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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

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 (P...

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Main Authors: González Martín, Antonio (Author) , Desauw, Christophe (Author) , Heitz, Florian (Author) , Cropet, Claire (Author) , Gargiulo, Piera (Author) , Berger, Regina (Author) , Ochi, Hiroyuki (Author) , Vergote, Ignace (Author) , Colombo, Nicoletta (Author) , Mirza, Mansoor R. (Author) , Tazi, Youssef (Author) , Canzler, Ulrich (Author) , Zamagni, Claudio (Author) , Guerra-Alia, Eva M. (Author) , Levaché, Charles B. (Author) , Marmé, Frederik (Author) , Bazan, Fernando (Author) , de Gregorio, Nikolaus (Author) , Dohollou, Nadine (Author) , Fasching, Peter A. (Author) , Scambia, Giovanni (Author) , Rubio-Pérez, María J. (Author) , Milenkova, Tsveta (Author) , Costan, Cristina (Author) , Pautier, Patricia (Author) , Ray-Coquard, Isabelle (Author)
Format: Article (Journal)
Language:English
Published: 5 September 2022
In: European journal of cancer
Year: 2022, Volume: 174, Pages: 221-231
ISSN:1879-0852
DOI:10.1016/j.ejca.2022.07.022
Online Access:Verlag, lizenzpflichtig, Volltext: https://doi.org/10.1016/j.ejca.2022.07.022
Verlag, lizenzpflichtig, Volltext: https://www.sciencedirect.com/science/article/pii/S0959804922004476
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Author Notes:Antonio González-Martín, Christophe Desauw, Florian Heitz, Claire Cropet, Piera Gargiulo, Regina Berger, Hiroyuki Ochi, Ignace Vergote, Nicoletta Colombo, Mansoor R. Mirza, Youssef Tazi, Ulrich Canzler, Claudio Zamagni, Eva M. Guerra-Alia, Charles B. Levaché, Frederik Marmé, Fernando Bazan, Nikolaus de Gregorio, Nadine Dohollou, Peter A. Fasching, Giovanni Scambia, María J. Rubio-Pérez, Tsveta Milenkova, Cristina Costan, Patricia Pautier, Isabelle Ray-Coquard on behalf ofthe PAOLA1/ENGOT-ov25 investigators
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Summary: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.
Item Description:Gesehen am 12.01.2023
Physical Description:Online Resource
ISSN:1879-0852
DOI:10.1016/j.ejca.2022.07.022

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