尼拉帕利作为维持治疗用于复发性卵巢癌老年患者（≥70 岁）的疗效和安全性：ENGOT-OV16/NOVA 试验的结果。
Efficacy and safety of niraparib as maintenance treatment in older patients (≥ 70 years) with recurrent ovarian cancer: Results from the ENGOT-OV16/NOVA trial.
机构信息
Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO), Paris, France; Institut du Cancer de Montpellier, Montpellier, France.
Stephenson Cancer Center, University of Oklahoma HSC, Oklahoma City, OK, USA; Sarah Cannon Research Institute, Nashville, TN, USA.
出版信息
Gynecol Oncol. 2019 Mar;152(3):560-567. doi: 10.1016/j.ygyno.2018.12.009. Epub 2019 Jan 9.
OBJECTIVE
To analyze the safety and efficacy of niraparib in patients aged ≥70 years with recurrent ovarian cancer in the ENGOT-OV16/NOVA trial.
METHODS
The trial enrolled 2 independent cohorts with histologically diagnosed recurrent ovarian, fallopian tube, or peritoneal cancer who responded to platinum rechallenge, on the basis of germline breast cancer susceptibility gene mutation (gBRCAmut) status. Patients were randomized 2:1 to receive niraparib (300 mg) or placebo once daily until disease progression. The primary endpoint was progression-free survival (PFS) by blinded independent central review. Adverse events (AEs) of special interest were based on the known safety profile of poly(ADP-ribose) polymerase inhibitors.
RESULTS
Patients aged ≥70 years in the gBRCAmut cohort receiving niraparib (n = 14) had not yet reached a median PFS compared with a median PFS of 3.7 months for the same age group in the placebo arm (hazard ratio [HR], 0.09 [95% confidence interval (CI), 0.01 to 0.73]). Non-gBRCAmut patients aged ≥70 years receiving niraparib (n = 47) had a median PFS of 11.3 months compared with 3.8 months in the placebo arm (HR, 0.35 [95% CI, 0.18 to 0.71]). Median duration of follow-up in the niraparib arm was 17.3 months in patients ≥70 years and 17.2 months in patients <70 years. Frequency, severity of AEs, and dose reductions in the niraparib arm were similar in patients aged <70 and ≥ 70 years population. The most common grade ≥ 3 AEs in patients ≥70 years were hematologic: thrombocytopenia event (34.4%), anemia event (13.1%), and neutropenia event (16.4%).
CONCLUSIONS
For patients ≥70 years of age receiving niraparib as maintenance treatment in the ENGOT-OV16/NOVA trial, PFS benefits and incidence of any grade or serious treatment-emergent AEs were comparable to results in the younger population. Use of niraparib should be considered in this population.
目的
分析 ENGOT-OV16/NOVA 试验中，年龄≥70 岁的复发性卵巢癌患者使用尼拉帕利的安全性和疗效。
方法
该试验纳入了 2 个独立队列，患者均经组织学诊断为复发性卵巢癌、输卵管癌或腹膜癌，且对铂类药物再挑战有反应，基于种系乳腺癌易感基因突变（gBRCAmut）状态。患者按 2:1 随机分组，分别接受尼拉帕利（300mg）或安慰剂每日 1 次治疗，直至疾病进展。主要终点为盲法独立中心评估的无进展生存期（PFS）。特别关注的不良事件（AE）基于聚（ADP-核糖）聚合酶抑制剂的已知安全性特征。
结果
gBRCAmut 队列中接受尼拉帕利治疗的年龄≥70 岁患者中位 PFS尚未达到，而安慰剂组同年龄段患者中位 PFS 为 3.7 个月（风险比 [HR]，0.09[95%置信区间（CI），0.01 至 0.73]）。非 gBRCAmut 队列中接受尼拉帕利治疗的年龄≥70 岁患者中位 PFS为 11.3 个月，而安慰剂组为 3.8 个月（HR，0.35[95%CI，0.18 至 0.71]）。尼拉帕利组≥70 岁患者中位随访时间为 17.3 个月，<70 岁患者为 17.2 个月。年龄<70 岁和≥70 岁患者中，尼拉帕利组 AE 的频率、严重程度和剂量减少情况相似。年龄≥70 岁患者最常见的≥3 级 AE 为血液学毒性：血小板减少事件（34.4%）、贫血事件（13.1%）和中性粒细胞减少事件（16.4%）。
结论
在 ENGOT-OV16/NOVA 试验中，年龄≥70 岁的患者接受尼拉帕利维持治疗，PFS 获益和任何级别或严重治疗相关不良事件的发生率与年轻患者相似。在该人群中应考虑使用尼拉帕利。
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