Bevacizumab for Newly Diagnosed Ovarian Cancers: Best Candidates Among High-Risk Disease Patients (ICON-7).

Adrian D Cook,Julien Peron,Benoit You,Christophe Sajous,Timothy J Perren,Gilles Freyer,Michel Tod,Olivier Colomban,Alexandra Leary

doi:10.1093/jncics/pkaa026

Abstract

Bevacizumab is approved as a maintenance treatment in first-line setting in advanced-stage III-IV ovarian cancers, because GOG-0218 and ICON-7 phase III trials demonstrated progression-free survival benefits. However, only the subgroup of patients with high-risk diseases (stage IV, and incompletely resected stage III) derived an overall survival (OS) gain in the ICON-7 trial (4.8 months). The modeled CA-125 elimination rate constant K (KELIM) parameter, based on the longitudinal CA-125 kinetics during the first 100 days of chemotherapy, is a potential indicator of the tumor primary chemo-sensitivity. In the ICON-7 trial dataset, the OS of patients within the low- and high-risk disease groups was assessed according to treatment arms and KELIM. Among the patients with high-risk diseases, those with favorable standardized KELIM of at least 1.0 (n = 214, 46.7%) had no survival benefit from bevacizumab, whereas those with unfavorable KELIM less than 1.0 (n = 244, 53.2%) derived the highest OS benefit (absolute difference = 9.1 months, 2-sided log-rank P = .10; Cox hazard ratio = 0.78, 95% confidence interval = 0.58 to 1.04, 2-sided P = .09).

Highlights

In June 2018, the Food and Drug Administration approved bevacizumab in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV ovarian carcinoma patients after initial surgical resection [1]
Bevacizumab is approved as a maintenance treatment in first-line setting in advanced-stage III-IV ovarian cancers, because GOG-0218 and ICON-7 phase III trials demonstrated progression-free survival benefits
This approval is based on the outcomes of 2 parallel phase III trials, GOG-0218 (NCT00262847) and ICON-7 (NCT00483782), which demonstrated benefits in progression-free survival with the addition of bevacizumab to standard first-line chemotherapy in patients with advanced-stage III-IV ovarian cancers [2,3]

Summary

Introduction

In June 2018, the Food and Drug Administration approved bevacizumab in combination with carboplatin and paclitaxel, followed by single-agent bevacizumab, for stage III or IV ovarian carcinoma patients after initial surgical resection [1]. Only the subgroup of patients with high-risk diseases (stage IV, and incompletely resected stage III) derived an overall survival (OS) gain in the ICON-7 trial (4.8 months).

Results

Conclusion