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目的观察化疗后再次使用表皮生长因子受体—酪氨酸酶抑制剂(EGFR-TKI)治疗晚期获得性EGFR-TKI耐药非小细胞肺癌(NSCLC)患者的临床效果及安全性。方法收集2010年1月—2013年12月辽宁省丹东中心医院诊治晚期获得性EGFR-TKI耐药NSCLC患者79例,采用随机数字表法分为序贯组(先化疗,再采用EGFRTKI治疗)39例和化疗组(单纯给予化疗)40例,对比2组肿瘤标记物、近期疗效、远期疗效及不良反应发生情况。结果序贯组的近期疗效缓解率(20.5%)高于化疗组的(10.0%),但差异无统计学意义(P>0.05);序贵组的总有效率(74.4%)显著高于化疗组(50.0%),差异具有统计学意义(P<0.05)。序贯组的无进展中位生存时间(PFS)为(3.4±0.9)个月,显著长于化疗组的(2.5±0.8)个月(‘=3.981,P<0.05)。序贯组患者总生存时间(OS)为(6.4±1.2)个月,显著长于化疗组的(4.3±1.5)个月,且差异具有统计学意义(t=4.182,P<0.05)。治疗后序贯组的血清癌胚抗原(CEA)、经元特异性烯醇化酶(NSE)、细胞角质蛋白19片段(CYFRA21·1)水平显著低于化疗组(P<0.05)。2组间不良反应发生率及严重程度差异均无统计学意义(P>0.05)。结论化疗后再次使用EGFR-TKI治疗晚期获得性EGFR-TKI耐药NSCLC患者可以延长患者的生存时间且安全可靠。
Objective To observe the clinical efficacy and safety of EGFR-TKI in the treatment of advanced acquired EGFR-TKI resistant non-small cell lung cancer (NSCLC) after chemotherapy. Methods Totally 79 advanced NSCLC patients with acquired EGFR-TKI were collected from January 2010 to December 2013 in Dandong Central Hospital of Liaoning Province. They were randomly divided into sequential group (chemotherapy and EGFRTKI). Cases and chemotherapy group (chemotherapy alone) 40 cases, compared with two groups of tumor markers, short-term efficacy, long-term efficacy and adverse reactions. Results The response rate of sequential group was 20.5% higher than that of chemotherapy group (10.0%), but the difference was not statistically significant (P> 0.05). The total effective rate (74.4%) in sequential group was significantly higher than that of chemotherapy Group (50.0%), the difference was statistically significant (P <0.05). The progression-free median survival time (PFS) in the sequential group was (3.4 ± 0.9) months, significantly longer than that in the chemotherapy group (2.5 ± 0.8) months (’= 3.981, P <0.05). The overall survival time (OS) in the sequential group was (6.4 ± 1.2) months, significantly longer than that in the chemotherapy group (4.3 ± 1.5) months. The difference was statistically significant (t = 4.182, P <0.05). The levels of CEA, NSE and CYFRA21.1 in the sequential group after treatment were significantly lower than those in the chemotherapy group (P <0.05). There was no significant difference in the incidence and severity of adverse reactions between the two groups (P> 0.05). Conclusions The re-use of EGFR-TKI after chemotherapy for advanced acquired EGFR-TKI-resistant NSCLC patients can prolong the survival time and be safe and reliable.