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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/m 2 ) 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., Competing Interests: Competing interests: Dr Daniele reports travel and accommodations from Roche, outside the submitted work. Dr Raspagliesi reports grants from Roche, grants from GSK, grants from MSD, grants from Pharmamar, outside the submitted work. Dr Colombo reports personal fees from Roche, personal fees from Pharmamar, personal fees from AstraZeneca, personal fees from MSD, personal fees from Tesaro, personal fees from GSK, personal fees from Clovis, personal fees from Amgen, personal fees from Pfizer, personal fees from Biogen, personal fees from BIOCAD, outside the submitted work. Dr De Giorgi reports personal fees from Astellas - Pharma, personal fees from Bayer, personal fees and non-financial support from Bristol Myers-Squibb, personal fees and non-financial support from Ipsen, personal fees and non-financial support from Janssen, personal fees and non-financial support from Pfizer, grants and personal fees from Sanofi, personal fees from Novartis, personal fees from MSD, grants and non-financial support from Roche, grants from AstraZeneca, personal fees from Pharmamar, outside the submitted work. Dr Lorusso reports grants, personal fees and non-financial support from Pharmamar, grants and personal fees from MSD, grants and personal fees from Clovis, grants, personal fees and non-financial support from GSK, personal fees and non-financial support from AstraZeneca, personal fees from Merck Serono, personal fees from Amgen, non-financial support from Roche, outside the submitted work. Dr Salutari reports personal fees from MSD, personal fees from GSK, personal fees from Tesaro, personal fees from AstraZeneca, personal fees from Roche, personal fees from Eisai, personal fees from Clovis, outside the submitted work. Dr Piccirillo reports personal fees from Daichii Sankyo, personal fees from GSK, personal fees from MSD, grants from Roche, grants and personal fees from AstraZeneca, non-financial support from Bayer, outside the submitted work. Dr Perrone reports grants from Roche, during the conduct of the study; grants, personal fees and non-financial support from Bayer, personal fees from Sandoz, grants and personal fees from Incyte, personal fees from Celgene, grants and personal fees from AstraZeneca, personal fees from Pierre Fabre, personal fees from Janssen Cilag, grants from Roche, grants from Pfizer, outside the submitted work. Dr Pignata reports grants from Roche, during the conduct of the study; personal fees from AZ, personal fees from MSD, personal fees from Clovis, personal fees and non-financial support from Tesaro GSK, personal fees from Roche, outside the submitted work. The other authors do not declare conflicts of interests., (© IGCS and ESGO 2021. No commercial re-use. See rights and permissions. Published by BMJ.)

Background Few data are available on the outcome of surgery after a bevacizumab-containing regimen. The MITO 16A- MaNGO OV2A phase 4 trial evaluates the outcomes of first-line CPB in a clinical-practice-like setting. Here we present the results of the subgroup of patients undergoing IDS after neoadjuvant treatment or suboptimal primary surgery. Methods 400 chemonaïve epithelial ovarian cancer patients, age ≥ 18, ECOG PS 0–2 were eligible to receive C (AUC 5 d1, q21) plus P (175 mg/m 2 d1, q21) and B (15 mg/kg d1 q21) for 6 cycles followed by B maintenance until cycle 22nd. Results 79 patients (20%) underwent IDS. Overall, 74 patients received at least one administration of B before IDS. Median age was 61.2, 70% of the patients had FIGO IIIC disease. The median number of cycles before IDS was 3 both for chemotherapy and bevacizumab respectively. A residual disease ≤ 1 cm was achieved in 64 patients (86.5%). Four percent of the patients experienced fever and 4% required blood transfusion after surgery. Surgical wound infection and/or dehiscence, pelvic abscess, intestinal sub-occlusion and fistula were experienced by one patient each. Conclusions In the MITO16A-MaNGO OV2A phase 4 trial, combined chemotherapy and bevacizumab did not hamper IDS and the rate of perioperative complications was similar to what expected without bevacizumab. These data support the hypothesis that adding bevacizumab to first line chemotherapy for ovarian cancer might not be denied to patients for whom IDS is planned. [ABSTRACT FROM AUTHOR]