Maintenance olaparib plus bevacizumab in patients with newly diagnosed advanced high-grade ovarian cancer: Main analysis of second progression-free survival in the phase III PAOLA-1/ENGOT-ov25 trial

González-Martín A, Desauw C, Heitz F, Cropet C, Gargiulo P, Berger R, Ochi H, Vergote I, Colombo N, Mirza MR, Tazi Y, Canzler U, Zamagni C, Guerra-Alia EM, Levaché CB, Marmé F, Bazan F, de Gregorio N, Dohollou N, Fasching P, Scambia G, Rubio-Pérez MJ, Milenkova T, Costan C, Pautier P, Ray-Coquard I (2022)

Publication Type: Journal article

Publication year: 2022

Journal

Book Volume: 174

Pages Range: 221-231

DOI: 10.1016/j.ejca.2022.07.022

Abstract

Background: PAOLA-1/ENGOT-ov25 (NCT02477644) demonstrated a significant progression-free survival (PFS) benefit with maintenance olaparib plus bevacizumab versus placebo plus bevacizumab in newly diagnosed, advanced ovarian cancer. We report the prespecified main second progression-free survival (PFS2) analysis for PAOLA-1. Methods: This randomised, double-blind, phase III trial was conducted in 11 countries. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were in response after first-line platinum-based chemotherapy plus bevacizumab. Patients were randomised 2:1 to olaparib (300 mg twice daily) or placebo for up to 24 months; all patients received bevacizumab (15 mg/kg every 3 weeks) for up to 15 months. Primary PFS end-point was reported previously. Time from randomisation to second disease progression or death was a key secondary end-point included in the hierarchical-testing procedure. Results: After a median follow-up of 35.5 months and 36.5 months, respectively, median PFS2 was 36.5 months (olaparib plus bevacizumab) and 32.6 months (placebo plus bevacizumab), hazard ratio 0.78; 95% confidence interval (CI) 0.64–0.95; P = 0.0125. Median time to second subsequent therapy or death was 38.2 months (olaparib plus bevacizumab) and 31.5 months (placebo plus bevacizumab), hazard ratio 0.78; 95% CI 0.64–0.95; P = 0.0115. Seventy-two (27%) patients in the placebo plus bevacizumab group received a poly(ADP-ribose) polymerase inhibitor as first subsequent therapy. No new safety signals were observed for olaparib plus bevacizumab. Conclusion: In newly diagnosed, advanced ovarian cancer, maintenance olaparib plus bevacizumab provided continued benefit beyond first progression, with a significant PFS2 improvement and a time to second subsequent therapy or death delay versus placebo plus bevacizumab.

Authors with CRIS profile

Involved external institutions

MD Anderson Cancer Center Madrid Spain (ES) Centre Hospitalier Régional Universitaire de Lille (CHRU de Lille) France (FR) Kliniken Essen-Mitte Germany (DE) Centre Léon-Bérard (UNICANCER) France (FR) Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" Italy (IT) Medizinische Universität Innsbruck Austria (AT) University of Tsukuba / 筑波大学 Japan (JP) University Hospital Leuven (UZ) / Universitaire ziekenhuizen Leuven Belgium (BE) European Institute of Oncology / Istituto Europeo di Oncologia (IEO) Italy (IT) Rigshospitalet Denmark (DK) Strasbourg Oncologie Libérale France (FR) Universitätsklinikum Carl Gustav Carus Dresden Germany (DE) Ospedaliero Universitaria di Bologna Policlinico S.Orsola-Malpighi Italy (IT) Hospital Universitario Ramón y Cajal Spain (ES) Hôpital Privé Francheville France (FR) Universitätsklinikum Mannheim Germany (DE) Centre hospitalier régional et universitaire de Besançon (CHRU Besancon) France (FR) SLK-Kliniken Heilbronn GmbH Germany (DE) Polyclinique Bordeaux Nord Aquitaine France (FR) Fondazione Policlinico Universitario Agostino Gemelli IRCCS Italy (IT) Hospital Universitario Reina Sofía de Córdoba Edificio IMIBIC Spain (ES) University of Cambridge United Kingdom (GB) Hôpital Albert Michallon France (FR) Institut Gustave-Roussy France (FR) Université Claude Bernard Lyon 1 (UCB) France (FR)

How to cite

APA:

González-Martín, A., Desauw, C., Heitz, F., Cropet, C., Gargiulo, P., Berger, R.,... Ray-Coquard, I. (2022). Maintenance olaparib plus bevacizumab in patients with newly diagnosed advanced high-grade ovarian cancer: Main analysis of second progression-free survival in the phase III PAOLA-1/ENGOT-ov25 trial. European Journal of Cancer, 174, 221-231. https://doi.org/10.1016/j.ejca.2022.07.022

MLA:

González-Martín, Antonio, et al. "Maintenance olaparib plus bevacizumab in patients with newly diagnosed advanced high-grade ovarian cancer: Main analysis of second progression-free survival in the phase III PAOLA-1/ENGOT-ov25 trial." European Journal of Cancer 174 (2022): 221-231.

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