Abstract

To evaluate the efficacy of postoperative adjuvant chemotherapy for completely resected p-stage I non-small cell lung cancer (NSCLC). Patients who underwent complete resection with lymph node dissection for p-stage I NSCLC (T1N0, T2N0, adenocarcinoma or squamous cell carcinoma, were eligible. After surgery, 150 patients were stratified according to tumor size and histologic type, and then randomly assigned to 1 of 3 groups (50 patients each group): surgery alone (control group), surgery with chemotherapy; PVU group (2 courses of cisplatin 80 mg/m2, i.v. x 1 (day 1), vindesine 3 mg/m2, i.v. x 1 (days 1 and 8) and UFT 400 mg/day, p.o. for a period of 2 years), and UFT group (UFT 400 mg/day, p.o. for 2 years). The 5-year survival rates of the PVU group, the UFT group, and the control group were 87.9, 67.7, and 66.3%, respectively. The difference in 5-year survival between the PVU group and the control group was statistically significant (p = 0.045, log rank). The 5-year disease-free survival rate of the PVU group (81.1%) was also significantly better than that of the control group (66.5%) (p = 0.042, log rank). According to multivariate analysis using Cox's proportional hazard model, the only significantly positive factor on outcome was PVU chemotherapy after surgery. Postoperative PVU chemotherapy is effective for Japanese patients with completely resected p-stage I NSCLC.

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