The clinicaltrials.gov database was queried for interventional clinical trials directed at clinically advanced (stage III/IV) RCC that enrolled patients from only the US. A total of 375 patients from 18 Phase I-II trials that met eligibility criteria were identified. The American College of Surgeons’ National Cancer Database (NCDB) which includes data on approximately 70% of all US cancer diagnoses was queried and overall a total of 75,308 patients with advanced (stage III/IV) RCC were identified. These two populations were compared in (Table 1).
Compared to the US population of advanced RCC (NCDB), significant under-representation in clinical trials was observed for patients aged 65+ (50.4% vs. 26.3%; p=0.05). Female patients made up 30.3% of trial enrollees and 33.3% of the advanced RCC population (p=0.221).
The limitations reported by the authors include the relatively smaller number of patients in the clinical trials cohort compared to the NCDB cohort, and the hospital-based differences in patient populations between clinical trial sites and NCDB cancer centers.
In conclusion, significant under-representation was observed for elderly and Hispanic patients, however black race and female gender were appropriately represented in Phase I-II RCC clinical trials. Greater efforts to include under-represented populations are necessary to improve the effectiveness and generalizability of clinical trials in kidney cancer.
Presented by: Alain Kaldany, New York, NY, USA
Co-Authors: Kyle Blum, David Paulucci, Isuru Jayaratna, John Sfakianos, Ketan Badani, New York, NY
Written by: Hanan Goldberg, MD, Urologic Oncology Fellow (SUO), University of Toronto, Princess Margaret Cancer Centre @GoldbergHanan at the 2018 AUA Annual Meeting - May 18 - 21, 2018 – San Francisco, CA USA