奥拉帕尼
医学
内科学
PARP抑制剂
危险系数
卵巢癌
临床终点
肿瘤科
安慰剂
癌症
外科
临床试验
置信区间
聚ADP核糖聚合酶
病理
化学
替代医学
基因
聚合酶
生物化学
作者
Paul DiSilvestro,Susana Banerjee,Nicoletta Colombo,Giovanni Scambia,Byoung‐Gie Kim,Ana Oaknin,Michael Friedlander,Alla Sergeevna Lisyanskaya,Anne Floquet,Alexandra Léary,Gabe S. Sonke,Charlie Gourley,Amit M. Oza,Antonio González-Martín,Carol Aghajanian,William H. Bradley,Cara Mathews,Joyce F. Liu,John McNamara,Elizabeth Lowe,Mei-Lin Ah-See,Kathleen Moore
摘要
In SOLO1/GOG 3004 (ClinicalTrials.gov identifier: NCT01844986), maintenance therapy with the poly(ADP-ribose) polymerase inhibitor olaparib provided a sustained progression-free survival benefit in patients with newly diagnosed advanced ovarian cancer and a BRCA1 and/or BRCA2 (BRCA) mutation. We report overall survival (OS) after a 7-year follow-up, a clinically relevant time point and the longest follow-up for any poly(ADP-ribose) polymerase inhibitor in the first-line setting.This double-blind phase III trial randomly assigned patients with newly diagnosed advanced ovarian cancer and a BRCA mutation in clinical response to platinum-based chemotherapy to maintenance olaparib (n = 260) or placebo (n = 131) for up to 2 years. A prespecified descriptive analysis of OS, a secondary end point, was conducted after a 7-year follow-up.The median duration of treatment was 24.6 months with olaparib and 13.9 months with placebo, and the median follow-up was 88.9 and 87.4 months, respectively. The hazard ratio for OS was 0.55 (95% CI, 0.40 to 0.76; P = .0004 [P < .0001 required to declare statistical significance]). At 7 years, 67.0% of olaparib patients versus 46.5% of placebo patients were alive, and 45.3% versus 20.6%, respectively, were alive and had not received a first subsequent treatment (Kaplan-Meier estimates). The incidence of myelodysplastic syndrome and acute myeloid leukemia remained low, and new primary malignancies remained balanced between treatment groups.Results indicate a clinically meaningful, albeit not statistically significant according to prespecified criteria, improvement in OS with maintenance olaparib in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation and support the use of maintenance olaparib to achieve long-term remission in this setting; the potential for cure may also be enhanced. No new safety signals were observed during long-term follow-up.
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