(UroToday.com) The Bladder Cancer Advocacy Network (BCAN) Bladder Cancer Think Tank 2025 held in Washington, D.C., United States, between July 30th and August 1st. was host to the Session: Lessons Learned from Clinical Trials. Dr. Seth Lerner and Dr. Andrea Apolo co-chaired this session, bringing together expert panelists to reflect on key lessons learned from their involvement in bladder cancer clinical trials. Dr Lerner discussed Lessons Learned from the SWOG S1011 clinical trial.
Dr. Lerner opened his presentation by discussing the SWOG S1011 trial, a randomized clinical study evaluating the benefit of limited versus extended pelvic lymph node dissection at the time of radical cystectomy for bladder cancer.1 The concept was first proposed by Dr. Bernie Bochner in 2003, with Dr. Ian Thompson, then-chair of the SWOG GU Committee, helping to create the opportunity for trial development. The first draft of the concept was written in 2009, and the first patient was enrolled in November 2011. A key to success, Dr. Lerner noted, was building early consensus meeting with surgeons at SUO and AUA meetings both before and after trial activation to generate buy-in. Maintaining momentum was critical. The team demonstrated feasibility quickly, completing quality control on the first 15 patients and enrolling the first 100 within a year. Ultimately, the trial met its accrual target on time.
Surgeon and hospital volume are well-established predictors of quality outcomes following radical cystectomy, which led to a rigorous credentialing process for SWOG S1011. Every participating surgeon was required to undergo credentialing by the study committee. This included proof of completed accredited residency training, a minimum of 50 radical cystectomies performed in the past three years, and at least 30 cases per year at their institution. Surgeons also had to submit operative and pathology reports from five recent cases, along with representative intraoperative photos or video. In total, 36 surgeons across 27 sites in the U.S. and Canada were credentialed. Importantly, surgeons were required to submit operative notes, pathology reports, and intra-op photos for every enrolled case to ensure consistent surgical quality across the trial.
To ensure consistency and rigor in SWOG S1011, Dr. Lerner and colleagues implemented a surgical quality control (QC) initiative on the first 100 patients enrolled 50 from each trial arm. This QC effort involved two external peer reviewers, Dr. Karim Chamie (UCLA) and Dr. John Taylor (University of Kansas), who evaluated operative and pathology reports along with intraoperative photos to assess the completeness of lymphadenectomy. Each participating surgeon had at least one case reviewed. This initiative, developed in collaboration with the SWOG Surgery Committee, not only upheld surgical standards within the trial but also set a precedent for future surgical oncology studies, influencing trial design in areas such as prostate and penile cancer.
Dr. Lerner highlighted the importance of embedding translational research into clinical trial design from the outset. For SWOG S1011, a translational medicine hypothesis was written into the protocol early, enabling the collection of biological samples though nearly 75% of accrual had occurred before sample collection could formally begin. Despite this, the team successfully implemented a biospecimen effort as early as 2011, with much of the downstream work supported by the SWOG biobank. The translational objective was to explore the relationship between markers of epithelial–mesenchymal transition (EMT) in the primary bladder tumor and key clinical outcomes, including local tumor stage, lymph node metastatic burden, and risk of disease progression among patients undergoing cystectomy for muscle-invasive bladder cancer.
The translational medicine work from SWOG S1011 continues into 2025, demonstrating the long-term scientific value of embedding biospecimen collection into trial design. Over 350 tumor specimens have been quality-controlled by Dr. Scott Lucia, with DNA and RNA extracted by the SWOG Biobank through a national effort. RNA sequencing was initiated by Dr. Theresa Koppie using Illumina platforms and completed at Baylor College of Medicine. Ongoing efforts now include the development of a custom NanoString codeset tailored to the TCGA bladder cancer classifier. As shown in the figure, results from the NanoString testing cohort (n=48) and validation cohort (n=278) are now being compared with TCGA RNA-seq data, providing a robust framework for future molecular classification and biomarker development in bladder cancer.
Dr. Lerner wrapped up his presentation with the following key messages on how SWOG S1011 was built:
- Seize opportunity, provide leadership, build consensus, and mine data that emerges along the way
- Future trials should prioritize rigorous surgical quality and quality control
- SWOG S1011 helped set a new standard for surgical trials and influenced the design of studies in other disease sites
- Translational medicine opportunities can and should be pursued independently of the trial’s primary and secondary endpoints
Presented by: Seth Lerner, MD, FACS, Professor of Urology, Baylor College of Medicine, Houston, TX
Written by: Julian Chavarriaga, MD – Urologic Oncologist at Cancer Treatment and Research Center (CTIC) via Society of Urologic Oncology (SUO) Fellow at The University of Toronto. @chavarriagaj on Twitter during the Bladder Cancer Advocacy Network (BCAN) Bladder Cancer Think Tank 2025 held in Washington, D.C., United States, between July 30th and August 1st
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