title: Efficacy and safety of bevacizumab-containing neoadjuvant therapy followed by interval debulking surgery in advanced ovarian cancer: Results from the ANTHALYA trial.
abstract: 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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
authors.affiliation: Institut Curie, Saint-Cloud-Paris, UNiversité Versailles-Saint-Quentin, France. Electronic address: roman.rouzier@curie.fr.
authors.forename: Roman
authors.initials: R
authors.lastname: Rouzier
authors.affiliation: Institut Gustave Roussy, Villejuif, France.
authors.forename: Sébastien
authors.initials: S
authors.lastname: Gouy
authors.affiliation: GHU-Est Tenon, Paris, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Selle
authors.affiliation: Institut Paoli-Calmettes, Marseille, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Lambaudie
authors.affiliation: Institut Bergonié, Bordeaux, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Floquet
authors.affiliation: Institut Curie, Saint-Cloud-Paris, UNiversité Versailles-Saint-Quentin, France.
authors.forename: Virginie
authors.initials: V
authors.lastname: Fourchotte
authors.affiliation: Centre Jean Perrin, Clermont-Ferrand, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Pomel
authors.affiliation: Institut régional du Cancer de Montpellier, Val d'Aurelle, Montpellier, France.
authors.forename: Pierre-Emmanuel
authors.initials: PE
authors.lastname: Colombo
authors.affiliation: CHU Besançon, Besançon, France.
authors.forename: Elsa
authors.initials: E
authors.lastname: Kalbacher
authors.affiliation: Centre François Baclesse, Caen, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Martin-Francoise
authors.affiliation: CHU Amiens, Amiens, France.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Fauvet
authors.affiliation: Centre Antoine Lacassagne, Nice, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Follana
authors.affiliation: Centre Oscar Lambret, Lille, France.
authors.forename: Anne
authors.initials: A
authors.lastname: Lesoin
authors.affiliation: European Hospital George Pompidou, Paris, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Lecuru
authors.affiliation: Roche, Boulogne-Billancourt, France.
authors.forename: Youssef
authors.initials: Y
authors.lastname: Ghazi
authors.affiliation: ITM stat for Roche, Boulogne-Billancourt, France.
authors.forename: Julien
authors.initials: J
authors.lastname: Dupin
authors.affiliation: Institut Paoli-Calmettes, Marseille, France.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Chereau
authors.affiliation: Centre de Recherche des Cordeliers, Université Paris 5, Université Paris 6, Paris, France.
authors.forename: Sarah
authors.initials: S
authors.lastname: Zohar
authors.affiliation: Institut Curie, Saint-Cloud-Paris, UNiversité Versailles-Saint-Quentin, France.
authors.forename: Paul
authors.initials: P
authors.lastname: Cottu
authors.affiliation: Centre François Baclesse, Caen, France. Electronic address: f.joly@baclesse.unicancer.fr.
authors.forename: Florence
authors.initials: F
authors.lastname: Joly
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000601:surgery*; D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage; D016190:Carboplatin / Q000008:administration & dosage; D065426:Cytoreduction Surgical Procedures; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000601:surgery*; D017239:Paclitaxel / Q000008:administration & dosage; D010534:Peritoneal Neoplasms / Q000188:drug therapy / Q000601:surgery
chemical_list: D020533:Angiogenesis Inhibitors; D000068258:Bevacizumab; D016190:Carboplatin; D017239:Paclitaxel
keywords: Bevacizumab; Interval debulking surgery; Neoadjuvant chemotherapy