Final Overall Survival Results of GOG 240 Trial Adding Bevacizumab to Chemotherapy in Advanced Cervical Cancer
As reported in The Lancet by Tewari et al, the final overall survival results of the phase III Gynecologic Oncology Group (GOG) 240 trial show continued benefit of the addition of bevacizumab (Avastin) to chemotherapy in patients with metastatic, persistent, or recurrent cervical carcinoma.
Study Details
In the open-label trial, 452 patients were randomized 1:1:1:1 between April 2009 and January 2012 to receive cisplatin plus paclitaxel or topotecan plus paclitaxel with (n = 227) or without (n = 225) bevacizumab in 21 day cycles until disease progression, unacceptable toxic effects, voluntary withdrawal, or complete response. At a prior second interim analysis (after 271 deaths), resulting in the 2014 approval of bevacizumab in this setting, median overall survival was 17.0 months in the bevacizumab plus chemotherapy group vs13.3 months in the chemotherapy-alone group (hazard ratio [HR] = 0.71, P = .004).
Overall Survival
In the final analysis, after 348 deaths, median overall survival was 16.8 months in the bevacizumab plus chemotherapy group vs 13.3 months in the chemotherapy-alone group (HR = 0.77, P = .007). Among patients not receiving previous pelvic radiotherapy, median overall survival was 24.5 vs 16.8 months (HR = 0.64, P = .11). Median post–disease progression overall survival was 8.4 vs 7.1 months (HR = 0.83, P = .06).
Fistula Risk
Any-grade fistula occurred in 15% of the bevacizumab plus chemotherapy group vs 1% of the chemotherapy-alone groups, with all patients in both groups with fistula having received previous radiotherapy. Grade 3 fistula occurred in 6% vs < 1%, respectively. No fistulas resulted in surgical emergencies, sepsis, or death.
The investigators concluded: “The benefit conferred by incorporation of bevacizumab is sustained with extended follow-up as evidenced by the overall survival curves remaining separated. After progression while receiving bevacizumab, we did not observe a negative rebound effect (ie, shorter survival after bevacizumab is stopped than after chemotherapy alone is stopped). These findings represent proof of concept of the efficacy and tolerability of antiangiogenesis therapy in advanced cervical cancer.”
The study was funded by the National Cancer Institute.
Krishnansu S.Tewari, MD, of the University of California-Irvine Medical Center, is the corresponding author of The Lancet article.
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