埃克替尼联合个体化胸部放疗治疗Ⅳ期非小细胞肺癌43例临床研究

Icotinib Concurrent with Individualized Radiotherapy for Patients with Stage Ⅳ Non-Small Cell Lung Cancer

[目的]探讨个体化胸部放疗在埃克替尼治疗有效的Ⅳ期NSCLC患者中的价值和可行性。[方法]回顾性分析2006年1月至2014年12月期间口服标准剂量埃克替尼有效的Ⅳ期NSCLC病例,同时接受原发灶放射治疗的患者43例。所有患者治疗中及治疗后评价毒副反应并进行复查和随访。[结果]随访截止日期为2016年10月16日,中位随访时间38.9个月,2例失访。到随访截止日期36例患者进展,中位肿瘤进展时间为15.0个月,1、2、3年无进展生存率分别为62.8%、39.5%和19.6%。32例患者死亡,全组中位生存时间为30.9个月,1、2、3年生存率分别为97.7%、71.8%和39.7%。所有患者均顺利完成放疗,两组常见毒副反应为皮疹、放射性食管炎和骨髓抑制,大多为1~2级。3级毒副反应发生率低,无4级及以上毒性。单因素分析发现基因突变类型(P=0.006)和是否肝转移(P=0.013)与预后相关,而女性(P=0.084)和生物放疗剂量≥62Gy(P=0.067)有提高生存的趋势。多因素分析提示基因突变类型(HR=1.565,95%CI:1.067~2.296)为影响预后的独立因素。[结论]具有EGFR活化突变Ⅳ期NSCLC患者采用单药埃克替尼联合局部放射治疗是可行的,有提高长期生存的潜力,且不良反应轻微,值得设计前瞻性随机对照研究进一步证实。

[Objective] To explore the value and feasibility of individualized thoracic radiotherapy in the subset of stage Ⅳ NSCLC patients who have benefit from icotinib.[Methods] Forty-theree stage Ⅳ NSCLC patients who have benefit from standard dose of icotinib and received thoracic radiotherapy between January 2006 and December 2014 were analyzed retrospectively.All the patients were evaluated and followed up during and after treatment.[Results] The last follow up date was October 16th2016,the median follow-up time was 38.9 months,2 patients were lost.36 patients suffered form tumor progression and 32 dead.The median progression time was 15 months.The 1-,2-and 3-year progression free survival rate were 62.8%,39.5% and 19.6%,respectively.Overall survival time was 30.9 months,the 1-,2-and 3-year survival rate were97.7%,71.8% and 39.7%,respectively.All the patients received completed radiotherapy.Rash,esophagitis and myelosuppression were the common side effects and the majority was grade 1 and2,the grade 3 was rare and none in grade 4 or above.Univariate analysis indicated the type of gene mutation（P=0.006） and liver metastasis（P=0.013） were significantly correlated with the prognosis.Women（P=0.084） and BED≥62Gy（P=0.067） were correlated with the trend of better survival.Further,multivariate analysis showed that the type of EGFR mutation（HR=1.565,95%CI：1.067～2.296,P =0.022） was an independent factor of prognosis.[Conclusion] Icotinib combined with thoracic radiotherapy treatment was feasible for EGFR mutations stage Ⅳ NSCLC,which was associated with better survival and mild side effects.Further prospective randomized controlled study was needed.