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背景与目的:核苷酸切除修复交叉互补组1(excision repair cross complementing 1,ERCC1)参与非小细胞肺癌(non-small cell lung cancer,NSCLC)铂类化疗药物的耐药发生。本研究旨在探讨ERCC1蛋白表达水平的检测在晚期NSCLC患者个体化治疗中的作用及其意义。方法:从2006年8月—2009年7月,共入组222例晚期(ⅢB-Ⅳ期)NSCLC患者。采用免疫组化方法检测ERCC1蛋白在患者肺癌组织的表达。按2∶1的比例随机分为个体化治疗组(n=147)及标准治疗组(n=75)。标准治疗组采用含铂化疗方案健择/顺铂或诺维本/顺铂。个体化治疗组中ERCC1蛋白高表达的患者采用非铂化疗方案健择/诺维本,ERCC1蛋白低表达的患者采用健择/顺铂或诺维本/顺铂化疗方案。主要观察指标包括有效率、总生存期及疾病进展时间。两组间比较采用χ2检验。1年生存率和生存期的比较采用Life table和Kaplan-meier方法分析。结果:随访数据截至2012年9月30日。标准治疗组的有效率为26.6%,个体化治疗组为27.2%,两组差异无统计学意义(P=0.931)。标准治疗组的1年生存率为40.0%,个体化治疗组为48.3%,两组差异无统计学意义(χ2=1.379,P=0.24)。标准治疗组的中位生存时间为10.2个月(95%CI:8.67~11.73个月),个体化治疗组为13.3月(95%CI:12.46~14.14个月),两组差异有统计学意义(P=0.041)。标准治疗组的疾病进展时间为4.8个月(95%CI:4.12~5.48个月),个体化治疗组的疾病进展时间为4.7个月(95%CI:3.88~5.52个月),两组差异无统计学意义(P=0.395)。结论:个体化治疗组的中位生存时间较标准治疗组有所延长,但ERCC1蛋白的检测指导晚期NSCLC的个体化治疗并未体现出有效率、生存期及疾病进展时间方面的优势,分子指标的检测能否指导临床合理选择化疗方案有待于更深入的临床研究加以解决。
BACKGROUND & AIM: Excision repair cross complementing 1 (ERCC1) is involved in the drug resistance of non-small cell lung cancer (NSCLC) platinum chemotherapeutics. This study aimed to investigate the role of ERCC1 protein in the individualized treatment of patients with advanced NSCLC and its significance. Methods: From August 2006 to July 2009, a total of 222 patients with advanced stage ⅢB-Ⅳ NSCLC were enrolled. The expression of ERCC1 protein in lung cancer tissues was detected by immunohistochemistry. The patients were randomly divided into individualized treatment group (n = 147) and standard treatment group (n = 75) according to the ratio of 2: 1. The standard treatment group received platinum-based chemotherapy with gemcitabine / cisplatin or novibenzide / cisplatin. Patients with high expression of ERCC1 protein in the individualized treatment regimen treated with gemcitabine / noviben and ERCC1 protein in non-platinum regimens were treated with chemotherapy with gemcitabine / cisplatin or novibenz / cisplatin. MAIN OUTCOME MEASURES INCLUDE EFFICIENCY, TOTAL SURVIVAL AND DISEASE TIME. Comparison between the two groups using χ2 test. One-year survival and survival were compared using the Life table and Kaplan-meier methods. Results: Follow-up data as of September 30, 2012. The standard treatment group, the effective rate was 26.6%, individualized treatment group was 27.2%, the difference between the two groups was not statistically significant (P = 0.931). The 1-year survival rate was 40.0% in the standard treatment group and 48.3% in the individualized treatment group, with no significant difference between the two groups (χ2 = 1.379, P = 0.24). The median survival time was 10.2 months (95% CI: 8.67 to 11.73 months) in the standard treatment group and 13.3 months (95% CI: 12.46 to 14.14 months) in the individualized treatment group, with significant differences between the two groups (P = 0.041). The standard treatment group had a progression of 4.8 months (95% CI: 4.12 to 5.48 months) and 4.7 months (95% CI: 3.88 to 5.52 months) in the individualized treatment group, with differences between the two groups No statistical significance (P = 0.395). CONCLUSIONS: The median survival time of individualized treatment group was longer than that of standard treatment group. However, the detection of ERCC1 protein in individualized treatment of advanced NSCLC did not reflect the advantages of efficiency, survival and disease progression time. The molecular index The detection of clinical guidance can guide the rational choice of chemotherapy remains to be more in-depth clinical studies to be resolved.