[关键词]
[摘要]
目的:评估多种PD-1 抑制剂联合化疗用于晚期、复发或转移性食管鳞状细胞癌(ESCC)患者一线治疗的成本效用。方法:基于 4 项晚期 ESCC 一线Ⅲ期临床试验(JUPITER-06、ESCORT-1st、ORIENT-15 和 KEYNOTE-590 研究),应用TreeagePro 2011软件建立传统的马尔科夫(Markov)模型,包括无进展生存期(PFS)、疾病进展(PD)和死亡3种状态,以质量调整生命年(QALY)为主要效用指标衡量健康结果,以增量成本-效用比(ICER)为治疗策略经济学效益的评价指标,进一步通过敏感性分析验证结果可靠性。结果:特瑞普利单抗联合化疗组、卡瑞利珠单抗联合化疗组、信迪利单抗联合化疗组、帕博利珠单抗联合化疗组和安慰剂联合化疗组的总成本分别为66 327.58、63 473.64、62 268.18、295 515.26 和32 753.79 元,效用值分别为0.648、0.605、0.673、0.585 和0.536 QALY;其中,信迪利单抗联合化疗组的ICER 值为217 018.13 元/QALY,低于中国患者意愿支付阈值的242 928 元/QALY,是一种相对可接受的治疗策略。敏感性分析显示,贴现率及信迪利单抗的成本对模型影响最大。结论:在中国目前的经济形势下,信迪利单抗联合化疗是ESCC患者可接受的一种一线PD-1抑制剂免疫治疗的策略。
[Key word]
[Abstract]
Objective: To determine the cost-effectiveness of adding PD-1 inhibitors to standard chemotherapy as the first-line treatment in patients with advanced, relapsed or metastatic esophageal squamous cell carcinoma (ESCC). Methods: Based on four first-line phase Ⅲ clinical trials of advanced ESCC: JUPITER-06, ESCORT-1st, ORIENT-15 and KEYNOTE-590 studies, Treeage Pro 2011 was used to establish traditional Markov model. The Markov model included three states: progression-free survival (PFS), progressive disease (PD) and death. Health outcomes were measured in quality-adjusted life years (QALYs) and incremental cost effectiveness ratio (ICER) was used to evaluate the economic benefits of treatment strategies. The sensitivity analysis was employed to further validate the above listed results. Results: The total cost of toripalizumab-chemotherapy group, camrelizumab-chemotherapy group, sintilimab-chemotherapy group, pembrolizumab-chemotherapy group and placebo-chemotherapy group were 66 327.58, 63 473.64, 62 268.18,295 515.26, and 32 753.79 yuan, respectively. The utility values were 0.648, 0.605, 0.673, 0.585, and 0.536 QALY, respectively. Among them, the ICER value of sintilimab-chemotherapy group was 217 018.13 yuan/QALY, which was lower than the Chinese willingness-to-pay (WTP) threshold (242 928 yuan/QALY), and it was a comparatively acceptable treatment strategy. Sensitivity analysis showed that the discount rate and the cost of sintilimab had the greatest influence on the model. Conclusion: Under the current economic situation in China, sintilimab combined with chemotherapy is an acceptable first-line PD-1 inhibitors immunotherapy strategy for the treatment of advanced ESCC.
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[基金项目]
金华市科技计划项目(No. 2019-4-008, No. 2021-4-015)