Postoperative immunostimulation after complete resection improves survival of patients with stage I nonsmall cell lung carcinoma

BACKGROUND. Approximately 40% of primary lung carcinoma patients who die within 1 month after a complete resection have residual tumor in regional or distant organs, emphasizing the importance of postoperative adjuvant therapy. In this study, the effectiveness of transfer factor (TF) and nocardia rubra-cell wail skeleton (N-CWS) as adjuvant therapy for patients with primary, completely resected nonsmall cell carcinoma of the lung was evaluated in a randomized controlled trial. METHODS. A total of 82 patients with Stage I disease who had a complete resection were allocated randomly into 2 groups: TF + CWS (n = 41) or control (surgery only) (n = 41). RESULTS. The distributions of age, sex, histology, differentiation, T classification, tumor size, visceral pleural invasion, and the site of origin, were similar in the two groups. The 5- and 10-year disease specific survival rates in the TF + N-CSW group were 85% and 85%, respectively and those in the control group were 72% and 64%, respectively. There was a statistically significant difference between the two groups (P = 0.041). When the survival was analyzed according to clinical characteristics, significant differences were observed in patients with no visceral pleural invasion or with T1 disease. The frequency of distant metastasis was significantly less in the TF + N-CWS group than in the control group. CONCLUSIONS. These results indicate that TF + N-CWS is beneficial as adjuvant therapy after surgical treatment of Stage I nonsmall cell carcinoma of the lung. (C) 1996 American Cancer Society.