埃克替尼与吉非替尼治疗Ⅳ期表皮因子受体敏感基因突变肺腺癌患者临床疗效比较

Comparison of the clinical efficacy of icotinib and gefitinib in the treatment of stage Ⅳ lung adenocarcinomapatients with EGFR sensitive gene mutation

目的比较埃克替尼与吉非替尼治疗晚期（Ⅳ期）表皮生长因子受体（EGFR）敏感基因突变肺腺癌的临床效果。方法选取54例Ⅳ期EGFR敏感基因突变肺腺癌患者为研究对象。采用随机数字表法将患者分为两组，每组27例。埃克替尼组实施盐酸埃克替尼靶向治疗，吉非替尼组实施吉非替尼口服治疗。观察比较两组临床疗效、生活质量评分、不良反应、无疾病进展生存期（PFS）。结果两组临床疗效差异均无统计学意义[完全缓解（0例比0例），部分缓解（9例比8例），稳定（12例比14例），进展（6例比5例），客观缓解率（33.3%比29.6%），疾病控制率（77.8%比81.5%），Z＝1.060，χ2＝0.143、0.100，均P〉0.05]。治疗后吉非替尼组生活质量评分中躯体功能、社会功能、心理功能、共性症状及副作用、特异性模块与治疗前相比，差异均无统计学意义（t＝1.402、1.199、1.840、1.860、1.275，均P〉0.05），而埃克替尼组躯体功能、心理功能、共性症状及副作用、特异性模块较治疗前显著改善（t＝2.525、3.335、4.477、3.778，均P〈0.05），埃克替尼组心理功能、共性症状及副作用、特异性模块等生活质量评分分别为（39.72±4.23）分、（38.84±4.67）分、（38.94±4.56）分，均高于吉非替尼组的（37.08±5.14）分、（35.48±5.02）分、（35.85±4.97）分（t＝2.061、2.546、2.380，均P〈0.05）。两组不良反应Ⅰ-Ⅱ级发生率差异无统计学意义（χ2＝4.667，P〉0.05），Ⅲ-Ⅳ级不良反应发生率埃克替尼组为7.4%，低于吉非替尼组的25.9%（χ2＝9.000，P〈0.05）；埃克替尼组不良反应总发生率为40.7%，显著低于吉非替尼组的70.4%（χ2＝25.694，P〈0.05）。EGFR基因19delete突变下两组平均PFS比较差异无统计学意义（t＝0.795，P〉0.05）；EGFR基因21L858R突变下埃克替尼组平均PFS为（14.62±3.85）个月，长于吉非替尼组的（10.73±5.61）个月（t＝2.971，P〈0.05）。结论埃克替尼、吉非替尼治疗Ⅳ期EGFR敏感基因突变肺腺癌的临床疗效相当，但埃克替尼安全性更高，耐受性更好，且可显著提高患者生活质量，延长EGFR基因21L858R突变患者的生存期。

ObjectiveTo compare the clinical efficacy of icotinib and gefitinib in the treatment of advanced（stage Ⅳ） lung adenocarcinoma patients with epidermal growth factor receptor（EGFR） sensitive gene mutation.MethodsFifty-four advanced（stage Ⅳ） lung adenocarcinoma patients with EGFR sensitive gene mutation were selected.According to the random number table method, the patients were divided into two groups, with 27 cases in each group.The icotinib group received icotinib hydrochloride targeted therapy, and the gefitinib group was orally given gefitinib.The clinical efficacy, quality of life score, adverse reactions, progression free survival（PFS） were compared between the two groups.ResultsThere were no statistically significant differences in clinical curative effect between the two groups[complete remission（0 cases vs.0 cases）, partial remission（9 cases vs.8 cases）, stable（12 cases vs.14 cases）, progress disease（6 cases vs.5 cases）, objective response rate（33.3% vs.29.6%）, disease control rate（77.8% vs.81.5%）, Z=1.060, χ2=0.143, 0.100, all P〉0.05]. After treatment, the differences of body function, social function, psychological function, common symptoms and side effects, specific modules in the gefitinib group were not statistically significant compared with those before treatment（t=1.402, 1.199, 1.840, 1.860, 1.275, all P〉0.05）. The icitinib group had better body function, psychological function, common symptoms, side effects and specific modules than before treatment（t=2.525, 3.335, 4.477, 3.778, all P〈0.05）. The psychological function, common symptoms and side effects, specific module life quality scores in the icotinib group were （39.72±4.23）points, （38.84±4.67）points, （38.94±4.56）points, respectively, which were higher than （37.08±5.14）points, （35.48±5.02）points, （35.85±4.97）points in the gefitinib group（t=2.061, 2.546, 2.380, all P〈0.05）. The incidence rate of Ⅰ-Ⅱ grade adverse reactions between the two groups had no statistically significant difference （χ2=4.667, P〉0.05）. The incidence rate of Ⅲ-Ⅳ grade adverse reactions of the icotinib group was 7.4%, which was lower than 25.9% of the gefitinib group（χ2=9.000, P〈0.05）. The total incidence rate of adverse reactions of the icotinib group was 40.7%, which was significantly lower than 70.4% of the gefitinib group（χ2=25.694, P〈0.05）. There was no statistically significant difference in mean PFS between the two groups in the 19delete mutation of EGFR gene（t=0.795, P〉0.05）. The average PFS of the icotinib group under EGFR gene 21L858R mutation was （14.62±3.85）months, which was longer than （10.73±5.61）months of the gefitinib group（t=2.971, P〈0.05）.ConclusionIcotinib, gefitinib in the treatment of advanced（stage Ⅳ） lung adenocarcinoma patients with EGFR sensitive gene mutation has similar clinical effect, but icotinib has higher safety, better tolerability, and can significantly improve the quality of life of patients, prolong the EGFR mutation of the 21L858R gene under the survival of patients.