Real-world effectiveness of post-trastuzumab emtansine treatment for human epidermal growth factor receptor 2-positive metastatic breast cancer: a multicenter, matched cohort analysis from the Epidemiology Strategy and Medical Economics database (2008-2018)

C. Courtinard , V. Barbet , R. Schiappa , F. Pilleul , S. Michiels , S. Dabakuyo , S. Gourgou , A. Jaffre , B. Asselain , L. Bosquet , K. Dunton , M. Rosenlund , Z. Liang , J. Cathcart , S. Delaloge
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Abstract

Background

Real-world data (RWD) can contextualize clinical trial data. We present real-world evidence that supplemented the single-arm DESTINY-Breast01 trial, which assessed the efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (mBC) previously treated with trastuzumab emtansine (T-DM1).

Patients and methods

Patients from the French Epidemiology Strategy and Medical Economics (ESME) mBC database who initiated treatment for HER2+ mBC between 1 January 2008 and 31 December 2016, and received one or more treatment lines following T-DM1 were propensity score matched 1 : 1 to patients from DESTINY-Breast01 to create an ESME DB-01 matched cohort. Treatment patterns, real-world best overall response, real-world objective response rate (rwORR), real-world disease control rate (rwDCR), real-world progression-free survival (rwPFS), and overall survival (OS) were estimated, including by prior pertuzumab exposure and de novo/relapsed mBC status.

Results

A total of 137 patients from the ESME mBC database (78 received prior pertuzumab, 59 did not) were matched to 137 patients from DESTINY-Breast01. In the ESME DB-01 matched cohort, 73.7% received an anti-HER2 drug after T-DM1 treatment. The rwORR was 12.2% (95% confidence interval [CI] 6.2% to 18.2%; only partial responses) and rwDCR was 73.9% (95% CI 65.9% to 81.9%). The median rwPFS was 4.7 months (95% CI 3.8-6.0 months) and similar regardless of prior pertuzumab exposure or de novo/relapsed mBC status. The median OS was 24.1 months (95% CI 18.5-26.4 months) and longer in patients naive to versus exposed to pertuzumab and in patients with de novo versus relapsed mBC.

Conclusion

These RWD contextualized results of DESTINY-Breast01 and demonstrated an unmet medical need in patients with HER2+ mBC after T-DM1 treatment.

人表皮生长因子受体 2 阳性转移性乳腺癌曲妥珠单抗埃坦单抗后治疗的实际效果:来自流行病学战略和医疗经济学数据库(2008-2018 年)的多中心匹配队列分析
背景真实世界数据(RWD)可以为临床试验数据提供背景信息。该试验评估了曲妥珠单抗德鲁司坦(T-DXd)在既往接受过曲妥珠单抗恩坦辛(T-DM1)治疗的人表皮生长因子受体 2 阳性(HER2+)转移性乳腺癌(mBC)患者中的疗效和安全性。患者和方法将法国流行病学战略和医疗经济学(ESME)mBC数据库中2008年1月1日至2016年12月31日期间开始接受HER2+ mBC治疗、在T-DM1治疗后接受过一次或多次治疗的患者与DESTINY-Breast01中的患者进行倾向评分1:1匹配,以创建ESME DB-01匹配队列。对治疗模式、真实世界最佳总反应、真实世界客观反应率(rwORR)、真实世界疾病控制率(rwDCR)、真实世界无进展生存期(rwPFS)和总生存期(OS)进行了估算,包括按既往接受过百妥珠单抗治疗和新发/复发 mBC 状态进行估算。在ESME DB-01匹配队列中,73.7%的患者在T-DM1治疗后接受了抗HER2药物治疗。rwORR为12.2%(95%置信区间[CI] 6.2%至18.2%;仅为部分反应),rwDCR为73.9%(95%置信区间[CI] 65.9%至81.9%)。中位rwPFS为4.7个月(95% CI为3.8-6.0个月),与之前服用过百妥珠单抗或新发/复发mBC的情况相似。中位OS为24.1个月(95% CI为18.5-26.4个月),在未使用过与使用过百妥珠单抗的患者中,以及在新发与复发的mBC患者中,OS时间更长。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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