Document Type

Article

Publication Title

Gynecologic oncology

Abstract

OBJECTIVE: To report long-term outcomes from the OVARIO trial of niraparib plus bevacizumab maintenance following first-line platinum-based chemotherapy with bevacizumab in advanced ovarian cancer.

METHODS: The phase 2, single-arm, open-label trial enrolled adult patients with stage IIIB-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer (NCT03326193). Patients were required to have attempted debulking surgery and have a complete or partial response or no evidence of disease following first-line, platinum-based chemotherapy with ≥3 cycles of bevacizumab. The primary endpoint was 18-month progression-free survival (PFS) rate, per RECIST. Secondary endpoints included PFS, overall survival (OS), safety, and health-related quality of life (HRQOL) as assessed by the Functional Assessment of Cancer Therapy-Ovarian Symptoms Index (FOSI). Final analysis cutoff date, August 12, 2024.

RESULTS: The median duration of follow-up was 65.7 months. Among evaluable patients (N = 105), PFS results were consistent with the primary analysis. Median OS (95% CI) was 61.1 months (44.9 months-not evaluable [NE]; 52.4% maturity) in the overall population, NE (58.2 months-NE) in the homologous recombination-deficient, 38.7 months (21.9-63.8 months) in the homologous recombination-proficient, and 39.8 months (21.7 months-NE) in the homologous recombination status not determined subgroups. Most patients (73.3%) received subsequent anticancer therapy; 30.5% received subsequent PARP inhibitor therapy. No new safety signals were identified; safety remained consistent with the primary analysis. Per FOSI, HRQOL was not negatively affected.

CONCLUSION: In OVARIO, median OS was 61.1 months in the overall population. Safety was consistent with known safety profiles of niraparib and bevacizumab as monotherapies.

First Page

96

Last Page

102

DOI

10.1016/j.ygyno.2025.06.014

Publication Date

8-1-2025

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