San Antonio, Texas USA (UroToday.com) Dr Robert Uzzo started this session by introducing the SUO-CTC experience on different adjuvant treatment options for metastatic RCC. 354 members in 195 institutions are responsible for 35 clinical trials which included 910 patients.
Following was Dr. Chris Wood who described the ADAPT trial. This is a randomized phase 3 trials that examines the use of patient specific RNA obtained from the tumor for immune system activation. 462 Patients with stage 4 kidney cancer participate and will be randomized to vaccination or standard of care arms. The results are expected to publish next year. The main outcome of this trial is overall survival with safety and progression free survival (PFS) being secondary outcomes.
Then, Dr. David Chen reviewed the ASSURE trial. This trial included high risk kidney cancer patients (Grade 3-4, >T2, N+) who were randomized to adjuvant placebo, sunitinib and surafenib arms. The primary endpoint was PFS with OS as the secondary endpoint. Unfortunately, this trial was negative and did not demonstrate any benefit in PFS or OS for any of the arms. The conclusion of the panel was that there is no indication for these drugs in the adjuvant setting.
Following, Dr. Viraj Master analyzed the results of the S-TRAC trial that compared sunitinib and placebo in the adjuvant setting. In contrast to the ASSURE trial, PFS in the S-TRAC trial was better in the treatment arm with a Hazard ratio of 0.76 (CI 0.59-0.98). No improvement in OS was demonstrated. Lastly the adverse effect (AE) profile in this trial was reviewed. The treatment arm showed significant AE that the panel considered unacceptable (e.g 56% grade 3 diarrhea.
Finally, Dr. Monty Pal described the IMmotion trial which is a new study, aiming to examine the efficacy of atezolizumab in the adjuvant setting. This trial will include 664 high risk patients (>T2,N+). The patients will be randomized to placebo or atezolizumab for 16 cycles. The results will be stratified according to stage and PD-L1 status.
Written By: Miki Haifler, MD, M.Sc., Society of Urologic Oncology Fellow, Fox Chase Cancer Center
17th Annual Meeting of the Society of Urologic Oncology - November 30 -December 2, 2016 – San Antonio, Texas USA