811P - Prognostic ability of early tumor shrinkage on overall survival (OS) in metastatic renal cell carcinoma (mRCC) – a validation study

Date 09 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Renal Cell Cancer
Presenter Gregory R. Pond
Citation Annals of Oncology (2016) 27 (6): 266-295. 10.1093/annonc/mdw373
Authors G.R. Pond1, M. Dietrich2, V. Grünwald3
  • 1Oncology, Escarpment Cancer Research Institute, McMaster Medical Centre, L8V 1C3 - Hamilton/CA
  • 2Natural Sciences, Leibniz University Hannover, Hannover/DE
  • 3Clinic For Hematology, Hemostasis, Oncology And Stemcelltransplantation, Hannover Medical School, 30625 - Hannover/DE

Abstract

Background

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).

Methods

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.

Results

Conclusions

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

NCT00720941

Legal entity responsible for the study

GSK sponsored study. Current analysis is retrospective on the initial data set.

Funding

Medical School Hannover, McMaster University

Disclosure

V. Grünwald: Honoraria: Novartis, Pfizer, BMS Consultation: Novartis, Pfizer, BMS. All other authors have declared no conflicts of interest.