PMID- 27914243
OWN - NLM
STAT- MEDLINE
DCOM- 20170807
LR  - 20171230
IS  - 1879-0852 (Electronic)
IS  - 0959-8049 (Linking)
VI  - 70
DP  - 2017 Jan
TI  - Efficacy and safety of bevacizumab-containing neoadjuvant therapy followed by 
      interval debulking surgery in advanced ovarian cancer: Results from the ANTHALYA 
      trial.
PG  - 133-142
LID - S0959-8049(16)32482-0 [pii]
LID - 10.1016/j.ejca.2016.09.036 [doi]
AB  - 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.
CI  - Copyright (c) 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Rouzier, Roman
AU  - Rouzier R
AD  - Institut Curie, Saint-Cloud-Paris, UNiversite Versailles-Saint-Quentin, France. 
      Electronic address: roman.rouzier@curie.fr.
FAU - Gouy, Sebastien
AU  - Gouy S
AD  - Institut Gustave Roussy, Villejuif, France.
FAU - Selle, Frederic
AU  - Selle F
AD  - GHU-Est Tenon, Paris, France.
FAU - Lambaudie, Eric
AU  - Lambaudie E
AD  - Institut Paoli-Calmettes, Marseille, France.
FAU - Floquet, Anne
AU  - Floquet A
AD  - Institut Bergonie, Bordeaux, France.
FAU - Fourchotte, Virginie
AU  - Fourchotte V
AD  - Institut Curie, Saint-Cloud-Paris, UNiversite Versailles-Saint-Quentin, France.
FAU - Pomel, Christophe
AU  - Pomel C
AD  - Centre Jean Perrin, Clermont-Ferrand, France.
FAU - Colombo, Pierre-Emmanuel
AU  - Colombo PE
AD  - Institut regional du Cancer de Montpellier, Val d'Aurelle, Montpellier, France.
FAU - Kalbacher, Elsa
AU  - Kalbacher E
AD  - CHU Besancon, Besancon, France.
FAU - Martin-Francoise, Sandrine
AU  - Martin-Francoise S
AD  - Centre Francois Baclesse, Caen, France.
FAU - Fauvet, Raffaele
AU  - Fauvet R
AD  - CHU Amiens, Amiens, France.
FAU - Follana, Philippe
AU  - Follana P
AD  - Centre Antoine Lacassagne, Nice, France.
FAU - Lesoin, Anne
AU  - Lesoin A
AD  - Centre Oscar Lambret, Lille, France.
FAU - Lecuru, Fabrice
AU  - Lecuru F
AD  - European Hospital George Pompidou, Paris, France.
FAU - Ghazi, Youssef
AU  - Ghazi Y
AD  - Roche, Boulogne-Billancourt, France.
FAU - Dupin, Julien
AU  - Dupin J
AD  - ITM stat for Roche, Boulogne-Billancourt, France.
FAU - Chereau, Elisabeth
AU  - Chereau E
AD  - Institut Paoli-Calmettes, Marseille, France.
FAU - Zohar, Sarah
AU  - Zohar S
AD  - Centre de Recherche des Cordeliers, Universite Paris 5, Universite Paris 6, 
      Paris, France.
FAU - Cottu, Paul
AU  - Cottu P
AD  - Institut Curie, Saint-Cloud-Paris, UNiversite Versailles-Saint-Quentin, France.
FAU - Joly, Florence
AU  - Joly F
AD  - Centre Francois Baclesse, Caen, France. Electronic address: 
      f.joly@baclesse.unicancer.fr.
LA  - eng
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20161201
PL  - England
TA  - Eur J Cancer
JT  - European journal of cancer (Oxford, England : 1990)
JID - 9005373
RN  - 0 (Angiogenesis Inhibitors)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - BG3F62OND5 (Carboplatin)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - Adenocarcinoma/*drug therapy/*surgery
MH  - Adult
MH  - Aged
MH  - Angiogenesis Inhibitors/administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Bevacizumab/administration & dosage
MH  - Carboplatin/administration & dosage
MH  - *Cytoreduction Surgical Procedures
MH  - Female
MH  - Humans
MH  - Middle Aged
MH  - Neoadjuvant Therapy
MH  - Ovarian Neoplasms/*drug therapy/*surgery
MH  - Paclitaxel/administration & dosage
MH  - Peritoneal Neoplasms/drug therapy/surgery
OTO - NOTNLM
OT  - Bevacizumab
OT  - Interval debulking surgery
OT  - Neoadjuvant chemotherapy
EDAT- 2016/12/04 06:00
MHDA- 2017/08/08 06:00
CRDT- 2016/12/04 06:00
PHST- 2016/07/15 00:00 [received]
PHST- 2016/09/01 00:00 [revised]
PHST- 2016/09/26 00:00 [accepted]
PHST- 2016/12/04 06:00 [pubmed]
PHST- 2017/08/08 06:00 [medline]
PHST- 2016/12/04 06:00 [entrez]
AID - S0959-8049(16)32482-0 [pii]
AID - 10.1016/j.ejca.2016.09.036 [doi]
PST - ppublish
SO  - Eur J Cancer. 2017 Jan;70:133-142. doi: 10.1016/j.ejca.2016.09.036. Epub 2016 Dec 
      1.