Ondrácková B, Demlová R, Komínek J
Farmakologický ústav LF MU, Brno.
Klin Onkol. 2010;23(6):439-45.
Targeted biologic therapy has been proven to be effective compared to the current therapy of metastatic renal cell carcinoma (mRCC) in clinical studies as well as in actual clinical practice, but its high cost is a potentially limiting factor. Since the local cost-effectiveness analysis is missing, we assessed the cost of sunitinib and sorafenib in the treatment of mRCC in a comprehensive cancer centre.
A total of 31 patients were treated with sunitinib and/or sorafenib between 06/2006 and 09/2009 and then followed for at least 12 months. Clinical (disease progression, adverse events, dose reduction) and cost data (medication, examination, hospitalization) were assessed in the comprehensive cancer centre (1 Euro = 25.78 CZK).
The multikinase inhibitors were the second line treatment for most patients after INF-alpha therapy failure (86.7%). The mean cost per month to progression (PD) was 94,141.8 CZK/3651.7 Euro (sunitinib: 11 months to PD, cost to PD 1,267,648.5 CZK/49,171.8 Euro; sorafenib: 8 months to PD, cost to PD 896,670.1 CZK / 34,781.6 Euro). The incremental cost-effectiveness ratio was 123,659.5 CZK / 4796.7 Euro per progression-free month in sunitinib vs sorafenib patients. The mean cost per month after PD was 45,767.0 CZK/1775.3 Euro with sequential therapy (sorafenib after sunitinib failure and vice-versa in more than half of patients) or best supportive care. 16 patients died during the study period with mean cost of 1,180,795.4CZK/45,802.8 Euro per 12 months (median between treatment initiation with sunitinib or sorafenib and death). 8 patients (26%) did not achieve progression (median progression-free survival to 09/2009: sunitinib 18 months, sorafenib 14 months).
The cost of medication made up more than 95% of total costs to PD and more than 90% after PD. The cost per progression-free month was 123,659.5 CZK/4796.7 Euro in mRCC patients treated with sunitinib vs sorafenib.
在临床研究以及实际临床实践中，与转移性肾细胞癌（mRCC）的当前治疗方法相比，靶向生物疗法已被证明是有效的，但其高昂的成本是一个潜在的限制因素。由于缺乏局部成本效益分析，我们在一家综合癌症中心评估了舒尼替尼和索拉非尼治疗mRCC的成本。
2006年6月至2009年9月期间，共有31例患者接受了舒尼替尼和/或索拉非尼治疗，随后随访至少12个月。在综合癌症中心评估了临床（疾病进展、不良事件、剂量减少）和成本数据（药物、检查、住院）（1欧元 = 25.78捷克克朗）。
对于大多数患者而言，多激酶抑制剂是α干扰素治疗失败后的二线治疗（86.7%）。至疾病进展（PD）的每月平均成本为94,141.8捷克克朗/3651.7欧元（舒尼替尼：至PD为11个月，至PD的成本为1,267,648.5捷克克朗/49,171.8欧元；索拉非尼：至PD为8个月，至PD的成本为896,670.1捷克克朗/34,781.6欧元）。舒尼替尼组与索拉非尼组患者每无进展月的增量成本效益比为123,659.5捷克克朗/4796.7欧元。疾病进展后序贯治疗（半数以上患者在舒尼替尼失败后使用索拉非尼，反之亦然）或最佳支持治疗的每月平均成本为45,767.0捷克克朗/1775.3欧元。16例患者在研究期间死亡，每12个月的平均成本为1,180,795.4捷克克朗/45,802.8欧元（从开始使用舒尼替尼或索拉非尼治疗至死亡的中位数）。8例患者（26%）未出现疾病进展（至2009年9月的无进展生存期中位数：舒尼替尼为18个月，索拉非尼为14个月）。
至疾病进展的总成本中，药物成本占比超过95%，疾病进展后这一比例超过90%。舒尼替尼组与索拉非尼组mRCC患者每无进展月的成本为123,659.5捷克克朗/4796.7欧元。
