当前位置: X-MOL 学术N. Engl. J. Med. › 论文详情
Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer.
The New England Journal of Medicine ( IF 74.699 ) Pub Date : 2019-12-19 , DOI: 10.1056/nejmoa1911361
Isabelle Ray-Coquard,Patricia Pautier,Sandro Pignata,David Pérol,Antonio González-Martín,Regina Berger,Keiichi Fujiwara,Ignace Vergote,Nicoletta Colombo,Johanna Mäenpää,Frédéric Selle,Jalid Sehouli,Domenica Lorusso,Eva M Guerra Alía,Alexander Reinthaller,Shoji Nagao,Claudia Lefeuvre-Plesse,Ulrich Canzler,Giovanni Scambia,Alain Lortholary,Frederik Marmé,Pierre Combe,Nikolaus de Gregorio,Manuel Rodrigues,Paul Buderath,Coraline Dubot,Alexander Burges,Benoît You,Eric Pujade-Lauraine,Philipp Harter,

BACKGROUND Olaparib has shown significant clinical benefit as maintenance therapy in women with newly diagnosed advanced ovarian cancer with a BRCA mutation. The effect of combining maintenance olaparib and bevacizumab in patients regardless of BRCA mutation status is unknown. METHODS We conducted a randomized, double-blind, international phase 3 trial. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum-taxane chemotherapy plus bevacizumab. Patients were eligible regardless of surgical outcome or BRCA mutation status. Patients were randomly assigned in a 2:1 ratio to receive olaparib tablets (300 mg twice daily) or placebo for up to 24 months; all the patients received bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks for up to 15 months in total. The primary end point was the time from randomization until investigator-assessed disease progression or death. RESULTS Of the 806 patients who underwent randomization, 537 were assigned to receive olaparib and 269 to receive placebo. After a median follow-up of 22.9 months, the median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab (hazard ratio for disease progression or death, 0.59; 95% confidence interval [CI], 0.49 to 0.72; P<0.001). The hazard ratio (olaparib group vs. placebo group) for disease progression or death was 0.33 (95% CI, 0.25 to 0.45) in patients with tumors positive for homologous-recombination deficiency (HRD), including tumors that had BRCA mutations (median progression-free survival, 37.2 vs. 17.7 months), and 0.43 (95% CI, 0.28 to 0.66) in patients with HRD-positive tumors that did not have BRCA mutations (median progression-free survival, 28.1 vs. 16.6 months). Adverse events were consistent with the established safety profiles of olaparib and bevacizumab. CONCLUSIONS In patients with advanced ovarian cancer receiving first-line standard therapy including bevacizumab, the addition of maintenance olaparib provided a significant progression-free survival benefit, which was substantial in patients with HRD-positive tumors, including those without a BRCA mutation. (Funded by ARCAGY Research and others; PAOLA-1 ClinicalTrials.gov number, NCT02477644.).
更新日期:2019-12-19

 

全部期刊列表>>
胸部和胸部成像专题
自然科研论文编辑服务
ACS ES&T Engineering
ACS ES&T Water
屿渡论文,编辑服务
鲁照永
华东师范大学
苏州大学
南京工业大学
南开大学
中科大
唐勇
跟Nature、Science文章学绘图
隐藏1h前已浏览文章
中洪博元
课题组网站
新版X-MOL期刊搜索和高级搜索功能介绍
ACS材料视界
x-mol收录
广东实验室
南京大学
王杰
南科大
刘尊峰
湖南大学
清华大学
王小野
中山大学化学工程与技术学院
试剂库存
天合科研
down
wechat
bug