For this study, the authors note that based on the SWENOTECA data from one course of adjuvant carboplatin AUC7 , the estimated relapse rate in patients with one or two risk factors is 9%. Following orchiectomy and confirmation of stage I seminoma, patients will be randomized 1:1 to carboplatin vs BEP. The primary outcome will be relapse-free survival (RFS). The authors consider a reduction in RFS of 7% to be the minimum difference that will lead to routine use of one course of adjuvant BEP. To demonstrate an improvement in relapse rate from 9% to 2% with an α of 0.05 and β of 0.80, the study will require 332 evaluable patients.
Enrollment for this study started in 2015, and as of May 19, 2017, 84 patients have been enrolled at a rate of 5-6 patients per month. Although the investigators feel accrual has been slower than anticipated, the momentum is increasing and they are inviting investigators and collaborative groups to participate in the study.
Presented By: Parminder Singh, Mayo Clinic Arizona, Phoenix, AZ, USA
Co-Authors: Tangen Catherine, Seth P. Lerner, David McConkey, Melissa Plets, M. Scott Lucia, Michael Woods, Trinity Bivalacqua, Wassim Kassouf, Richard Carlton Bangs, Ian Murchie Thompson, Peter C. Black
Written By: Zachary Klaassen, MD, Urologic Oncology Fellow, University of Toronto, Princess Margaret Cancer Centre
at the 2017 ASCO Annual Meeting - June 2 - 6, 2017 – Chicago, Illinois, USA
Tandstad T, Stahl O, Dahl O, et al. Treatment of stage I seminoma, with one course of adjuvant carboplatin or surveillance, risk-adapted recommendations implementing patient autonomy: A report from the Swedish and Norwegian Testicular Cancer Group (SWENOTECA). Ann Oncol 2016 Jul;27(7):1299-1304.