TY - JOUR T1 - Bevacizumab, carboplatin, and paclitaxel in the first line treatment of advanced ovarian cancer patients: the phase IV MITO-16A/MaNGO-OV2A study JF - International Journal of Gynecologic Cancer JO - Int J Gynecol Cancer DO - 10.1136/ijgc-2021-002434 SP - ijgc-2021-002434 AU - Gennaro Daniele AU - Francesco Raspagliesi AU - Giovanni Scambia AU - Carmela Pisano AU - Nicoletta Colombo AU - Simona Frezzini AU - Germana Tognon AU - Grazia Artioli AU - Angiolo Gadducci AU - Rossella Lauria AU - Annamaria Ferrero AU - Saverio Cinieri AU - Andrea De Censi AU - Enrico Breda AU - Paolo Scollo AU - Ugo De Giorgi AU - Andrea Alberto Lissoni AU - Dionyssios Katsaros AU - Domenica Lorusso AU - Vanda Salutari AU - Sabrina Chiara Cecere AU - Eleonora Zaccarelli AU - Margherita Nardin AU - Giorgio Bogani AU - Mariagrazia Distefano AU - Stefano Greggi AU - Maria Carmela Piccirillo AU - Roldano Fossati AU - Gaia Giannone AU - Laura Arenare AU - Ciro Gallo AU - Francesco Perrone AU - Sandro Pignata Y1 - 2021/04/30 UR - http://ijgc.bmj.com/content/early/2021/04/29/ijgc-2021-002434.abstract N2 - Objective To explore the clinical and biological prognostic factors for advanced ovarian cancer patients receiving first-line treatment with carboplatin, paclitaxel, and bevacizumab.Methods A multicenter, phase IV, single arm trial was performed. Patients with advanced (FIGO (International Federation of Gynecology and Obstetrics) stage IIIB-IV) or recurrent, previously untreated, ovarian cancer received carboplatin (AUC (area under the curve) 5), paclitaxel (175 mg/m2) plus bevacizumab (15 mg/kg) on day 1 for six 3-weekly cycles followed by bevacizumab single agent (15 mg/kg) until progression or unacceptable toxicity up to a maximum of 22 total cycles. Here we report the final analysis on the role of clinical prognostic factors. The study had 80% power with a two-tailed 0.01 α error to detect a 0.60 hazard ratio with a factor expressed in at least 20% of the population. Both progression-free and overall survival were used as endpoints.Results From October 2012 to November 2014, 398 eligible patients were treated. After a median follow-up of 32.3 months (IQR 24.1–40.4), median progression-free survival was 20.8 months (95% CI 19.1 to 22.0) and median overall survival was 41.1 months (95% CI 39.1 to 43.5). Clinical factors significantly predicting progression-free and overall survival were performance status, stage, and residual disease after primary surgery. Neither baseline blood pressure/antihypertensive treatment nor the development of hypertension during bevacizumab were prognostic. There were two deaths possibly related to treatment, but no unexpected safety signal was reported.Conclusions Efficacy and safety of bevacizumab in combination with carboplatin and paclitaxel and as maintenance were comparable to previous data. Hypertension, either at baseline or developed during treatment, was not prognostic. Performance status, stage, and residual disease after primary surgery remain the most important clinical prognostic factors.Trial registration number EudraCT 2012-003043-29; NCT01706120.Data of this study will be shared with publication upon reasonable and motivated request to the Principal Investigator of the study (s.pignata@istitutotumori.na.it). The following IPD will be available for sharing: baseline characteristics of patients, treatment data, safety data, follow-up data. There will be no time limit for data sharing. ER -