Adjuvant chemotherapy after complete resection in non-small-cell lung cancer. West Japan Study Group for Lung Cancer Surgery.

摘要

PURPOSE: We performed a study to determine whether postoperative mild chemotherapy to maintain the patient's quality of life (QOL) and immunoactivity could also prolong survival. SUBJECT AND METHODS: From December 1985 to July 1988, 323 patients with completely resected primary non-small-cell lung cancer (stage I to III) were enrolled. The subjects were randomized into three treatment groups, as follows: cisplatin (CDDP) 50 mg/m2 body surface, vindesine (VDS) 2 to 3 mg/kg body weight for three courses, and 1-year oral administration of tegafur (FT) plus uracil (UFT) 400 mg/kg body weight (CVUft group, 115 patients); 1-year oral administration of UFT 400 mg/kg body weight (Uft group, 108 patients); or surgical treatment only (control group, 100 patients). RESULTS: The overall 5-year survival rates were 60.6% for the CVUft group and 64.1% for the Uft group versus 49.0% for the control group. The results of statistical testing were P = .053 (log-rank test) and P = .044 (generalized Wilcoxon test) among the three groups, P = .083 (log-rank) and P = .074 (Wilcoxon) between the CVUft and the control groups, and P = .022 (log-rank) and P = .019 (Wilcoxon) between the Uft and the control groups, which indicates higher survival rates in the CVUft and the Uft groups compared with the control group. A multivariate statistical analysis on prognostic factors using Cox's proportional hazards model was performed with the following results: P = .037, hazards ratio = 0.64 with a 95% confidence interval (CI) of 0.42 to 0.97 (control v CVUft group); and P = .009, hazards ratio = 0.55 with a 95% CI of 0.36 to 0.86 (control v Uft group). CONCLUSION: Significantly favorable results were obtained in the CVUft and Uft groups compared with surgery alone. These data showed significant prognostic advantages in the postoperative adjuvant chemotherapy groups.