Is There a Benefit of Maintenance Bevacizumab During Chemotherapy-Free Intervals in Metastatic Colorectal Cancer?
As reported by Aparicio et al in the Journal of Clinical Oncology, a French phase III trial (PRODIGE 9) showed no benefit of maintenance bevacizumab (Avastin) during postinduction chemotherapy-free intervals in metastatic colorectal cancer.
Study Details
In the open-label trial, 491 patients from 66 sites were randomized between March 2010 and July 2013 to bevacizumab maintenance (n = 246) or observation (n = 245) during the chemotherapy-free interval after induction chemotherapy with 12 cycles of fluorouracil, leucovorin, and irinotecan plus bevacizumab. The induction regimen was repeated for eight cycles after disease progression, followed by a subsequent chemotherapy-free interval. The primary endpoint was tumor control duration.
Overall, disease progression or death occurred during induction chemotherapy in 85 patients (17%); 261 patients (53%) had at least one reinduction, 107 (22%) had two reinductions, and 56 (11%) had three or more reinductions.
Efficacy Outcomes
Median tumor control duration was 15 months in both the bevacizumab maintenance and observation groups (P = .57). Median progression-free survival from randomization was 9.2 vs 8.9 months (P = .316). Median overall survival was 21.7 vs 22.0 months (P = .500).
In the per-protocol population of patients with at least one reinduction after first progression, median duration of the first chemotherapy-free interval was 4.3 vs 4.3 months; median tumor control duration was 17.8 vs 23.3 months (P = .339); median progression-free survival was 9.9 vs 9.5 months (P = .339); and median overall survival was 27.6 vs 28.5 months (P = .424). On multivariate analysis, female sex, WHO performance status ≥ 2, and unresected primary tumor were associated with shorter tumor control duration.
The investigators concluded, “Bevacizumab maintenance monotherapy did not improve [tumor control duration, chemotherapy-free interval duration, progression-free survival, or overall survival].”
The study was supported by the Fédération Francophone de Cancérologie Digestive, Ligue Nationale Contre le Cancer, and Hoffmann-La Roche.
Thomas Aparicio, MD, PhD, of Assistance Publique Hôpitaux de Paris and Université Paris 7, Sorbonne Paris Cité, is the corresponding author for the Journal of Clinical Oncology article.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
