Added by |
standudu |
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) |