Division of Breast Surgery, Department of Surgery, Taipei Veterans General Hospital, 201, Section 2, Shih-Pai Road, Taipei, 112, Taiwan.
Comprehensive Breast Health Center, Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan.
Clin Exp Med. 2024 Aug 12;24(1):185. doi: 10.1007/s10238-024-01458-1.
Cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) combined with endocrine therapy have demonstrated significant clinical benefits in progression-free and overall survival. This study investigates the outcomes associated with two kinds of CDK4/6i in patients with hormone receptor (HR)-positive metastatic and relapsed breast cancer to inform real-world evidence of treatment strategies.
This retrospective study included 340 Taiwanese patients with HR-positive advanced breast cancer from the Taipei Veterans General Hospital, between 2018 and 2023. We analyzed patient characteristics, treatment strategies and outcomes associated with two CDK4/6i. The efficacy of patients who experienced economic burden and interrupted CDK4/6i treatment after 2 years of National Health Insurance (NHI) reimbursement was also investigated.
Patients receiving ribociclib and palbociclib showed no significant differences in age, histology, body mass index(BMI), or pathologic status. The distribution of disease status and endocrine therapy partners was comparable between the two groups. Dose reduction was similar, while patients with palbociclib tended to discontinue CDK4/6i usage, and those with ribociclib tended to switch to the other CDK4/6i or endocrine partners. There was no significant difference in progression-free survival (PFS) between the two CDK4/6i in the first-line setting. Adverse prognostic factors were increasing HER2 IHC score, higher Ki-67 levels, visceral and liver metastasis, prior chemotherapy, and endocrine therapy resistance, while higher BMI, bone-only metastasis, and letrozole treatment were associated with a lower risk of progression. The limited follow-up time in our study was insufficient to assess the outcomes of patients treated with interrupted CDK4/6i for up to two years under the NHI reimbursement policy.
Treatment outcomes between the two types of CDK4/6i did not differ significantly, indicating the safety and efficacy of CDK4/6i for the Asian population. Ribociclib and palbociclib showed similar efficacy in PFS in the real-world setting.
细胞周期蛋白依赖性激酶 4/6 抑制剂（CDK4/6i）联合内分泌治疗在无进展生存期和总生存期方面显示出显著的临床获益。本研究旨在探讨两种 CDK4/6i 在激素受体（HR）阳性转移性和复发性乳腺癌患者中的应用结果，为治疗策略提供真实世界的证据。
本回顾性研究纳入了 2018 年至 2023 年期间来自台北荣民总医院的 340 名 HR 阳性晚期乳腺癌台湾患者。我们分析了两种 CDK4/6i 相关的患者特征、治疗策略和结局。还研究了在接受国家健康保险（NHI）报销 2 年后经历经济负担和中断 CDK4/6i 治疗的患者的疗效。
接受瑞博西利和哌柏西利的患者在年龄、组织学、体重指数（BMI）或病理状态方面无显著差异。两组患者的疾病状态和内分泌治疗伙伴的分布相似。剂量减少相似，但接受哌柏西利的患者更倾向于停止使用 CDK4/6i，而接受瑞博西利的患者更倾向于改用其他 CDK4/6i 或内分泌治疗伙伴。在一线治疗中，两种 CDK4/6i 的无进展生存期（PFS）无显著差异。不良预后因素包括 HER2 IHC 评分升高、Ki-67 水平升高、内脏和肝转移、既往化疗和内分泌治疗耐药，而较高的 BMI、骨转移和来曲唑治疗与较低的进展风险相关。本研究随访时间有限，不足以评估在 NHI 报销政策下，中断 CDK4/6i 治疗长达两年的患者的结局。
两种 CDK4/6i 的治疗结果无显著差异，表明 CDK4/6i 对亚洲人群的安全性和有效性。在真实世界环境中，瑞博西利和哌柏西利在 PFS 方面表现出相似的疗效。
