非小细胞肺癌NCCN指导2017第4版讨论:克唑替尼(crizotinib)

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2021年2月6日11:16:07非小细胞肺癌NCCN指导2017第4版讨论:克唑替尼(crizotinib)已关闭评论
摘要

非小细胞肺癌NCCN指导2017第4版讨论:靶向医治Crizotinib 克唑替尼(crizotinib)Crizotinib is approved by the FDA for p

本文标签:赛可瑞克唑替尼胶囊

非小细胞肺癌NCCN指南2017第4版讨论:靶向治疗

克唑替尼,Crizotinib,赛可瑞,Xalkori,印度克唑替尼,孟加拉克唑替尼,

Crizotinib 克唑替尼(crizotinib)(crizotinib)

克唑替尼,Crizotinib,赛可瑞,Xalkori,印度克唑替尼,孟加拉克唑替尼,

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 dra tic response rates (>80%) to crizotinib in patients who had previously progressed. Patients receiving crizotinib reported clinically significant improvements in pain, dyspnea, and cough. A 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 y also be continued for patients with ALK rearrangements who have progressed if patients do not have multiple systemic sympto tic lesions. FDA批准克唑替尼(crizotinib)(crizotinib)用于ALK基因重排阳性的局部晚期或转移扩散扩散性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(crizotinib)(crizotinib)戏剧性的应答(>80%)。接受克唑替尼(crizotinib)(crizotinib)的患者报告临床上显著改善疼痛、呼吸困难和咳嗽。一项3期试验在ALK重排的患者中对比一线克唑替尼(crizotinib)(crizotinib)与化疗;与接受化疗者相比,接受克唑替尼(crizotinib)(crizotinib)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专家推荐克唑替尼(crizotinib)(crizotinib)一线治疗(1类);小组还认为,克唑替尼(crizotinib)(crizotinib)适于PS 0-4的患者。对于已经进展的ALK重排患者,如果患者没有全身多发有症状的病变,克唑替尼(crizotinib)(crizotinib)也可以继续使用。山东省肿瘤医院呼吸内科张品良

Crizotinib is also very effective for patients with ROS1 rearrangements with response rates of about 70% including complete responses (see ROS1 Rearrangements in this Discussion). For the 2017 update (Version 1), the NCCN Panel moved the recommendation for ROS1 testing into the in algorithm (and deleted the footnote recommending ROS1 testing), added a new algorithm for ROS1, and added a new section on ROS1 to the molecular diagnostic stu s section based on data showing the efficacy of crizotinib for patients with ROS1 rearrangements and on the recent FDA approval (see Principles of Pathologic Review in the NCCN Guidelines for NSCLC). Alectinib and ceritinib are not effective in patients with ROS1 rearrangements whose disease become resistant to crizotinib. 对于具有ROS1重排的患者,克唑替尼(crizotinib)(crizotinib)也是非常有效的,有效率约70%,包括完全缓解(见本讨论中的ROS1重排)。2017第1版更新,NCCN小组将ROS1检测的推荐移到主要工作步骤中(同时删除了推荐ROS1检测的脚注),根据克唑替尼(crizotinib)(crizotinib)对ROS1重排患者有效的数据和最近FDA的批准,增加了一个新的ROS1工作步骤,并增加了ROS1分子诊断研究的新章节(见NSCLC NCCN指南中的病理检查原则)。阿雷替尼和色瑞替尼(ceritinib)(ceritinib)对克唑替尼(crizotinib)(crizotinib)耐药的ROS1重排患者无效。

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