Fagnani Francis, Colin Xavier, Arveux Patrick, Coudert Bruno, Misset Jean-Louis
Cemka Eval, 43, boulevard du Maréchal-Joffre, 92340 Bourg-la-Reine.
Bull Cancer. 2007 Jul;94(7):711-20.
Trastuzumab (Herceptin), a recombinant, humanised, monoclonal-antibody that targets human epidermal growth factor receptor 2 (HER2), has been approved as an adjuvant therapy for HER2-positive early breast cancer. The aim of this study was to assess the incremental cost-effectiveness ratio of this treatment compared with adjuvant therapy alone in the French setting. A cost-effectiveness analysis was performed using a Markov state transition model. The transition probabilities were estimated from the interim results of the Hera trial. Unit costs data were mainly estimated in a French Oncology Center (Georges-François Leclerc, Dijon). The model estimated that overall mean survival of patients treated with trastuzumab was 20.08 years versus 16.23 in the observation group (3.85 life-years gained). For 1 000 patients with a 10-year follow-up, an adjuvant therapy with trastuzumab would avoid 49.7 loco-regional recurrences, 179.5 distant recurrences and 133.4 deaths. The incremental discounted cost of trastuzumab therapy over a lifetime horizon was estimated at 27594 euro per patient in association with a discounted gain of 2.27 life-years. In accordance with the techniques of economical evaluation, the utilization of trastuzumab as an adjuvant therapy in patients with early HER2 positive breast cancer improves patient survival with an acceptable cost-effectiveness ratio in the French setting (incremental cost-effectiveness ratio of 12,148 euros /LYG).
曲妥珠单抗（赫赛汀）是一种重组人源化单克隆抗体，作用靶点为人类表皮生长因子受体2（HER2），已被批准作为HER2阳性早期乳腺癌的辅助治疗药物。本研究旨在评估在法国背景下，这种治疗方法相对于单纯辅助治疗的增量成本效益比。使用马尔可夫状态转移模型进行成本效益分析。转移概率根据Hera试验的中期结果估算。单位成本数据主要在法国肿瘤中心（第戎的乔治 - 弗朗索瓦·勒克莱尔中心）估算。模型估计，接受曲妥珠单抗治疗的患者总体平均生存期为20.08年，而观察组为16.23年（增加了3.85个生命年）。对于1000例接受10年随访的患者，曲妥珠单抗辅助治疗可避免49.7例局部区域复发、179.5例远处复发和133.4例死亡。曲妥珠单抗治疗在终身范围内的增量贴现成本估计为每位患者27594欧元，贴现收益为2.27个生命年。根据经济评估技术，在法国背景下，将曲妥珠单抗用作HER2阳性早期乳腺癌患者的辅助治疗可提高患者生存率，且成本效益比可接受（增量成本效益比为12,148欧元/生命年增益）。
