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Niraparib治疗新诊断晚期卵巢癌患者的疗效
作者:小柯机器人 发布时间:2019/9/29 16:07:43

西班牙卵巢癌研究小组(GEICO)和纳瓦拉大学临床肿瘤学系Antonio González-Martín等研究人员,评估了Niraparib治疗新诊断晚期卵巢癌患者的疗效。2019年9月28日,《新英格兰医学杂志》在线发表了这项成果。
 
Niraparib是聚腺苷二磷酸核糖聚合酶(PARP)抑制剂,在铂类化疗后复发的卵巢癌患者中,无论是否存在BRCA突变,Niraparib均显著增加了无进展生存率。但Niraparib对一线铂类化疗后新诊断的晚期卵巢癌患者的疗效尚不清楚。

在这项随机、双盲、临床3期试验中,研究组将新诊断的晚期卵巢癌患者按2:1随机分为两组:在铂类化疗缓解后,一组接受Niraparib治疗,一组接受安慰剂治疗。

在733名接受随机分组的患者中,373名(50.9%)患有同源重组缺陷肿瘤。在这类患者中,Niraparib组的中位无进展生存期为21.9个月,明显长于安慰剂组(10.4个月)。在整个人群中,Niraparib组和安慰剂组的无进展生存期分别为13.8个月和8.2个月,差异具有统计学意义。在24个月的中期分析中,Niraparib组和安慰剂组的总生存率分别为84%和77%,死亡风险比为0.70。最常见的3级及以上不良反应为贫血(占31.0%)、血小板减少(占28.7%)和中性粒细胞减少(占12.8%)。两组中均未发生与治疗相关的死亡事件。

综上,在对铂类化疗有反应的新诊断的晚期卵巢癌患者中,无论是否存在同源重组缺陷,Niraparib治疗与安慰剂相比显著延长了患者的无进展生存期。
 
附:英文原文
 
Title:Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer
 
Author: Antonio González-Martín, M.D., Ph.D., Bhavana Pothuri, M.D., Ignace Vergote, M.D., Ph.D., René DePont Christensen, Ph.D., Whitney Graybill, M.D., Mansoor R. Mirza, M.D., Colleen McCormick, M.D., M.P.H., Domenica Lorusso, M.D., Ph.D., Paul Hoskins, M.D., Gilles Freyer, M.D., Klaus Baumann, M.D., Kris Jardon, M.D., Andrés Redondo, M.D., Ph.D., Richard G. Moore, M.D., Christof Vulsteke, M.D., Ph.D., Roisin E. O’Cearbhaill, M.D., Bente Lund, M.D., Floor Backes, M.D., Pilar Barretina-Ginesta, M.D., Ashley F. Haggerty, M.D., Maria J. Rubio-Pérez, M.D., Mark S. Shahin, M.D., Giorgia Mangili, M.D., William H. Bradley, M.D., Ilan Bruchim, M.D., Kaiming Sun, Ph.D., Izabela A. Malinowska, M.D., Ph.D., Yong Li, Ph.D., Divya Gupta, M.D., and Bradley J. Monk, M.D. for the PRIMA/ENGOT-OV26/GOG-3012 Investigators*
 
Issue&Volume:2019-09-28
 
Abstract:
 
BACKGROUND
Niraparib, an inhibitor of poly(adenosine diphosphate [ADP]–ribose) polymerase (PARP), has been associated with significantly increased progression-free survival among patients with recurrent ovarian cancer after platinum-based chemotherapy, regardless of the presence or absence of BRCA mutations. The efficacy of niraparib in patients with newly diagnosed advanced ovarian cancer after a response to first-line platinum-based chemotherapy is unknown.

METHODS
In this randomized, double-blind, phase 3 trial, we randomly assigned patients with newly diagnosed advanced ovarian cancer in a 2:1 ratio to receive niraparib or placebo once daily after a response to platinum-based chemotherapy. The primary end point was progression-free survival in patients who had tumors with homologous-recombination deficiency and in those in the overall population, as determined on hierarchical testing. A prespecified interim analysis for overall survival was conducted at the time of the primary analysis of progression-free survival.

RESULTS
Of the 733 patients who underwent randomization, 373 (50.9%) had tumors with homologous-recombination deficiency. Among the patients in this category, the median progression-free survival was significantly longer in the niraparib group than in the placebo group (21.9 months vs. 10.4 months; hazard ratio for disease progression or death, 0.43; 95% confidence interval [CI], 0.31 to 0.59; P<0.001). In the overall population, the corresponding progression-free survival was 13.8 months and 8.2 months (hazard ratio, 0.62; 95% CI, 0.50 to 0.76; P<0.001). At the 24-month interim analysis, the rate of overall survival was 84% in the niraparib group and 77% in the placebo group (hazard ratio, 0.70; 95% CI, 0.44 to 1.11). The most common adverse events of grade 3 or higher were anemia (in 31.0% of the patients), thrombocytopenia (in 28.7%), and neutropenia (in 12.8%). No treatment-related deaths occurred.

CONCLUSIONS
Among patients with newly diagnosed advanced ovarian cancer who had a response to platinum-based chemotherapy, those who received niraparib had significantly longer progression-free survival than those who received placebo, regardless of the presence or absence of homologous-recombination deficiency. 
 
DOI: 10.1056/NEJMoa1910962
 
Source:https://www.nejm.org/doi/full/10.1056/NEJMoa1910962

期刊信息

The New England Journal of Medicine:《新英格兰医学杂志》,创刊于1812年。隶属于麻省医学协会,最新IF:70.67
官方网址:http://www.nejm.org/
投稿链接:http://www.nejm.org/page/author-center/home