非小细胞肺癌NCCN指南2017第4版讨论:色瑞替尼
2018年07月27日 【健康号】 张品良

非小细胞肺癌NCCN指南2017第4版讨论:靶向治疗

Ceritinib 色瑞替尼

Ceritinib is approved by the FDA for patients with ALK-positive metastatic NSCLC who have progressed on or are intolerant to crizotinib. The approval is based on an expanded phase 1 study (ASCEND-1) showing overall response rates of 56% to ceritinib in patients (92/163) who had previously received crizotinib; the median duration of response was 8.3 months (6.8-9.7). Common grade 3 to 4 adverse events included increased alanine aminotransferase (73 [30%] patients) and increased aspartate aminotransferase (25 [10%]). Some patients with CNS lesions responded to ceritinib. Based on the study and the FDA approval, the NCCN Panel recommends ceritinib as subsequent therapy for patients with ALK-positive NSCLC who have progressed after crizotinib; patients who do not tolerant crizotinib may be switched to ceritinib or alectinib. A recent phase 2 trial (ASCEND-2) assessed ceritinib in patients who had previously received at least 2 or more treatments, had progressed on crizotinib, and had brain metastases. The overall response rate was 38%; the duration of response was 9.7 months (95% CI, 7.1–11.1 months). The intracranial overall response rate was 45.0% (95% CI, 23.1%–68.5%). FDA批准了色瑞替尼用于克唑替尼进展或不能耐受、ALK阳性的转移性NSCLC患者。批准是根据一项扩展的1期研究(ASCEND-1)显示,在既往已接受克唑替尼治疗的患者中,色瑞替尼治疗的总有效率为56%(92/163);中位疗效持续时间是8.3个月(6.8-9.7)。常见的3-4级不良事件包括丙氨酸氨基转移酶升高(73例[30%])及天冬氨酸转氨酶升高(25例[10%])。某些具有CNS病变的患者对色瑞替尼应答。基于该研究和FDA的批准,研究小组建议色瑞替尼作为ALK阳性的NSCLC患者在克唑替尼进展后的后续治疗;不耐受克唑替尼的患者可以转换至色瑞替尼或阿雷替尼。最近一项2期试验(ASCEND-2)评估了色瑞替尼治疗既往曾接受过至少2个或以上治疗、克唑替尼进展并有脑转移的患者。总有效率是38%;疗效持续时间是9.7个月(95%CI,7.1-11.1个月)。颅内病变总有效率为45.0%(95%CI,23.1%-68.5%)。山东省肿瘤医院呼吸肿瘤内科张品良

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