Treatment With Niraparib Maintenance Therapy in Patients With Newly Diagnosed Advanced Ovarian Cancer

作者：Ning Li, Jianqing Zhu, Rutie Yin, Jing Wang, Lingya Pan, Beihua Kong, Hong Zheng, Jihong Liu, Xiaohua Wu, Li Wang, Yi Huang, Ke Wang, Dongling Zou, Hongqin Zhao, Chunyan Wang, Weiguo Lü, Lin An, Ge Lou, Guiling Li, Pengpeng Qu, Hongying Yang, Yu Zhang, Hongbing Cai, Yueyin Pan, Min Hao, Ziling Liu, Heng Cui, Yingjie Yang, Shuzhong Yao, Xiaoa Zhen, Wenzhao Hang, Jianmei Hou, Juan Wang, Lingying Wu · 发表于：JAMA Oncology · 年份：2023 · DOI：10.1001/jamaoncol.2023.2283 · 被引用次数：165 · 研究领域：PARP inhibition in cancer therapy、Advanced Breast Cancer Therapies、Ovarian cancer diagnosis and treatment

Importance: The efficacy of niraparib maintenance therapy with an individualized starting dose (ISD) warrants further investigation in a broad population with newly diagnosed advanced ovarian cancer (aOC), including patients without postoperative residual disease. Objective: To evaluate the efficacy and safety of niraparib with an ISD in a broad population with newly diagnosed aOC (R0 resection permitted). Design, Setting, and Participants: This multicenter, randomized, double-blind, placebo-controlled, phase 3 study was conducted in China and enrolled 384 patients with newly diagnosed aOC who received primary or interval debulking surgery and responded to treatment with first-line platinum-based chemotherapy. By data cutoff (September 30, 2021), median follow-up for progression-free survival (PFS) was 27.5 (IQR, 24.7-30.4) months. Interventions: Patients were randomized 2:1 to receive niraparib or placebo with ISD (200 mg/d for those with a body weight of <77 kg and/or platelet count of <150 ×103/μL [to convert to ×109/μL, multiply by 1] at baseline; 300 mg/d otherwise) stratified by germline BRCA variant status, tumor homologous recombination deficiency status, neoadjuvant chemotherapy, and response to first-line platinum-based chemotherapy. Main Outcomes and Measurements: The primary end point was blinded, independent central review-assessed PFS in the intention-to-treat population. Results: A total of 384 patients were randomized (255 niraparib [66.4%]; median [range] age...