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Abstract：
OBJECTIVE: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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.
摘要：
目的：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具有显著的临床获益。这项研究调查了激素受体（HR）阳性转移性和复发性乳腺癌患者中与两种CDK4/6i相关的结果，以告知治疗策略的现实证据。
方法：这项回顾性研究纳入了台北市荣民总医院340例HR阳性晚期乳腺癌台湾患者，2018年至2023年。我们分析了病人的特点,与两个CDK4/6i相关的治疗策略和结果。还调查了在国家健康保险（NHI）报销2年后经历经济负担并中断CDK4/6i治疗的患者的疗效。
结果：接受瑞博西尼和帕博西尼治疗的患者在年龄上没有显著差异，组织学,体重指数（BMI），或病理状态。两组之间的疾病状态和内分泌治疗伙伴的分布具有可比性。剂量减少是相似的，而palbociclib患者倾向于停止使用CDK4/6i，和那些与ribociclib倾向于切换到其他CDK4/6i或内分泌伴侣。在一线设置中，两个CDK4/6i之间的无进展生存期（PFS）没有显着差异。不良预后因素是HER2IHC评分增加，更高的Ki-67水平，内脏和肝转移，先前的化疗，和内分泌治疗抵抗，虽然BMI较高，仅骨转移，来曲唑治疗与较低的进展风险相关.根据NHI报销政策，我们研究中有限的随访时间不足以评估中断CDK4/6i治疗长达两年的患者的预后。
结论：两种CDK4/6i的治疗结果没有显著差异，表明CDK4/6i对亚洲人群的安全性和有效性。在现实世界中，Ribociclib和palbociclib在PFS中显示出相似的功效。
方法：这项回顾性研究纳入了台北市荣民总医院340例HR阳性晚期乳腺癌台湾患者，2018年至2023年。我们分析了病人的特点,与两个CDK4/6i相关的治疗策略和结果。还调查了在国家健康保险（NHI）报销2年后经历经济负担并中断CDK4/6i治疗的患者的疗效。
结果：接受瑞博西尼和帕博西尼治疗的患者在年龄上没有显著差异，组织学,体重指数（BMI），或病理状态。两组之间的疾病状态和内分泌治疗伙伴的分布具有可比性。剂量减少是相似的，而palbociclib患者倾向于停止使用CDK4/6i，和那些与ribociclib倾向于切换到其他CDK4/6i或内分泌伴侣。在一线设置中，两个CDK4/6i之间的无进展生存期（PFS）没有显着差异。不良预后因素是HER2IHC评分增加，更高的Ki-67水平，内脏和肝转移，先前的化疗，和内分泌治疗抵抗，虽然BMI较高，仅骨转移，来曲唑治疗与较低的进展风险相关.根据NHI报销政策，我们研究中有限的随访时间不足以评估中断CDK4/6i治疗长达两年的患者的预后。
结论：两种CDK4/6i的治疗结果没有显著差异，表明CDK4/6i对亚洲人群的安全性和有效性。在现实世界中，Ribociclib和palbociclib在PFS中显示出相似的功效。
