151. Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer.
- Author
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UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'oncologie médicale, Ray-Coquard, Isabelle, Pautier, Patricia, Pignata, Sandro, Pérol, David, González-Martín, Antonio, Berger, Regina, Fujiwara, Keiichi, Vergote, Ignace, Colombo, Nicoletta, Mäenpää, Johanna, Selle, Frédéric, Sehouli, Jalid, Lorusso, Domenica, Guerra Alía, Eva M, Reinthaller, Alexander, Nagao, Shoji, Lefeuvre-Plesse, Claudia, Canzler, Ulrich, Scambia, Giovanni, Lortholary, Alain, Marmé, Frederik, Combe, Pierre, de Gregorio, Nikolaus, Rodrigues, Manuel, Buderath, Paul, Dubot, Coraline, Burges, Alexander, You, Benoît, Pujade-Lauraine, Eric, Harter, Philipp, PAOLA-1 Investigators, D'Hondt, Lionel, UCL - SSS/IREC/MONT - Pôle Mont Godinne, UCL - (MGD) Service d'oncologie médicale, Ray-Coquard, Isabelle, Pautier, Patricia, Pignata, Sandro, Pérol, David, González-Martín, Antonio, Berger, Regina, Fujiwara, Keiichi, Vergote, Ignace, Colombo, Nicoletta, Mäenpää, Johanna, Selle, Frédéric, Sehouli, Jalid, Lorusso, Domenica, Guerra Alía, Eva M, Reinthaller, Alexander, Nagao, Shoji, Lefeuvre-Plesse, Claudia, Canzler, Ulrich, Scambia, Giovanni, Lortholary, Alain, Marmé, Frederik, Combe, Pierre, de Gregorio, Nikolaus, Rodrigues, Manuel, Buderath, Paul, Dubot, Coraline, Burges, Alexander, You, Benoît, Pujade-Lauraine, Eric, Harter, Philipp, PAOLA-1 Investigators, and D'Hondt, Lionel
- Abstract
Olaparib has shown significant clinical benefit as maintenance therapy in women with newly diagnosed advanced ovarian cancer with a mutation. The effect of combining maintenance olaparib and bevacizumab in patients regardless of mutation status is unknown. We conducted a randomized, double-blind, international phase 3 trial. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum-taxane chemotherapy plus bevacizumab. Patients were eligible regardless of surgical outcome or mutation status. Patients were randomly assigned in a 2:1 ratio to receive olaparib tablets (300 mg twice daily) or placebo for up to 24 months; all the patients received bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks for up to 15 months in total. The primary end point was the time from randomization until investigator-assessed disease progression or death. Of the 806 patients who underwent randomization, 537 were assigned to receive olaparib and 269 to receive placebo. After a median follow-up of 22.9 months, the median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab (hazard ratio for disease progression or death, 0.59; 95% confidence interval [CI], 0.49 to 0.72; P<0.001). The hazard ratio (olaparib group vs. placebo group) for disease progression or death was 0.33 (95% CI, 0.25 to 0.45) in patients with tumors positive for homologous-recombination deficiency (HRD), including tumors that had mutations (median progression-free survival, 37.2 vs. 17.7 months), and 0.43 (95% CI, 0.28 to 0.66) in patients with HRD-positive tumors that did not have mutations (median progression-free survival, 28.1 vs. 16.6 months). Adverse events were consistent with the established safety profiles of olaparib and bevacizumab. In patients with advanced ovarian cancer receiving first-line standard therapy including bevacizumab, the addition of maintenan
- Published
- 2019