国际肿瘤学杂志

国际肿瘤学杂志 ›› 2016, Vol. 43 ›› Issue (8): 659-663.doi: 10.3760/cma.j.issn.1673422X.2016.09.005

• 论著 • 上一篇    下一篇

吉非替尼与厄洛替尼治疗EGFR19/21外显子突变非小细胞肺癌的临床效果比较

申洁,李怡蓉,高院,高辉,白璐   

  1. 716000 延安市人民医院呼吸内科(申洁、高院、高辉)，耳鼻喉科（李怡蓉）；西安市第一人民医院老年病科（白璐）
  • 出版日期:2016-09-08 发布日期:2016-08-04
  • 通讯作者: 申洁，Email: shenjie19810726@126.com E-mail:shenjie19810726@126.com

Comparison of clinical efficacy of gefitinib and erlotinib treating nonsmallcell lung cancer with epidermal growth factor receptor mutation in either exon 19 or 21

Shen Jie, Li Yirong, Gao Yuan, Gao Hui, Bai Lu   

  1. Department of Respiratory Medicine, Yan′an People′s Hospital, Yan′an 716000, China
  • Online:2016-09-08 Published:2016-08-04
  • Contact: Shen Jie E-mail:shenjie19810726@126.com

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摘要： 【摘要】目的比较吉非替尼与厄洛替尼治疗表皮生长因子受体（EGFR）19/21外显子突变非小细胞肺癌（NSCLC）的临床效果。方法选取2013年5月至2014年12月于我院诊断为EGFR19/21外显子突变NSCLC患者242例，以年龄、性别、吸烟史、美国东部肿瘤协作组行为状态（ECOG PS）评分及EGFR突变类型配对后随机分为A、B两组。A组患者（n=121）接受吉非替尼药物治疗，B组患者（n=121）接受厄洛替尼药物治疗。根据实体瘤疗效评价标准（RECIST）评估患者的总缓解率（ORR）、疾病控制率（DCR）、无进展生存期（PFS）。Cox回归单变量和多变量分析PFS的独立危险因素。对将研究药物作为一线治疗的63例NSCLC患者进行亚组分析，评价A、B两组的药物不良反应及生命质量。结果A、B两组的中位PFS分别是11.6个月和9.5个月，差异无统计学意义（HR=0.39，P＞0.05）。两组患者的ORR和DCR分别为76.9%、74.4%（χ2=1.03，P=0.58）和90.1%、86.8%（χ2=1.46，P=0.31）。ECOG PS≥2（HR=2.60, 95%CI为1.54～4.43, P=0.001）和非腺癌（HR=3.61, 95%CI为1.54～8.66, P=0.003）是PFS欠佳的独立危险因素。 对于将两种药物作为一线治疗的患者，A、B两组的ORR分别为76.6%、90.2%（χ2=0.83，P=0.12），中位PFS分别为11.6个月、14.4个月（HR=0.59，P＞0.05），差异无统计学意义。不良反应方面，两组情感功能（F=10.27, P=0.03）、腹泻（F=10.24, P=0.03）及疼痛（F=9.02, P=0.04）差异有统计学意义。A、B两组患者接受药物治疗后各项生命质量评分均较治疗前得到改善，且大部分差异有统计学意义（P＜0.05）。结论对于EGFR19/21外显子突变NSCLC，吉非替尼和厄洛替尼两种药物耐受性良好，表现出相似的临床疗效。

关键词: 癌, 非小细胞肺, 受体, 表皮生长因子, 吉非替尼, 厄洛替尼

Abstract: 【Abstract】ObjectiveTo compare the clinical outcomes of gefitinib and erlotinib treating nonsmallcell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutation in either exon 19 or 21. MethodsA total of 242 patients diagnosed as NSCLC with EGFR mutation in either exon 19 or 21 from May 2013 to December 2014 in our hospital were chosen in this study. According to age, sex, smoking history, eastern cooperative oncology group performance status and types of EGFR mutation, all the patients were matched to 121 pairs, and randomly divided into group A and B. Patients in group A received gefitinib treatment, and those in group B received erlotinib treatment. Based on the response evaluation criteria in solid tumors (RECIST), overall response rate (ORR), disease control rate (DCR), progressionfree survival (PFS) were assessed. To assess the independent risk factors for PFS by univariate and multivariate Cox regression analysis. The subgroup analysis was performed for the 63 NSCLC patients using these two drugs as the firstline treatment. To evaluate the adverse drug reactions and quality of life between A and B groups. ResultsThe median PFS of group A and B were 11.6 months and 9.5 months， respectively, with no significant difference (HR=0.39, P＞0.05). The ORR and DCR in the two groups were 76.9%, 74.4% (χ2=1.03, P=0.58) and 90.1%, 86.8% (χ2=1.46, P=0.31). The independent risk factors of poor PFS were ECOG PS≥2 (HR=2.60, 95%CI：1.54-4.43, P=0.001) and nonadenocarcinoma (HR=3.61, 95%CI：1.548.66, P=0.003). For patients receiving these two drugs as the firstline treatment, there was no significant difference between two groups in overall response rates (76.6% vs. 90.2%, χ2=0.83, P=0.12) and median PFS (11.6 months vs. 14.4 months, HR=0.59, P＞0.05). The adverse drug reactions were significant differences in emotion function (F=10.27, P=0.03), diarrhea (F=10.24, P=0.03) and pain (F=9.02, P=0.04). After receiving drug treatment, the quality of life scores were improved, and most of the differences were statistically significant between A and B groups(P＜0.05). ConclusionAs for NSCLC with EGFR mutation in either exon 19 or 21, both gefitinib and erlotinib are well tolerated and have similar clinical effectiveness.

Key words: Carcinoma, nonsmallcell lung, Receptor, epidermal growth factor, Gefitinib, Erlotinib