Danish Breast Cancer Group, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Department of Oncology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.
Acta Oncol. 2023 Mar;62(3):290-297. doi: 10.1080/0284186X.2023.2194030. Epub 2023 Apr 3.
The recommended first-line treatment for advanced, ER+/HER2 negative breast cancer is a CDK 4/6 inhibitor in combination with an endocrine backbone. This study investigated the use of palbociclib, as first- or second-line therapy for advanced breast cancer patients in a real-world setting.
This retrospective, population-based study included all Danish, advanced breast cancer patients with ER+/HER2 negative disease who initiated first- or second-line treatment with palbociclib from January 1, 2017, until December 31, 2020. The primary outcomes were PFS and OS.
The study included 1054 advanced breast cancer patients with a mean age of 66.8 years. Median OS was 51.7 months (95% CI, 44.9-54.6) for all patients in the first-line setting ( = 728) and median PFS was 24.3 months (95% CI, 21.7-27.8). Patients treated in second line ( = 326) had a median OS of 32.5 months (95% CI, 29.9-35.9) and a median PFS of 13.6 months (95% CI, 11.5-15.7). In first-line setting, the PFS and OS were significantly different for endocrine sensitive patients treated with AI (aromatase inhibitor) ( = 423) vs. fulvestrant ( = 158) as endocrine backbone to palbociclib (median PFS AI 31.3 months vs fulvestrant 19.9 months, = 0.002 and median OS AI 56.9 months vs. fulvestrant 43.6 months, = 0.001). In endocrine resistant patients ( = 145), no statistically significant difference in PFS was shown (median PFS AI 21.5 months vs. fulvestrant 12.0 months, = 0.09), whereas OS was significantly different (median OS AI 43.5 months vs. fulvestrant 28.8 months, = 0.02).
In this real-world study, treatment with palbociclib combination therapy met the standards of efficacy set by the phase III trials, PALOMA-2 and PALOMA-3, and the standards set by real-world studies in other countries. The study showed significantly different outcomes in terms of PFS and OS in endocrine sensitive patients comparing AI vs. fulvestrant as endocrine backbone to palbociclib as first-line therapy.
对于晚期 ER+/HER2 阴性乳腺癌，CDK4/6 抑制剂联合内分泌治疗是推荐的一线治疗方案。本研究旨在调查帕博西尼作为晚期乳腺癌患者在真实世界环境中的一线或二线治疗的应用。
本回顾性、基于人群的研究纳入了所有丹麦的晚期 ER+/HER2 阴性乳腺癌患者，这些患者在 2017 年 1 月 1 日至 2020 年 12 月 31 日期间接受了一线或二线的帕博西尼治疗。主要终点为无进展生存期（PFS）和总生存期（OS）。
研究共纳入了 1054 名晚期乳腺癌患者，平均年龄为 66.8 岁。在一线治疗（n=728）中，所有患者的中位 OS 为 51.7 个月（95%CI，44.9-54.6），中位 PFS 为 24.3 个月（95%CI，21.7-27.8）。二线治疗（n=326）的患者中位 OS 为 32.5 个月（95%CI，29.9-35.9），中位 PFS 为 13.6 个月（95%CI，11.5-15.7）。在一线治疗中，内分泌敏感患者（n=423，接受 AI 作为内分泌治疗）与内分泌耐药患者（n=145，接受氟维司群作为内分泌治疗）相比，接受帕博西尼联合 AI 或氟维司群治疗的 PFS 和 OS 差异有统计学意义（中位 PFS：AI 组为 31.3 个月，氟维司群组为 19.9 个月，P=0.002；中位 OS：AI 组为 56.9 个月，氟维司群组为 43.6 个月，P=0.001）。而对于内分泌耐药患者，AI 与氟维司群治疗的 PFS 差异无统计学意义（中位 PFS：AI 组为 21.5 个月，氟维司群组为 12.0 个月，P=0.09），但 OS 差异有统计学意义（中位 OS：AI 组为 43.5 个月，氟维司群组为 28.8 个月，P=0.02）。
在这项真实世界研究中，帕博西尼联合治疗的疗效标准达到了 PALOMA-2 和 PALOMA-3 三期临床试验的标准，也达到了其他国家真实世界研究的标准。研究表明，在一线治疗中，对于内分泌敏感患者，与氟维司群相比，AI 作为内分泌治疗的疗效显著不同，表现为 PFS 和 OS 有差异。
