Certara UK Limited, London, UK.
Certara France, Paris, France.
Breast Cancer Res Treat. 2024 Apr;204(3):579-588. doi: 10.1007/s10549-023-07201-w. Epub 2024 Jan 11.
To assess real-world treatment patterns in patients diagnosed with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (mBC) who received cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in combination with an aromatase inhibitor (AI) or fulvestrant at first line.
Patient characteristics, treatment history, and outcomes data were extracted from the French 'Système National des Données de Santé' (SNDS) database for patients diagnosed with HR+/HER2- mBC between January 2014 and June 2019 and who received combination therapy with a CDK4/6 inhibitor and endocrine therapy. Kaplan-Meier methodology was used to assess time to next treatment (TTNT) and time to treatment discontinuation (TTTD).
The cohort comprised 6061 patients including 4032 patients who received CDK4/6 inhibitors + AIs and 2029 patients who received CDK4/6 inhibitors + fulvestrant. Median follow-up was 13.5 months (IQR 9.5-18.1). The median TTTD of first line treatment with CDK4/6 inhibitors + AIs and CDK4/6 inhibitors + fulvestrant was 17.3 months (95% CI 16.8-17.9) and 9.7 months (95% CI 9.0-10.2), respectively. Chemotherapy was the most common second line therapy. Median TTTD of subsequent treatment lines was progressively shorter following first line treatment with CDK4/6 inhibitors + AIs (2nd line: 4.6 months (95% CI 4.4-4.9) and with CDK4/6 inhibitors + fulvestrant (2nd line: 4.7 months (95% CI 4.3-5.1). TTNT was longer than TTTD across lines of therapy.
This real-world analysis confirms the effectiveness of CDK4/6 inhibitor-based regimens in French patients and highlights the frequent use of chemotherapy as second line therapy.
评估在一线接受细胞周期蛋白依赖性激酶 4/6(CDK4/6)抑制剂联合芳香酶抑制剂(AI)或氟维司群治疗的激素受体阳性(HR+)、人表皮生长因子受体 2 阴性(HER2-)转移性乳腺癌(mBC)患者的真实世界治疗模式。
从法国“国家健康数据系统(SNDS)”数据库中提取 2014 年 1 月至 2019 年 6 月期间诊断为 HR+/HER2-mBC 并接受 CDK4/6 抑制剂联合内分泌治疗的患者的患者特征、治疗史和结局数据。采用 Kaplan-Meier 法评估至下一次治疗时间(TTNT)和治疗终止时间(TTTD)。
该队列包括 6061 例患者,其中 4032 例接受 CDK4/6 抑制剂+AI,2029 例接受 CDK4/6 抑制剂+氟维司群。中位随访时间为 13.5 个月(IQR 9.5-18.1)。CDK4/6 抑制剂+AI 和 CDK4/6 抑制剂+氟维司群一线治疗的中位 TTTD 分别为 17.3 个月(95%CI 16.8-17.9)和 9.7 个月(95%CI 9.0-10.2)。化疗是最常见的二线治疗。CDK4/6 抑制剂+AI 一线治疗后,后续治疗线的中位 TTTD 逐渐缩短(二线:4.6 个月(95%CI 4.4-4.9)和 CDK4/6 抑制剂+氟维司群(二线:4.7 个月(95%CI 4.3-5.1)。在治疗线中,TTNT 均长于 TTTD。
这项真实世界分析证实了 CDK4/6 抑制剂为基础的方案在法国患者中的有效性,并强调了化疗作为二线治疗的频繁使用。