Phase 2 single-arm study on the safety of maintenance niraparib in japanese patients with platinum-sensitive relapsed ovarian cancer

Kazuhiro Takehara, Takashi Matsumoto, Junzo Hamanishi, Kosei Hasegawa, Motoki Matsuura, Kiyonori Miura, Shoji Nagao, Hidekatsu Nakai, Naotake Tanaka, Hideki Tokunaga, Kimio Ushijima, Hidemichi Watari, Yoshihito Yokoyama, Yoichi Kase, Shuuji Sumino, Ajit Suri, Hiroaki Itamochi, Nobuhiro Takeshima

研究成果: Article査読

3 被引用数 (Scopus)

抄録

Objective: The primary objective of this study was to evaluate the safety of niraparib 300 mg/day in Japanese patients with platinum-sensitive, relapsed ovarian cancer in a maintenance setting. Methods: Phase 2, multicenter, open-label, single-arm study enrolled Japanese patients with platinum-sensitive, relapsed ovarian cancer who had received ≥2 platinum-based regimens. The primary endpoint (incidence of grade 3 or 4 thrombocytopenia-related events within 30 days after initial niraparib administration) was justified by the incidences of a global pivotal phase 3 study and its post-hoc safety analysis on thrombocytopenia, the major hematological adverse event of niraparib. The overall safety analysis examined other treatment-emergent adverse events (TEAEs). Results: Enrolled patients (n=19) had a median (min, max) body weight of 53.9 (40.8–79.1) kg; all but one patient weighed <77 kg. Most (94.7%) patients initially received niraparib 300 mg/day but this decreased in subsequent cycles (mean±standard deviation dose intensity, 191.6±65.7 mg/day). In total, 6/19 (31.6%) patients experienced grade 3 or 4 thrombocytopenia-related events within 30 days of initial niraparib administration. Other common TEAEs included nausea, and decreased platelet or neutrophil counts. No progression-free or overall survival events occurred; only 1 of 4 response-evaluable patients had a post-baseline tumor assessment (stable disease). Conclusion: The incidence of grade 3 or 4 thrombocytopenia-related events in Japanese ovarian cancer patients was similar to that in the corresponding non-Japanese study. Overall, the safety profile was acceptable and consistent with the known safety profile and previous experience with niraparib. Trial Registration: ClinicalTrials.gov Identifier: NCT03759587.

本文言語English
論文番号e21
ページ(範囲)1-11
ページ数11
ジャーナルJournal of gynecologic oncology
32
2
DOI
出版ステータスPublished - 2021

ASJC Scopus subject areas

  • 腫瘍学
  • 産婦人科学

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