Wen Feng, Zheng Hanrui, Zhang Pengfei, Hutton David, Li Qiu
Department of Medical Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.
West China Biostatistics and Cost-Benefit Analysis Center, Sichuan University, Chengdu, China.
BMJ Open. 2018 Apr 13;8(4):e020128. doi: 10.1136/bmjopen-2017-020128.
Erlotinib, the first generation of epidermoid growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI), has been recommended as an essential treatment in patients with non-small-cell lung cancer (NSCLC) with EGFR mutation. Although it has improved progression-free survival (PFS), overall survival (OS) was limited and erlotinib can be expensive. This cost-effectiveness analysis compares erlotinib monotherapy with gemcitabine-included doublet chemotherapy.
First-line treatment of Asian patients with NSCLC with EGFR mutation.
A Markov model was created based on the results of the ENSURE (NCT01342965) and OPTIMAL (CTONG-0802) trials which evaluated erlotinib and chemotherapy. The model simulates cancer progression and all causes of death. All medical costs were calculated from the perspective of the Chinese healthcare system.
The primary outcomes are costs, quality-adjusted life years (QALYs) and incremental cost-effectiveness ratios (ICERs).
The combined PFS was 11.81 months and 5.1 months for erlotinib and chemotherapy, respectively, while the OS was reversed at 24.68 months for erlotinib and 26.16 months for chemotherapy. The chemotherapy arm gained 0.13 QALYs compared with erlotinib monotherapy (1.17 QALYs vs 1.04 QALYs), while erlotinib had lower costs ($55 230 vs $77 669), resulting in an ICER of $174 808 per QALY for the chemotherapy arm, which exceeds three times the Chinese GDP per capita. The most influential factors were the health utility of PFS, the cost of erlotinib and the health utility of progressed disease.
Erlotinib monotherapy may be acceptable as a cost-effective first-line treatment for NSCLC compared with gemcitabine-based chemotherapy. The results were robust to changes in assumptions.
NCT01342965 and CTONG-0802.
厄洛替尼作为第一代表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKI），已被推荐用于表皮生长因子受体（EGFR）突变的非小细胞肺癌（NSCLC）患者的一线治疗。尽管它改善了无进展生存期（PFS），但总生存期（OS）有限，且厄洛替尼价格昂贵。本成本效益分析比较了厄洛替尼单药治疗与含吉西他滨的双联化疗。
亚洲EGFR突变的NSCLC患者的一线治疗。
基于评估厄洛替尼和化疗的ENSURE（NCT01342965）和OPTIMAL（CTONG-0802）试验结果建立马尔可夫模型。该模型模拟癌症进展和所有死因。所有医疗成本均从中国医疗保健系统的角度计算。
主要结局为成本、质量调整生命年（QALY）和增量成本效益比（ICER）。
厄洛替尼组和化疗组的联合PFS分别为11.81个月和5.1个月，而OS则相反，厄洛替尼组为24.68个月，化疗组为26.16个月。与厄洛替尼单药治疗相比，化疗组多获得0.13个QALY（1.17个QALY对1.04个QALY），而厄洛替尼成本更低（55230美元对77669美元），化疗组的ICER为每QALY 174808美元，超过中国人均GDP的三倍。最有影响的因素是PFS的健康效用、厄洛替尼的成本和疾病进展的健康效用。
与基于吉西他滨的化疗相比，厄洛替尼单药治疗作为NSCLC的具有成本效益的一线治疗可能是可接受的。结果对假设的变化具有稳健性。
NCT01342965和CTONG-0802。
