Li Yi, Xie Yizhao, Gong Chengcheng, Zhao Yannan, Zhang Jian, Zhang Sheng, Wang Leiping, Chen She, Hu Xichun, Wang Biyun
Department of Medical Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai 200032, People's Republic of China.
Key Laboratory of Glycoconjugate Research Ministry of Public Health, Department of Biochemistry and Molecular Biology, School of Basic Medical Sciences, Fudan University, Shanghai 200032, People's Republic of China.
Ther Clin Risk Manag. 2020 Jun 30;16:607-615. doi: 10.2147/TCRM.S255365. eCollection 2020.
Fulvestrant (FUL) and the combination of everolimus and exemestane (EVE-EXE) were the options to treat hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (MBC) patients who were refractory to aromatase inhibitors (AIs). The practical knowledge of treatment patterns and outcomes between the two regimens is essential for improving treatment decisions.
HR+/HER2- MBC patients, who were refractory to AI, were treated with FUL or EVE-EXE from June 2013 to June 2016 were included. Treatment patterns, progression-free survival (PFS), overall survival (OS), and toxicity were reported. Propensity score matching (PSM) was used to minimize potential confounders.
A total of 168 patients were enrolled. Of 168 patients, 124 patients were treated with FUL and 44 patients received EVE-EXE. Patients who were treated with EVE-EXE were younger, more likely to have visceral, liver, multiple sites of metastases, and had received more prior chemotherapy. After adjusting for propensity score matching (PSM), no significant difference in PFS was found between two groups (=0.419). However, in the subgroup of multiple metastatic sites, the median PFS was significantly improved in the EVE-EXE arm compared with FUL arm (6.1 vs 3.2 months, respectively, =0.012). More patients in EVE-EXE arm discontinued treatment due to adverse events than in the FUL arm.
A substantial difference in treatment patterns was observed between the two arms. Clinical outcomes were comparable after PSM.
NCT03695341 (May 14, 2018).
氟维司群（FUL）以及依维莫司与依西美坦联合用药（EVE - EXE）是治疗对芳香化酶抑制剂（AI）耐药的激素受体阳性（HR +）/人表皮生长因子受体2阴性（HER2 -）转移性乳腺癌（MBC）患者的选择。了解这两种治疗方案的实际治疗模式和疗效对于改善治疗决策至关重要。
纳入2013年6月至2016年6月期间接受FUL或EVE - EXE治疗、对AI耐药的HR + /HER2 - MBC患者。报告其治疗模式、无进展生存期（PFS）、总生存期（OS）及毒性反应。采用倾向评分匹配（PSM）以尽量减少潜在混杂因素。
共纳入168例患者。其中，124例患者接受FUL治疗，44例患者接受EVE - EXE治疗。接受EVE - EXE治疗的患者更年轻，更易出现内脏、肝脏、多处转移，且接受过更多的既往化疗。经倾向评分匹配（PSM）调整后，两组间PFS无显著差异（P = 0.419）。然而，在多发转移部位亚组中，EVE - EXE组的中位PFS较FUL组显著改善（分别为6.1个月和3.2个月，P = 0.012）。与FUL组相比，EVE - EXE组因不良事件停药的患者更多。
两组间观察到明显不同的治疗模式。倾向评分匹配后临床疗效相当。
NCT03695341（2018年5月14日）
