Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Complete resection rate at interval debulking surgery after bevacizumab containing neoadjuvant therapy: primary objective of the ANTHALYA trial

Date

08 Oct 2016

Session

Gynaecological cancers

Presenters

Roman Rouzier

Citation

Annals of Oncology (2016) 27 (6): 296-312. 10.1093/annonc/mdw374

Authors

R. Rouzier1, S. Gouy2, F. Selle3, F. Guyon4, E. Lambaudie5, V. Fourchotte6, C. Pomel7, P. Colombo8, E. Kalbacher9, S. Martin-Francoise10, R. Fauvet11, P. Follana12, A. Lesoin13, F. Lecuru14, Y. Ghazi15, J. Dupin15, E. Chereau5, S. Zohar16, P. Cottu17, F. Joly18

Author affiliations

  • 1 Surgery, Curie, 92210 - St-Cloud/FR
  • 2 Service De Chirurgie Générale, Gustave Roussy, Villejuif/FR
  • 3 Medical Oncology, APHP, CancerEst, Tenon University Hospital, Paris/FR
  • 4 Surgery, Institute Bergonié, Bordeaux/FR
  • 5 Chirurgie Oncologique, Institute Paoli Calmettes, 13274 - Marseille/FR
  • 6 Surgical Oncology, Institut Curie, Paris/FR
  • 7 Surgery, Centre Jean Perrin, Clermont-Ferrand/FR
  • 8 Surgery, ICM Regional Cancer Institute of Montpellier, Montpellier/FR
  • 9 Surgery, CHU Besançon, Hôpital Jean Minjoz, Besançon/FR
  • 10 Surgery, Centre Francois Baclesse, Caen/FR
  • 11 Gynecology, CHU Amiens-Picardie, Amiens/FR
  • 12 Medical Oncology, Centre Antoine Lacassagne, Nice/FR
  • 13 Département De Gynécologie, Centre Oscar Lambret, Lille/FR
  • 14 Gynecology, Hopital European George Pompidou, Paris/FR
  • 15 Medical Affairs, Roche, Boulogne-Billancourt/FR
  • 16 U1138, Team 22, Inserm, Paris/FR
  • 17 Medical Oncology, Institut Curie, 75248 - Paris/FR
  • 18 Medical Oncology, Centre Francois Baclesse, Caen/FR
More

Resources

Abstract 2551

Background

Previously reported safety data from ANTHALYA indicated that adding 3 cycles of bevacizumab (B) to neoadjuvant carboplatin and paclitaxel (CP) was feasible in FIGO stage IIIc/IV ovarian, tubal or peritoneal adenocarcinoma, initially deemed unresectable. BCP had a good safety profile and a pre-specified stopping rule for toxicity based on Bev-related adverse events (AEs) of special interest was not reached. Here, we evaluated if BCP could help to achieve optimal debulking, as measured by the complete resection rate (CRR) at interval debulking surgery (IDS).

Methods

In this multicenter, open-label, randomized non comparative Phase II study, patients were randomized 2:1 to 4 cycles of neoadjuvant CP ±3 cycles of B (15 mg/kg). IDS was scheduled 28 ±7 days after the last neoadjuvant treatment course. The primary objective was to assess the superiority of the CRR at IDS (defined as a Completeness of Cytoreduction score [CC] of 0) in the BCP group compared to a reference rate of 45% (Vergote et al. N Engl J Med 2010;363:943-53) using the Fleming A'Hern method (p0 = 45%; p1 = 65%; α = 5%; � = 10%).

Results

205 patients were screened at 15 French sites and 95 were randomized and included in the modified intention to treat population. Median age was 63 years, 92% had ECOG-PS 0/1, with 70% FIGO stage IIIc and 30% stage IV tumors. In the BCP group (58 patients) the CRR at IDS was 58.6% (34 patients) with a lower confidence limit of 47.0%, significantly higher than the prespecified minimum threshold of 45%. IDS was performed in 69% (40 patients) of whom 85% had a complete resection. The CRR was 63.5% in patients with ≥2 cycles of Bev (52 patients). In the CP group (37 patients), IDS was done in 22 (60%) patients with a CRR of 51.4%.

Conclusions

The study primary objective was met as the CRR was significantly higher than the previously reported reference rate. Adding Bev to neoadjuvant CP achieved an encouraging CRR at IDS in patients with initially unresectable FIGO stage IIIc/IV ovarian, tubal or peritoneal adenocarcinoma.

Clinical trial identification

NCT01739218

Legal entity responsible for the study

Roche

Funding

Roche

Disclosure

R. Rouzier: Advisory board. S. Gouy, F. Selle, C. Pomel, E. Chereau, P. Cottu, F. Joly: Board Y. Ghazi, J. Dupin: Employee. All other authors have declared no conflicts of interest.

Resources from the same session

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings