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目的探讨顺铂与长春瑞滨联用(NP方案)在中国人非小细胞肺癌(non-small cell lung cancer,NSCLC)根治术后的疗效。方法 2002年1月至2004年11月451例Ⅰ、Ⅱ、Ⅲa期NSCLC根治术后患者接受或不接受NP方案辅助化疗并随访5年。对两组患者的总生存期(OS)及无病生存期(DFS)进行评估,并记录化疗的不良反应。分层分析评估影响OS期和DFS期的潜在因素。结果化疗组86.7%患者至少完成4个疗程的治疗。化疗组患者的生存期显着长于观察组(P<0.001)。相比观察组,2年和5年的生存率提高3.8%[危险比(HR)=0.674,95%可信区间(CI)0.554～0.820,P<0.0001]和13.0%(HR=0.732,95%CI0.579～0.926,P=0.009)。4年的DFS改善2.1%(HR=0.327,95%CI0.214～0.500,P<0.0001)。多因素分析显示:年龄,组织分型,病理分期等因素能影响化疗组患者的预后,而非性别和吸烟状况。多数患者有产生Ⅰ～Ⅲ级的药物不良反应,但无治疗相关死亡。结论 NP方案作为NSCLC术后辅助化疗方案在中国NSCLC患者中是有效且可以被耐受的。
Objective To investigate the efficacy of cisplatin combined with vinorelbine (NP) in the treatment of Chinese non-small cell lung cancer (NSCLC). Methods From January 2002 to November 2004, 451 patients with stage I, II and IIIa NSCLC underwent radical or postoperative adjuvant chemotherapy with NP regimen and were followed up for 5 years. The overall survival (OS) and disease-free survival (DFS) of both groups were assessed and the adverse effects of chemotherapy were recorded. Hierarchical analysis assesses potential factors that affect the OS and DFS phases. Results Chemotherapy group 86.7% of patients completed at least 4 courses of treatment. Patients in the chemotherapy group had significantly longer survival than those in the observation group (P <0.001). The 2- and 5-year survival rates increased by 3.8% compared with the observation group (hazard ratio (HR) = 0.674, 95% CI 0.554-0.820, P <0.0001] and 13.0% (HR = 0.732, 95 % CI 0.579 ~ 0.926, P = 0.009). The 4-year DFS improvement was 2.1% (HR = 0.327, 95% CI 0.214-0.500, P <0.0001). Multivariate analysis showed that age, histological type, pathological stage and other factors could affect the prognosis of patients in chemotherapy group, not gender and smoking status. Most patients have grade Ⅰ ~ Ⅲ drug adverse reactions, but no treatment-related deaths. Conclusion The NP regimen as a postoperative adjuvant chemotherapy regimen for NSCLC is effective and tolerable in Chinese NSCLC patients.