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曲妥珠单抗在日常实践中用于HER2阳性转移性乳腺癌的研究:一项以老年人群为重点的基于人群的研究。

Use of trastuzumab for HER2-positive metastatic breast cancer in daily practice: a population-based study focusing on the elderly.

作者信息

van Rooijen Johan M, de Munck Linda, Teeuwen Guusje M, de Graaf Jacques C, Jansman Frank G, Boers James E, Siesling Sabine

机构信息

aDepartment of Internal Medicine, Martini Hospital bDepartment of Medical Oncology, University Medical Center Groningen cDepartment of Pharmacotherapy and Pharmaceutical Care, University of Groningen, Groningen dDepartment of Research, Netherlands Comprehensive Cancer Organisation, Utrecht eDepartment of Medical Oncology fDepartment of Pathology, Isala, Zwolle gDepartment of Clinical Pharmacy, Deventer Hospital, Deventer hDepartment of Health Technology and Services Research, MIRA Institute, University of Twente, Enschede, The Netherlands.

出版信息

Anticancer Drugs. 2016 Feb;27(2):127-32. doi: 10.1097/CAD.0000000000000310.

Abstract

The addition of trastuzumab to chemotherapy in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) prolongs overall survival (OS) in clinical trials. However, treatment patterns and survival in daily practice are unknown. This study aims to compare trastuzumab use and outcome in HER2-positive MBC patients in a population-based cohort with clinical trial cohorts, with a special focus on elderly patients. MBC patients treated with trastuzumab-based chemotherapy in north-east Netherlands between 2005 and 2009 were identified from 23 hospital pharmacies and the Netherlands Cancer Registry. Baseline, treatment, and survival characteristics (Kaplan-Meier analysis) were compared with those found in clinical trials and differences in patients aged less than 65 versus 65 years or more were studied. Of 225 HER2-positive MBC patients (median: 54.8 years), 130 were treated with first-line trastuzumab. In first-line treatment, the median treatment duration was 9 months and the median OS was 30.7 months, which is comparable with the OS of 31.2 months found in a clinical trial with comparable baseline characteristics. In 25 patients aged 65 years or more compared with those aged less than 65 years treated with first-line trastuzumab, patients with a history of early breast cancer had less often been treated with adjuvant chemotherapy (36 vs. 71%; P=0.001). Other baseline characteristics and OS were similar. Patient, treatment, and survival characteristics in a HER2-positive MBC population-based cohort share considerable similarities to those found in clinical trials. The influence of age on trastuzumab treatment was not detected.

摘要

在人表皮生长因子受体2(HER2)阳性转移性乳腺癌(MBC)患者中,化疗联合曲妥珠单抗可延长总体生存期(OS),这已在临床试验中得到证实。然而,在日常临床实践中的治疗模式及生存情况尚不清楚。本研究旨在比较基于人群队列的HER2阳性MBC患者与临床试验队列中曲妥珠单抗的使用情况及治疗结果,特别关注老年患者。通过荷兰东北部23家医院药房及荷兰癌症登记处,确定了2005年至2009年间接受基于曲妥珠单抗化疗的MBC患者。将其基线、治疗及生存特征(Kaplan-Meier分析)与临床试验中的数据进行比较,并研究年龄小于65岁和65岁及以上患者之间的差异。在225例HER2阳性MBC患者(中位年龄:54.8岁)中,130例接受了一线曲妥珠单抗治疗。在一线治疗中,中位治疗持续时间为9个月,中位OS为30.7个月,这与具有相似基线特征的临床试验中31.2个月的OS相当。在接受一线曲妥珠单抗治疗的患者中,65岁及以上的25例患者与年龄小于65岁的患者相比,早期乳腺癌病史患者接受辅助化疗的比例更低(36%对71%;P=0.001)。其他基线特征及OS相似。基于人群队列的HER2阳性MBC患者的患者、治疗及生存特征与临床试验中的情况有相当多的相似之处。未检测到年龄对曲妥珠单抗治疗的影响。

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