ArticlesCarboplatin-based doublet plus bevacizumab beyond progression versus carboplatin-based doublet alone in patients with platinum-sensitive ovarian cancer: a randomised, phase 3 trial
Introduction
The addition of bevacizumab to chemotherapy is one of the most recent advances in treatment of advanced ovarian cancer. When this study was designed in 2012, bevacizumab was known to improve progression-free survival not only in the first-line setting, concomitantly with platinum-based chemotherapy and then as maintenance,1, 2 but also in recurrent disease.3, 4 Regulatory approval of bevacizumab in Europe for patients with recurrent advanced ovarian cancer at least 6 months after platinum-based chemotherapy stemmed from the OCEANS trial,3 in which a significant progression-free survival benefit was observed when bevacizumab was added to carboplatin and gemcitabine in patients not previously treated with bevacizumab. However, evidence in patients with colorectal cancer suggested that continuing anti-angiogenic therapy beyond progression could be efficacious.5 This trial aimed to test if the addition of bevacizumab to chemotherapy, at the first platinum-sensitive recurrence of ovarian cancer, prolonged progression-free survival of patients who had already received bevacizumab during first-line treatment.
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Study design and participants
MITO16b/MANGO–OV2/ENGOT–ov17 is an academic, multicentre, open-label, randomised phase 3 trial of carboplatin-based doublet plus or minus bevacizumab for patients with recurrent advanced ovarian cancer. The trial was sponsored by Istituto Nazionale per lo Studio e la Cura dei Tumori–IRCCS Fondazione Pascale (Naples, Italy) and done within the European Network for Gynaecological Oncological Trial (ENGOT) collaboration in Italy (Multicenter Italian Trials in Ovarian cancer and gynecologic
Results
Between Dec 6, 2013, and Nov 11, 2016, 406 patients were recruited. 203 patients (50%) were randomly assigned to receive either a carboplatin-based doublet plus bevacizumab (bevacizumab group) and 203 (50%) were randomly assigned to receive a carboplatin-based doublet alone (standard chemotherapy group). One patient in the bevacizumab group was subsequently found to be ineligible at histology revision, because of a colon cancer (figure 1).
Baseline characteristics are shown in table 1. 130
Discussion
Results from this study show that adding bevacizumab to a platinum-based doublet is safe and improves progression-free survival in patients with platinum-sensitive recurrent ovarian cancer already treated with bevacizumab during first-line therapy.
To date, two randomised controlled trials have investigated bevacizumab plus platinum-based regimens in patients with platinum-sensitive recurrence of ovarian cancer. In the OCEANS study,3 484 patients not previously treated with bevacizumab were
Data sharing
Data for this study will be shared with publication on reasonable and motivated request to the Principal Investigator of the study ([email protected]). The following individual patient data will be available for sharing: baseline characteristics of patients, treatment data, safety data, and follow-up data. There will be no time limit for data sharing.
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For a full list of the MITO16b/MANGO–OV2/ENGOT–ov17 Investigators, see appendix (pp 9–13)