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曲妥珠单抗-美坦新偶联物治疗人表皮生长因子受体 2 阳性转移性乳腺癌:来自全人群澳大利亚队列的结果。

Trastuzumab emtansine for HER2-positive metastatic breast cancer: Outcomes from a whole-of-population Australian cohort.

机构信息

Medicines Policy Research Unit, Centre for Big Data Research in Health, UNSW, Sydney, Australia.

NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia.

出版信息

Breast. 2021 Aug;58:106-112. doi: 10.1016/j.breast.2021.05.001. Epub 2021 May 7.

Abstract

PURPOSE

We aim to describe the treatment patterns and overall survival (OS) outcomes in patients receiving trastuzumab emtansine (T-DM1) for HER2-positive metastatic breast cancer (HER2+MBC) in routine clinical care.

METHODS

Retrospective, whole-of-population cohort study of people initiating T-DM1 for HER2+MBC between October 2015 and May 2019 in Australia. We used dispensing claims to estimate time-to-T-DM1 initiation, duration of treatment, and treatments administered prior to and following T-DM1 therapy. We estimated OS from T-DM1 initiation and stratified results based on whether patients received first- or second-line T-DM1 treatment. We benchmarked outcomes to those reported in the pivotal, EMILIA trial.

RESULTS

345 patients initiated T-DM1: 309 as second-line therapy for HER2+MBC and 36 as first-line therapy. 51% of patients had received endocrine therapy and 98% of second-line patients received pertuzumab prior to starting T-DM1. The median age was 57 years (53 in EMILIA); median time-to-T-DM1 initiation from start of HER2-targeted therapy for HER2+MBC was 11.6 months (IQR: 7.9-16.6); median duration of T-DM1 treatment was 6.5 months (3.1-13.5; 7.6 months in EMILIA), and median OS was 19.3 months (7.9-29.5; 29.9 months in EMILIA).

CONCLUSIONS

Our findings highlight differences in patient characteristics (older, more previous pertuzumab therapy) and outcomes (shorter OS) from the T-DM1 pivotal trial and provide real-world estimates that can inform patient, clinician and policy, decisions around the use of HER2-targeted therapies in routine clinical care.

摘要

目的

本研究旨在描述在常规临床护理中接受曲妥珠单抗-美坦新偶联物(T-DM1)治疗人表皮生长因子受体 2 阳性(HER2+)转移性乳腺癌(MBC)患者的治疗模式和总生存期(OS)结局。

方法

本研究是一项回顾性、全人群队列研究,纳入了 2015 年 10 月至 2019 年 5 月期间在澳大利亚开始接受 T-DM1 治疗的 HER2+MBC 患者。我们使用配药记录来估计 T-DM1 起始时间、治疗持续时间以及在 T-DM1 治疗之前和之后给予的治疗。我们从 T-DM1 起始时间估计 OS,并根据患者接受一线或二线 T-DM1 治疗进行分层。我们将结果与关键的 EMILIA 试验报告的结果进行了基准比较。

结果

345 例患者开始接受 T-DM1 治疗:309 例为 HER2+MBC 的二线治疗,36 例为一线治疗。51%的患者接受了内分泌治疗,98%的二线患者在开始 T-DM1 治疗前接受了帕妥珠单抗治疗。中位年龄为 57 岁(EMILIA 为 53 岁);从 HER2 靶向治疗开始至 HER2+MBC 开始接受 T-DM1 的中位时间为 11.6 个月(IQR:7.9-16.6);T-DM1 治疗的中位持续时间为 6.5 个月(3.1-13.5;EMILIA 为 7.6 个月),中位 OS 为 19.3 个月(7.9-29.5;EMILIA 为 29.9 个月)。

结论

我们的研究结果突出了患者特征(年龄较大,先前接受过更多的帕妥珠单抗治疗)和结局(OS 较短)与 T-DM1 关键试验的差异,并提供了真实世界的估计值,可用于在常规临床护理中使用 HER2 靶向治疗的患者、临床医生和政策制定者的决策。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4c34/8138859/48abd32a06d4/gr1.jpg

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