Objective To explore the clinical efficacy of crizotinib in treatment of advanced ALK positive NSCLC which compared with chemotherapy. Methods 86 ALK positive NSCLC patients were randomly divided into the treatment group (n=43) and the chemotherapy group (n=43). The treatment group was given crizotinib thera-py, and the chemotherapy group received standard chemotherapy ( pemetrexed plug, paclitaxel or gemcitabine com-bined with cisplatin or carboplatin) . All the patients were followed up for 12 months to assess the efficacy and toxici-ty. Results The ORR of the treatment group was 62% (26/43), which was significantly higher than 27. 9% of the chemotherapy group ( 12/43 ) , and the median progression free survival ( PFS ) was 7. 0 months in the treatment group (95% CI:6. 0-8. 0 months), higher than 3. 0 months in the chemotherapy group (95% CI:1. 180-4. 820 months) . The most frequent treatment-related AEs in the treatment group were gastrointestinal? disturbance, fol-lowed by increased glutamic-pyruvic transaminase, vision disorder, and most toxicities were grade 1 and 2. The most frequent treatment-related AEs in the chemotherapy group were nausea, fatigue, vomiting, and loss of appetite. Con-clusion The clinical efficacy of crizotinib in patients with ALK positive advanced NSCLC is better than that of con-ventional chemotherapy, which can prolong the median PFS and improve the quality of life.%目的：尽管国际上研究表明克唑替尼对非小细胞肺癌( NSCLC)患者疗效佳,毒副作用少,但对我国人口的有效证据尚不充足。本研究将探索克唑替尼相较于化疗对棘皮动物微管结合蛋白样4-间变性淋巴瘤激酶( EML4-ALK)融合基因阳性的中晚期NSCLC患者的临床疗效。方法筛选ALK 阳性的NSCLC患者86例,随机分配为克唑替尼组和化疗组,每组各43例。随访12个月,评估克唑替尼组与标准化疗组的疗效及毒副作用。结果克唑替尼的客观缓解率(ORR)为62%(26/43),远高于化疗组的27．9%(12/43),中位无进展生存时间(PFS)为7．0个月(95% CI 6．0-8．0月),高于化疗组的3．0个月(95% CI 1．2-4．8月)。克唑替尼不良反应主要为消化道症状,其次是谷丙转氨酶升高,视觉障碍,大部分为1-2级。化疗患者的不良反应为恶心、疲劳、呕吐、食欲下降。结论克唑替尼在ALK阳性中晚期NSCLC患者的临床疗效优于常规化疗,可延长中位PFS,提高患者生存质量。
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