Fulvestrant Versus Anastrozole in Endocrine Therapy-Naïve Women With Hormone Receptor-Positive Advanced Breast Cancer: Final Overall Survival in the Phase III FALCON Trial.

IF 42.1 1区 医学 Q1 ONCOLOGY
John F R Robertson, Zhimin Shao, Shinzaburo Noguchi, Igor Bondarenko, Lawrence Panasci, Sandeep Singh, Shankar Subramaniam, Matthew J Ellis
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Abstract

The randomized phase III FALCON trial demonstrated significant improvement in progression-free survival (PFS) with fulvestrant versus anastrozole in postmenopausal women with endocrine therapy-naïve, hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. Herein, the prespecified final overall survival (OS) analysis is reported. After the primary PFS analysis, data were collected on survival, serious adverse events, and health-related quality of life. The final OS analysis was triggered at ≥65% maturity and ≥8 years since the last patient was enrolled. Analyses were descriptive with nominal P values (one-sided α threshold .01845). At the data cutoff (July 11, 2022), 314 (68.0%) of 462 patients had died (fulvestrant, 157/230 [68.3%], anastrozole, 157/232 [67.7%]). The final OS analysis of FALCON demonstrated no significant difference between fulvestrant and anastrozole (medians, 44.8 and 42.7 months, respectively; hazard ratio [HR], 0.97 [95% CI, 0.77 to 1.21]; P = .7579). Among patients with nonvisceral disease (n = 208), a trend showed a 15% reduction in the relative risk of death with fulvestrant versus anastrozole (median OS, 65.2 v 47.8 months; HR, 0.85 [95% CI, 0.60 to 1.20]). Data from FALCON are consistent with published evidence of long-term clinical benefit with fulvestrant and other endocrine therapies in the subset of patients with nonvisceral disease.

富维司汀与阿那曲唑治疗内分泌Therapy-Naïve激素受体阳性晚期乳腺癌妇女:III期FALCON试验的最终总生存期
随机III期FALCON试验显示,在绝经后内分泌therapy-naïve、激素受体阳性/人表皮生长因子受体2阴性的晚期乳腺癌患者中,氟维司汀与阿那曲唑的无进展生存期(PFS)显著改善。本文报告了预先指定的最终总生存期(OS)分析。在初步PFS分析后,收集有关生存、严重不良事件和健康相关生活质量的数据。最终OS分析在≥65%成熟度和距离最后一名患者入组≥8年时触发。描述性分析采用名义P值(单侧α阈值为0.01845)。截至数据截止日期(2022年7月11日),462例患者中有314例(68.0%)死亡(氟维司汀,157/230[68.3%],阿那曲唑,157/232[67.7%])。FALCON的最终OS分析显示,氟维司汀和阿那曲唑之间无显著差异(中位数分别为44.8和42.7个月;风险比[HR], 0.97 [95% CI, 0.77 ~ 1.21];P = .7579)。在非内脏疾病患者中(n = 208),有趋势显示氟维司汀与阿那曲唑的相对死亡风险降低15%(中位生存期,65.2 vs 47.8个月;HR, 0.85 [95% CI, 0.60 ~ 1.20])。FALCON的数据与已发表的证据一致,即氟维司汀和其他内分泌疗法对非内脏疾病患者亚群的长期临床获益。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Journal of Clinical Oncology
Journal of Clinical Oncology 医学-肿瘤学
CiteScore
41.20
自引率
2.20%
发文量
8215
审稿时长
2 months
期刊介绍: The Journal of Clinical Oncology serves its readers as the single most credible, authoritative resource for disseminating significant clinical oncology research. In print and in electronic format, JCO strives to publish the highest quality articles dedicated to clinical research. Original Reports remain the focus of JCO, but this scientific communication is enhanced by appropriately selected Editorials, Commentaries, Reviews, and other work that relate to the care of patients with cancer.
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