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张品良 副主任医师 山东省肿瘤医院 呼吸肿瘤内科

NSCLC靶向治疗NCCN指南:克唑替尼/赛可瑞

张品良 副主任医师 山东省肿瘤医院 呼吸肿瘤内科
发表于2016-09-18
人已读

Non-Small Cell Lung Cancer非小细胞肺癌

NCCN Guidelines Version 4.2016  NCCN指南2016第4版

Discussion 讨论

Treatment Approaches 治疗手段山东省肿瘤医院呼吸肿瘤内科张品良

Targeted Therapies 靶向治疗

Crizotinib 克唑替尼(Xalkori,赛可瑞, 辉瑞)

Crizotinib is approved by the FDA for patients with locally advanced or metastatic NSCLC who are positive for the ALK gene rearrangement. The approval is based on a phase 2 trial that showed dramatic response rates (>80%) to crizotinib in patients who had previously progressed. Patients receiving crizotinib reported clinically significant improvements in pain, dyspnea, and cough. A recent phase 3 trial compared first-line crizotinib versus chemotherapy in patients with ALK rearrangements; patients receiving crizotinib had improved PFS, quality of life, and response rates when compared with those receiving chemotherapy. The NCCN Panel recommends first-line therapy with crizotinib (category 1) based on this phase 3 trial and the FDA approval; the panel also feels that crizotinib is appropriate for patients with PS 0 to 4. Crizotinib may also be continued for patients with ALK rearrangements who have progressed if patients do not have multiple systemic symptomatic lesions.  FDA批准克唑替尼用于ALK基因重排阳性的局部晚期或转移性NSCLC患者。批准是基于一项2期试验显示既往已经进展的患者对克唑替尼戏剧性的应答(>80%)。接受克唑替尼的患者报告临床上显著改善疼痛、呼吸困难和咳嗽。最近一项3期试验在ALK重排的患者中对比一线克唑替尼与化疗;与接受化疗者相比,接受克唑替尼的患者PFS、生活质量和有效率均改善。基于这项3期试验和FDA的批准NCCN专家建议克唑替尼一线治疗(1类);小组还认为,克唑替尼适于PS 0-4的患者。对于已经进展的ALK重排患者,如果病人没有全身多发有症状的病变,克唑替尼也可以继续使用。

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