Niraparib的日本患者有大量预处理，同源重组缺陷型卵巢癌：多中心2期研究的最终结果
Niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer: final results of a multicenter phase 2 study
影响因子:3.70000
分区:医学2区 / 妇产科学3区 肿瘤学3区
发表日期:2024 Sep
作者:
Daisuke Aoki, Tsutomu Tabata, Satoshi Yanagida, Toshiaki Nakamura, Eiji Kondo, Junzo Hamanishi, Kenichi Harano, Kosei Hasegawa, Takeshi Hirasawa, Kensuke Hori, Shinichi Komiyama, Motoki Matsuura, Hidekatsu Nakai, Hiroko Nakamura, Jun Sakata, Kazuhiro Takehara, Munetaka Takekuma, Yoshihito Yokoyama, Yoichi Kase, Shuuji Sumino, Junpei Soeda, Ai Kato, Ajit Suri, Aikou Okamoto, Toru Sugiyama
摘要
评估Niraparib对日本卵巢癌的日本女性的长期疗效和安全性。这是对2期，多中心，开放标签，单臂单臂研究的后续分析，对日本女性，具有同源性重组缺陷，铂敏感性，铂敏感性，高级，高级的纯种卵巢卵形卵形卵形卵形卵形，或者是高级纯种卵形的效果，或者化学疗法线和聚（ADP-核糖）聚合酶抑制剂幼稚。参与者每天在连续的28天周期中每天接受一次Niraparib（起始剂量，300 mg），直到客观疾病进展，不可接受的毒性或同意戒断。正如使用实体瘤版本1.1的响应评估标准评估的主要终点（ORR）确认了目标响应率（ORR）。安全评估包括治疗急性不良事件（TEAES）.20患者参与了研究，并包括在功效和安全分析中。总研究持续时间中位数为759.5天。中位剂量强度为201.3毫克/天。确认的ORR为60.0％（90％置信区间[CI] = 39.4-78.3）; 2名患者有完全反应，10例患者有部分反应。中位反应持续时间为9.9个月（95％CI = 3.9-26.9），疾病控制率为90.0％（95％CI = 68.3-98.8）。最常见的茶是贫血（n = 15），恶心（n = 12）和血小板计数降低（n = 11）。据报道，导致研究药物剂量降低，中断或中断的茶据报道，分别为16（80.0％），15（75.0％）和2例患者（10.0％）。Niraparib的长期疗效和安全性与非犹太人患者的先前发现相一致。尚未确定新的安全信号。ClinicalTrials.gov标识符：NCT03759600。
Abstract
To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer.This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3-4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs).20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4-78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9-26.9) and the disease control rate was 90.0% (95% CI=68.3-98.8). The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively.The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified.ClinicalTrials.gov Identifier: NCT03759600.