印度代购提示：MONARCH 2是一项3期、随机、双盲、安慰剂对照的试验，对象是正接受内分泌治疗但病情仍有进展的669名HR+/HER2-转移性乳腺癌患者。患者按2:1随机分为Verzenio加氟维司群，或安慰剂加氟维司群。参加该研究的患者在在新辅助（neoadjuvant）或辅助（adjuvant）治疗方案下接受内分泌治疗，然而在12个月之内出现疾病进展；或在接受一线内分泌治疗时出现疾病进展，但不包括接受过化疗或多于一种内分泌治疗的转移性乳腺癌患者。

MONARCH 2 is a Phase 3, randomized, double-blind, placebo-controlled trial in 669 patients with progressive HR+/ HER2-metastatic breast cancer undergoing endocrine therapy. Patients were randomized 2:1 to Verzenio plus flurvistrine or placebo plus flurvistrine. Patients in the study who received endocrine therapy under neoadjuvant or adjuvant regimen developed disease progression within 12 months; Or disease progression while receiving first-line endocrine therapy, but not in patients with metastatic breast cancer who have received chemotherapy or more than one endocrine therapy.

Verzenio

　　印度代购提示：MONARCH 3是一项3期，双盲，安慰剂对照研究，旨在评估Verzenio与芳香酶抑制剂（阿那曲唑或来曲唑）的组合疗法，作为初始内分泌治疗，对没有经历过全身性治疗，HR+/HER2-绝经后的晚期（局部复发或转移性）乳腺癌患者的安全性和有效性。共有493名患者以2:1的比例随机分组接受每日2次口服150 mg Verzenio或安慰剂，以及每日一次1 mg阿那曲唑或2.5 mg来曲唑。

　　印度代购提示：这些探索性事后分析来自于这1,000多名患者的数据，采用了两步法：首先，确定来自整个人群的独立预后变量；其次，在每个确定的预后亚组中单独进行内分泌治疗与Verzenio组合疗法效果的比较。在两项研究中，预后因素包括肝转移，非骨骼转移，分裂更快的癌细胞（高肿瘤分级）和不表达黄体酮受体（PR-）的癌细胞（因此对激素治疗产生缓解的可能性较小）。

　　印度代购提示：探索性分析表明，尽管在所有患者亚组中都观察到Verzenio的添加益处，但是携带导致预后不良因素的患者从组合疗法中获益最大。特别是发生肝转移，具有PR-，或分裂更快的癌细胞的患者，可以从持续Verzenio治疗中获得明显实质性益处，缓解率的差异超过30%。此外，MONARCH 3试验数据表明，那些在辅助治疗结束后可能迅速复发的癌症患者，从Verzenio内分泌组合疗法中收益更多。亚组分析产生的假设仍需要在前瞻性临床试验中进行评估，但为HR+/HER2-转移性乳腺癌的个体化治疗提供了思考和研究的基础。

Exploratory analyses showed that, while the additive benefit of Verzenio was observed in all patient subgroups, patients with factors contributing to poor prognosis benefited most from combination therapy. In particular, patients with liver metastases, PR-, or faster-dividing cancer cells could benefit significantly from continued Verzenio treatment, with a difference in remission rates of more than 30%. In addition, data from the MONARCH 3 trial showed that patients with cancers that were likely to relapse quickly after adjuvant therapy ended benefited more from the Verzenio endocrine combination therapy. The hypotheses generated by the subgroup analysis still need to be evaluated in prospective clinical trials, but provide a basis for thinking and research on the individualized treatment of HR+/ HER2-metastatic breast cancer.