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细胞周期蛋白依赖性激酶4/6抑制剂治疗晚期或转移性乳腺癌的综述

Review of cyclin-dependent kinase 4/6 inhibitors in the treatment of advanced or metastatic breast cancer.

作者信息

Husinka Lakyn, Koerner Pamela H, Miller Rick T, Trombatt William

机构信息

AllianceRx Walgreens Prime, Pittsburgh, PA, USA.

Duquesne University School of Pharmacy, Pittsburgh, PA, USA.

出版信息

J Drug Assess. 2020 Dec 18;10(1):27-34. doi: 10.1080/21556660.2020.1857103.

DOI:10.1080/21556660.2020.1857103
PMID:33414982
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7751387/
Abstract

OBJECTIVE

The purpose of this study is to review CDK 4/6 inhibitors used to treat metastatic breast cancer for patient safety, cost and utilization. By evaluating patient outcomes and payer influence, this study will provide critical information to aid prescribers in therapeutic decisions.

METHODS

This retrospective cohort study included patients from a national specialty pharmacy with a diagnosis of breast cancer and received either palbociclib, abemaciclib, or ribociclib for treatment. Patients were stratified into four subgroups based on their total oncolytic regimen at the time of their first eligible study medication dispense. Pharmacy claims data were reviewed to determine cost and therapy adherence.

RESULTS

The mean proportion of days covered was highest in patients on combination therapy with a hormone agent, 81.0%. While secondary insurances largely affected final patient out-of-pocket costs, final copays were significantly lower than the average wholesale price (AWP) of each CDK 4/6 inhibitor. When analyzing patient reported side effects, over 60% of the study population did not experience an adverse drug event (ADE) during the study time period. Ribociclib had the fewest number of reported side effects with abemaciclib patients reporting the most. Although reported ADE profiles were similar across all three study medications, difference in frequency should be evaluated when considering medication choice with specific comorbidities.

CONCLUSION

CDK 4/6 inhibitors have demonstrated safety and tolerability in HR-positive/HER2-negative breast cancer patients. Real world safety data and out-of-pocket patient costs in addition patient specific comorbidities should be considered when developing a treatment plan that includes a CDK 4/6 inhibitor selection.

摘要

目的

本研究旨在评估用于治疗转移性乳腺癌的CDK 4/6抑制剂的患者安全性、成本及使用情况。通过评估患者预后和支付方的影响,本研究将提供关键信息,以帮助开处方者做出治疗决策。

方法

这项回顾性队列研究纳入了来自一家全国性专科药房、被诊断为乳腺癌且接受哌柏西利、阿贝西利或瑞博西利治疗的患者。根据首次符合条件的研究药物配药时的总溶瘤方案,将患者分为四个亚组。审查药房报销数据以确定成本和治疗依从性。

结果

接受激素药物联合治疗的患者的平均覆盖天数比例最高,为81.0%。虽然二级保险在很大程度上影响了患者最终的自付费用,但最终的共付额明显低于每种CDK 4/6抑制剂的平均批发价(AWP)。在分析患者报告的副作用时,超过60%的研究人群在研究期间未发生药物不良事件(ADE)。瑞博西利报告的副作用数量最少,阿贝西利患者报告的副作用最多。尽管所有三种研究药物报告的ADE概况相似,但在考虑针对特定合并症的药物选择时,应评估频率差异。

结论

CDK 4/6抑制剂在激素受体阳性/人表皮生长因子受体2阴性乳腺癌患者中已证明具有安全性和耐受性。在制定包括选择CDK 4/6抑制剂的治疗方案时,应考虑真实世界的安全性数据、患者自付费用以及患者特定的合并症。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84b1/7751387/09f637a0e53b/IJDA_A_1857103_F0004_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84b1/7751387/c391af93161b/IJDA_A_1857103_F0001_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84b1/7751387/2b6aa1e506d8/IJDA_A_1857103_F0002_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84b1/7751387/4682b1715431/IJDA_A_1857103_F0003_C.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84b1/7751387/09f637a0e53b/IJDA_A_1857103_F0004_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84b1/7751387/c391af93161b/IJDA_A_1857103_F0001_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84b1/7751387/2b6aa1e506d8/IJDA_A_1857103_F0002_B.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84b1/7751387/4682b1715431/IJDA_A_1857103_F0003_C.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/84b1/7751387/09f637a0e53b/IJDA_A_1857103_F0004_B.jpg

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