(2): 452-53. 93. Fajkovic H, Cha EK, Jeldres C, Donner G, Chromecki TF, Margulis V, Novara G, Lotan Y, Raman JD, Kassouf W, Seitz C, Bensalah K, Weizer A, Kikuchi E, Roscigno M, Remzi M, Matsumoto K, Breinl E, Pycha A, Ficarra V, Montorsi F, Karakiewicz PI, Scherr DS, Shariat SF. Prognostic value of extranodal extension and other lymph node parameters in patients with upper tract urothelial carcinoma. J Urol 2012 Mar; 187(3): 845-51. Epub 2012 Jan 15. PMID: 22248522. 94. Cha EK, Shariat SF, Kormaksson M, Novara G, Chromecki TF, Scherr DS, Lotan Y, Raman JD, Kassouf W, Zigeuner R, Remzi M, Bensalah K, Weizer A, Kikuchi E, Bolenz C, Roscigno M, Koppie TM, Ng CK, Fritsche HM, Matsumoto K, Walton TJ, Ehdaie B, Tritschler S, Fajkovic H, Martinez-Salamanca JI, Pycha A, Langner C, Ficarra V, Patard JJ, Montorsi F, Wood CG, Karakiewicz PI, Margulis V. Predicting clinical outcomes after radical nephroureterectomy for upper tract urothelial carcinoma. Eur Urol 2012 Apr; 61(4): 818-25. Epub 2012 Jan 23. PMID: 22284969. 95. Shariat SF, Zigeuner R, Rink M, Margulis V, Hansen J, Kikuchi E, Kassouf W, Raman JD, 14 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 26 of 46 PAGEID #: 60390 Remzi M, Koppie TM, Bensalah K, Guo CC, Mikami S, Sircar K, Ng CK, Haitel A, Kabbani W, Chun FK, Wood CG, Scherr DS, Karakiewicz PI, Langner C. Subclassification of pT3 urothelial carcinoma of the renal pelvicalyceal system is associated with recurrence-free and cancer-specific survival: proposal for a revision of the current TNM classification. Eur Urol 2012 Aug; 62(2): 224-31. Epub 2012 Jan 24. PMID: 22285763. 96. Rink M, Ehdaie B, Cha EK, Green DA, Karakiewicz PI, Babjuk M, Margulis V, Raman JD, Svatek RS, Fajkovic H, Lee RK, Novara G, Hansen J, Daneshmand S, Lotan Y, Kassouf W, Fritsche HM, Pycha A, Fisch M, Scherr DS, Shariat SF; Bladder Cancer Research Consortium (BCRC); Upper Tract Urothelial Carcinoma Collaboration (UTUCC). Stagespecific impact of tumor location on oncologic outcomes in patients with upper and lower tract urothelial carcinoma following radical surgery. Eur Urol 2012 Oct; 62(4): 677-84. Epub 2012 Feb 15. PMID: 22349570. 97. Lughezzani G, Burger M, Margulis V, Matin SF, Novara G, Roupret M, Shariat SF, Wood CG, Zigeuner R. Prognostic factors in upper urinary tract urothelial carcinomas: a comprehensive review of the current literature. Eur Urol 2012 Jul; 62(1): 100-14. Epub 2012 Feb 23. PMID: 22381168. 98. Xylinas E, Rink M, Margulis V, Karakiewicz P, Novara G, Shariat SF; Upper Tract Urothelial Carcinoma Collaboration (UTUCC). Multifocal carcinoma in situ of the upper tract is associated with high risk of bladder cancer recurrence. Eur Urol 2012 May; 61(5): 1069-70. Epub 2012 Feb 25. PMID: 22402109. 99. Youssef RF, Margulis V. Urothelial carcinoma: Endoscopy to predict outcomes in upper tract urothelial cancer. Nat Rev Urol 2012 Apr 3; 9(5): 242-3. PMID: 22472593. 100. Xylinas E, Rink M, Margulis V, Karakiewicz PI, Bensalah K, Shariat SF; Upper Tract Urothelial Carcinoma Collaboration. Histologic variants of upper tract urothelial carcinoma do not affect response to adjuvant chemotherapy after radical nephroureterectomy. Eur Urol 2012 Jul; 62(1):e-25-6. Epub 2012 Apr 17. PMID: 22537797. 101. Bagrodia A, Youssef RF, Kapur P, Darwish OM, Cannon C, Belsante MJ, Gerecci D, Sagalowsky AI, Shariat SF, Lotan Y, Margulis V. Prospective evaluation of molecular markers for the staging and prognosis of upper tract urothelial carcinoma. Eur Urol 2012 Jul; 62(1):3-27-9. Epub 2012 Apr 17. PMID: 22552216. 102. Xylinas E, Rink M, Cha EK, Clozel T, Lee RK, Fajkovic H, Comploj E, Novara G, Margulis V, Raman JD, Lotan Y, Kassouf W, Fritsche HM, Weizer A, Martinez-Salamanca JI, Matsumoto K, Zigeuner R, Pycha A, Scherr DS, Seitz C, Walton T, Trinh QD, Karakiewicz PI, Matin S, Montorsi F, Zerbib M, Shariat SF; for the Upper Tract Urothelial Carcinoma Collaboration. Impact of distal ureter management on oncologic outcomes following radical nephroureterectomy for upper tract urothelial carcinoma. Eur Urol 2014: 65(1): 21017.PMID: 2257904. 103. Sivanand S, Pena-Llopis S, Zhao H, Kucejova B, Spence P, Pavia-Jimenez A, Yamasaki T, McBride DJ, Gillen J, Wolff NC, Morlock L, Lotan Y, Raj GV, Sagalowsky A, Margulis V, Cadeddu JA, Ross MT, Bentley DR, Kabbani W, Xie XJ, Kapur P, Williams NS, Brugarolas J. A validated tumorgraft model reveals activity of dovitinib against renal cell carcinoma. Sci Transl Med 2012 Jun 6; 4(137): 137ra75.doi:10.1126/scitranslmed.3003643. PMID: 22674553. 104. Pena-Llopis S, Vega-Rubin-de-Celis S, Liao A, Leng N, Pavia-Jimnez A, Wang S, Yamasaki T, Zhrebker L, Sivanand S, Spence P, Kinch L, Hambuch T, Jain S, Lotan Y, Margulis V, Sagalowsky AI, Summerour PB, Kabbani W, Wong SW, Grishin N, Laurent M, Xie XJ, Haudenschild CD, Ross MT, Bentley DR, Kapur P, Brugarolas J. BAP1 loss defines a new class of renal cell carcinoma. Nat Genet 2012 Jun 10; 44(7): 751-9. Erratum in: Nat 15 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 27 of 46 PAGEID #: 60391 Genet 2012 Sep; 44(9): 1072. PMID: 2268371. 105. Pea Llopis S, Vega-Rubin-De-Celis S, Liao A, Leng N, Pavia-Jimenez A, Wang S, Yamasaki T, Zhrebker L, Sivanand S, Spence P, Kinch L, Hambuch T, Jain S, Lotan Y, Margulis V, Sagalowsky AI, Summerour PB, Kabbani W, Wong SWW, Grishin N, Laurent M, Xie X-J, Haudenschild CD, Ross MT, Bentley DR, Kapur P, Brugarolas J. BAP1 loss defines a new class of renal cell carcinoma. Nature Genetics 2012 44(7): 751-59. 106. Youssef RF, Cost NG, Darwish OM, Margulis V. Prognostic markers in renal cell carcinoma: A focus on the `mammalian target of rapamycin' pathway. Arab Journal of Urology 2012 10(2): 110-117. 107. Rink M, Robinson BD, Green DA, Cha EK, Hansen J, Comploj E, Margulis V, Raman JD, Ng CK, Remzi M, Bensalah K, Kabbani W, Haitel A, Rioux-Leclercq N, Guo CC, Chun FK, Kikuchi E, Kassouf W, Sircar K, Sun M, Sonpavde G, Lotan Y, Pycha A, Karkakiewicz PI, Scherr DS, Shariat SF. Impact of histological variants on clinical outcomes of patients with upper urinary tract urothelial carcinoma. J Urol 2012 Aug; 188(2): 398-404. Epub 2012 Jun 13. PMID: 22698626. 108. Bagrodia A, Darwish OM, Rapoport Y, Margulis V. Risk prediction in the management of small renal masses. Curr Opin Urol 2012 Sep; 22(5): 347-52. PMID: 22706070. 109. Rink M, Xylinas E, Margulis V, Cha EK, Ehdaie B, Raman JD, Chun FK, Matsumoto K, Lotan Y, Furberg H, Babjuk M, Pycha A, Wood CG, Karakiewicz PI, Fisch M, Scherr DS, Shariat SF; Upper Tract Urothelial Carcinoma Collaboration. Impact of smoking on oncologic outcomes of upper tract urothelial carcinoma after radical nephroureterectomy. Eur Urol 2013 Jun; 63(6): 1082-90. Epub 2012 Jun 22. PMID: 22743166. 110. Rink M, Sjoberg D, Comploj E, Margulis V, Xylinas E, Lee RK, Hansen J, Cha EK, Raman JD, Remzi M, Bensalah K, Novara G, Matin SF, Chun FK, Kikuchi E, Kassouf W, MartinezSalamanca JI, Lotan Y, Seitz C, Pycha A, Zigeuner R, Karakiewicz PI, Scherr DS, Vickers AJ, Shariat SF. Risk of cancer-specific mortality following recurrence after radical nephroureterectomy. Ann Surg Oncol 2012 Dec; 19(13): 4337-44. Epub 2012 Jul 18. PMID: 22805867. 111. Cost NG, Adibi M, Lubahn JD, Romman A, Raj GV, Sagalowsky AI, Margulis V. Effect of testicular germ cell tumor therapy on renal function. Urology 2012 Sep; 80(3): 641-8. Epub 2012 Jul 26. PMID: 22840865. 112. Adibi M, Youssef R, Shariat SF, Lotan Y, Wood CG, Sagalowsky AI, Zigeuner R, Montorsi F, Bolenz C, Margulis V. Oncological outcomes after radical nephroureterectomy for upper tract urothelial carcinoma: comparison over the three decades. Int J Urology 2012 Dec; 19(12): 1060-6; author reply 1066-7. Epub 2012 Aug 12. PMID: 22772743. 113. Cost NG, Lubahn JD, Granberg CF, Sagalowsky AI, Wickiser JE, Gargollo PC, Baker LA, Margulis V, Rakheja D. Pathological review of Wilms tumor nephrectomy specimens and potential implications for nephron sparing surgery in Wilms tumor. J Urol 2012 Oct; 188(4 Suppl): 1506-10. Epub 2012 Aug 19. PMID: 22910241. 114. Lubahn JD, Cost NG, Kwon J, Powell JA, Yang M, Granberg CF, Wickiser JE, Rakheja D, Gargollo PC, Baker LA, Margulis V. Correlation between preoperative staging computerized tomography and pathological findings after nodal sampling in children with Wilms tumor. J Urol 2012 Oct; 188(4 Suppl): 1500-4. Epub 2012 Aug 19. PMID: 22910268. 115. Fajkovic H, Cha EK, Xylinas E, Rink M, Pycha A, Seitz C, Bolenz C, Dunning A, Novara G, Trinh QD, Karakiewicz PI, Margulis V, Raman JD, Walton TJ, Baba S, Carballido J, Otto W, Montorsi F, Lotan Y, Kassouf W, Fritsche HM, Bensalah K, Zigeuner R, Scherr DS, Sonpavde G, Roupret M, Shariat SF. Disease-free survival as a surrogate for overall survival in upper tract urothelial carcinoma. World J Urol 2013 Feb; 31(1): 5-11 Epub 2012 Sep 26. 16 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 28 of 46 PAGEID #: 60392 PMID: 23011256. 116. Sudarshan S, Karam JA, Brugarolas J, Thompson RH, Uzzo R, Rini B, Margulis V, Patard JJ, Escudier B, Linehan WM. Metabolism of kidney cancer: from the lab to clinical practice. Eur Urol 2013 Feb; 63(2): 244-51. Epub 2012 Sep 28. PMID: 23063455. 117. Rouprt M, Hupertan V, Seisen T, Colin P, Xylinas E, Yates DR, Fajkovic H, Lotan Y, Raman JD, Zigeuner R, Remzi M, Bolenz C, Novara G, Kassouf W, Ouzzane A, Rozet F, Cussenot O, Martinez-Salamanca JI, Fritsche HM, Walton TJ, Wood CG, Bensalah K, Karakiewicz PI, Montorsi F, Margulis V, Shariat SF; French National Database on Upper Tract Tumors; Upper Tract Urothelial Carcinoma Collaboration. Prediction of cancer specific survival after radical nephroureterectomy for upper tract urothelial carcinoma: development of an optimized postoperative nomogram using decision curve analysis. J Urol 2013 May; 189(5): 1662-9. Epub 2012 Oct 24. PMID: 23103802. 118. Xylinas E, Rink M, Margulis V, Faison T, Comploj E, Novara G, Raman JD, Lotan Y, Guillonneau B, Weizer A, Pycha A, Scherr DS, Seitz C, Sun M, Trinh QD, Karakiewicz PI, Montorsi F, Zerbib M, Gonen M, Shariat SF; UTUC Collaboration. Prediction of true nodal status in patients with pathological lymph node negative upper tract urothelial carcinoma at radical nephroureterectomy. J Urol 2013 Feb; 189(2): 468-73. Epub 2012 Dec 14. PMID: 23253960. 119. Margulis V, Shariat SF, Rapoport Y, Rink M, Sjoberg DD, Tannir NM, Abel EJ, Culp SH, Tamboli P, Wood CG. Development of accurate models for individualized prediction of survival after cytoreductive nephrectomy for metastatic renal cell carcinoma. Eur Urol 2013 May; 63(5): 947-52. Epub 2012 Nov 23. PMID: 2327368. 120. Darwish OM, Kapur P, Youssef RF, Bagrodia A, Belsante M, Alhalabi F, Sagalowsky AI, Lotan Y, Margulis V. Cumulative number of altered biomarkers in mammalian target of rapamycin pathway is an independent predictor of outcome in patients with clear cell renal cell carcinoma. Urology 2013 Mar; 81(3): 581-6. Epub 2013 Jan 3. PMID: 23290145. 121. Gayed BA, Thoreson GR, Margulis V. The role of systemic chemotherapy in management of upper tract urothelial cancer. Curr Urol Rep 2013 Apr; 14(2): 94-101. PMID: 23344684. 122. Belsante M, Darwish O, Youssef R, Bagrodia A, Kapur P, Sagalowsky AI, Lotan Y, Margulis V. Lymphovascular invasion in clear cell renal cell carcinoma-Association with disease-free and cancer-specific survival. Urol Oncol 2014 Jan; 32(1): 30.e23-8. Epub 2013 Feb 18. PMID: 23428539. 123. Abel EJ, Wood CG, Eickstaedt N, Fang JE, Kenney P, Bagrodia A, Youssef RF, Sagalowsky AI, Margulis V. Preoperative pulmonary embolism does not predict poor postsurgical outcomes in RCC patients with venous thrombus. J Urol 2013 Aug; 190(2): 452-7. Epub 2013 Feb 19. PMID: 23434945. 124. Xylinas E, Rink M, Margulis V, Clozel T, Lee RK, Comploj E, Novara G, Raman JD, Lotan Y, Weizer A, Roupret M, Pycha A, Scherr DS, Seitz C, Ficarra V, Trinh QD, Karakiewicz PI, Montorsi F, Zerbib M, Shariat SF; UTUC Collaboration. Impact of renal function on eligibility for chemotherapy and survival in patients who have undergone radical nephroureterectomy. BJU Int 2013 Mar 6. Aug; 112(4): 453-61. Epub 2013 Mar 6. PMID: 23464979. 125. Rink M, Xylinas E, Trinh QD, Lotan Y, Margulis V, Raman JD, Fisch M, Lee RK, Chun FK, Abdennabi J, Seitz C, Pycha A, Zlotta AR, Karakiewicz PI, Babjuk M, Scherr DS, Shariat SF; Upper Tract Urothelial Carcinoma Collaboration (UTUCC). Gender-specific effect of smoking on upper tract urothelial carcinoma outcomes. BJU Int 2013 Sep; 112(5): 623-37. Epub 2013 Mar 6. PMID: 23465088. 126. Bagrodia A, Kuehhas FE, Gayed BA, Wood CG, Raman JD, Kapur P, Derweesh IH, 17 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 29 of 46 PAGEID #: 60393 Bensalah K, Sagalowsky AI, Shariat SF, Lotan Y, Margulis V. Comparative analysis of oncologic outcomes of partial ureterectomy vs radical nephroureterectomy in upper tract urothelial carcinoma. Urology 2013 May; 81(5): 972-8. Epub 2013 Mar 20. PMID: 23523292. 127. Xylinas E, Kluth LA, Crivelli JJ, Rieken M, Margulis V, Seitz C, Shariat SF. Impact of statin use on oncologic outcomes of patients with upper tract urothelial carcinoma treated with radical nephroureterectomy. Eur Urol 2013 Jun; 63(6): 1134-5. Epub 2013 Mar 19. PMID: 23540954. 128. Smith PJ, Lotan Y, Raj GV, Sagalowsky AI, Margulis V. Assessing treatment response after induction Bacillus Calmette-Guerin for carcinoma in situ of the urinary bladder: can post induction random bladder biopsies be avoided? Cytopathology 2014 Apr; 25(2): 108-11. Epub 2013 Apr 2. PMID: 23551700. 129. Lotan Y, Bagrodia A, Passoni N, Rachakonda V, Kapur P, Arriaga Y, Bolenz C, Margulis V, Raj GV, Sagalowsky AI, Shariat SF. Prospective evaluation of a molecular marker panel for prediction of recurrence and cancer-specific survival after radical cystectomy. Eur Urol 2013 Sep; 64(3): 465-71. Epub 2013 Apr 3. PMID: 23571005. 130. Bagrodia A, Harrow B, Liu ZW, Olweny EO, Faddegon S, Yin G, Tan YK, Han WK, Lotan Y, Margulis V, Cadeddu JA. Evaluation of anatomic and morphologic nomogram to predict malignant and high-grade disease in a cohort of patients with small renal masses. Urol 2014 Jan; 32(1): 37.e17-23. Epub 2013 Apr 28. PMID: 23628308. 131. Margulis V, Shariat SF, Rapoport Y, Rink M, Sjoberg DD, Tannir NM, Abel EJ, Culp SH, Tamboli P, Wood CG. Development of accurate models for individualized prediction of survival after cytoreductive nephrectomy for metastatic renal carcinoma. Eur Urol 2013 May; 63(5): 947-52. Epub 2012 Nov 23. PMID: 23273681. 132. Gayed BA, Youssef RF, Bagrodia A, Kapur P, Darwish OM, Krabbe LM, Sagalowsky AI, Lotan Y, Margulis V. Prognostic role of cell cycle and proliferative biomarkers in patients with clear cell renal cell carcinoma. J Urol 2013 Nov; 190(5): 1662-7. Epub 2013 Jun 20. PMID: 23792148. 133. Cost NG, Krabbe LM, Bagrodia A, Margulis V. The use of preoperative targeted molecular therapy to allow nephron sparing for T1b tumors. Curr Opin Urol 2013 Sep; 23(5): 411-7. PMID: 23841980. 134. Krabbe LM, Bagrodia A, Lotan Y, Gayed BA, Darwish OM, Youssef RF, John G, Harrow B, Jacobs C, Gaitonde M, Sagalowsky AI, Shariat SF, Kapur P, Margulis V. Prospective analysis of ki-67 is an independent predictor of oncological outcomes in patients with high grade upper tract urothelial carcinoma. J Urol 2014; Jan; 191(1): 28-34. Epub 2013 Jul 16. PMID: 23871758. 135. Hakiman H, Margulis V, Kapur P, Huerta S. Rapid progression of a germ cell tumor encasing the inferior vena cava and aorta following a radical orchiectomy. Rare Tumors 2013 Jun 7; 5(2): 79-82. PMID: 23888221. 136. Gayed BA, Youssef RF, Bagrodia A, Darwish OM, Kapur P, Sagalowsky A, Lotan Y, Margulis V. Ki67 is an independent predictor of oncological outcomes in patients with localized clear-cell renal cell carcinoma. BJU Int 2014 Apr; 113(4): 668-73. Epub 2013 Aug 13. PMID: 23937277. 137. Xylinas E, Kluth LA, Rieken M, Lee RK, Elghouayel M, Ficarra V, Margulis V, Lotan Y, Roupret M, Martinez-Salamanca JI, Matsumoto K, Seitz C, Karakiewicz PI, Zerbib M, Scherr DS, Shariat SF; UTUC Collaboration. Impact of smoking status and cumulative exposure on intravesical recurrence of upper tract urothelial carcinoma after radical nephroureterectomy. BJU Int 2014 Jul; 114(1): 56-61. PMID: 24053463. 18 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 30 of 46 PAGEID #: 60394 138. Krabbe LM, Lotan Y, Bagrodia A, Gayed BA, Darwish OM, Youssef RF, Bolenz C, Sagalowsky AI, Raj GV, Shariat SF, Kapur P, Margulis V. Prospective comparison of molecular signatures in urothelial cancer of the bladder and the upper urinary tract: is there evidence for discordant biology? J Urol 2014 Apr; 191(4): 926-31. Epub 2013 Sep 20. PMID: 24060642. 139. Kapur P, Christie A, Raman JD, Then MT, Nuhn P, Buchner A, Bastian P, Seitz C, Shariat SF, Bensalah K, Rioux-Leclercq N, Xie XJ, Lotan Y, Margulis V, Brugarolas J. BAP1 immunohistochemistry predicts outcomes in a multi-institutional cohort with clear cell renal cell carcinoma. J Urol 2014 Mar; 191(3): 603-10. Epub 2013 Sep 25. PMID: 24076305. 140. Xylinas E, Kluth L, Passonni N, Trinh QD, Rieken M, Lee RK, Fajkovic H, Novarra G, Margulis V, Raman JD, Lotan Y, Rouprt M, Aziz A, Fritsche HM, Weizer A, MartinezSalamanca JI, Matsumoto K, Seitz C, Remzi M, Walton T, Karakiewicz PI, Montorsi F, Zerbib M, Scherr DS, Shariat SF; for the UTUC Collaboration. Prediction of intravesical recurrence after radical nephroureterectomy: development of a clinical decision-making tool. Eur Urol 2014 Mar; 65(3): 650-8. Epub 2013 Sep 19. PMID: 24070577. 141. Cost NG, Lubahn JD, Adibi M, Romman A, Wickiser JE, Raj GV, Sagalowsky AI, Margulis V. A comparison of pediatric, adolescent, and adult testicular germ cell malignancy. Pediatr Blood Cancer 2014 Mar; 61(3): 446-51. Epub 2013 Sep 17. PMID: 24106160. 142. Rieken M. Xylinas E. Kluth L, Trinh QD, Lee RK, Fajkovic H, Novara G, Margulis V, Lotan Y, Martinez-Salamanca JI, Matsumoto K, Seitz C, Remzi M, Karakiewicz P, Scherr DS, Briganti A, Kautzky-Willer A, Bachmann A, Shariat SF; UTUC Collaboration. Diabetes mellitus without metformin intake is associated with worse oncologic outcomes after radical nephroureterectomy for upper tract urothelial carcinoma. Eur J Surg Oncol 2014 Jan; 40(1): 113-20. Epub 2013 Sep 20 PMID: 24113620. 143. Krabbe LM, Westerman ME, Bagrodia A, Gayed BA, Darwish OM, Haddad AQ, Khalil D, Kapur P, Sagalowsky AI, Lotan Y, Margulis V. Dysregulation of beta-catenin is an independent predictor of oncological outcomes in patients with clear cell renal cell carcinoma. J Urol 2014; 191(6): 1671-1677. Epub 2013 Nov 26. PMID: 24291548. 144. Youssef RF, Lotan Y, Sagalowsky AI, Shariat SF, Wood CG, Raman JD, Langner C, Zigeuner R, Roscigno M, Montorsi F, Bolenz C, Kassouf W, Margulis V. Radical nephroureterectomy for pathologic T4 upper tract urothelial cancer: can oncologic outcomes be improved with multimodality therapy? Int Braz J Urol 2013 Sep-Oct; 39(5): 614-21. PMID: 24267122. 145. Abel EJ, Thompson RH, Margulis V, Heckman JE, Merril MM, Darwish OM, Krabbe LM, Boorjian SA, Leibovich BC, Wood CG. Perioperative outcomes following surgical resection of renal cell carcinoma with inferior vena cava thrombus extending above the hepatic veins: a contemporary multicenter experience. Eur Urol 2014; 66(3): 584-592. Epub 2013 Nov 7. PMID: 24262104. 146. Krabbe LM, Westerman ME, Bagrodia A, Gayed BA, Khalil D, Kapur P, Shariat SF, Raj GV, Sagalowsky AI, Cadeddu JA, Lotan Y, Margulis V. Surgical management of the distal ureter during radical nephroureterectomy is an independent predictor of oncological outcomes: Results of a current series and a review of the literature. Urol Oncol 2014 Jan; 32(1): 54.e19-26. PMID: 24360665. 147. Krabbe LM, Bagrodia A, Margulis V, Wood CG. Surgical Management of Renal Cell Carcinoma. Semin Intervent Radiol 2014 Mar; 31(1): 27-32. Review. PMID: 24596437. 148. Porten S, Siefker-Radtke AO, Xiao L, Margulis V, Kamat AM, Wood CG, Jonasch E, Dinney CP, Matin SF. Neoadjuvant chemotherapy improves survival of patients with upper 19 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 31 of 46 PAGEID #: 60395 tract urothelial carcinoma. Cancer 2014 Jun 15; 120(12): 1794-9. Epub 2014 Mar 13. PM1D: 24633966. 149. Cost NG, Lubahn JD, Adibi M, Romman A, Wickiser JE, Raj GV, Sagalowsky AI, Margulis V. Risk stratification of pubertal children and pospubertal adolescents with clinical stage T 1 testicular nonseminomatous germ cell tumors. J Urol 2014 May; 191 (5 Suppl): 1485-90. Epub 2014 Mar 26. PMID: 24679874. 150. Haddad AQ, Wood CG, Abel EJ, Krabbe LM, Darwish OM, Thompson RH, Heckman JE, Merril MM, Gayed BA, Sagalowsky AI, Boorjian SA, Margulis V, Leibovich BC. Oncologic outcomes following surgical resection of renal cell carcinoma with IVC thrombus extending above the hepatic veins: a contemporary multi-center cohort. J Urol 2014 Oct; 192(4): 1050 6. Epub 2014 Apr 2. PMID: 24704115. 151. Rieken M, Schubert T, Xylinas E, Kluth L. Rouprt M, Trinh Q-D, Lee RK, Al Hussein Al Awamlh B, Fajkovic H, Novara G, Margulis V, Lotan Y, Martinez-Salamanca JI, Matsumoto K, Seitz C, Remzi M, Karakiewicz PI, Scherr DS, Briganti A, Bachmann A, Shariat SF. Association of perioperative blood transfusion with oncologic outcomes after radical nephroureterectomy for upper tract urothelial carcinoma. European Journal of Surgical Oncology 2014. 152. Krabbe LM, Haddad AQ, Westerman ME, Margulis V. Surgical management of metastatic renal cell carcinoma in the era of targeted therapies. World J Urol 2014 Jun; 32(3): 615-22. Epub 2014 Apr 4. PMID: 24700309. 153. Haddad AH, Kapur P, Singla N, Raman JD, Then MT, Nuhn P, Buchner A, Bastian P, Seitz C, Shariat SF, Bensaleh K, Rioux-Leclercq N, Sagalowksy A, Lotan Y, Margulis V. Validation of mammalian target of rapamycin biomarker panel in patients with clear cell renal cell carcinoma (submitted March 2014). 154. Lee DJ, Xylinas E, Rieken M, Khani F, Klatte T, Wood CG, Karam JA, Weizer AZ, Raman JD, Remzi M, Guo CC, Rioux-Leclercq N, Haitel A. Bolenz C, Bensalah K, Sagalowsky AI, Montorsi F, Lotan Y, Shariat SF, Robinson BD, Margulis V. Insulin-like Growth Factor Messenger RNA-binding Protein 3 Expression Helps Prognostication in Patients with Upper Tract Urothelial Carcinoma. Eur Urol 2014; 66(2): 379-385. Epub 2013 Dec 25. PMID: 24388440. 155. Lucca I, Kassouf W, Kapoor A, Fairey A, Rendon RA, Izawa JI, Black FC, Fajkovic H, Seitz C, Remzi M, Nyirdy P, Rouprt M, Margulis V, Lotan Y, de Martino M, Hofbauer SL, Karakiewicz P, Briganti A, Novara G, Shariat SF, Klatte T. The role of adjuvant chemotherapy for lymph node-positive upper tract urothelial carcinoma following radical nephroureterectomy: a retrospective study. BJU Int. 2014 May 13. [Epub ahead of print] PMID: 24825476. 156. Rieken M, Schubert T, Xylinas E, Kluth L. Rouprt M, Trinh QD, Lee RK, Al Hussein Al Awamlh B, Fajkovic H. Novara G, Margulis V, Lotan Y, Martinez-Salamanca JI, Matsumoto K, Seitz C, Remzi M, Karakiewitz PI, Scherr DS, Briganti A, Bachmann A, Shariat SF; for the UTUC Collaboration. Association of perioperative blood transfusion with oncologic outcomes after radical nephroureterectomy for upper tract urolthelial carcinoma. Eur J Surg Oncol 2014 Apr 13. [Epub ahead of print] PMID: 24780094. 157. Haddad AQ, Margulis V. Editorial Comment. J Urol 2014 Sep; 192(3): 688. Epub 2014 Jun 12. PMID: 24931703. 158. Krabbe LM, Bagrodia A, Westerman ME, Margulis V. Diagnosis and management of upper tract urothelial carcinoma. Minerva Urol Nefrol. 2014 Mar; 66(1): 37-48. PMID: 24721939. 20 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 32 of 46 PAGEID #: 60396 159. Chung PH, Krabbe LM, Darwish OM, Westerman ME, Bagrodia A, Gayed BA, Haddad AQ, Kapur P, Sagalowsky AI, Lotan Y, Margulis V. Degree of hydronephrosis predicts adverse pathological features and worse oncologic outcomes in patients with high-grade urothelial carcinoma of the upper urinary tract. Urol Oncol 2014 Jul 8. [Epub ahead of print] PMID: 25022858. 160. Apolo AB, Hoffman V, Kaag MG, Latini DM, Lee CT, Rosenberg JE, Knowles M, Theodorescu D, Czerniak BA, Efstathiou JA, Albert ML, Sridhar SS, Margulis V, Matin SF, Galsky MD, Hansel D, Kamat AM, Flaig TW, Smith AB, Messing E, Zipursky Quale D, Lotan Y: Summary of the 8th annual bladder cancer think tank: Collaborating to move research forward. Urol Oncol 2014 Jul 24. Doi.org.10.1016/j.urolonc.2014.06.013 PMID: 25065704. 161. Ploussard G, Xylinas E, Lotan Y, Novara G, Margulis V, Rouprt M. Matsumoto K, Karakiewicz PI, Montorsi F, Remzi M, Seitz C. Scherr DS, Kapoor A, Fairey AS, Rendon R, Izawa J. Black PC, Lacombe L, Shariat SF, Kassouf W. Conditional survival after radical nephroureterectomy for upper tract carcinoma. Eur Urol Aug 18. [Epub ahead of print] PMID: 25145551. 162. Meissner MA, Margulis V, Gayed BA. Editorial comment to equivalent survival and improved preservation of renal function after distal ureterectomy compared with nephroureterectomy in patients with urothelial carcinoma of the distal ureter A propensity score matched multicenter study Int J Urol 2014 Nov; 21(11): 1105. Epub 2014Aug 28. PMID: 25168572. 163. Haddad AQ, Kapur P, Singla N, Raman JD, Then MT, Nuhn P, Buchner A, Bastian P, Seitz C, Shariat SF, Bensalah K, Rioux-Leclercq N, Sagalowsky A, Lotan Y, Margulis V. Validation of mammalian target of rapamycin biomarker panel in patients with clear cell renal cell carcinoma. Cancer 2014 Sep 3. [Epub ahead of print] PMID: 25186283. 164. Mathieu R, Shariat SF, Seitz C, Karakiewicz PI, Fajkovic H. Sun M, Lotan Y, Scherr DS, Tewari A, Montorsi F, Briganti A, Rouprt M, Lucca I, Margulis V, Rink M, Kluth LA, Rieken M, Bachman A, Xylinas E, Robinson BD, Bensalah K, Margreiter M. Multi institutional validation of the prognostic value of Ki-67 labeling index in patients treated with radical prostatectomy. World J Urol 2014 Oct 26 [Epub ahead of print] PMID: 25344896. Reviews, Chapters, Monographs and Editorials 1. Margulis V, Matin SF, Wood CG. Benign renal masses. In: Campbell-Walsh Urology, (Eds. Wein AJ, Kavoussi LR, Partin AW, Peters CA) Elsevier Press, in press. 2. Chromecki T, Margulis V, Shariat SF. Diagnosis and treatment of upper tract urothelial carcinoma. In: Essentials and Updates in Urologic Oncology. (Eds. Droller M) Elsevier Press, (2): 409-30. 3. Margulis V, Lotan Y, Lerner SP. Transitional cell carcinoma of the urinary bladder: Prediction of survival after radical cystectomy, In: Methods of Cancer Diagnosis, Therapy and Prognosis, (Ed. Hayat MA) Beam Institute of the Oncology Group, in press. 4. Margulis V, Wood CG. Renal Cell Carcinoma: Overview, Diagnosis and Surgical Treatment, In: New Treatment Paradigms in Renal Cell Cancer. (Ed. Bukowski R) Beam Institute of the Oncology Group, 2007. 5. Margulis V, Wood CG. Surgical Management of Locally Advanced Renal Cell Carcinoma, In: Renal Cell Carcinoma, (Eds. Rini B, Campbell S) BC Decker, in press. 21 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 33 of 46 PAGEID #: 60397 6. Margulis V, Matin S, Wood CG. Surveillance Strategies Following Curative Therapy for Localized Renal Cell Carcinoma, In: Clinical Management of Renal Tumors, (Eds, Bukowski R, Novick A,) Human Press, 2007. 7. Shariat SF, Margulis V, Karakiewicz PI. Rebuttal from authors re: James W.F. Catto. More nomograms or better evidence of efficacy: what do we need in urologic oncology? Eur Urol 2008; 54:11-12. Eur Urol 2008 Jul; 54(1): 13-5. Epub 2008 Mar 4. PMID: 18329787. 8. Margulis V, Wood CG. Is patient performance status always an accurate surrogate for predicting tumor biology in patients with metastatic renal cancer? Cancer 2008 Sep 15; 113(6): 1282-3. PMID: 18662508. 9. Ward JF, Margulis V. Continuous improvement of TNM staging system for bladder cancer. Cancer 2009 Feb 15; 115(4): 704-705. PMID: 19117038. 10. Margulis V, Wood CG. Editorial comment. Journal of Urology 2009 181(3): 1027. 11. Cost NG, Margulis V. Editorial Comment. J Urol 2011 Feb; 185(2): 431; author reply 414. Epub 2010 Dec 17. PMID: 21168168. 12. Bagrodia A, Gayed BA, Margulis V. Reply. Urology 2013 May; 81(5): 978. Epub 2013 Mar 20. PMID: 23523300. 13. Youssef RF, Margulis V. Editorial comment. J Urol 2011 Aug; 186(2): 415; author reply 415 6. Epub 2011 Jun 17. PMID: 21683395. 14. Cost NG, Margulis V. Reply from authors re: Axel Bex, Noel Clark.e, Targeted caval cytoreduction: Solid foundations or shifting sands? Eur Urol 2011; 59-919-29. European Urology, 2011, 59(6): 921-922. 15. Olweny EO, Margulis V. Editorial comment. J Urol 2012 Mar; 187(3): 806. Epub 2012 Jan 15. PMID: 22245320. 16. Faddegon S, Margulis V. Editorial comment. J Urol 2012 Apr; 187(4): 1182. Epub 2012 Feb 20. PMID: 22357171. 17. Youssef RF, Margulis V. Editorial comment. J Urol 2012 May; 187(5): 1711-2. Epub 2012 Mar 15. PMID: 22425043. 18. Sleeper J, Margulis V. Editorial comment. Urology 2012 May; 79(5): 1091; author reply 1091. Epub 2012 Mar 23. PMID: 22446335. 19. Youssef R, Margulis V. Reply. BJU International, 2012, 110(11): E435-E436. 20. Gayed BA, Margulis V. Editorial comment. Urology 2013 Apr; 81(4): 835. Epub 2013 Mar 7. PMID: 23465145. 21. Gayed BA, Karam JA, Margulis V, Wood CG: Integration of Targeted Therapy with Cytoreductive Nephrectomy and Metastasectomy in the Management of Metastatic Renal Cell Carcinoma. RCC Book Chapter 8 (Tannir Editor), in press May 2014 22. Youssef RF, Shariat SF, Lotan Y, Cost N, Wood CG, Sagalowsky AI, Zigeuner R, Langner C, Chromecki TF, Motorsi F, Bolenz C, Margulis V. Urothelial carcinoma at the uretero-enteric junction: Multi-center evaluation of oncologic outcomes after radical nephroureterectomy. Urologic Oncology: Seminars and Original Investigations 2013 31(5): 676-681. 23. Meissner MA, Margulis V, Gayed, BA: Editoral Comment. J Urol 2014 August; DOI: 10.111/iju.12590. Abstract Presentations 1. Margulis V, Yasbin R. Identification and isolation of salt-sensitive S. Aureus mutants. Research Thesis Presentation, University of Texas, June 1997 22 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 34 of 46 PAGEID #: 60398 2. Matsumoto ED, Margulis V, Heller H, Brinkley LJ, Adams-Huet B, Pak CY, Pearle MS. Effect of high and low calcium diet during liberal oxalate intake: impact on stone forming risk. World Congress of Endourology Meeting, Mumbai, India, November 2004 3. Matsumoto ED, Margulis V, Johnson DB, Ogan K, Anderson K Cadeddu JA. Radiofrequency ablation of small renal tumors: intermediate term efficacy. World Congress of Endourology Meeting, Mumbai, India, November 2004 4. Margulis V, Matsumoto ED, Knudsen BE, Chew BH, Denstedt JE, Cadeddu JA, Pearle MS. Percutaneous Renal Collecting System Access: Can virtual reality training shorten the learning curve? World Congress of Endourology Meeting, Mumbai, India, November 2004 5. Margulis V, Matsumoto ED, Taylor G, Kabbani W, Cadeddu JA. Retrograde renal cooling during radiofrequency ablation to protect from renal collecting system injury. World Congress of Endourology Meeting, Mumbai, India, November 2004 6. Shulman MJ, Margulis V, Benaim EA. Rise in PSA following intramuscular testosterone injection correlates highly with tumor volume and Gleason sum in men with PSA 2.5-4 diagnosed with prostate cancer following transrectal ultrasound-guided prostate biopsy. Society of Urologic Oncology Meeting, Bethesda, December 2004 7. Margulis V, Shulman MJ, Benaim EA. Rise in PSA following intramuscular testosterone is an independent predictor of subsequent diagnosis of adenocarcinoma on transrectal ultrasoundguided prostate biopsy in men with PSA 2.5-4.0. Society of Urologic Oncology Meeting, Bethesda, December 2004 8. Svatek R, Margulis V, Matsumoto ED, Kabbani W, Cadeddu JA, Lotan Y. Application of novel hemostatic agent Quikclot during laparoscopic partial nephrectomy. American Urologic Association Meeting, San Antonio, May 2005 9. Margulis V, Matsumoto ED, Knudsen BE, Chew BH, Denstedt JE, Cadeddu JA, Pearle MS. Percutaneous Renal Collecting System Access: Can virtual reality training shorten the learning curve? American Urologic Association, San Antonio, May 2005 10. Shulman MJ, Margulis V, Benaim EA. Rise in PSA following intramuscular testosterone injection correlates highly with tumor volume and Gleason sum in men with PSA 2.5-4 diagnosed with prostate cancer following transrectal ultrasound-guided prostate biopsy. American Urologic Association, San Antonio, May 2005 11. Margulis V, Matsumoto ED, Taylor G, Kabbani W, Cadeddu JA. Retrograde renal cooling during radiofrequency ablation to protect from renal collecting system injury. American Urologic Association, San Antonio, May 2005 12. Margulis V, Stern J, Lotan Y, Sagalowsky AI. Radical cystectomy for transitional cell carcinoma of the bladder: what percentage of patients qualify for bladder preservation protocols? Society of Urologic Oncology, Bethesda, December 2005 13. Margulis V, Shariat SF, Ashfaq R, Thompson M, Sagalowsky AI, Hsieh JT, Lotan Y. Correlation of cyclooxygenase-2 expression with molecular markers, pathologic features and clinical outcome of transitional cell carcinoma of the urinary bladder. American Urologic Association, Atlanta, May 2006 14. Margulis V, Shulman MJ, Benaim EA. Rise in PSA following intramuscular testosterone is an independent predictor of subsequent diagnosis of adenocarcinoma on transrectal ultrasoundguided prostate biopsy in men with PSA 2.5-4.0. South Central Section AUA, Santa Fe, October 2006 15. Margulis V, Maity T, Copland J, Wood CG. Evaluation of adenoviral gene therapy with transforming growth factor beta receptor type 3 in vivo and animal models of renal cell carcinoma. Kidney Cancer Association, Chicago, November 2006 16. Margulis V, Maity T, Copland J, Wood CG. Adenoviral gene therapy with transforming 23 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 35 of 46 PAGEID #: 60399 growth factor beta receptor type 3 induces apoptosis in conventional renal cell carcinoma. Society of Urologic Oncology, Bethesda, December 2006 17. Margulis V, Shariat SF, Ashfaq R, Sagalowsky AI, Lotan Y. Ki-67 is an independent predictor of bladder cancer outcome in patients treated with radical cystectomy for organ-confined disease. American Association for Cancer Research, Los Angeles, April 2007 18. Margulis V, Tamboli P, Matin SF, Meissner M, Swanson DA, Wood CG. Redefining pT3 Renal Cell Carcinoma in the modern era: a proposal for a revision of the current TNM primary tumor classification system. American Urologic Association, Anaheim, May 2007 19. Margulis V, Wood CG, From Upper Tract Urothelial Carcinoma Collaboration. Outcomes of radical nephroureterectomy: a series from upper tract urothelial carcinoma collaboration. Society of Urologic Oncology, Bethesda, December 2007 20. Margulis V, Matin SF, Tannir N, Swanson DA, Jonasch E, Wood CG. Surgical morbidity associated with administration of targeted molecular therapy prior to cytoreductive nephrectomy or resection of locally recurrent renal cell carcinoma. American Urologic Association, Orlando, May 2008 21. Margulis V, Wood CG, From Upper Tract Urothelial Carcinoma Collaboration. Outcomes of radical nephroureterectomy: a series from upper tract urothelial carcinoma collaboration. American Urologic Association, Orlando, May 2008 22. Margulis V, Maity T, Zhang XY, Cooper S, Copland J, Wood CG. Type III TGF-P Receptor mediates apoptosis in renal cell carcinoma independent of the canonical TGF-P signaling pathway. American Urologic Association, Orlando, May 2008 23. Margulis V, Lin J, Hushan Y, Wood CG, Wu X. Genetic Susceptibility to Renal Cell Carcinoma: The Role of DNA Double Strand Break Repair Pathway. American Urologic Association, Orlando, May 2008 24. Margulis V, McDonald M, Matin SF, Swanson DA, Wood CG. Predictors of oncologic outcome after resection of locally recurrent renal cell carcinoma. Society of Urologic Oncology, Bethesda, December 2008 25. Margulis V, Karakiewicz P, Fradet Y, Ashfaq R, Bolenz C, Lotan Y, Sagalowsky AI, Shariat SF. Multi-institutional external validation of the predictive value of Ki-67 labeling index in patients treated with radical cystectomy. Society of Urologic Oncology, Bethesda, December 2008 26. Margulis V, Wood CG, From Upper Tract Urothelial Carcinoma Collaboration. Development of prognostic models for individual risk stratification in patients treated with radical nephroureterectomy: a new tool to help with patient selection for adjuvant therapy. American Urologic Association, Chicago, May 2009 27. Margulis V, Kattan M, Matin SF, Tamboli P, Tannir N, Jonasch E, Swanson DA, Wood CG. Prognostic nomograms for prediction of survival before or after cytoreductive nephrectomy for metastatic renal cell carcinoma. American Urologic Association, Chicago, May 2009 28. Margulis V, McDonald M, Matin SF, Swanson DA, Wood CG. Predictors of oncologic outcome after resection of locally recurrent renal cell carcinoma. American Urologic Association, Chicago, May 2009 29. Margulis V, Karakiewicz P, Fradet Y, Ashfaq R, Bolenz C, Lotan Y, Sagalowsky AI, Shariat SF. Multi-institutional external validation of the predictive value of Ki-67 labeling index in patients treated with radical cystectomy. American Urologic Association, Chicago, May 2009 30. Margulis V, Matin S, Jonasch E, Tamboli P, Tannir N, Swanson D, Wood C: Impact of delay from diagnosis to cytoreductive nephrectomy on oncologic outcomes of patients with metastatic renal cell carcinoma. J Urol. 183, No. 4, Supplement (Abstract no. 1657) 2010. 31. Youssef R, Shariat S, Lotan Y, Wood C, Sagalowsky A, Zigeuner R, Kikuchi E, Weizer A, 24 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 36 of 46 PAGEID #: 60400 Raman J, Remzi M, Roscigno M, Montorsi F, Bolez C, Kassouf W, Margulis V: Upper urinary tract urothelial carcinoma with locoregional nodal metastases: experience with aggressive integration of systemic therapy followed by radical nephroureterectomy. J Urol. 183, No. 4, Supplement (Abstract no. 421) 2010. 32. Cost NG, Delacroix S, Sleeper J, Smith P, Youssef R, Chapin B, Karam J, Culp S, E. Abel J, Brugarolas J, Raj G, Sagalowsky A, Wood C, Margulis V: The impact of targeted molecular therapies on the level of renal cell carcinoma vena caval tumor thrombus. J. Urol. 185, No. 4, Supplement (Abstract no. 1771) 2011. 33. Youssef R, Gurbuz C, Shariat S, Lotan Y, Wood C, Sagalowsky A, Cost NG, Zigeuner R, Langner C, Montorsi F, Bolenz C, Kikuchi E, Weizer A, Raman J, Remzi M, Roscigno M, Kassouf W, Margulis V: The impact of previous ureteroscopic tumor ablation on oncologic outcomes after radical nephroureterectomy for upper urinary tract urothelial carcinoma. J. Urol. 185, No. 4, Supplement (Abstract no. 1388) 2011. 34. Cost NG, Lubahn J, Penn H, Granberg C, Schlomer B, Wickiser J, Rakheja D, Gargollo P, Leonard D, Baker L, Margulis V: Oncologic outcomes of partial (PN) versus radical nephrectomy (RN) for unilateral wilms tumor (UWT). J. Urol. 185, No. 4, Supplement (Abstract no. 1376) 2011. 35. Alhalabi F, Arendt T, Bagrodia A, Bensalah K, Kabbani W, Kapur P, Lotan Y, Margulis V, Rakheja D, Youssef R: The number of aberrantly expressed constituents of the mammalian target of rapamycin pathway: correlation with oncologic outcomes in clear cell renal cell carcinoma. J. Urol. 185, No. 4, Supplement (Abstract no. 1081) 2011. 36. Bolenz C, Cost NG, Langner C, Lotan Y, Margulis V, Montorsi F, Sagalowsky AI, Shariat SF, Wood CG, Youssef R, Zigeuner R: Prognostic impact of urinary bladder carcinoma in situ on clinical outcome of subsequent upper tract urothelial carcinoma. J. Urol. 185, No. 4, Supplement (Abstract no. 663) 2011. 37. Abel EJ, Culp S, Karam J, Margulis V, Tamboli P, Wang H, Wood CG, Zhang XY: Development and characterization of clinically relevant tumor models from patients with renal cell carcinoma. J. Urol. 185, No. 4, Supplement (Abstract no. 399) 2011. 38. Youssef R, Arendt T, Cost NG, Sagalowsky A, Lotan Y, Margulis V: Prospective evaluation of biomarkers in patients with upper tract urothelial carcinoma: prognostic role of cell cycle regulators. J. Urol. 185, No. 4, Supplement (Abstract no. 363) 2011. 39. Smith P, Lotan Y, Raj G, Sagalowsky A, Margulis V: Assessing Treatment Response after Induction BCG for CIS of the Urinary Bladder: Can Post-Induction Random Bladder Biopsies be Avoided? (Abstract #67, Bladder Cancer Podium, 90th Annual Meeting South Central Section, AUA, September 14-17, 2011) 40. Adibi M, Youssef R, Margulis V: Comparison of Outcomes after Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma over Three Decades (Poster #14, Concurrent Poster Session II, 90th Annual Meeting South Central Section, AUA, September 14 17, 2011) 41. Youssef R, Shariat S, Lotan Y, Cost NG, Wood C, Sagalowsky A, Zigeuner R, Langner C, Chromecki T, Montorsi F, Bolenz C, Margulis V: Urothelial Carcinoma at the Uretero-Enteric Junction: Multi-Center Evaluation of Oncologic Outcomes after Radical Nephroureterectomy (Abstract #31, Renal and Ureteral Disease Podium, 90th Annual Meeting South Central Section, AUA, September 14-17, 2011) 42. Margulis V, Shariat S, Rink M, Sjober D, Jonasch E, Tamboli P, Vickers A, Wood C: Development of accurate models for individualized prediction of survival at 6 and 12 months after cytoreductive nephrectomy for metastatic renal cell carcinoma. J Urology 187, No. 4 Supplement (Abstract no. 1804) 2012. 25 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 37 of 46 PAGEID #: 60401 43. Darwish O, Youssef R, Kapur P, Bagrodia A, Belsante M, Alhalabi F, Lotan Y, Margulis V: Number of altered biomarkers in the mammalian target of rapamycin independently correlates with oncologic outcomes in patients with clear cell renal cell carcinoma. J Urology 187, No. 4 Supplement (Abstract no. 1297) 2012. 44. Youssef R, Darwish O, Belsante M, Bagrodia A, Kapur P, Alhalabi F, Lotan Y, Margulis V: Clear cell renal carcinoma: alterations in mammalian target of rapamycin pathway constituents correlate with pathological features. J Urology 187, No. 4 Supplement (Abstract no. 983) 2012. 45. Adibi M, Cost NG, Lubahn J, Romman A, Margulis V: Novel predictors of benign pathology in stage Ia or Ib patients with non-seminomatous testicular germ cell malignancy undergoing primary retroperitoneal lymph node dissection. J Urology 187, No. 4 Supplement (Abstract no. 917)2012. 46. Lubahn J, Cost NG, Adibi M, Romman A, Raj G, Sagalowsky A, Margulis V: A novel risk stratification system for chemotherapy failure in testicular germ cell tumor. J Urology 187, No. 4 Supplement (Abstract no. 666) 2012. 47. Cost NG, Adibi M, Lubahn J, Romman A, Raj G, Sagalowsky A, Margulis V: The impact of surgical or systemic therapy for testicular germ cell malignancy on renal function. J Urology 187, No. 4 Supplement (Abstract no. 662) 2012. 48. Youssef R, Lotan Y, Shariat S, Wood C, Sagalowsky A, Darwish O, Raman J, Langner C, Roscigno M, Montorsi F, Bolenz C, Kassouf W, Margulis V: Impact of lymphadenectomy and systematic chemotherapy on survival of patients with t4 upper tract urothelial cancer. J Urology 187, No. 4 Supplement (Abstract no. 647) 2012. 49. Adibi M, Youssef R, Shariat S, Lotan Y, Wood C, Sagalowsky A, Zigeuner R, Langner C, Montorsi F, Bolenz C, Margulis V: Oncologic outcomes after radical nephroureterectomy for upper tract urothelial carcinoma: Comparison over the three decades. J Urology 187, No. 4 Supplement (Abstract no. 645) 2012. 50. Raman JD, Lotan Y, Kassouf W, Fritsche HM, Bensalah K, Weizer A, Kikuchi E, Roscigno M, Remzi M, Matsumoto K, Zigeuner R, Scherr DS, Mazumdar M, Sonpavde G, Shariat SF, Cha EK, Fajkovic H, Rink M, Pycha A, Dunning A, Novara G, Karakiewicz PI, Margulis V: Disease-free survival at a surrogate for 5-year overall survival in upper tract urothelial carcinoma. J Urology 187, No. 4 Supplement (Abstract no. 392) 2012. 51. Bagrodia A, Youssef R, Darwish O, Cannon C, Belsante M, Kapur P, Lotan Y, Margulis V: Prospective evaluation of cell cycle biomarkers for prediction of cancer-specific mortality in patients with upper tract urothelial carcinoma. J Urology 187, No. 4 Supplement (Abstract no. 387) 2012. 52. Darwish O, Bagrodia A, Abel J, Ramirez D, Youssef R, Rapoport Y, Tamboli P, Sagalowsky A, Wood C, Margulis V: Does pulmonary embolism at diagnosis confer a worse prognosis in patients with renal cell carcinoma with venous thrombus? (Abstract#65 - Renal Cancer Podium) 2012 AUA South Central Section Meeting, October 24-27, Colorado Springs, CO 53. Rapoport Y, Darwish O,Youssef R, Belsante M, Bagrodia A, Kapur P, Lotan Y, Margulis V: Prognostic role of lymphovascular invasion in papillary renal cell carcinoma. (Abstract #21 Kidney Poster Session) 2012 AUA South Central Section Meeting, October 24-27, Colorado Springs, CO 54. Adibi M, Cost NG, Lubahn J, Romman A, Margulis V: Novel predictors of benign pathology in stage Ia or Ib patients with non-seminomatrous testicular germ cell malignancy undergoing primary retroperitoneal lymph node dissection. (Abstract # 30 - Oncology - Bladder & Testis Podium) 2012 AUA South Central Section Meeting, October 24-27, Colorado Springs, CO 55. Lubahn J, Cost NG, Adibi M, Romman A, Raj G, Sagalowsky A, Margulis V: Embryonal pathology as predictor for failure of surveillance in management of stage I nonseminomatous 26 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 38 of 46 PAGEID #: 60402 testicular germ cell tumor. (Abstract # 29 - Oncology - Bladder & Testis Podium) 2012 AUA South Central Section Meeting, October 24-27, Colorado Springs, CO 56. Lubahn J, Cost NG, Adibi M, Romman A, Raj G, Sagalowsky A, Margulis V: A novel risk stratification system for chemotherapy failure in testicular germ cell tumor (T-GCT). (Abstract # 5 - Resident Essay Finalist Podium) 2012 AUA South Central Section Meeting, October 24 27, Colorado Springs, CO 57. Belsante M, Darwish O, Youssef R, Bagrodia A, Kapur P, Lotan Y, Margulis V: Lymphovascular invasion is an independent predictor of cancer recurrence in organ confined, but not in locally advanced clear cell renal cell carcinoma. (Abstract #3 - Resident Essay Finalist Podium) 2012 AUA South Central Section Meeting, October 24-27, Colorado Springs, CO 58. Cost NG, Lubahn JD, Adibi M, Romman A, Wickiser JE, Raj GV, Sagalowsky Ai, and Margulis V: A comparison of pediatric and adolescent testicular germ cell malignancy. (Abstract 16697 - American Academy of Pediatrics (AAP) 2012 Annual Meeting, October 20 23, New Orleans, LA 59. Sonpavde G, Amiel G, Margulis V, Link RE, Lerner SP, Raj G, Mayer WA, Palapattu GS, Lotan Y, Sagalowsky AI, Higgins LC, Tello SA, Pavia-Jimenez A, VonMerveldt D, Brugarolas J: Neoadjuvant therapy preceeding cytoreductive nephrectomy to develop individualized firstline therapy with everolimus for advanced renal cell carcinoma (RCC). (Abtract # TPS4678 Kidney Poster Session, Genitourinary Cancer, J Clin Oncol 30, 2012) ASCO Annual Meeting 2012. 60. Abel EJ, Wood C, Eickstaedt N, Fang JE, Kenney P, Bagrodia A, Ramirez D, Gayed BA, Downs TM, Youssef RF, Odom C, Sagalowsky A, Margulis V: Preoperative pulmonary embolism does not predict poor postsurgical outcomes in rcc patients with venous thrombus. (Abstract no. 1906, The Journal of Urology, 189, S4, May 2013) 61. Lotan Y, Bagrodia A, Passoni N, Rachakonda V, Kapur P, Arriaga Y, Margulis V, Raj G, Sagalowsky A, Shariat SF: Five year prospective evaluation of a molecular marker panel for prediction of recurrence after radical cystectomy. (Abstract no. 1433, The Journal of Urology, 189, S4, May 2013) 62. Belsante M, Darwish O, Youssef R, Bagrodia A, Kapur P, Sagalowsky A, Lotan Y, Margulis V: Lymphovascular invasion in clear cell renal cell carcinoma - Association with disease free and cancer specific survival. (Abstract no. 1075, The Journal of Urology, 189, S4, May 2013) 63. Xylinas E, Trinh QD, Kluth L, Green D, Scherr D, Novara G, Lotan Y, Karakiewicz P, Montorsi F, Zerbib M, Pycha A, Comploj E, Roupret M, Raman J, Weizer A, Seitz C, Margulis V, Sharia St: Prediction of intravesical recurrence after radical nephroureterectomy: Development of a clinical decision-making tool. (Abstract no. 896, The Journal of Urology, 189, S4, May 2013) 64. Roupret M, Xylinas E, Colin P, Audenet F, Yates D, Karakiewicz P, Margulis V, Shariat S: Oncologic outcomes and survival in pto tumors after radical nephroureterectomy for upper tract urothelial carcinoma: Results from a large multicenter international collaborative study. (Abstract no. 686, The Journal of Urology, 189, S4, May 2013) 65. Rink M, Sjoberg D, Xylinas E, Margulis V, Kluth LA, Cha EK, Raman JD, Remzi M, Bensalah K, Novara G, Chun FK, Kikuchi E, Kassouf W, Martinez-Salamanca J, Lotan Y, Seitz C, Pycha A, Zigeuner R, Scherr DS, Vickers AF, Shariat SF. Time to disease recurrence is a strong predictor of cancer-specific mortality in upper tract urothelial carcinoma. Poster Session 67 Advanced urothelial cancer: Disease outcomes, Abstract no. 813. EAU Meeting Milan, Italy March 2013. 66. Roupret M, Hupertan V, Seisen T, Colin P, Xylinas E, Yates D, Fajkovic H, Lotan Y, Raman J, 27 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 39 of 46 PAGEID #: 60403 Zigeuner R, Remzi M, Bolenz C, Novara G, Kassouf W, Ouzzane A, Rozet F, Cussenot O, Martinez-Salamanca J, Fritsche H-M, Walton T, Wood C, Bensalah K, Karakiewicz PI, Montorsi F, Margulis V, Shariat SF. Prediction of cancer-specific survival after radical nephroureterectomy for upper tract urothelial carcinoma: Development of an optimized post operative nomogram using decision curve analysis. Poster Session 47 Urothelial Cancer: Transurethral surgery and intravesical recurrence. EAU Meeting Milan, Italy, March 2013 67. Xylinas EN, Rink M, Kluth LA, Margulis V, Lee RK, Comploj E, Novara G, Raman JD, Lotan Y, Weizer A, Roupret M, Pycha A, Scherr D, Seitz C, Ficarra V, Trinh Q-D, Karakiewicz PI, Montorsi F, Zerbib M, Shariat SF. Impact of renal function on eligibility for chemotherapy and survival in patients who underwent radical nephroureterectomy. Poster Session 7 Non-surgical treatment of advanced urothelial cancer, Abstract no. 78. EAU Meeting Milan, Italy, March 2013 68. Bagrodia A, Gayed B, Gaitonde M, Youssef R, Kapur P, Sagalowsky A, Lotan Y, Margulis V: Feasibility of obtaining biomarker profiles from endoscopic biopsy specimens in upper tract urothelial carcinoma: Preliminary results. (Abstract Poster #41, South Central Section of the AUA, Inc., 92nd Annual Meeting, September 18-21, 2013, Chicago, IL 69. Bagrodia A, Gayed B, Kapur P, Darwish O, Bernstein I, Krabbe LM, Wood C, Shariat S, Zigeuner R, Bolenz C, Weizer A, Raman J, Bensalah K, Giacomo Novara, Fritsche HM, Sagalowsky A, Lotan Y, Margulis V: Multi-institutional evaluation of the prognostic significance of altered mammalian target of rapamycin (MTOR) pathway biomarkers in upper tract urothelial carcinoma (UTUC). (Abstract Podium #5, South Central Section of the AUA, Inc, 92nd Annual Meeting, September 18-21, 2013, Chicago, IL 70. Krabbe LM, Darwish OM, Raj G, Youssef RF, Kapur P, Bagrodia A, Belsante M, Lotan Y, Margulis V. Novel stratification of the recurrence risk following surgical extirpation of clear cell renal cell carcinoma using tissue biomarkers in the mammalian target of rapamycin pathway. (Abstract #4581 - General Poster Session, Genitourinary (Nonprostate) Cancer, J Clin Oncol 31, 2013) ASCO Annual Meeting 2013. 71. Rieken M, Xylinas E, Lee D, Khani F, Klatte T, Wood C, Karam J, Weizer A, Raman J, Remzi M, Guo C, Rioux-Leclercq N, Haitel A, Bolenz C, Bensalah K, Sagalowsky A, Montorsi F, Lotan Y, Bachmann A, De Marzo A, Shariat SF, Robinson B, Margulis V. Frequency and prognostic value of PTEN loss in patients with upper tract urothelial carcinoma. Poster 2, Abstract 17, EAU MEETING, STOCKHOLM, April 11-15, 2014. 72. Rieken M, Schubert T, Xylinas E, Kluth L, Roupret M, Quoc-Dien T, Lee RK, Al Hussein Al Waamlh B, Fajkovic H, Novara G, Margulis V, Lotan Y, Martinez-Salamanca J, Matsumoto K, Seitz C, Remzi M, Karakiewicz P, Scherr D, Briganti A, Bachmann A, Shariat SF. Association of perioperative blood transfusion with oncologic outcomes after radical nephroureterectomy for upper tract urothelial carcinoma. Poster 2, Abstract 21, EAU Meeting, STOCKHOLM, April 11-15, 2014. 73. Yury Rapoport, Boris Feldkoren, Wen-Xiu Zhang, Vitaly Margulis: Integrin signaling potentates transforming growth factor-beta 1 (TGF-B1) dependent down-regulation of ECADHERIN expression - important implications for epithelial to mesenchymal transition (EMT) in renal cell carcinoma. (Abstract No. MP23-20, J Urol 191(4S), 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL 74. Nirmish Singla, Aditya Bagrodia, Bishoy Gayed, Kerrin Palazzi, Hossein Mirheydar, Brian Harrow, Corbin Jacobs, Ramy Youssef, Oussama Darwish, Arthur Sagalowsky, Yair Lotan, Ithaar Derweesh, Vitaly Margulis: Multi-institutional analysis of renal function outcomes following radical nephroureterectomy and partial ureterectomy for upper tract urothelial carcinoma. (Abstract No. MP30-08, J Urol 191(4S), 2014. 28 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 40 of 46 PAGEID #: 60404 AUA National Meeting, May 16-21, 2014, Orlando, FL. 75. Malte Rieken, Luis Kluth, Evanguelos Xylinas, Umberto Capitanio, Alberto Briganti, Laura Maria Krabbe, Vitaly Margulis, Jay Raman, Mikhail Regelman, Tobias Klatte, Matthew Kent, Daniel Sjoberg, Alexander Bachmann, Shahrokh Shariat: Predictions of cancer-specific survival after disease recurrence in patients with renal cell carcinoma: The effect of time to recurrence. (Abstract No. MP40-14, J Urol 191(4S), 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL. 76. Bishoy Gayed, Matthew Meissner, Ramdev Konijeti, Laura-Maria Krabbe, Paul Chung, Adita Bagrodia, Ahmad Haddad, Ganesh Raj, Arthur Sagalowsky, Yair Lotan, Vitaly Margulis: Statin use is an independent predictor of improved survival in patients with metastatic renal cell carcinoma. (Abstract No. MP57-02, J Urol 191(4S), 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL. 77. E. Jason Abel, R. Houston Thompson, Vitaly Margulis, Jennifer E. Heckman, Megan M. Merrill, Oussam M. Darwish, Laura-Maria Krabbe, Stephen A. Boorjian, Bradley C. Leibovich, Christopher G. Wood: Risk factors for major complications and perioperative mortality following surgical resection of renal cell carcinoma with upper level IVC thrombus: A contemporary multi-center experience. (Abstract No. MP57-10, J Urol 191(4S), 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL. 78. Ramy Youssef, Bishoy Gayed, Oussama Darwish, Payal Kapur, Ganesh Raj, Michael DiMaio, Arthur Sagalowsky, Vitaly Margulis: Multi-disciplinary management of renal cell carcinoma with venous tumor thrombus: Are we getting better. (Abstract No. MP57-15, J Urol 191(4S), 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL 79. Nathalie Rioux-Leclerq, Andrea Haitel, Christian Bolenz, Karim Bensalah, Arthur Sagalowsky, Francesco Montorsi, Yair Lotan, Shahrokh Shariat, Brian Robinson, Vitaly Margulis: Insulin like growth factor MRNA-binding protein 3 (IMP3) expression helps prognostication in patients with upper tract urothelial carcinoma. (Abstract No. MP77-02, J Urol 191(4S), 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL. 80. Aditya Bagrodia, Laura Krabbe, Bishoy Gayed, Payal Kapur, Oussama Darwish, Ira Bernstein, Xian-Jin Xie, Christopher Wood, Richard Zigeugern Alon Weizer, Jay Raman, Mesut Remzi, Cord Langner, Marco Roscigno, Francesco Montorsi, Christian Bolenz, Karim Bensalah, Jose Karam, Arthur Sagalowsky, Shahrokh Shariat, Yair Lotan, Vitaly Margulis: Multi-institutional evaluation of the prognostic significance of altered mammalian target of rapamycin (MTOR) pathway biomarkers in upper tract urothelial carcinoma (UTUC). (Abstract No. MP77-04, J Urol 191(4S), 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL. 81. Malte Rieken, Tina Schubert, Evanguelos Xylinas, Luis Kluth, Morgan Roupret, Quoc-Dien Trinh, Richard Lee, Bashir Al Hussein Al Awamlh, Harun Fajkovic, Giacomo Novara, Vitaly Margulis, Yair Lotan, Juan Martinez-Salamanca, Kazumasa Matsumoto, Christian Seitz, Mesut Remzi, Pieere Karakiewicz, Douglas Scherr, Alberto Briganti, , Alexander Bachmann, Shahrokh Shariat: Association of perioperative blood transfusion with oncologic outcomes after radical nephroureterectomy for upper tract urothelial carcinoma. (Abstract No. MP77-05, J Urol 191(4S), 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL. 82. Malte Rieken, Evanguelos Xylinas, Daniel Lee, Francesca Khani, Tobias Klatte, Christopher Wood, Jose Karam, Alon Weizer, Jay Raman, Mesut Remzi, Charles Guo, Nathalie RiouxLeclercq, Andrea Haitel, Christian Bolenz, Karim Bensalah, Arthur Sagalowsky, Francesco Montorsi, Yair Lotan, Alexander Bachmann, Angelo De Marzo, Shahrokh Shariat, Brian Robinson, Vitaly Margulis: Frequency and prognostic value of PTEN loss in patients with upper tract urothelial carcinoma. (Abstract No. 77-06, J Urol 191(4S), 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL. 29 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 41 of 46 PAGEID #: 60405 83. Evanguelos Xylinas, Luis Kluth, Malte Rieken, Tobias Klatte, Yair Lotan, Eiji Kikuchi, Alon Weizer, Mesut Remzi, Jay Raman, Karim Bensalah, Francesco Montorsi, Vitaly Margulis, JuanIgnazio Martinez-Salamanca, Morgan Roupret, Marc Zerbib, Shahrokh Shariat: Impact of smoking status and cumulative exposure on intravesical recurrence of upper tract urothelial carcinoma after radical nephroureterectomy. (Abstract No. MP77-07, J Urol 191(4S), 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL.doi.10.1111/bju.12400 84. Bishoy Gayed, Aditya Bagrodia, Mani Gaitonde, Laura-Maria Krabbe, Matthew Meissner, Payal Kapur, Ramy Youssef, Arthur Sagalowsky, Yair Lotan, Vitaly Margulis: Feasibility of obtaining biomarker profiles from endoscopic biopsy specimens in upper tract urothelial carcinoma: Preliminary results. (Abstract No. MP77-09, J Urol 191(4S), 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL. 85. Paul Chung, Laura-Maria Krabbe, Oussama Darwish, Mary Westerman, Aditya Bagrodia, Bishoy Gayed, Ahmed Haddad, Payal Kapur, Arthur Sagalowsky, Yair Lotan, Vitaly Margulis: Degree of hydronephrosis predicts adverse pathological features and worse oncologic outcomes in high-grade upper tract urothelial carcinoma. (Abstract No. 77-15, J Urol 191(4S), 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL. 86. Tyler M. Bauman, Vitaly Margulis, Christopher G. Wood, William P. Christensen, Vishnukamal Golla, Ramy F. Youssef, Laura-Maria Krabbe, David F. Jarrard, Tracy M. Downs, E. Jason Abel: Curative surgery in RCC with thrombus; A comprehensive risk model from a modern multicenter analysis. (Abstract No. PD16-04, J Urol 191(4S), 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL. 87. Ramy Youssef, Laura-Maria Krabbe, Shahrokh F. Shariat, Yair Lotan, Arthur Sagalowsky, Jay D. Raman, Christopher G. Wood, Alon Z. Weizer, Christian Bolenz, Mesut Remzi, Karim Bensalah, Wassim Kassouf, Francesco Montorsi, Vitaly Margulis, UTUC Collaboration: TALL score for prediction of oncological outcomes after radical nephroureterectomy for high grade upper tract urothelial carcinoma. (Abstract No. PD35-09, J Urol 191(4S, 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL. 88. Kuan Lin, Erik Lehman, Laura-Maria Krabbe, Vitaly Margulis, Tobias Klatte, Shahrokh Shariat, Alex Arnouk, Costa Lallas, Edouard Trabulsi, Gregory Bozzini, Pierre Colin, Sarah Drouin, Morgan Roupret, Benoit Peyronnet, Karim Bensalah, Kari Bailey, David Canes, Jay Raman: Preoperative factors associated with complications following radical nephroureterectomy. (Abstract No. PD35-12, J Urol 191(4S), 2014. AUA National Meeting, May 16-21, 2014, Orlando, FL. 89. Cost N, Adibi M, Raj G, Sagalowsky A, Margulis V, Referral patterns in testicular cancer: Is there an impact on oncologic outcomes? 90. Chung PH, Krabbe LM, Darwish OM, Westerman ME, Brogrodia A, Gayed BA, Haddad AQ, Kapur P, Sagalowsky AI, Lotan Y, Margulis V: Degree of hydronephrosis predicts adverse pathological features and worse oncologic outcomes in patients with high-grade urothelial carcinoma of the upper urinary tract, Urologic Oncology, doi.org.10.1016.urolonc.2014.02.018. 91. Haddad A,Wood Christopher, Abel J, Krabbe LM, Darwish O, Thompson RH, Heckman J, Merril M, Gayed B,Sagalowsky A, Boorjian S, Margulis V, Leibovich B: Oncologic outcomes following surgical resection of renal cell carcinoma with IVC thrombus extending above the hepatic veins: a contemporary multi-center conhort. (Abstract # 29 Podium Session) South Central Section of the AUA, Inc. 93rdAnnual Meeting, October 8-11, 2014, Rancho Mirage, CA. 92. Youssef R, Lotan Y, Sagalowsky A, Shariat S, Wood C, Raman J, Margulis V, Roscigno M, Montorsi F, Bolenz C, Kassouf W: Radical nephroureterectomy for pathologic T4 upper tract urothelial cancer: Can oncologic outcomes be improved with multimodality therapy? (Abstract 30 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 42 of 46 PAGEID #: 60406 #31 Podium Session) South Central Section of the AUA, Inc. 93rdAnnual Meeting, October 8 11, 2014, Rancho Mirage, CA. 93. Youssef R, Lotan Y, Shariat S, Sagalowsky A, Wood C, Weizer A, Raman J, Roscigno M, Montorsi F, Bolenz, Kassouf W, Krabbe LM, Margulis V: Tall score for prediction of oncological outcomes after radical nephroureterectomy for high grade upper tract urothelial carcinoma. (Abstract #32 Podium Session) South Central Section of the AUA, Inc. 93rdAnnual Meeting, October 8-11, 2014, Rancho Mirage, CA. 94. Haddad A, Singla N, Kapur P, Raman J, Then M, Nuhn P, Buchner A, Bastian P, Seitz C, Shariat S, Bensalah K, Rioux-Leclerog N, Lotan Y, Margulis V: Validation of mammalian target of rapamycin biomarker panel in patients with clear cell renal cell carcinoma. (Abstract #37 Podium Session) South Central Section of the AUA, Inc. 93rdAnnual Meeting, October 8 11, 2014, Rancho Mirage, CA. 31 Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 43 of 46 PAGEID #: 60407 APPENDIX B WILL BE SUPPLEMENTED UNDER SEPARATE COVER Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 44 of 46 PAGEID #: 60408 APPENDIX C: FEE SCHEDULE Review of legal documents and medical records $600/hour Depositions (1 hour minimum) $850/hour Witness stand time (1 hour minimum) $1,250/hour Time away from office (minimum) $4,000/day Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 45 of 46 PAGEID #: 60409 APPENDIX D Materials Relied On, Reviewed, and/or Considered Case: 2:13-md-02433-EAS-EPD Doc #: 3441-5 Filed: 05/15/15 Page: 46 of 46 PAGEID #: 60410