MONARCH 2 是一项针对 阿贝西利 或安慰剂联合氟维司群用于治疗 669 名 内分泌治疗(ET)后疾病进展的 HR+,HER2- 晚期乳腺癌女性的随机、双盲、安慰剂对照的 3 期试验。1
该研究中的大多数患者为
在东亚人群中,与安慰剂相比,阿贝西利联合氟维司群组的PFS中位数延长(HR = 0.525; 95%CI:0.380-0.726; p <.001;中位值:21.2 vs 11.6个月)。3
在ITT人群中,212名亚洲患者被随机分为阿贝西利联合氟维司群组(n=147)或安慰剂联合氟维司群组(n=65)。总共观察到 89 个总体生存事件。安慰剂组的中位 OS 持续时间为 48.9 个月,而阿贝西利组未达到(HR=0.79;p=.377)。 42 个月时,阿贝西利联合氟维司群组的 OS 率为 64%,安慰剂联合氟维司群组的 OS 率为 53%。3,4
有关接受阿贝西利联合氟维司群的亚洲患者的其他有效性数据,请参见MONARCH 2的东亚ITT人群 。
ABE + FULV (n=147) |
|||
PFS2 |
TTC |
CFS |
|
HR (95% CI) |
0.588 (0.420-0.823) |
0.601 (0.411-0.877) |
0.573 (0.402-0.815) |
P value |
.001 |
.008 |
.002 |
缩略词: ABE = 阿贝西利; CFS = 无化疗生存期; FULV = 氟维司群; HR = 风险比; ITT = 意向治疗; PFS2 = 第二次疾病进展时间; TTC = 化疗时间 。
上次审阅日期:2023年11月17日
1Sledge GW Jr, Toi M, Neven P, et al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2− advanced breast cancer who had progressed while receiving endocrine therapy. J Clin Oncol. 2017;35(25):2875-2884. https://doi.org/10.1200/JCO.2017.73.7585
2Data on file, Eli Lilly and Company and/or one of its subsidiaries.
3Toi M, Huang CS, Im YH et al. Abemaciclib plus fulvestrant in East Asian women with HR+, HER2− advanced breast cancer: overall survival from MONARCH 2. Cancer Science. 2023;114(1):221-226. https://doi.org/10.1111/cas.15600
4Huang CS, Toi M, Im YH, et al. Abemaciclib plus fulvestrant in East Asian women with HR+, HER2- advanced breast cancer: overall survival from MONARCH 2. Paper presented at: 1st European Society for Medical Oncology Asia Congress (ESMO Asia Virtual); November 20-22, 2020. Accessed November 17, 2020. https://oncologypro.esmo.org/meeting-resources/esmo-asia-virtual-congress-2020/abemaciclib-plus-fulvestrant-in-east-asian-women-with-hr-her2-advanced-breast-cancer-overall-survival-from-monarch-2