Association Of Clinical Benefit Rate (Cbr) With Survival: A Pooled-Analysis Of Metastatic Breast Cancer (Mbc) Trials Submitted To The Us Food And Drug Administration (Fda)

e18091Background: CBR is commonly used as one the secondary endpoints in many cancer clinical trials. There are no comprehensive analyses to demonstrate that CBR adds to the value of the conventional time-to-event efficacy endpoints of progression-free and overall survival (PFS and OS) in clinical trials, and to date, CBR data are not reported in the clinical studies section of the U.S. package inserts for products approved for the treatment of MBC. We conducted a pooled analysis of data from MBC trials submitted to the FDA to understand the association of CBR with PFS and OS. In this analysis, CBR is defined as the percentage of patients with MBC who have achieved complete response, partial response or stable disease ≥ 6 months. Methods: We identified 13 trials of experimental agents with 10,263 patients submitted for treatment of MBC in initial or supplemental New Drug or Biologics License Applications since 2005. Criteria for inclusion of the trials in this analysis were: randomized, active-controlled,...