Olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer: Japan subset from the PAOLA-1/ENGOT-ov25 trial
- Author:
Keiichi FUJIWARA
1
;
Hiroyuki FUJIWARA
;
Hiroyuki YOSHIDA
;
Toyomi SATOH
;
Kan YONEMORI
;
Shoji NAGAO
;
Takashi MATSUMOTO
;
Hiroaki KOBAYASHI
;
Hughes BOURGEOIS
;
Philipp HARTER
;
Anna Maria MOSCONI
;
Isabel Palacio VAZQUEZ
;
Alexander REINTHALLER
;
Tomoko FUJITA
;
Philip ROWE
;
Eric PUJADE-LAURAINE
;
Isabelle RAY-COQUARD
Author Information
- Publication Type:Original Article
- From:Journal of Gynecologic Oncology 2021;32(5):e82-
- CountryRepublic of Korea
- Language:English
-
Abstract:
Objective:The addition of maintenance olaparib to bevacizumab demonstrated a significant progression-free survival (PFS) benefit in patients with newly diagnosed, advanced ovarian cancer in the PAOLA-1/ENGOT-ov25 trial (NCT02477644). We evaluated maintenance olaparib plus bevacizumab in the Japan subset of PAOLA-1.
Methods:PAOLA-1 was a randomized, double-blind, phase III trial. Patients received maintenance olaparib tablets 300 mg twice daily or placebo twice daily for up to 24 months, plus bevacizumab 15 mg/kg every 3 weeks for up to 15 months in total. This prespecified subgroup analysis evaluated investigator-assessed PFS (primary endpoint).
Results:Of 24 randomized Japanese patients, 15 were assigned to olaparib and 9 to placebo. After a median follow-up for PFS of 27.7 months for olaparib plus bevacizumab and 24.0 months for placebo plus bevacizumab, median PFS was 27.4 versus 19.4 months, respectively (hazard ratio [HR]=0.34; 95% confidence interval [CI]=0.11–1.00). In patients with tumors positive for homologous recombination deficiency, the HR for PFS was 0.57 (95% CI=0.16–2.09). Adverse events in the Japan subset were generally consistent with those of the PAOLA-1 overall population and with the established safety and tolerability profiles of olaparib and bevacizumab.
Conclusion:
Results:in the Japan subset of PAOLA-1 support the overall conclusion of the PAOLA-1 trial demonstrating that the addition of maintenance olaparib to bevacizumab provides a PFS benefit in patients with newly diagnosed, advanced ovarian cancer.
