RT Journal Article
T1 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.
A1 González-Martín, Antonio
A1 Desauw, Christophe
A1 Heitz, Florian
A1 Cropet, Claire
A1 Gargiulo, Piera
A1 Berger, Regina
A1 Ochi, Hiroyuki
A1 Vergote, Ignace
A1 Colombo, Nicoletta
A1 Mirza, Mansoor R
A1 Tazi, Youssef
A1 Canzler, Ulrich
A1 Zamagni, Claudio
A1 Guerra-Alia, Eva M
A1 Levaché, Charles B
A1 Marmé, Frederik
A1 Bazan, Fernando
A1 de Gregorio, Nikolaus
A1 Dohollou, Nadine
A1 Fasching, Peter A
A1 Scambia, Giovanni
A1 Rubio-Pérez, María J
A1 Milenkova, Tsveta
A1 Costan, Cristina
A1 Pautier, Patricia
A1 Ray-Coquard, Isabelle
A1 PAOLA1/ENGOT-ov25 investigators, 
K1 Antiangiogenic agent
K1 Bevacizumab
K1 Olaparib
K1 Ovarian cancer
K1 PARP inhibitor
K1 Second progression-free survival
AB 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. 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. 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. 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.
YR 2022
FD 2022-09-05
LK http://hdl.handle.net/10668/22178
UL http://hdl.handle.net/10668/22178
LA en
DS RISalud
RD Apr 14, 2025