The use and impact of trastuzumab (Herceptin) for early and late stage HER-2 positive breast cancer in Australia

This project was established to conduct a long-term evaluation of the way in which trastuzumab (Herceptin) is used to treat early and late stage breast cancer in the real world clinical setting. Secondary health data sets were linked to examine all patients receiving trastuzumab since the inception of the Herceptin Program (for late stage disease) in December 2001 and since its listing on the Pharmaceutical Benefits Scheme for early stage disease in October 2006. The data linkages have been set up in such a way that it is possible to track individuals receiving PBS-subsidised trastuzumab for early stage disease and upon disease progression patients receiving the drug via the Herceptin Program for metastatic disease. Data access and linkage was facilitated by Medicare Australia, the administering body of both programs. The study currently has approval for annual data updates until 2015. Originating source(s): Medicare Australia -[Herceptin Program] [Pharmaceutical Benefits Scheme] [Medical Benefits Scheme] and [Patient/Medicare enrolment data]

本项目旨在开展长期评估，探究曲妥珠单抗（trastuzumab，商品名赫赛汀（Herceptin））在真实世界临床场景中用于早期与晚期乳腺癌的临床使用模式。研究通过关联二级医疗数据集，对两类时间节点后所有接受曲妥珠单抗治疗的患者开展分析：其一为2001年12月赫赛汀项目（Herceptin Program，针对晚期疾病）启动以来的患者，其二为2006年10月该药物纳入药品福利计划（Pharmaceutical Benefits Scheme，PBS）报销范围、用于早期疾病治疗以来的患者。该数据关联体系可实现患者个体追踪：既可跟踪接受PBS补贴的曲妥珠单抗治疗早期疾病的患者，也可追踪疾病进展后通过赫赛汀项目接受该药物治疗转移性疾病的患者。数据访问与关联工作由两项项目的共同管理机构——澳大利亚医疗保险（Medicare Australia）提供协助。本研究目前已获批每年更新数据，有效期至2015年。本研究的原始数据来源包括：澳大利亚医疗保险（Medicare Australia）提供的[赫赛汀项目（Herceptin Program）]、[药品福利计划（Pharmaceutical Benefits Scheme）]、[医疗福利计划（Medical Benefits Scheme）]以及[患者/医疗保险登记数据（Patient/Medicare enrolment data）]