Over the past 15 years, several randomized controlled trials have reinforced pre-surgery chemotherapy as a first step to shrink tumors followed by surgery as the gold standard treatment for muscle-invasive bladder cancer. However, a new randomized study of 317 patients with this type of bladder cancer conducted by Columbia University Medical Center and Memorial Sloan Kettering Cancer Center finds that median survival among patients assigned to surgical removal of the bladder alone was 46 months, compared with 77 months for patients who received pre-surgery chemotherapy followed by surgery.
Gen Li, PhD, assistant professor of Biostatistics at Columbia’s Mailman School of Public Health, provided the statistical analysis for the study, which was presented at the American Society of Clinical Oncology meeting, June 1-5, which brought together more than 32,000 oncology professionals from around the world to discuss state-of-the-art treatments.
Patients in the study included those with muscle-invasive bladder cancer who underwent neoadjuvant platinum-based chemotherapy followed by a radical and complete bladder resection; had a complete and successful response to treatment; and opted for surveillance only. The authors defined a complete response as a radical resection, a urine test that found no infection or cancerous cells, and imaging. The patients were subsequently followed up with regular physical exams and testing.
According to Li, the strength of this study is the multi-institutional collaboration of two large cancer centers, allowing for a pooling of patients and events to undertake the research. A randomized trial of patients who completely recovered after neoadjuvant chemotherapy to surveillance compared with radical cystectomy would offer even more definitive conclusions. Based on these findings, patients who responded completely to chemotherapy who opt for surveillance only may also have favorable outcomes. “Future studies should aim to improve patient selection by identifying biomarkers predictive of invasive relapse and developing novel imaging methods for detection,” says Li.
Co-authors include Patrick Mazza, George Moran, Gen Li, Dennis Robins, Justin Matulay, Harry Herr, Christopher Anderson, and James McKiernan of Columbia University Medical Center and Memorial Sloan Kettering Cancer Center.