Early tumor shrinkage (eTS) of 10% has been identified as a putative prognostic marker in mRCC, which could serve as an early read-out in clinical trials. We aimed to validate the prognostic role of eTS in first line TKI treatment using data from the COMPARZ study (NCT00720941).
A retrospective analysis on data of 1100 1st line patients treated with sunitinib or pazopanib was performed. Tumor response was measured according to RECIST 1.1. eTS was a priori defined as tumor shrinkage by ≥10%. The Kaplan-Meier method was used to estimate time-to-event outcomes. A landmark analysis was performed on day (d) 42 and d 90 after randomization. Cox proportional hazards regression was performed to evaluate the effect of prognostic factors on overall survival after d 42 and d 90.
Similar results were found for eTS at the 42 and 90 days landmarks. eTS ≥10% has prognostic relevance in mRCC and reflects a valid early endpoint in clinical trials.
Clinical trial identification
Legal entity responsible for the study
GSK sponsored study. Current analysis is retrospective on the initial data set.
Medical School Hannover, McMaster University
V. Grünwald: Honoraria: Novartis, Pfizer, BMS Consultation: Novartis, Pfizer, BMS. All other authors have declared no conflicts of interest.