2026-04-17T14:59:24Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/105342024-12-13T10:50:58Zcom_2072_378070com_2072_378040col_2072_378092

Atezolizumab Combined With Bevacizumab and Platinum-Based Therapy for Platinum-Sensitive Ovarian Cancer: Placebo-Controlled Randomized Phase III ATALANTE/ENGOT-ov29 Trial Kurtz, Jean-Emmanuel PUJADE-LAURAINE, Eric Belin, Lisa Leitner, Katharina OAKNIN, ANA Cibula, David Institut Català de la Salut [Kurtz JE] Department of Medical and Surgical Oncology & Hematology, ICANS, Strasbourg, France. [Pujade-Lauraine E] Association de Recherche sur les CAncers dont GYnécologiques (ARCAGY)-GINECO, Paris, France. [Oaknin A] Gynaecologic Cancer Programme, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Vall d’Hebron Hospital Universitari, Barcelona, Spain. [Belin L] Biostatistics and Public Health Department, Sorbonne Université, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique – Hôpitaux de Paris, Hôpitaux Universitaires Pitié Salpětriére – Charles Foix, Paris, France. [Leitner K] Gynecology and Obstetrics Department, Medical University of Innsbruck, Innsbruck, Austria. [Cibula D] Department of Obstetrics and Gynecology, General University Hospital in Prague, Charles University, Prague, Czech Republic Vall d'Hebron Barcelona Hospital Campus Platí Ovaris - Càncer - Tractament Anticossos monoclonals - Ús terapèutic DISEASES::Neoplasms::Neoplasms by Site::Endocrine Gland Neoplasms::Ovarian Neoplasms Other subheadings::Other subheadings::Other subheadings::/drug therapy CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Monoclonal CHEMICALS AND DRUGS::Inorganic Chemicals::Elements::Metals, Heavy::Platinum ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de las glándulas endocrinas::neoplasias ováricas Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos::anticuerpos monoclonales COMPUESTOS QUÍMICOS Y DROGAS::compuestos inorgánicos::elementos::metales pesados::platino (metal) Atezolizumab; Ovarian cancer; Platinum Atezolizumab; Càncer d'ovari; Platí Atezolizumab; Cáncer de ovario; Platino 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. 2023-10-30T07:48:39Z 2023-10-30T07:48:39Z 2023-10-20 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Kurtz JE, Pujade-Lauraine E, Oaknin A, Belin L, Leitner K, Cibula D, et al. Atezolizumab Combined With Bevacizumab and Platinum-Based Therapy for Platinum-Sensitive Ovarian Cancer: Placebo-Controlled Randomized Phase III ATALANTE/ENGOT-ov29 Trial. J Clin Oncol. 2023 Oct 20;41(30):4768–78. 1527-7755 https://hdl.handle.net/11351/10534 10.1200/JCO.23.00529 37643382 http://hdl.handle.net/11351/10534 eng Journal of Clinical Oncology;41(30) http://dx.doi.org/10.1200/JCO.23.00529 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess application/pdf American Society of Clinical Oncology Scientia