Dr. Thompson was invited to speak in the first state-of-the-art lecture of the SUO winter meeting and addressed the audience about making a difference for patients with next generation clinical trials in GU oncology. He argued that there are essentially three opportunities to make a difference for our patients.
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The first is to design and conduct complex, adaptive, targeted clinical trials. There are multiple new trial designs including enrichment, umbrella, MATCH, equal randomized marker-stratified, and Bayesian adaptive randomized maker-stratified design strategies. Many require dedicated statisticians as a part of the team. A potential pitfalls with these strategies include large numbers of target markers, which may become overwhelming and the reduce number of patients who qualify as criteria become more stringent. Another consideration in marker utilization for targeted clinical trial design is tumor heterogeneity. These issues need to be worked out in the design phase of the study.
Second, Dr. Thompson discussed conducting niche trials that make a difference. These are trials that test a very specific question, determine what is best for the patient, provide immediate guidance for physicians and patients, and can be done by anyone. Examples are looking at what local anesthetic to use and when to use it during the surgical course to reduce pain postoperatively. He cited the RAZOR trial, which randomized patients to robotic versus open radical cystectomy in order to determine what approach might offer better outcomes. Such niche trials can be done anyway and we have an obligation to our patients to be conducting them.
The third opportunity to make a difference is to ask and test a question that everyone thinks is already answered. An example of this is extended pelvic lymph node dissection (ePLND) at the time of radical cystectomy. Most retrospective data suggest improved survival outcomes for patients who have more lymph nodes removed at the time of surgery (Herr et al, Urology 2003). Dr. Thompson cautioned, however, that similar retrospective data suggested this benefit in pancreatic and gastric cancers until the clinical trials showing no difference in extended versus standard node dissection were done. NCT01224665 is a randomized trial of patients to standard versus ePLND. Of the target 620 patients, 542 have enrolled and the study is powered to detect an improvement in DFS from 55-65%. Results are expected in 2019.
Dr. Thompson concluded with the comment that we ought to seek opportunities to provide unbiased evidence that a test or treatment will help a patient. At the end of the day, it’s all about our finding better ways to treat the people entrusted to our care.
Ian M. Thompson, Jr, MD
University of Texas San Antonio Health Science Center
Benjamin T. Ristau, MD. from the Society of Urologic Oncology Meeting - December 2 - 4, 2015 – Washington, DC.
Fox Chase Cancer Center, Temple University Health System, Philadelphia, PA