• Roman Rouzier, Sébastien Gouy, Frédéric Selle, Eric Lambaudie, Anne Floquet, Virginie Fourchotte, Christophe Pomel, Pierre-Emmanuel Colombo, Elsa Kalbacher, Sandrine Martin-Francoise, Raffaele Fauvet, Philippe Follana, Anne Lesoin, Fabrice Lecuru, Youssef Ghazi, Julien Dupin, Elisabeth Chereau, Sarah Zohar, Paul Cottu, and Florence Joly.
• Institut Curie, Saint-Cloud-Paris, UNiversité Versailles-Saint-Quentin, France. Electronic address: roman.rouzier@curie.fr.
• Eur. J. Cancer. 2017 Jan 1; 70: 133-142.

AimTo investigate whether adding bevacizumab to neoadjuvant carboplatin-paclitaxel (CP) helps achieve optimal debulking, measured by complete resection rate (CRR) at interval debulking surgery (IDS), in patients with initially unresectable International Federation of Gynecology and Obstetrics stage IIIC/IV ovarian, tubal or peritoneal adenocarcinoma.MethodsMulticentre, open-label, non-comparative phase II study. Ninety-five patients randomised (2:1) to receive four cycles of neoadjuvant CP ±3 concomitant cycles of bevacizumab 15 mg/kg (BCP) followed by IDS. Primary objective is to evaluate the CRR at IDS in the BCP group (reference CRR rate defined as 45% CRR). A stopping rule based on bevacizumab-related adverse events (AEs) of special interest was implemented.ResultsIn the BCP group (N = 58), IDS was performed in 40 (69%) patients, of whom 85% had a complete resection. The CRR of this group was therefore 58.6% (34 patients), statistically over pre-defined 45%. The CRR in the CP group was 51.4%: 22 (60%) patients underwent IDS (85% had a complete resection). Grade ≥3 adverse events occurred in 62% of the BCP-treated patients and 63% of the CP-treated patients: mainly blood and lymphatic, gastrointestinal and vascular disorders, without more toxicity with BCP. Postoperative complications (mainly wound, infectious and gastrointestinal complications) occurred in 28% and 36% of the patients, respectively. The pre-specified safety stopping rule was not reached.ConclusionThe primary objective was met as the CRR with BCP was significantly higher than the reference rate. Bevacizumab may be safely added to a preoperative program in patients deemed non-optimally resectable, whatever the final surgical decision. Bevacizumab's role in this setting should be further investigated.Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

28 keywords...

hide…