EGFR-TKI联合全脑放射治疗非小细胞肺癌脑转移疗效和安全性分析

Study of efficacy and safety of EGFR-TKI combined whole brain radiotherapy in treatment of non-small cell lung cancer patients with brain metastases

目的探讨表皮生长因子受体(EGFR)-酪氨酸激酶抑制剂(TKI)联合全脑放射治疗非小细胞肺癌(NSCLC)脑转移患者的疗效和安全性。方法选择NSCLC脑转移患者96例,其中男性51例,女性45例,年龄50~81岁,平均年龄68岁。将患者随机分为2组,即EGFR-TKI联合全脑放射治疗组(研究组)48例和全脑放射治疗组(对照组)48例。研究组男性25例,女性23例,年龄53~81岁,平均年龄69岁。对照组男性26例,女性22例,年龄50~79岁,平均年龄68岁。全脑放射治疗2个月后对疗效进行评估,并对1年生存率和1年无进展生存率及不良反应进行统计分析。结果研究组客观缓解率为41.7%,疾病控制率为83.3%;对照组客观缓解率为27.1%,疾病控制率为73.0%。两组客观缓解率和疾病控制率相比,差异均有统计学意义(χ~2=2.374、1.384,P <0.05)。研究组1年生存率为60.4%,1年无进展生存率为43.8%;对照组1年生存率为33.3%,1年无进展生存率为20.8%。两组患者1年生存率和1年无进展生存率相比,差异均有统计学意义(χ~2=1.741、0.979,P <0.05)。不良反应,研究组主要有腹泻、皮疹、头痛、白细胞减少和恶心,对照组主要有头痛、白细胞减少和恶心。两组腹泻、皮疹不良反应发生率相比,差异具有显著统计学意义(χ~2=0.831、0.967,P <0.01)。结论 EGFR-TKI联合全脑放射治疗EGFR突变NSCLC脑转移效果良好,可以有效控制脑转移,延长患者生存时间,而且患者耐受性良好,无严重的不良反应发生。

Objective To investigate the efficacy and safety of epidermal growth factor receptor(EGFR)-tyrosine kinase inhibitor(TKI) combined whole brain radiotherapy in non-small cell lung cancer(NSCLC) patients with brain metastases. Methods A total of 96 NSCLC patients with brain metastases were enrolled, which included 51 males and 45 females, aged 50-81 years old with mean age of 68 years old. All of them were randomly divided into EGFR-TKI combined whole brain radiotherapy group(study group, n = 48, which included 25 males and 23 females, aged 53-81 years old with mean age of 69 years old)and whole brain radiotherapy group(control group, n = 48, which included 26 males and 22 females, aged 50-79 years old with mean age of 68 years old). The efficacy was evaluated 2-month post whole brain radiotherapy, the 1-year survival rate,1-year progression-free survival rate and adverse reactions were statistically analyzed. Results The objective response rate of study group was 41.7 %, and disease control rate was 83.3 %. The objective response rate of control group was 27.1 %, and disease control rate was 73.0 %. There were significant differences in objective response rate and disease control rate between2 groups(χ~2= 2.374, 1.384, P < 0.05). The 1-year survival rate of study group was 60.4 % and 1-year progression-free survival rate was 43.8 %. The 1-year survival rate of control group was 33.3 %, and 1-year progression-free survival rate was20.8 %, which were statistically decreased than those of study group(χ~2= 1.741, 0.979, P < 0.05). For adverse reactions, study group mainly with diarrhea, rash, headache, leukopenia and nausea. The control group mainly with headache, leukopenia and nausea, which were statistically significant difference between 2 groups(χ~2= 0.831, 0.967, P < 0.01). Conclusion It is demonstrated that EGFR-TKI combined whole brain radiotherapy is effective in treatment of EGFR-mutant NSCLC with brain metastasis. It could effectively control brain metastasis, prolong survival time with well tolerated, without serious adverse reac-tions.