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Group name EquipeCTCS
Item Type Journal Article
Title Efficacy and safety of bevacizumab-containing neoadjuvant therapy followed by interval debulking surgery in advanced ovarian cancer: Results from the ANTHALYA trial
Creator Rouzier et al.
Author Roman Rouzier
Author Sébastien Gouy
Author Frédéric Selle
Author Eric Lambaudie
Author Anne Floquet
Author Virginie Fourchotte
Author Christophe Pomel
Author Pierre-Emmanuel Colombo
Author Elsa Kalbacher
Author Sandrine Martin-Francoise
Author Raffaele Fauvet
Author Philippe Follana
Author Anne Lesoin
Author Fabrice Lecuru
Author Youssef Ghazi
Author Julien Dupin
Author Elisabeth Chereau
Author Sarah Zohar
Author Paul Cottu
Author Florence Joly
Abstract AIM: To 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. METHODS: Multicentre, 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. RESULTS: In 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. CONCLUSION: The 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.
Publication European Journal of Cancer (Oxford, England: 1990)
Volume 70
Pages 133-142
Date 01 2017
Journal Abbr Eur. J. Cancer
Language eng
DOI 10.1016/j.ejca.2016.09.036
ISSN 1879-0852
Short Title Efficacy and safety of bevacizumab-containing neoadjuvant therapy followed by interval debulking surgery in advanced ovarian cancer
Library Catalog PubMed
Extra PMID: 27914243
Tags Adenocarcinoma, Adult, Aged, Angiogenesis Inhibitors, Antineoplastic Combined Chemotherapy Protocols, Bevacizumab, Carboplatin, clinic, Cytoreduction Surgical Procedures, Female, Humans, Interval debulking surgery, Middle Aged, Neoadjuvant chemotherapy, Neoadjuvant Therapy, Ovarian Neoplasms, Paclitaxel, Peritoneal Neoplasms
Date Added 2019/05/31 - 16:39:58
Date Modified 2019/05/31 - 16:40:10
Notes and Attachments PubMed entry (Attachment)


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