Robert Nicholas, Chen Connie, Doan Justin, Venkatasetty Divea, Espirito Janet L, Aguilar Kathleen M
Real World Research, Ontada, Boston, MA, USA.
Breast Cancer and Precision Medicine, Pfizer, New York, NY, USA.
Future Oncol. 2025 Jan;21(1):83-94. doi: 10.1080/14796694.2024.2442302. Epub 2025 Jan 15.
To investigate real-world treatment patterns and outcomes among patients with hormone receptor-positive/human epidermal growth factor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) who initiated first-line palbociclib-fulvestrant.
PATIENTS & METHODS: Retrospective observational study of iKnowMed electronic health records among patients who initiated first-line palbociclib-fulvestrant between 1 February 2016 and 31 December 2019 and were followed through 30 June 2020. Demographic, clinical, and treatment characteristics were evaluated descriptively. Endpoints including real-world progression-free survival, overall survival, time to chemotherapy, real-world duration of therapy, and time to next treatment were assessed using Kaplan-Meier methods from first-line treatment initiation.
317 patients were included (median age 67.3 years, 90.5% post-menopausal, 36.9% bone-only disease, 15.9 months median follow-up). Among those with prior adjuvant treatment ( = 269), 66.2% ( = 178) had disease-free intervals less than 12 months. Median real-world progression-free survival was 19.6 months (95% CI 15.2-23.6).
These results suggest favorable real-world clinical outcomes associated with first-line palbociclib-fulvestrant among patients with HR+/HER2- mBC. (clinical trial registration: NCT04498481).
调查开始一线使用哌柏西利-氟维司群治疗的激素受体阳性/人表皮生长因子2阴性(HR+/HER2-)转移性乳腺癌(mBC)患者的真实世界治疗模式和结局。
对2016年2月1日至2019年12月31日开始一线使用哌柏西利-氟维司群且随访至2020年6月30日的患者的iKnowMed电子健康记录进行回顾性观察研究。对人口统计学、临床和治疗特征进行描述性评估。从一线治疗开始,使用Kaplan-Meier方法评估包括真实世界无进展生存期、总生存期、化疗时间、真实世界治疗持续时间和下次治疗时间在内的终点指标。
纳入317例患者(中位年龄67.3岁,90.5%为绝经后,36.9%为仅骨转移疾病,中位随访15.9个月)。在接受过辅助治疗的患者(n = 269)中,66.2%(n = 178)的无病间期小于12个月。真实世界中位无进展生存期为19.6个月(95%CI 15.2 - 23.6)。
这些结果表明,HR+/HER2- mBC患者一线使用哌柏西利-氟维司群可获得良好的真实世界临床结局。(临床试验注册号:NCT04498481)