Abstract
Trastuzumab, a humanized monoclonal antibody that targets the human epidermal growth factor receptor 2 (HER-2), is an important cell proliferation regulator in HER2-overexpressing breast cancer. It has been implemented as a standard adjuvant treatment in combination with chemotherapy for early-stage breast cancer in many countries. The aim of this study was to analyse the cost-effectiveness of 1-year of trastuzumab given every three weeks compared with observation in patients with early-stage breast cancer (HER-2-positive) after excision and completion of chemotherapy, from the Health Service of Regione Toscana perspective. A Markov health-state transition model was constructed to simulate the natural development of breast cancer based on HERceptin Adjuvant (HERA) trial; outcomes included overall mean survival (Life Years, LYs), quality adjusted life years (QALYs) and direct costs (value year 2009). The model results showed that the utilization of adjuvant trastuzumab treatment increased life expectancy by 2.10 LYs (2.01 QALYs), compared with the observation group. The incremental cost-effectiveness ratio (ICER) of trastuzumab for an additional life-year gained (LYG) was €7,135.43. If measured by quality-adjusted life-years, the ICER was €7,461.91. Univariate and probabilistic sensitivity analyses confirmed robustness of results. Our findings seem to suggest that 1-year of treatment with trastuzumab after adjuvant chemotherapy among women with HER-2-positive breast cancer significantly improves overall survival with reasonable costs if compared to the internationally accepted threshold.
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