表皮生长因子受体基因突变不明的晚期非小细胞肺癌患者在吉非替尼治疗失败后行厄洛替尼治疗的疗效分析

Efficacy of erlotinib after the failure of gefitinib in patients with metastasis of non-small cell lungcancer with unknown EGFR mutation status

目的探讨表皮生长因子受体（EGFR）基因突变不明但初始吉非替尼治疗有效而最终耐药的晚期非小细胞肺癌（NSCLC）患者行厄洛替尼治疗的疗效，并比较直接换用厄洛替尼与先化疗再行厄洛替尼治疗的差异。方法40例EGFR基因突变不明的晚期NSCLC患者，行吉非替尼治疗3个月以上，疗效为部分缓解或稳定。其中16例疾病进展后直接换用厄洛替尼（G-E组），24例先化疗再口服厄洛替尼（G-C-E组），直至病变进展。比较G-E组和G-C-E组的临床疗效。结果40例患者中，厄洛替尼的疾病控制率（DCR）为52．5％，有效率（RR）为10．0％。G-E组和G-C-E组的RR分别为6．2％和12．5％，DCR分别为56．2％和50．0％，差异均无统计学意义（P值分别为0．638和0．755）。在G．E组和G-C-E组中，厄洛替尼的疗效与之前吉非替尼的疗效均无相关性（P值分别为0．365和0．658）。40例患者中，厄洛替尼治疗的中位无疾病进展生存时间（PFS）和生存时间（OS）分别为3．0个月和12．0个月。G-E组和G-C-E组的中位PFS分别为4．0和2．0个月，中位OS均为12．0个月，差异均无统计学意义（P值分别为0．768和0．510）。结论疾病进展后直接换用厄洛替尼治疗或者先化疗再厄洛替尼治疗，均可作为吉非替尼治疗晚期NSCLC耐药后的备选治疗方法。

Objective To evaluate the efficacy of erlotinib in patients with metastasis of non-small cell lung cancer who had benefits from initial gefitinib treatment but finally demonstrated resistance, especially in those of unknown EGFR mutation status, and to compare the efficacy of erlotinib between patients who received erlotinib immediately after gefitinib failure and those who received chemotherapy before erlotinib. Methods Forty Chinese patients who had been treated with erlotinib （150 mg daily） after gefitinib （250 mg daily） failure were evaluated retrospectively. All of these patients had achieved gefitinib treatment for at least three months with response of partial remission or stable disease. Among them, 16 patients shifted to erlotinib immediately after progression （ Group G-E） , and the other 24 patients inserted chemotherapy between gefitinib and erlotinib （ Group G-C-E）. Results In the whole group, the disease control rate （DCR） of erlotinib was 52.5% （21/40） while the objective response rate （RR） was only 10.0% （4/40）. The RR of the group G-E was 6.2% and the group G-C-E was 12.5% , and the DCR was 56.2% and 50.0% in the two groups, respectively, both without significant differences （P = 0. 638 and P = 0.755 ）. There was no correlation between the efficacy of erlotinib and that of initial gefitinib in both group G-E and group G-C-E（ P = 0. 365 and P = 0. 658 ）. The median progression-free survival （PFS） and overall survival （OS） for the erlotinib treatment were 3.0 and 12.0 months in the 40 patients. Statistically no significant difference was observed in PFS （4 months in the group G-E and 2 months in the group G-C-E, P = 0.768 ） and OS （12 months in both Groups, P = 0.510）. Conclusions Erlotinib can be consideredeither immediately after gefitinib failure or following the insertion of chemotherapy after gefitinib failure in progressive non-small cell lung cancer patients who initially benefited from gefitinib.