J Gynecol Oncol.  2021 Sep;32(5):e82. 10.3802/jgo.2021.32.e82.

Olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer: Japan subset from the PAOLA-1/ENGOT-ov25 trial

• Fujiwara K
• Fujiwara H
• Yoshida H
• Satoh T
• Yonemori K
• Nagao S
• Matsumoto T
• Kobayashi H
• Bourgeois H
• Harter P
• Mosconi AM
• Vazquez IP
• Reinthaller A
• Fujita T
• Rowe P
• Pujade-Lauraine E
• Ray-Coquard I

• KMID: 2526133
• DOI: http://doi.org/10.3802/jgo.2021.32.e82

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.

Keyword

Newly Diagnosed Advanced Ovarian Cancer; PAOLA-1; Olaparib; Bevacizumab; BRCA Mutation; Homologous Recombination Deficiency