埃克替尼治疗晚期非小细胞肺癌近期疗效及不良反应评价

Short-term Response and Toxicity of Icotinib Hydrochloride in the Treatment for Advanced Non-small Cell Lung Cancer

[目的]观察盐酸埃克替尼治疗晚期非小细胞肺癌(NSCLC)的近期疗效及不良反应。[方法]67例晚期NSCLC患者,均口服盐酸埃克替尼单药治疗,服用至少1个月后评价疗效及安全性。[结果]全组67例患者中CR1例,PR25例,SD16例,PD25例。总有效率(ORR)38.8%(26/67),疾病控制率(DCR)62.7%(42/67)。其中治疗前CEA>30μg/L组ORR59.5%(22/37),DCR73.0%(27/37),而治疗前CEA<30μg/L组ORR13.3%(4/30),DCR46.7%(14/30),两组ORR、DCR差异均有统计学意义。男性DCR低于女性,且调整吸烟因素后,性别间DCR的差异同样具有统计学意义。多因素分析提示性别及治疗前CEA是否高于30μg/L为近期疗效的独立预测因素。治疗相关不良反应主要为皮疹26.8%(18/67)和腹泻13.4%(9/67)。[结论]盐酸埃克替尼单药治疗晚期NSCLC近期疗效肯定,治疗相关的不良反应较轻,耐受性好。女性或治疗前CEA较高的患者疗效更佳。

[Purpose ] To observe short-term response and toxicity of icotinib hydrochloride in the treatment for advanced non-small cell lung cancer （NSCLC）. [Methods] Sixty-seven cases with NSCLC treated with icotinib hydroehloride alone taken orally for at least one month were enrolled in the study. Efficacy and toxicity were evaluated. [Results] Objective response rate （ORR）was 38.8%（26/67）,and disease control rate （DCR）was 62.7%（42/67） in 67 cases, with complete re- sponse（CR）, 1 case; partial response（PR）,25 cases; stable disease（SD）, 16 cases; and progressive disease （PD）, 25 cases. ORR and DCR were 59.5 %（22/37） and 73.0%（27/37） respectively in pa- tients with CEA〉30μg/L, while those CEA〈30tμg/L were 13.3%（4/30） and 46.7%（14/30） respec- tively,with significant difference between the two groups. The DCR of male was lower than that of female, and the DCR between genders showed significant difference after adjusting smoking sta- tus. Multivariate analysis showed that gender and CEA（〉30μg/L ） were independent prognostic fac- tors for short-term response. The major toxicities were skin rash （26.8%） and diarrhea （13.4%）. [Conclusion] Monotherapy with icotinib hydrochloride is effective and tolerable for the patients with advanced NSCLC, especially for female patients or patients with CEA elevation.