medwireNews: Adding bevacizumab to standard chemotherapy, then using it as maintenance, improves overall survival by a clinically meaningful amount in patients with platinum-sensitive recurrent ovarian cancer, researchers report.
Robert Coleman (University of Texas MD Anderson Cancer Center, Houston, USA) and colleagues say their study “indicates that this strategy might be an important addition to the therapeutic armamentarium in these patients.”
The multicenter, open-label, randomized phase III GOG-0213 trial included 674 women with recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer, who had been disease-free for at least 6 months after achieving a clinical complete response to primary platinum-based chemotherapy.
The patients were randomly assigned to receive six 3-weekly cycles of standard chemotherapy with carboplatin and paclitaxel or standard chemotherapy plus bevacizumab (15 mg/kg of bodyweight), which was continued as maintenance every 3 weeks until disease progression or unacceptable toxicity.
During a median follow-up period of 49.6 months, 201 patients in the chemotherapy plus bevacizumab group and 214 in the chemotherapy only group died. The corresponding median overall survival times were 42.2 and 37.3 months, which gave a borderline significant hazard ratio (HR) of 0.83.
However, after adjustment for misclassification of the stated platinum-free interval, which was identified on audit in 45 patients, the HR was a significant 0.82.
Writing in The Lancet Oncology, Coleman et al say: “The difference in median overall survival (5 months) is clinically meaningful and is bolstered by a significant increase in both progression-free survival [PFS] and objective and complete responses in the bevacizumab group.”
Indeed, PFS was 13.8 months with bevacizumab and 10.4 months without it (HR=0.63), while the objective and complete responses were 78% and 32%, respectively, in the former group, versus 59% and 18% in the latter.
The researchers note that “the adverse event profiles for treated patients in both groups were consistent with the known safety profile of the agents under study.”
In the chemotherapy plus bevacizumab group, 96% of patients experienced at least one grade 3 or worse adverse event compared with 86% in the chemotherapy alone group. Nine treatment-related deaths occurred in the chemotherapy plus bevacizumab group compared with two in the chemotherapy group.
“The totality of data from this trial and other studies serves as evidence for the merit of bevacizumab in combination with chemotherapy for platinum-sensitive recurrent ovarian cancer, which should be considered in general clinical practice,” Coleman and team conclude.
In an accompanying commentary, Philipp Harter (Kliniken-Essen-Mitte, Germany) writes: “If the addition of bevacizumab to carboplatin–paclitaxel chemotherapy is approved in Europe, this combination would be a further option for the treatment of bevacizumab-naive patients with platinum-sensitive ovarian cancer.
“Doctors could counsel patients regarding the activity and side-effects (eg, alopecia, neurotoxicity) of two different platinum plus bevacizumab-based regimens so that patients can choose their preferred regimen.”
By Laura Cowen
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