| Added by | pcoopman |
|---|---|
| Group name | EquipePC |
| Item Type | Journal Article |
| Title | Atezolizumab Combined With Bevacizumab and Platinum-Based Therapy for Platinum-Sensitive Ovarian Cancer: Placebo-Controlled Randomized Phase III ATALANTE/ENGOT-ov29 Trial |
| Creator | Kurtz et al. |
| Author | Jean-Emmanuel Kurtz |
| Author | Eric Pujade-Lauraine |
| Author | Ana Oaknin |
| Author | Lisa Belin |
| Author | Katharina Leitner |
| Author | David Cibula |
| Author | Hannelore Denys |
| Author | Ora Rosengarten |
| Author | Manuel Rodrigues |
| Author | Nikolaus de Gregorio |
| Author | Jeronimo Martinez García |
| Author | Edgar Petru |
| Author | Roman Kocián |
| Author | Ignace Vergote |
| Author | Patricia Pautier |
| Author | Barbara Schmalfeldt |
| Author | Lydia Gaba |
| Author | Stephan Polterauer |
| Author | Marie-Ange Mouret Reynier |
| Author | Jalid Sehouli |
| Author | Cristina Churruca |
| Author | Frédéric Selle |
| Author | Florence Joly |
| Author | Véronique D'Hondt |
| Author | Émilie Bultot-Boissier |
| Author | Coriolan Lebreton |
| Author | Jean-Pierre Lotz |
| Author | Rémy Largillier |
| Author | Pierre-Etienne Heudel |
| Author | Florian Heitz |
| Abstract | PURPOSE: Platinum-based doublets with concurrent and maintenance bevacizumab are standard therapy for ovarian cancer (OC) relapsing after a platinum-free interval (PFI) >6 months. Immunotherapy may be synergistic with bevacizumab and chemotherapy. PATIENTS AND METHODS: ATALANTE/ENGOT-ov29 (ClinicalTrials.gov identifier: NCT02891824), a placebo-controlled double-blinded randomized phase III trial, enrolled patients with recurrent epithelial OC, one to two previous chemotherapy lines, and PFI >6 months. Eligible patients were randomly assigned 2:1 to atezolizumab (1,200 mg once every 3 weeks or equivalent) or placebo for up to 24 months, combined with bevacizumab and six cycles of chemotherapy doublet, stratified by PFI, PD-L1 status, and chemotherapy regimen. Coprimary end points were investigator-assessed progression-free survival (PFS) in the intention-to-treat (ITT) and PD-L1-positive populations (alpha .025 for each population). RESULTS: Between September 2016 and October 2019, 614 patients were randomly assigned: 410 to atezolizumab and 204 to placebo. Only 38% had PD-L1-positive tumors. After 3 years' median follow-up, the PFS difference between atezolizumab and placebo did not reach statistical significance in the ITT (hazard ratio [HR], 0.83; 95% CI, 0.69 to 0.99; P = .041; median 13.5 v 11.3 months, respectively) or PD-L1-positive (HR, 0.86; 95% CI, 0.63 to 1.16; P = .30; median 15.2 v 13.1 months, respectively) populations. The immature overall survival (OS) HR was 0.81 (95% CI, 0.65 to 1.01; median 35.5 v 30.6 months with atezolizumab v placebo, respectively). Global health-related quality of life did not differ between treatment arms. Grade ?3 adverse events (AEs) occurred in 88% of atezolizumab-treated and 87% of placebo-treated patients; grade ?3 AEs typical of immunotherapy were more common with atezolizumab (13% v 8%, respectively). CONCLUSION: ATALANTE/ENGOT-ov29 did not meet its coprimary PFS objectives in the ITT or PD-L1-positive populations. OS follow-up continues. Further research on biopsy samples is warranted to decipher the immunologic landscape of late-relapsing OC. |
| Publication | Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology |
| Volume | 41 |
| Issue | 30 |
| Pages | 4768-4778 |
| Date | 2023-10-20 |
| Journal Abbr | J Clin Oncol |
| Language | eng |
| DOI | 10.1200/JCO.23.00529 |
| ISSN | 1527-7755 |
| Short Title | Atezolizumab Combined With Bevacizumab and Platinum-Based Therapy for Platinum-Sensitive Ovarian Cancer |
| Library Catalog | PubMed |
| Extra | PMID: 37643382 PMCID: PMC10602539 |
| Tags | Antineoplastic Combined Chemotherapy Protocols, B7-H1 Antigen, Bevacizumab, Carcinoma, Ovarian Epithelial, clinic, Female, Humans, Neoplasm Recurrence, Local, Ovarian Neoplasms, Platinum, Quality of Life |
| Date Added | 2023/11/20 - 17:06:42 |
| Date Modified | 2023/11/20 - 17:06:58 |
| Notes and Attachments | PubMed entry (Attachment) Texte intégral (Attachment) |
Institut de Recherche en Cancérologie de
