T Fujisawa1, Y Yamaguchi. 1. Department of Surgery, Chiba University School of Medicine, Japan.
Abstract
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 wall 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 StageI disease who had a complete resection were allocated randomly into 2 groups: TF + N-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-CWS 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.
RCT Entities:
BACKGROUND: approximately 40% of primary lung carcinomapatients 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 wall 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 + N-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-CWS 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.