Department of Gynecologic Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, 42# Baiziting street, Nanjing, Jiangsu, 210009, People's Republic of China.
Department of Chemotherapy, Nanjing Medical University Affiliated Cancer Hospital, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, 42# Baiziting street, Nanjing, Jiangsu, 210009, People's Republic of China.
J Ovarian Res. 2021 May 17;14(1):68. doi: 10.1186/s13048-021-00803-2.
Niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, is approved for first/second-line maintenance treatment of ovarian cancer patients with complete or partial response to platinum-based chemotherapy, and multi-line monotherapy in BRCAmt patients or platinum-sensitive recurrence patients with homologous recombination deficiency (HRD). We present real-world experience from a single center of China.
Patients treated with niraparib in Jiangsu Cancer Hospital between June 2019 to July 2020 were recruited. The initial dose was given according to individualization. Response and adverse events (AEs) were analyzed by Response Evaluation Criteria in Solid Tumors v1.1. and National Cancer Institute Common Terminology Criteria for Adverse Events v5.0, respectively. HRD testing (AmoyDx®) was detected in most patients. Treatment was given until unequivocal progression or intolerable toxicity.
Twenty-two patients all received niraparib at a bolus of 200 mg/d. Fifty percent of patients with high-grade serous ovarian cancer are HRD-positive. Six patients underwent first-line maintenance therapy. Sixteen patients received exploratory therapy. Ultimately image evaluation revealed that two patients achieved partial response (PR) and one patient achieved stable disease (SD), yielding objective response rate (ORR) of 33.3% (95%CI = 0.060-0.759) and disease control rate (DCR) of 50% (95%CI = 0.140-0.861) in the exploratory multi-line monotherapy group. The most common AEs were nausea, thrombocytopenia, and anemia. Grade 3-4 thrombocytopenia were managed by dose reduction and interruption. Leg swelling was observed as a new adverse event.
It is feasible that patients receiving a bolus of 200 mg/d in patients from Chinese population can acquire promising efficacy and tolerance. This is the first real-world data about niraparib in ovarian cancer patients with available HRD status from China.
尼拉帕利是一种聚（ADP-核糖）聚合酶（PARP）抑制剂，已被批准用于对铂类化疗有完全或部分缓解的卵巢癌患者的一线/二线维持治疗，以及 BRCA 突变患者或同源重组缺陷（HRD）的铂类敏感复发患者的多线单药治疗。我们报告了来自中国一家单中心的真实世界经验。
我们招募了 2019 年 6 月至 2020 年 7 月期间在江苏省肿瘤医院接受尼拉帕利治疗的患者。初始剂量根据个体化给予。通过实体瘤反应评价标准 1.1 和国家癌症研究所不良事件通用术语标准 5.0 分别分析反应和不良事件（AE）。大多数患者进行了 HRD 检测（AmoyDx®）。治疗持续到明确进展或不可耐受的毒性。
22 名患者均以 200mg/d 的剂量接受尼拉帕利治疗。50%的高级别浆液性卵巢癌患者为 HRD 阳性。6 名患者接受一线维持治疗。16 名患者接受探索性治疗。最终影像学评估显示，2 名患者达到部分缓解（PR），1 名患者达到疾病稳定（SD），客观缓解率（ORR）为 33.3%（95%CI=0.060-0.759），探索性多线单药治疗组的疾病控制率（DCR）为 50%（95%CI=0.140-0.861）。最常见的 AE 是恶心、血小板减少和贫血。3-4 级血小板减少症通过减少剂量和中断治疗进行管理。下肢肿胀被观察到是一种新的不良反应。
中国人群中给予 200mg/d 负荷剂量的患者可以获得有希望的疗效和耐受性，这是中国关于有 HRD 状态的卵巢癌患者使用尼拉帕利的首个真实世界数据。
