RIBBON-2: NO EFFECT ON SURVIVAL YET

RIBBON-2 is the first positive phase III study of bevacizumab in second-line metastatic breast cancer

15.12.09

Category: Scientific News

Highlights from the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium, 9-13 December 2009, Texas, USA

Sarah Hurvitz, MD, from the University of California, Los Angeles, presented on 12 December 2009, results from the RIBBON-2 trial, a randomized, double blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of HER2-negative metastatic breast cancer. She reported final progression-free survival (PFS) and overall response rate (ORR) analyses, as well as the interim overall survival (OS) analysis (consisting of 315 events and accounting for ~57% of information). In this study, 684 previously treated patients with metastatic breast cancer were randomized to receive investigator-chosen chemotherapy plus placebo or investigator-chosen chemotherapy plus bevacizumab as second-line therapy. Patients were required to have no prior therapy with bevacizumab or any VEGF pathway–targeting therapy. The primary endpoint was PFS; secondary endpoints were OS, PFS within individual chemotherapy cohorts, ORR, duration of objective response, 1-year survival rate, and safety. For the primary efficacy analysis, PFS was 7.2 months in the bevacizumab treatment arm compared to 5.1 in the placebo arm (P=0.0072). Similar results were seen in the individual chemotherapy cohorts. ORR was 39.5% in the bevacizumab arm versus 29.6% in the placebo arm (P=0.0193). OS rates for the bevacizumab arm and the placebo arm (18.0 months and 16.4 months, respectively) were not significantly different, but these data are immature. As expected, patients receiving bevacizumab plus chemotherapy showed an increased incidence of neutropenia, hypertension, sensory neuropathy, and proteinuria. With the reporting of these results, RIBBON-2 became the first positive phase III study of bevacizumab in second-line metastatic breast cancer.