Adjuvant immunotherapy with nonviable mycobacterium smegmatis in resected primary lung carcinoma a randomized clinical trial of 219 patients

Two hundred and nineteen patients with resected lung carcinoma were randomized 3 weeks after surgery between two treatment arms: a control group (110 cases) and an immunotherapy group (109 cases). The immunostimulant was a nonviable saprophytic mycobacterium, M. smegmatis, given monthly by subcutaneous injection in four sites. The two groups were equivalent in terms of prognostic factors, including a nonsignificant difference favoring the control group based on the N (node) classification. This interim analysis was carried out on June 1, 1981. Treatment comparison by the log‐rank test did not show any significant differences between these two groups in regards to disease‐free interval and overall survival. There was no significant difference between the two groups after stratification of the comparison according to the N classification or adjustment with a subset of eight prognostic parameters through the Cox model. The initially expected difference (20% 1‐year survival) will probably not be achieved, given these interim results, but patients will continue to be treated and followed‐up according to the protocol as to allow further evaluation of this nonspecific immunotherapy.