Ribociclib+氟维司群治疗晚期乳腺癌可提高总生存率
作者：
小柯机器人 发布时间：2019/12/17 16:37:54
近期，美国加州大学洛杉矶分校转化肿瘤研究实验室Dennis J. Slamon研究小组探讨了Ribociclib+氟维司群治疗晚期乳腺癌的总生存率。该研究2019年12月11日发表在《新英格兰医学杂志》上。
在这项临床3期试验的早期分析中，对于激素受体阳性、人表皮生长因子受体2（HER2）阴性、晚期乳腺癌的绝经后患者，Ribociclib+氟维司群治疗后的无进展生存率优于氟维司群单用。
研究组近期报告了该特定方案的二次中期生存分析的结果。将患者按2：1随机分组，484名接受Ribociclib+氟维司群治疗，242名接受安慰剂+氟维司群治疗。
共有275例患者死亡，Ribociclib组中有167例（34.5%），安慰剂组中有108例（44.6%）。Ribociclib组的总生存效益优于安慰剂组。治疗42个月时，Ribociclib组的估计总生存率为57.8%，显著高于安慰剂组（45.9%）。大多数亚组的治疗获益一致。Ribociclib组的中位无进展生存期为33.6个月，安慰剂组为19.2个月。未观察到新的安全事件。
总而言之，在激素受体阳性、HER2阴性的晚期乳腺癌患者中，Ribociclib+氟维司群与安慰剂+氟维司群相比表现出更好的总体生存效益。
附：英文原文
Title: Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer
Author: Dennis J. Slamon, M.D., Ph.D.,, Patrick Neven, M.D., Ph.D.,, Stephen Chia, M.D.,, Peter A. Fasching, M.D.,, Michelino De Laurentiis, M.D., Ph.D.,, Seock-Ah Im, M.D., Ph.D.,, Katarina Petrakova, M.D., Ph.D.,, Giulia Val Bianchi, M.D.,, Francisco J. Esteva, M.D., Ph.D.,, Miguel Martín, M.D., Ph.D.,, Arnd Nusch, M.D.,, Gabe S. Sonke, M.D., Ph.D.,, Luis De la Cruz-Merino, M.D., Ph.D.,, J. Thaddeus Beck, M.D.,, Xavier Pivot, M.D., Ph.D.,, Manu Sondhi, M.D., M.P.H.,, Yingbo Wang, Ph.D.,, Arunava Chakravartty, Ph.D.,, Karen Rodriguez-Lorenc, M.D.,, Tetiana Taran, M.D.,, and Guy Jerusalem, M.D., Ph.D.
Issue&Volume: 2019-12-11
Abstract:
Background
In an earlier analysis of this phase 3 trial, ribociclib plus fulvestrant showed a greater benefit with regard to progression-free survival than fulvestrant alone in postmenopausal patients with hormone-receptor–positive, human epidermal growth factor receptor 2 (HER2)–negative advanced breast cancer. Here we report the results of a protocol-specified second interim analysis of overall survival.
Methods
Patients were randomly assigned in a 2:1 ratio to receive either ribociclib or placebo in addition to fulvestrant as first-line or second-line treatment. Survival was evaluated by means of a stratified log-rank test and summarized with the use of Kaplan–Meier methods.
Results
This analysis was based on 275 deaths: 167 among 484 patients (34.5%) receiving ribociclib and 108 among 242 (44.6%) receiving placebo. Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant. The estimated overall survival at 42 months was 57.8% (95% confidence interval [CI], 52.0 to 63.2) in the ribociclib group and 45.9% (95% CI, 36.9 to 54.5) in the placebo group, for a 28% difference in the relative risk of death (hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P=0.00455). The benefit was consistent across most subgroups. In a descriptive update, median progression-free survival among patients receiving first-line treatment was 33.6 months (95% CI, 27.1 to 41.3) in the ribociclib group and 19.2 months (95% CI, 14.9 to 23.6) in the placebo group. No new safety signals were observed.
Conclusions
Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant in patients with hormone-receptor–positive, HER2-negative advanced breast cancer.
DOI: 10.1056/NEJMoa1911149
Source: https://www.nejm.org/doi/full/10.1056/NEJMoa1911149
