吉非替尼进展后再治疗在EGFR罕见突变非小细胞肺癌中的临床研究

发布时间：2018-10-25 11:56

【摘要】：目的探讨表皮生长因子受体(EGFR)罕见突变非小细胞肺癌患者在吉非替尼治疗进展后,接受吉非替尼再治疗的疗效和安全性。方法选择2011年1月至2015年12月的EGFR罕见突变基因的非小细胞肺癌患者,接受吉非替尼治疗和进展后再治疗。初次疗效评价采用RECIST 1.1版,分析指标为客观缓解率(RR)和第1次无进展生存时间(PFS-1);再治疗评价根据临床医师经验,分析指标为第2次无进展生存时间(PFS-2)和总生存时间(OS)。毒性评价采用NCI-CTCAE 4.0版。采用Kaplan-Meier法对PFS-1、PFS-2和OS进行生存分析。结果 6例患者的初次疗效评价为部分缓解4例,稳定2例,RR达66.7%;中位PFS-1为10个月(95%CI:6.6~13.4);再治疗后的中位PFS-2为9个月(95%CI:6.9~11.1);中位OS为28个月(95%CI:10.4~45.6)。最常见的治疗相关不良反应为1~2级的皮疹、腹泻、乏力、恶心呕吐和转氨酶增高。结论本研究EGFR罕见突变肺癌患者在吉非替尼进展后再治疗中显示了较好的疗效和安全性。
[Abstract]:Objective to investigate the efficacy and safety of gifitinib in patients with rare mutation of epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC). Methods Non-small cell lung cancer patients with rare mutation gene of EGFR from January 2011 to December 2015 were treated with gifitinib and then treated with advanced therapy. The primary therapeutic effect was evaluated by RECIST version 1.1, the objective remission rate (RR) and the first progression-free survival time (PFS-1) were analyzed. According to the clinician's experience, the second time without progression survival time (PFS-2) and the total survival time (OS).) were analyzed in the retherapy evaluation. Toxicity was evaluated by NCI-CTCAE version 4.0. Kaplan-Meier method was used to analyze the survival of PFS-1,PFS-2 and OS. Results the initial curative effect of 6 patients was evaluated as partial remission in 4 cases, stable in 2 cases, RR in 66.7 months, median PFS-1 in 10 months (95%CI:6.6~13.4), median PFS-2 in 9 months (95%CI:6.9~11.1) and median OS in 28 months (95%CI:10.4~45.6). The most common treatment-related adverse reactions were grade 1 and 2 rash, diarrhea, fatigue, nausea and vomiting, and elevated aminotransferase. Conclusion in this study, EGFR rare mutation lung cancer patients showed good efficacy and safety in the treatment of gifitinib after progression.
【作者单位】：重庆市璧山区人民医院肿瘤科;
【基金】：重庆市卫计委基金项目(20142204) 重庆市科委项目(cstc2014jcyjA10126)
【分类号】：R734.2

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