A cyclin-dependent kinase 4/6 inhibitor combined with endocrine therapy is the standard of care for patients with hormone receptor-positive/human epidermal growth factor 2-negative (HR+/HER2−) metastatic breast cancer (mBC), but real-world effectiveness data for patients with lung or liver metastases are limited. This retrospective study included data from the US Flatiron Health database of patients with HR+/HER2− mBC and lung or liver metastases treated with first-line palbociclib (PAL) plus an aromatase inhibitor (AI) or an AI alone in routine clinical practice. Overall survival (OS) and real-world progression-free survival (rwPFS) were assessed. A total of 891 patients were included (622 with lung metastasis, 376 with liver metastasis, and 107 with both lung and liver metastasis). After stabilized inverse probability of treatment weighting to balance patient characteristics, PAL + AI versus AI alone was associated with significantly prolonged OS (HR = 0.62;p< 0.001) and rwPFS (HR = 0.55;p< 0.001) in patients with lung metastases and numerically longer OS (HR = 0.73;p= 0.056) and significantly longer rwPFS (HR = 0.57,p< 0.001) for those with liver metastases. Overall, PAL + AI versus AI alone was associated with prolonged OS and rwPFS in routine clinical practice, supporting the use of first-line PAL + AI for patients with HR+/HER2− mBC with lung and/or liver metastases.
细胞周期蛋白依赖性激酶4/6抑制剂联合内分泌治疗已成为激素受体阳性/人表皮生长因子受体2阴性(HR+/HER2−)转移性乳腺癌(mBC)患者的标准治疗方案,但针对伴有肺或肝转移患者的真实世界疗效数据仍较为有限。本研究基于美国Flatiron Health数据库的回顾性分析,纳入在常规临床实践中接受一线哌柏西利(PAL)联合芳香化酶抑制剂(AI)或单用AI治疗的HR+/HER2−转移性乳腺癌伴肺或肝转移患者,评估其总生存期(OS)和真实世界无进展生存期(rwPFS)。研究共纳入891例患者(其中肺转移622例,肝转移376例,肺肝同时转移107例)。经稳定逆概率加权平衡患者特征后分析显示:对于肺转移患者,PAL+AI相较于单用AI可显著延长OS(风险比=0.62,p<0.001)和rwPFS(风险比=0.55,p<0.001);对于肝转移患者,PAL+AI组OS呈延长趋势(风险比=0.73,p=0.056),rwPFS显著延长(风险比=0.57,p<0.001)。总体而言,在常规临床实践中,PAL+AI方案较单用AI可显著改善伴有肺和/或肝转移的HR+/HER2−转移性乳腺癌患者的生存结局,这支持将一线PAL+AI方案用于此类患者的临床治疗。