在 MONARCH plus 的中期分析中，在内分泌治疗 (ET) 中添加 abemaciclib 可改善主要为中国绝经后 HR /HER2- 晚期乳腺癌 (ABC) 女性的无进展生存期 (PFS) 和客观缓解率 (ORR)。本研究提出了最终的预先计划的 PFS 分析。 在 III 期 MONARCH plus 研究中，中国、印度、巴西和南非的绝经后女性患有 HR /HER2- ABC，且未在高级环境中接受过全身治疗（队列 A）或先前 ET 的进展（B 组）被随机 (2:1) 接受 abemaciclib（150 毫克，每日两次 [BID]）或安慰剂加：阿那曲唑（1.0 毫克/天）或来曲唑（2.5 毫克/天）（A 组）或氟维司群（500 毫克）（B 组）。主要终点是队列 A 的 PFS。次要终点包括队列 B PFS（关键次要终点）、ORR、总生存期 (OS)、安全性和健康相关生活质量 (HRQoL)。在队列 A 中（abemaciclib：n = 207；安慰剂：n = 99)，abemaciclib 加非类固醇芳香酶抑制剂改善了中位 PFS。安慰剂（28.27 个月 vs 14.73 个月，风险比 [HR]：0.476；95% 置信区间 [95% CI]：0.348-0.649）。在队列 B 中（abemaciclib：n = 104；安慰剂：n = 53），abemaciclib 加氟维司群与 0.5 相比改善了中位 PFS。安慰剂（11.41 个月 vs 5.59 个月，HR：0.480；95% CI：0.322-0.715）。 Abemaciclib 在数值上改善了 ORR。尽管尚未成熟，但观察到 abemaciclib 具有 OS 获益的趋势（队列 A：HR：0.893，95% CI：0.553-1.443；队列 B：HR：0.512，95% CI：0.281-0.931）。 abemaciclib 组中最常见的 ≥3 级不良事件是中性粒细胞减少症、白细胞减少症、贫血（两个队列）和淋巴细胞减少症（B 组）。与 . 相比，Abemaciclib 并未对患者报告的整体健康、功能或大多数症状造成有临床意义的变化。安慰剂.Abemaciclib 加 ET 可改善 PFS 和 ORR、可控的安全性和持续的 HRQoL，提供临床益处，且不会产生高毒性负担或降低生活质量。ClinicalTrials.gov (NCT02763566)。版权所有 © 2024 中华医学会，由 Wolters Kluwer, Inc. 根据 CC-BY-NC-ND 许可生产。

In the interim analysis of MONARCH plus, adding abemaciclib to endocrine therapy (ET) improved progression-free survival (PFS) and objective response rate (ORR) in predominantly Chinese postmenopausal women with HR+/HER2- advanced breast cancer (ABC). This study presents the final pre-planned PFS analysis.In the phase III MONARCH plus study, postmenopausal women in China, India, Brazil, and South Africa with HR+/HER2- ABC without prior systemic therapy in an advanced setting (cohort A) or progression on prior ET (cohort B) were randomized (2:1) to abemaciclib (150 mg twice daily [BID]) or placebo plus: anastrozole (1.0 mg/day) or letrozole (2.5 mg/day) (cohort A) or fulvestrant (500 mg) (cohort B). The primary endpoint was PFS of cohort A. Secondary endpoints included cohort B PFS (key secondary endpoint), ORR, overall survival (OS), safety, and health-related quality of life (HRQoL).In cohort A (abemaciclib: n  = 207; placebo: n  = 99), abemaciclib plus a non-steroidal aromatase inhibitor improved median PFS vs . placebo (28.27 months vs . 14.73 months, hazard ratio [HR]: 0.476; 95% confidence interval [95% CI]: 0.348-0.649). In cohort B (abemaciclib: n  = 104; placebo: n  = 53), abemaciclib plus fulvestrant improved median PFS vs . placebo (11.41 months vs . 5.59 months, HR: 0.480; 95% CI: 0.322-0.715). Abemaciclib numerically improved ORR. Although immature, a trend toward OS benefit with abemaciclib was observed (cohort A: HR: 0.893, 95% CI: 0.553-1.443; cohort B: HR: 0.512, 95% CI: 0.281-0.931). The most frequent grade ≥3 adverse events in the abemaciclib arms were neutropenia, leukopenia, anemia (both cohorts), and lymphocytopenia (cohort B). Abemaciclib did not cause clinically meaningful changes in patient-reported global health, functioning, or most symptoms vs . placebo.Abemaciclib plus ET led to improvements in PFS and ORR, a manageable safety profile, and sustained HRQoL, providing clinical benefit without a high toxicity burden or reduced quality of life.ClinicalTrials.gov (NCT02763566).Copyright © 2024 The Chinese Medical Association, produced by Wolters Kluwer, Inc. under the CC-BY-NC-ND license.