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Use of sorafenib in patients with hepatocellular carcinoma before liver transplantation: A cost-benefit analysis while awaiting data on sorafenib safety

机译:索拉非尼在肝移植前肝细胞癌患者中的应用:等待索拉非尼安全性数据的成本效益分析

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摘要

The role of bridging therapies for patients with hepatocellular carcinoma (HCC) on the waiting list for liver transplantation (LT) remains controversial. There is strong evidence to support the effectiveness of sorafenib in extending the time to progression of HCC. Using a Markov model, we compared two strategies: one using sorafenib as neoadjuvant therapy before LT (Strategy A), and the other using no bridging therapy in the first 6 months (Strategy B). Reference case: T2 HCC patient with compensated cirrhosis. The benefit of sorafenib in delaying time to HCC progression was expressed as the hazard ratio (HR) and taken from recently published randomized trials. The endpoints considered were: survival benefit measured in quality-adjusted life days (QALDs), transplant probability, costs (C) in €, willingness to pay (WTP), and net health benefit (NHB), where NHB = survival benefit − C/WTP. The calculated WTP of sorafenib in Italy was 346 € per QALD. Probabilistic sensitivity analysis showed a median survival benefit of 94 QALDs (10% percentile = 38, 90% percentile = 210). In the base-case scenario (HR = 0.47, monthly dropout probability = 5%, median time to LT = 3 months), the gain in LT probability due to sorafenib was 5% and it increased proportionally with increasing median times to LT and decreasing HR. In the cost-benefit analysis, the incremental NHB of Strategy A versus Strategy B was 37 QALDs; it increased as sorafenib HR decreased and when median times to LT were shorter than 6 months, whereas for longer times it gradually dropped, particularly when Strategy B included effective locoregional treatments. Conclusion: Sorafenib neoadjuvant therapy is cost-effective by comparison with no therapy for T2-HCC patients waiting for LT, particularly for median times to LT under 6 months. (H EPATOLOGY 2009.)
机译:在等待肝移植(LT)的患者中,桥接疗法对肝细胞癌(HCC)患者的作用仍存在争议。有强有力的证据支持索拉非尼延长肝癌进展时间的有效性。使用马尔可夫模型,我们比较了两种策略:一种在LT之前使用索拉非尼作为新辅助治疗(策略A),另一种在头6个月不使用桥接治疗(策略B)。参考病例:T2 HCC代偿性肝硬化患者。索拉非尼在延缓肝癌进展时间方面的益处表示为危险比(HR),取自最近发表的随机试验。考虑的终点为:以质量调整生命日(QALD)衡量的生存效益,移植概率,以欧元为单位的成本(C),支付意愿(WTP)和净健康收益(NHB),其中NHB =生存效益− C / WTP。意大利索拉非尼的计算得出的WTP为每QALD 346欧元。概率敏感性分析显示,中位生存获益为94个QALD(10%百分位= 38,90%百分位= 210)。在基本情况下(HR = 0.47,每月辍学概率= 5%,LT的中位时间= 3个月),索拉非尼带来的LT概率增加5%,并且与LT的中位数时间增加和降低的比例成比例地增加人力资源部在成本效益分析中,策略A与策略B的增量NHB为37 QALD。当索拉非尼HR降低且到LT的中位时间短于6个月时,它增加,而随着时间的延长,它逐渐下降,特别是当策略B包括有效的局部治疗时。结论:索拉非尼新辅助治疗与不治疗等待LT的T2-HCC患者相比,特别是在6个月内达到LT的中位时间相比,具有成本效益。 (H EPATOLOGY 2009.)

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