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目的:研究单药吉非替尼在成人肺腺癌常规化疗后维持治疗中的临床疗效和安全性。方法:60例ⅢB和Ⅵ期肺腺癌患者经过常规铂类为主的化疗方案后,随机分组,治疗组24例患者以吉非替尼250mg/d,口服进行维持治疗,对照组36例患者进行密切随访,研究终点为疾病进展或患者死亡。疾病无进展生存期(PFS)和总生存期(OS)使用Kaplan-Meier方法统计,并且分析影响预后的不同因素。结果:吉非替尼单药维持治疗组平均PFS为8.2[95%可信区间(confidence interval,CI):7.6～8.8]个月,随访组观察平均PFS为5.2(95%CI:4.6～5.8)个月,两组差异具有明显统计学意义(P<0.01);平均OS在两组分别为15.0(95%CI:12.2～17.8)个月和8.8(95%CI:8.5～9.1)个月,两组具有明显统计学差异(P<0.01)。吉非替尼组主要不良反应为皮肤反应、腹泻和厌食等,经过对症处理均可以控制,未发生药物相关死亡。结论:吉非替尼单药作为晚期肺腺癌常规维持治疗可以显著提高PFS和OS,并且不良反应相对较小。
Objective: To study the clinical efficacy and safety of single-agent gefitinib in the maintenance of adult lung adenocarcinoma after conventional chemotherapy. Methods: Sixty patients with stage ⅢB and Ⅳ lung adenocarcinoma were randomly divided into two groups: 24 cases received gefitinib 250mg / d orally and 36 cases in control group A close follow-up was carried out with the end of the study as the disease progressed or the patient died. Progression-free survival (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method and analyzed for various factors that influence prognosis. RESULTS: The average PFS for gefitinib monotherapy maintenance therapy was 8.2 (95% confidence interval CI: 7.6-8.8) months. The mean PFS was 5.2 (95% CI: 4.6-5.8) in the follow- ) Months, the difference between the two groups was statistically significant (P <0.01). The mean OS was 15.0 (95% CI: 12.2-17.8) months and 8.8 (95% CI: 8.5-9.1) months in the two groups , With significant difference between the two groups (P <0.01). The main adverse reactions in the gefitinib group were skin reactions, diarrhea and anorexia etc. After symptomatic treatment, no adverse drug-related deaths occurred. Conclusion: Gefitinib monotherapy as a routine maintenance treatment of advanced lung adenocarcinoma can significantly improve PFS and OS, and the adverse reaction is relatively small.