Seth P. Lerner, MD

Seth P. Lerner, MD

Baylor College of Medicine

Houston, Texas

Seth P. Lerner, MD, is Professor of Urology and Vice-Chair for Faculty Affairs in the Scott Department of Urology at the Baylor College of Medicine in Houston, Texas. He holds the Beth and Dave Swalm Chair in Urologic Oncology. Dr. Lerner is the Director of Urologic Oncology and the Multidisciplinary Bladder Cancer Program, also at Baylor. Dr. Lerner earned his medical degree from the Baylor College of Medicine, completed a surgical internship at Virginia Mason Hospital in Seattle, and returned to Baylor for his residency training. He completed a two-year fellowship at the University of Southern California in Urologic Oncology and Reconstructive Surgery and joined the full-time Baylor faculty in 1992. Dr. Lerner’s clinical practice, education, and research activities are devoted to urologic oncology, particularly to lower and upper tract urothelial cancer. Dr. Lerner is the author of 228 peer-reviewed articles, co-editor of a comprehensive Textbook on Bladder Cancer, and founding co-editor-in-chief of the Bladder Cancer journal. His research interests include the use of selective estrogen receptor modulators for treatment of bladder cancer, gene therapy, integrated proteogenomic analysis of bladder and upper urinary tract cancers, and outcomes of radical cystectomy and pelvic lymphadenectomy. Dr. Lerner has 30 years of experience as a clinical investigator for both National Cancer Institute (NCI) and industry-funded clinical trials. He is Principal Investigator of the ongoing SWOG NCI Phase III trial comparing extended vs. standard pelvic lymphadenectomy at time of radical cystectomy. He is active in the leadership of several national bladder cancer research enterprises, serving as chair of the Local Bladder Cancer committee of SWOG, founding and former co-chair of the NCI Bladder Cancer Task Force, and former co-chair of theNCI National Clinical Trials Network (NCTN) Genitourinary Steering Committee. He co-chaired the Analysis Working Group of The Cancer Genome Atlas Project for muscle invasive bladder cancer and was recently appointed to a 4-year term to the NCI Clinical Trials and Translational Research Advisory Committee. Dr. Lerner is very active in the Bladder Cancer Advocacy Network (BCAN) as a member of the Board of Directors, is past chair of the Bladder Cancer Think Tank, and is co-chair of the management committee of the Bladder Cancer Research Network. Dr. Lerner is an active member of the prestigious American Association of Genitourinary Surgeons and is listed routinely among “America’s Top Doctors” and “Best Doctors in America.”

Disclosures:

Dr. Lerner has the following disclosures:
Research Support: Endo International, PLC, FKD Therapies Oy, UroGen, Viventia
Advisory Committee Member: Anchiano Therapeutics, UroGen, QED Therapeutics, Genentech, Ferring
Has Served on Advisory Board: BioCancell, INucleix
Consultant: Anchiano Therapeutics, Vaxxion, UroGen
Honorarium Recipient: Nucleix, Dava Oncology

Talks by Seth P. Lerner, MD

Managing NMIBC in the BCG Shortage Era

Seth P. Lerner, MD, Professor of Urology and holder of the Beth and Dave Swalm Chair in Urologic Oncology in the Scott Department of Urology at Baylor College of Medicine, explains the bacillus Calmette-Guérin (BCG) shortage and discusses how physicians should adjust treatment decisions for non-muscle invasive bladder cancer (NMIBC). He outlines a joint guideline statement made by the AUA, AACU, BCAN, SUO, LUGPA, and UCF on February 19, 2019, which stated that BCG should not be used for low-risk disease, that alternative intravesical chemotherapy should be used for second-line intermediate-risk disease, that patients with high-risk NMIBC should be prioritized for full-strength BCG, and that if full doses are unavailable then reduced doses should be used. Dr. Lerner then discusses the SWOG BCG maintenance protocol, which shows a clear benefit over other protocols. He reviews the BCG dose reduction process and describes how to bill for it. Dr. Lerner also gives an overview of a trial on optimizing mitomycin delivery that found that dehydrating the patient and ensuring the bladder is empty prior to instillation is key, and that optimized delivery can double recurrence-free survival at 5 years. Dr. Lerner outlines BCG-naive clinical trial agents and shows data indicating that gemcitabine with docetaxel can be used to supplement BCG treatment. He states that very high-risk patients should receive radical cystectomies early due to a dropoff in survival in patients who wait to receive cystectomies. Dr. Lerner concludes that optimized intravesical mitomycin and doublet chemotherapy regimens are active in both intermediate and high-risk disease, and that radical cystectomy’s complete and usually durable response for pathologic NMIBC should not be ignored.

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Updates in Upper Tract Urothelial Cancer

Seth P. Lerner, MD, Professor of Urology and holder of the Beth and Dave Swalm Chair in Urologic Oncology in the Scott Department of Urology at Baylor University, provides an update on recent trials and treatment options for Upper Tract Urothelial Cancer (UTUC). He begins with the OLYMPUS study, outlines the rationale for neoadjuvant therapy, reviews ECOG’s EA8141 trial, and concludes with a discussion of adjuvant therapy.

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Advances in Treating Upper Tract Urothelial Cancer

Seth P. Lerner, MD, Professor of Urology and holder of the Beth and Dave Swalm Chair in Urologic Oncology in the Scott Department of Urology at Baylor College of Medicine, discusses developments in upper tract urothelial carcinoma (UTUC) treatment. He delivers a rationale for adjuvant therapy based on a lack of clinical staging accuracy, a lack of high-level evidence to support perioperative systemic therapy, the perceived benefit in cases of high-risk bladder cancer, and the ability of pathologic staging to identify patients most likely to benefit. He then reviews the POUT trial of adjuvant chemotherapy, noting that it found a statistically significant benefit in disease-free survival and metastasis-free survival. Dr. Lerner continues by summarizing guideline statements. The EAU statement recommends perioperative chemo to patients with muscle invasive UTUC. ICUD states that it is unknown if adjuvant chemotherapy or waiting for the development of clinically evident disease is better. The French ccAFU recommends adjuvant chemotherapy after radical nephroureterectomy in pT2-T4 N0-3 M0 disease. Dr. Lerner then discusses neoadjuvant therapy, which studies suggest is beneficial to patients with optimized renal function. A Hopkins study specifically displayed a pathologic complete response of 9.4%, while the EA8141 trial found a total pathologic complete response of 13.8%. Dr. Lerner continues with a review of management options for low-grade UTUC, a rare disease with limited treatment options. He posits that a kidney-sparing treatment option is needed for patients, as there is a high chance of recurrence and kidney damage with the treatments currently available. Dr. Lerner theorizes that if durability of complete response following ablation with UGN-101 is demonstrated, this could provide a potential new kidney-sparing treatment for patients with low-grade UTUC. Dr. Lerner concludes with a discussion of the OLYMPUS study on UGN-101, which found a complete response in 59% of patients.

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Updates in Upper Tract Urothelial Carcinoma

Seth P. Lerner, MD, Professor of Urology, Director of Urologic Oncology and the Multidisciplinary Bladder Cancer Program, and Faculty Group Practice Medical Director for the Urology Clinic at Baylor College of Medicine discusses the impact of several upper tract urothelial carcinoma studies on the treatment of the disease. The POUT phase III trial used adjuvant therapy for high-risk patients who didn’t receive neoadjuvant therapy and through increased survival rates supported the establishment of the new adjuvant therapy standard of care. ECOG, a phase II trial of neoadjuvant systemic chemotherapy followed by extirpative surgery in high-risk upper tract urothelial carcinoma found about a 10% pathological complete response rate from treatment. QED, an ongoing adjuvant trial, tested infigratinib, an oral FGFR1-3 selective kinase inhibitor, so far finding increased survival rates in patients. Dr. Lerner concludes with the Olympus Study, a phase III prospective study on patients with low-grade disease in the renal pelvis using mitomycin gel for treatment and found a 58% complete response rate and led to the treatment’s approval by the FDA.

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A Review of The OLYMPUS Trial: Nephron Sparing for UTUC

Seth P. Lerner, MD, Professor of Urology at Baylor College of Medicine, reviews the results of the Optimized DeLivery of Mitomycin for Primary UTUC Study (OLYMPUS) trial, of which he was the principal investigator. In this study, a thermal, reversible gel was used as a kidney-sparing treatment of low-grade upper tract urothelial cancer (UTUC). He discusses the difficulty of managing UTUC, the function of UGN-101, and the dramatic results in patient outcomes from this trial.

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