摘要
目的探讨克唑替尼对间变性淋巴瘤激酶(ALK)阳性的晚期非小细胞肺癌(NSCLC)的疗效和安全性,及与ALK变异体的相关性;分析克唑替尼的临床疗效和不良反应。方法收集皖南医学院弋矶山医院及南京军区南京总医院自2013年9月至2017年5月收治的68例ALK阳性晚期NSCLC患者,口服克唑替尼胶囊250 mg,2次/d。利用二代测序技术检测初治标本基因情况,探索ALK变异体与克唑替尼治疗的疗效。结果 68例患者的客观缓解率和疾病控制率分别为61.8%和85.3%,中位PFS和中位OS分别为10.5个月和33.9个月。根据二代测序结果,35例患者中变异体1最常见(42.9%),其次是变异体2(20.0%)。变异体1和非变异体1两组的中位PFS(10.7个月vs.9.8个月,P=0.647)和中位OS(27.33个月vs.22.40个月,P=0.831)没有统计学差异。患者的不良反应最常见是视觉影响和消化道反应,多数为Ⅰ~Ⅱ度。结论 ALK阳性的晚期NSCLC患者接受克唑替尼治疗具有较好的疗效且不良反应多可耐受。ALK阳性不同变异体之间与克唑替尼的疗效没有明显的生存差异。
Objective This study aims to evaluate the efficacy and tolerability of crizotinib for advanced ALK-positive patients with non-small-cell lung cancer(NSCLC). We compared clinical outcomes according to ALK fusion variants. Methods Six-eight ALK-positive patients with advanced NSCLC were given orally crizotinib of 250 mg/bid,and were followed up to estimate curative effect and safety. Tumor tissues before crizotinib administration were detected successfully by the next generation sequencing. We evaluated the efficacy of crizotinib in these patients. Results Among the 68 patients,the tumor objective response rate(ORR) and disease control rate(DCR) were 61.8% and 8.3%,respectively. The median PFS and median OS were 10. 5 months and 33.9 months,respectively. Combining the results of NGS detection,we found ALK variant 1 was the most common type(42.9%) and next was variant 2(20.0%). No PFS difference was found in patients between variant 1 and non-variant 1 of EML4-ALK(10.7 months vs. 9.8 months,P = 0.647). The median OS was not different in two groups(27. 33 months vs. 22. 40 months,P = 0. 831). In addition,the most common drugrelated adverse events were mild flickering vision and gastrointestinal reaction. Conclusion Crizotinib has promising efficacy and is well tolerated in ALK-positive patients with advanced NSCLC. And no survival difference was demonstrated between variants treated with crizotinib.
作者
张鹤
宋正波
吕镗烽
陆志伟
吴娟
宋勇
Zhang He1, Song Zhengbo2, Lyu Tangfeng3, Lu Zhiwei1, Wu Juan4, Song Yong3.(1Department ofRespiratory Medicine, Yijishan Hospital, Wannan Medical College, Wuhu 241002, China; 2Department ofMedical Oncology, Zhejiang Cancer Hospital, Hangzhou 310022, China; 3Department of Respiratory Medicine,Jinling Hospital, Nanjing University, School of Medicine, Nanjing 210002, China; 4Department of Pathologyand Pathophysiology, Wannan Medical College, Wuhu 241002, Chin)
出处
《中华肺部疾病杂志(电子版)》
CAS
2018年第2期154-158,共5页
Chinese Journal of Lung Diseases(Electronic Edition)
基金
国家自然科学基金面上资助项目(81772500)
2014年度皖南医学院重点科研项目培育基金(WK2014ZF08)