依据ERCC1及RRM1对晚期非小细胞肺癌实施个体化治疗的随机对照临床研究

Randomized and controlled clinical research of personalized therapy for advanced non-small cell lung cancer according to ERCC1 and RRM1

目的对晚期非小细胞肺癌(NSCLC)患者根据切除修复交叉互补基因1(ERCC1)及核糖核苷酸还原酶M1(RRM1)的检测结果选择敏感药物,观察疗效差异,以期对个体化治疗起到指导作用。方法对经病理确诊的晚期NSCLC的肿瘤细胞进行ERCC1及RRM1基因的联合检测。入组患者按照1∶2随机分为2组,对照组使用吉西他滨联合顺铂化疗;基因型组根据ERCC1及RRM1的表达情况分为4组进行个体化治疗。观察近期疗效及远期疗效。结果本研究共纳入174例患者,总体有效率为44.2%,对照组有效率为37.5%,基因型组有效率为47.5%,结果无统计学差异。基因型组中ERCC1阴性组有效率(56.7%)高于ERCC1阳性组(37.9%),结果有统计学差异。各组间中位无疾病进展生存期、中位生存期及1年生存率无统计学差异。结论 ERCC1低表达患者中使用个体化治疗可获得更高的有效率,而ERCC1高表达患者可能意味着对铂类耐药。

Objective To select sensitive drugs according to the detection results of excision repair cross-complementation group 1（ERCC1） and ribonucleotide reductase M1（RRM1） in advanced non-small cancer lung cancer（NSCLC） patients and observe the effect differences so as to guide individual treatment.Methods Combined detection of ERCC1 and RRM1 of tumor cells was performed in advanced NSCLC patients diagnosed pathologically.The patients were divided into two groups with a proportion of 2：1.The control group received gemcitabine and cisplatin,while the gene group was divided into four subgroups according to ERCC1 and RRM1 and received individual therapy separately.The short-term and long-term effects were observed.Results A total of 174 patients were observed,and the overall efficacy rate was 44.2%.The efficacy rate was 37.5% in the control group and 47.5% in the gene group.The difference was statistically insignificant.The efficacy rate of ERCC1（-）（56.7%） was higher than that of ERCC1（＋）（37.9%）in gene group,and the difference was statistically significant.The median progression-free survival,median survival and 1 year survival rate in each group had no significant difference.Conclusion The use of individual therapy in patients with lower expressions of ERCC1 can obtain higher efficacy rate,while the patients with higher expressions of ERCC1 may have drug resistance to platinums.