替吉奥联合吉非替尼治疗EGFR-TKI获得性耐药晚期NSCLC的临床疗效

doi:10.3760/cma.j.issn.1673-422X.2019.12.004

摘要/Abstract

摘要： 目的探讨替吉奥联合吉非替尼治疗表皮生长因子受体（EGFR）-酪氨酸激酶抑制剂（TKI）获得性耐药晚期非小细胞肺癌（NSCLC）的临床疗效。方法选择2016年1月至2017年8月在河北省迁安市人民医院就诊的74例晚期NSCLC患者作为研究对象，采用随机数字表法将患者分为对照组（n=37）和试验组（n=37）。对照组给予培美曲塞序贯吉非替尼治疗，试验组给予替吉奥联合吉非替尼治疗。比较两组患者临床疗效和不良反应发生情况。结果对照组和试验组患者有效率分别为21.62%（8/37）和27.03%（10/37），差异无统计学意义（χ²=0.294，P=0.588）；疾病控制率分别为75.68%（28/37）和78.38%（29/37），差异无统计学意义（χ²=0.076，P=0.782）。对照组和试验组患者中位无进展生存期分别为8.4个月和8.2个月，中位总生存期分别为9.8个月和10.5个月，差异均无统计学意义（χ²=0.186，P=0.666；χ²=0.608，P=0.436）。对照组和试验组患者腹泻发生率分别为56.76%（21/37）和62.16%（23/37），差异无统计学意义（χ²=0.224，P=0.636）；皮疹发生率分别为62.16%（23/37）和13.51%（5/37），白细胞降低发生率分别为35.14%（13/37）和5.41%（2/37），血小板减少发生率分别为27.03%（10/37）和2.70%（1/37），贫血发生率分别为40.54%（15/37）和10.81%（4/37），肝功能损害发生率分别为18.92%（7/37）和0（0/37），试验组均低于对照组，差异均有统计学意义（χ²=18.615，P＜0.001；χ²=10.118，P=0.001；χ²=8.650，P=0.003；χ²=8.568，P=0.003；χ²=5.680，P=0.017），两组患者均未发生Ⅲ~Ⅳ度不良反应。结论替吉奥联合吉非替尼治疗EGFR-TKI获得性耐药晚期NSCLC有效，患者耐受性好，不良反应小，且给药方式为口服给药，患者易于接受，是EGFR-TKI获得性耐药晚期NSCLC临床治疗的理想方式。

关键词: 癌,非小细胞肺, 培美曲塞, 表皮生长因子受体-酪氨酸激酶抑制剂, 获得性耐药, 替吉奥

Abstract: Objective To explore the clinical effect of S-1 combined with gefitinib in the treatment of advanced non-small cell lung cancer (NSCLC) with acquired resistance to epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI). MethodsA total of 74 patients with advanced NSCLC were selected as the study subjects from January 2016 to August 2017 in Qian′an People′s Hospital of Hebei Province. The patients were divided into control group (n=37) and experimental group (n=37) by random number table method. The control group was given sequential gefitinib with pemetrexed, and the experimental group was given S-1 combined with gefitinib. The clinical efficacy and adverse reactions of the two groups were compared. Results The effective rates of the control group and the experimental group were 21.62% (8/37) and 27.03% (10/37) respectively, and the difference was not statistically significant (χ²=0.294, P=0.588). The disease control rates were 75.68% (28/37) and 78.38% (29/37) respectively, and the difference was not statistically significant (χ²=0.076, P=0.782). The median progression-free survival of the control group and the experimental group were 8.4 months and 8.2 months, and the median overall survival were 9.8 months and 10.5 months respectively, and the differences were not statistically significant (χ2=0.186, P=0.666; χ2=0.608, P=0.436). The occurrence rate of diarrhea was 56.76% (21/37) in the control group and 62.16% (23/37) in the experimental group, with no significant difference (χ²=0.224，P=0.636). The occurrence rates of rash in the control group and the experimental group were 62.16% (23/37) and 13.51% (5/37), the occurrence rates of leukopenia were 35.14% (13/37) and 5.41% (2/37), the occurrence rates of thrombocytopenia were 27.03% (10/37) and 2.70% (1/37), the occurrence rates of anemia were 40.54% (15/37) and 10.81% (4/37), and the occurrence rates of liver damage were 18.92% (7/37) and 0 (0/37). The occurrence rates of the above adverse reactions in the experimental group were significantly lower than those in the control group, and the differences were statistically significant (χ²=18.615, P＜0.001; χ²=10.118, P=0.001; χ²=8.650, P=0.003; χ²=8.568, P=0.003; χ²=5.680, P=0.017). There were no grade Ⅲ-Ⅳ adverse reactions in the two groups. ConclusionThe combination of S-1 and gefitinib is effective in the treatment of advanced NSCLC with acquired resistance to EGFR-TKI and well tolerated, with mild adverse reactions, and oral administration is easy for patients to accept. It is an ideal way for clinical treatment of advanced NSCLC with EGFR-TKI acquired resistance.

Key words: Carcinoma, non-small-cell lung, Pemetrexed, Epidermal growth factor receptor-tyrosine kinase inhibitor, Acquired drug resistance, S-1

沈静侠, 韩彬, 王淑颖, 康海立, 王立东, 刘旭辉, 崔庆贵. 替吉奥联合吉非替尼治疗EGFR-TKI获得性耐药晚期NSCLC的临床疗效[J]. 国际肿瘤学杂志, 2019, 46(12): 723-727.

Shen Jingxia, Han Bin, Wang Shuying, Kang Haili, Wang Lidong, Liu Xuhui, Cui Qinggui. Clinical efficacy of S-1 combined with gefitinib in the treatment of advanced NSCLC with EGFR-TKI acquired drug resistance[J]. Journal of International Oncology, 2019, 46(12): 723-727.

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