吉非替尼单药维持治疗晚期非小细胞肺癌的疗效和安全性分析

目的 评价吉非替尼维持治疗晚期非小细胞肺癌(NSCLC)的疗效和安全性.方法 173例晚期NSCLC患者化疗后给予吉非替尼治疗,其中62例为诱导化疗后维持治疗,111例为复发后治疗.中位生存期采用Kaplan-Meier方法计算,不同因素分层生存期比较采用多因素Cox回归分析.结果 维持治疗组中位生存期为25.0个月,95%可信区间(CI)为19.3～30.7个月;复发后治疗组中位生存期为12.5个月,95%CI为9.3～15.7个月,两组差异有统计学意义(P＜0.01).维持治疗组中位无疾病进展生存期(PFS)为16.5个月,95%CI为8.7～24.3个月;复发后治疗组PFS为9.2个月,95%CI为7.5～10.9个月,两组差异有统计学意义(P＜0.01).维持治疗组生存的影响因素包括吸烟状况、病理类型、是否有肝脏转移和吉非替尼治疗的客观疗效.结论 晚期NSCLC患者化疗后给予吉非替尼维持治疗,其生存期和PFS明显长于复发后治疗的患者.

Efficacy and safety of gefitinib in maintenance therapy for patients with advanced non-small cell lung cancer

OBJECTIVE: To evaluate the efficacy and safety of gefitinib as maintenance therapy for patient with advanced non-small lung cancer (NSCLC). METHODS: From Oct. 2002 to Apr. 2006, 173 patients with advanced NSCLC received oral gefitinib 250 mg per day after completion of induction chemotherapy (62 patients, maintenance therapy group) or recurrence after one or more regimens of chemotherapy (111 patients, recurrent group). Median survival (MS) and progress free survival (PFS) were calculated using the Kaplan-Meier method, and Cox regression analysis was used to analyze the difference between the sub-groups stratified by smoking, pathological type, liver metastasis and gefitinib treatment result. RESULTS: MS of maintenance therapy group and recurrent group were 25.0 months (95% CI: 19.3-30.7) and 12.5 months (95% CI: 9.3-15.7), respectively. There was a statistically significant difference between the above two groups (P = 0.0004). PFS of maintenance therapy group and recurrent group was 16.5 months (95% CI: 8.7-24.3) and 9.2 months (95% CI: 7.5-10.9), respectively. There was also a statistically significant difference between these two groups (P = 0. 0000). It was found that median MS in maintenance therapy group was significantly correlated with smoking status, pathology type, liver metastasis and objective response of gefitinib. CONCLUSION: Maintenance therapy with gefitinib after induction chemotherapy may improve overall survival in patient with non-small cell lung cancer.