Detalle Publicación

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

Autores: González Martín, Antonio (Autor de correspondencia); Desauw, C.; Heitz, F.; Cropet, C.; Gargiulo, P.; Berger, R.; Ochi, H.; Vergote, I.; Colombo, N.; Mirza, M. R.; Tazi, Y.; Canzler, U.; Zamagni, C.; Guerra-Alia, E. M.; Levache, C. B.; Marme, F.; Bazán, F.; de Gregorio, N.; Dohollou, N.; Fasching, P. A.; Scambia, G.; Rubio-Pérez, M. J.; Milenkova, T.; Costan, C.; Pautier, P.; Ray-Coquard, I.
Título de la revista: EUROPEAN JOURNAL OF CANCER
ISSN: 0959-8049
Volumen: 174
Páginas: 221 - 231
Fecha de publicación: 2022
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 pre -specified 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 rando-mised 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 re-ported 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) polymer-ase 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 bevaci-zumab provided continued benefit beyond first progression, with a significant PFS2 improve-ment and a time to second subsequent therapy or death delay versus placebo plus bevacizumab.