Atezolizumab and nab-paclitaxel for advanced breast cancer in Danish real-world patients.

IF 1 4区 医学 Q3 MEDICINE, GENERAL & INTERNAL Danish medical journal Pub Date : 2023-08-23
Rasmus Garly, Ann Knoop, Maj-Britt Jensen, Tobias Berg, Hanne Melgaard Nielsen, Iben Kümler
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引用次数: 0

Abstract

Introduction: The Danish Medicines Council recommends that patients with estrogen receptor and human epidermal growth factor receptor 2-negative, programmed death-ligand 1 (PD-L1)-positive advanced breast cancer receive atezolizumab in combination with nab-paclitaxel. The approval was largely based on results from Impassion130 that showed a beneficial progression-free survival (PFS) and overall survival (OS) in PD-L1-positive patients who received atezolizumab and nab-paclitaxel.

Methods: We conducted a retrospective, population-based study that included patients who received atezolizumab for advanced breast cancer from October 2019 to September 2022. The primary endpoints were PFS and OS.

Results: This study included 74 advanced breast cancer patients. Their median age was 54.5 years, and 21 (28.4%) of the patients had de novo advanced disease. Most patients received first-line treatment with atezolizumab (83.8%). The median PFS was 6.0 months (95% confidence interval (CI): 4.7-8.4 months) and the median OS was 14.3 months (95% CI: 9.9-22.2 months). A total of 48 patients received atezolizumab and nab-paclitaxel in accordance with guidelines from the Danish Medicines Council.

Conclusions: This real-world study expectedly showed numerically lower survival outcomes than the phase III trial Impassion130, but met the standards of efficacy set by real-world studies in other countries. A need exists for increased attention to the criteria for receiving atezolizumab.

Funding: none.

Trial registration: The study was approved by the Oncological Committee of the DBCG, the Research Overview of the Capital (P-2022-828) and the Centre for Health of the Capital Region (R-22060674).

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Atezolizumab和nab-紫杉醇治疗丹麦现实世界晚期乳腺癌患者
丹麦医药委员会推荐雌激素受体和人表皮生长因子受体2阴性、程序性死亡配体1 (PD-L1)阳性的晚期乳腺癌患者接受atezolizumab联合nab-紫杉醇治疗。该批准主要基于Impassion130的结果,该结果显示接受atezolizumab和nab-紫杉醇治疗的pd - l1阳性患者的无进展生存期(PFS)和总生存期(OS)有益。方法:我们进行了一项基于人群的回顾性研究,纳入了2019年10月至2022年9月期间接受atezolizumab治疗晚期乳腺癌的患者。主要终点为PFS和OS。结果:本研究纳入74例晚期乳腺癌患者。他们的中位年龄为54.5岁,其中21例(28.4%)为新发晚期疾病。大多数患者接受了atezolizumab的一线治疗(83.8%)。中位PFS为6.0个月(95%可信区间(CI): 4.7-8.4个月),中位OS为14.3个月(95% CI: 9.9-22.2个月)。根据丹麦医药委员会的指南,共有48名患者接受了atezolizumab和nab-紫杉醇治疗。结论:这项现实世界的研究显示,与III期试验Impassion130相比,该研究的生存结果在数值上低于预期,但达到了其他国家现实世界研究设定的疗效标准。有必要增加对接受atezolizumab的标准的关注。资金:没有。试验注册:该研究得到了DBCG肿瘤学委员会、首都研究概况(P-2022-828)和首都地区卫生中心(R-22060674)的批准。
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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来源期刊
Danish medical journal
Danish medical journal MEDICINE, GENERAL & INTERNAL-
CiteScore
2.30
自引率
6.20%
发文量
78
审稿时长
3-8 weeks
期刊介绍: The Danish Medical Journal (DMJ) is a general medical journal. The journal publish original research in English – conducted in or in relation to the Danish health-care system. When writing for the Danish Medical Journal please remember target audience which is the general reader. This means that the research area should be relevant to many readers and the paper should be presented in a way that most readers will understand the content. DMJ will publish the following articles: • Original articles • Protocol articles from large randomized clinical trials • Systematic reviews and meta-analyses • PhD theses from Danish faculties of health sciences • DMSc theses from Danish faculties of health sciences.
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