Post-operative Treatment with Cisplatin and Vinorelbine in Chinese Patients with Non-small Cell Lung Cancer: A Clinical Prospective Analysis of 451 Patients

Purpose: To determine the efficacy of post-operative chemotherapy with cisplatin plus vinorelbine (NP) inChinese patients with non-small cell lung cancer (NSCLC).
Methods: A total of 451 patients with NSCLCs atstages I, II, and IIIA after surgical resection were treated with cisplatin plus vinorelbine for 4 cycles or volunteersobserved between January 2002 and November 2004 and were followed for five years. The therapeutic efficacywas evaluated with reference to overall survival (OS) and disease-free survival (DFS), and adverse effects werealso recorded. Potential factors affecting the lengths of OS and DFS were analyzed by multivariate analysis.
Results: Most patients (86.7%) completed at least 4 cycles of treatment. Patients with chemotherapy survivedsignificantly longer than those in the observation group (p<0.001). The absolute improvements in the 2 and 5-yearOS were 3.8% [hazard ratio (HR) =0.674, 95% confidence interval (CI): 0.554-0.820, P<0.0001] and 13.0%(HR=0.732, 95% CI: 0.579-0.926, P=0.009), respectively. The improvement at 4-year DFS was 2.1% (HR=0.327,95% CI: 0.214-0.500, P<0.0001). Stratification analysis revealed that older age, histological type, pathologicaldegree, but not the gender and smoking status, are independent factors affecting the length of survival in thispopulation. Many patients (63.3%) had grade 1-III tolerable adverse effects, and there was no treatment-relateddeath.
Conclusions: Post-operative chemotherapy with NP regimen is effective and tolerable in Chinese patientswith NSCLC.