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Olaparib plus bevacizumab as maintenance therapy in patients with newly diagnosed, advanced ovarian cancer: Japan subset from the PAOLA-1/ENGOT-ov25 trial
- Source :
- Journal of Gynecologic Oncology
- Publication Year :
- 2021
-
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. Trial Registration: ClinicalTrials.gov Identifier: NCT02477644
- Subjects :
- Oncology
medicine.medical_specialty
PAOLA-1
Bevacizumab
Population
Newly Diagnosed Advanced Ovarian Cancer
Placebo
Piperazines
Olaparib
chemistry.chemical_compound
Maintenance therapy
Double-Blind Method
Japan
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Clinical endpoint
Humans
education
Homologous Recombination Deficiency
Ovarian Neoplasms
education.field_of_study
business.industry
Hazard ratio
Ovary
Obstetrics and Gynecology
General Medicine
chemistry
Tolerability
Phthalazines
Female
Original Article
business
BRCA Mutation
medicine.drug
Subjects
Details
- ISSN :
- 20050399
- Volume :
- 32
- Issue :
- 5
- Database :
- OpenAIRE
- Journal :
- Journal of gynecologic oncology
- Accession number :
- edsair.doi.dedup.....6555cab0f667a29bb32ec3d235aa81ef