Efficacy and safety of olaparib maintenance monotherapy for Japanese patients with platinum-sensitive relapsed ovarian, fallopian tube, and primary peritoneal cancer
Efficacy and safety of olaparib maintenance monotherapy for Japanese patients with platinum-sensitive relapsed ovarian, fallopian tube, and primary peritoneal cancer
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DOI：
10.1007/s10147-022-02212-x
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发表时间：
2022-07-15
影响因子：
3.3
通讯作者：
Aoki, Daisuke
中科院分区：
文献类型：
--
作者：
Yoshihama, Tomoko;Kuroda, Yuka;Aoki, Daisuke
背景自2018年4月以来，奥拉帕利维持疗法用于铂敏感的复发性卵巢癌已在日本获得批准。在这里，我们报告了在我们医院实施这种疗法的经验，目的是评估在日本人群中的疗效和安全性。方法52例对铂类药物敏感的复发性卵巢癌、输卵管癌和原发腹膜癌患者。所有患者开始服用奥拉帕利布，每日两次，每次300毫克。从病历中回溯收集有关治疗效果和不良反应的信息。结果中位年龄58岁(33~80岁)，高级别浆液性癌占82.7%。16例患者(30.8%)具有BRCA1/2致病变异体(15个胚系和1个组织)，3例(5.8%)具有未知意义的变异体(2个胚系和1个组织)，16例(30.8%)具有野生型，17例(32.7%)未分析。中位无进展生存期15.3个月(95%可信区间9.0~21.6)。BRCA1/2致病变异型患者的PFS明显长于野生型BRCA1/2患者(p=0.007)。病情进展导致34例患者停用奥拉帕利。18名患者(34.6%)表现为3级贫血，尽管他们在适当的治疗后恢复了健康。1例患者因长期肾功能不全而停用奥拉帕利。另一名患者出现3级疲劳，但在中断2周并继续奥拉帕利治疗后恢复。结论在日本人群中，奥拉帕利维持疗法治疗对铂敏感的复发性卵巢癌是足够安全的，其疗效不亚于以往研究的报道。
Background Olaparib maintenance therapy for platinum-sensitive relapsed ovarian cancer has been approved in Japan since April 2018. Here, we report the experience administering this therapy in our hospital, with the aim of evaluating efficacy and safety in the Japanese population. Methods The study included 52 patients with platinum-sensitive relapsed ovarian, fallopian tube, and primary peritoneal cancer. All patients started olaparib at a dose of 300 mg twice daily. Information about treatment efficacy and adverse effects was collected retrospectively from medical records. Results Median age was 58 years old (range: 33-80), and 82.7% of the patients were diagnosed with high-grade serous carcinoma. Sixteen patients (30.8%) possessed the BRCA1/2 pathogenic variant (15 germline and 1 tissue), 3 (5.8%) possessed variants of unknown significance (2 germline and 1 tissue), 16 (30.8%) possessed wild type, and 17 (32.7%) were not analyzed. Median progression-free survival was 15.3 months (95% CI 9.0-21.6). Patients with BRCA1/2 pathogenic variants showed significantly longer PFS than patients with wild-type BRCA1/2 (p = 0.007). Disease progression caused 34 cases to discontinue olaparib. Eighteen (34.6%) individuals exhibited >= grade 3 anemia, although they recovered in response to appropriate management. One patient discontinued olaparib because of prolonged renal dysfunction. Another patient presented with grade 3 fatigue, but recovered after 2 weeks of interruption and continued olaparib treatment. Conclusion Olaparib maintenance therapy for platinum-sensitive recurrent ovarian cancer in the Japanese population is sufficiently safe and no less effective than reports from previous studies.