澳大利亚接受曲妥珠单抗治疗的 HER2 阳性转移性乳腺癌患者（新）辅助曲妥珠单抗治疗后的生存结局：一项全国性基于人群的观察性研究（2006-2014 年）。
Survival outcomes for Australian women receiving trastuzumab for HER2-positive metastatic breast cancer following (neo)adjuvant trastuzumab: a national population-based observational study (2006-2014).
机构信息
Medicines Policy Research Unit, Centre for Big Data Research in Health, University of New South Wales, Sydney, NSW 2052, Australia.
NHMRC Clinical Trials Centre, University of Sydney, Sydney, NSW 2050, Australia.
出版信息
Br J Cancer. 2018 Feb 6;118(3):441-447. doi: 10.1038/bjc.2017.405. Epub 2017 Nov 14.
BACKGROUND
Patients treated with (neo)adjuvant trastuzumab who relapse and receive trastuzumab for metastatic breast cancer (MBC) are a growing population with little outcome data given their exclusion from most clinical trials. We aim to estimate survival outcomes for this trastuzumab 'pre-treated' population.
METHODS
Population-based study of Australian women receiving trastuzumab for HER2-positive MBC between 2006 and 2014, who also received (neo)adjuvant trastuzumab. We used Kaplan-Meier methods to estimate the following: overall survival (OS) from initiation of trastuzumab for MBC; duration of trastuzumab for MBC; and time from last (neo)adjuvant trastuzumab to first trastuzumab for MBC.
RESULTS
Of 3199 patients dispensed trastuzumab for MBC, 634 (20%) had received (neo)adjuvant traztuzumab. Pre-treated patients had a median (interquartile range) OS of 21.8 months (10.9-51.6), trastuzumab duration of 12.8 months (4.7-17.5), and time from last (neo)adjuvant trastuzumab to first trastuzumab for MBC of 15.6 months (6.5-28.6). Median OS for patients initiating trastuzumab <12 months and ⩾12 months from their last (neo)adjuvant trastuzumab were 17.1 months and 24.8 months, respectively.
CONCLUSIONS
Patients starting trastuzumab for MBC following (neo)adjuvant trastuzumab had a median treatment duration of 1 year and OS of almost 2 years. These data help inform clinical practice and service planning for this under-researched population.
背景
接受（新）辅助曲妥珠单抗治疗后复发并接受曲妥珠单抗治疗转移性乳腺癌（MBC）的患者数量不断增加，但由于大多数临床试验都将其排除在外，因此针对这一人群的疗效数据十分有限。本研究旨在评估这一接受过曲妥珠单抗预处理的人群的生存结局。
方法
这是一项基于人群的研究，纳入了 2006 年至 2014 年间在澳大利亚接受曲妥珠单抗治疗 HER2 阳性 MBC 的女性患者，这些患者也接受了（新）辅助曲妥珠单抗治疗。我们采用 Kaplan-Meier 法评估以下内容：从开始使用曲妥珠单抗治疗 MBC 起的总生存（OS）；曲妥珠单抗治疗 MBC 的持续时间；从最后一次（新）辅助曲妥珠单抗到首次 MBC 曲妥珠单抗的时间。
结果
在 3199 例接受曲妥珠单抗治疗 MBC 的患者中，有 634 例（20%）曾接受（新）辅助曲妥珠单抗治疗。预处理患者的中位（四分位间距）OS 为 21.8 个月（10.9-51.6），曲妥珠单抗治疗持续时间为 12.8 个月（4.7-17.5），从最后一次（新）辅助曲妥珠单抗到首次 MBC 曲妥珠单抗的时间为 15.6 个月（6.5-28.6）。末次（新）辅助曲妥珠单抗治疗后 ⩽12 个月和 ⩾12 个月开始曲妥珠单抗治疗的患者中位 OS 分别为 17.1 个月和 24.8 个月。
结论
在接受（新）辅助曲妥珠单抗治疗后开始曲妥珠单抗治疗 MBC 的患者，曲妥珠单抗治疗持续时间中位数为 1 年，OS 近 2 年。这些数据有助于为这一研究较少的人群提供临床实践和服务规划方面的信息。
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