Carcinoma of the lung: Immunotherapy with intradermal BCG and allogeneic tumor cells

Abstract After lobectomy or pneumonectomy 45 patients with stage I and 6 with stage II non-small cell carcinoma of the lung were randomized to receive: no further therapy; intradermal BCG; or BCG plus allogeneic irradiated tumor cells intra-dermally twice monthly for 24 months. Patients were observed for 2–51 months at this writing. The homogeneity of the disease free interval (DFI) (i.e., differences in the pattern of relapses) was tested for the three groups. Analysis indicated signifance at the p −0.062 level comparing DFI from control to BCG treated patients to BCG + cells treated patients; a difference also was found when the control group was compared with the combined immunotherapy treated groups ( p = 0.061). When only patients with stage I disease were analyzed by trend analysis this difference was magnified in favor of the immunotherapy treated patients ( p = 0.027); analysis of the T 1 NoMo only groups revealed a similar result ( p = 0.042). No significant differences were seen when data were analyzed for survival. Moderately severe local inflammatory reactions occurred in 43% of patients who received BCG immunotherapy, requiring reduction in frequency of its administration. There were no adverse effects from the administration of allogeneic tumor cells. Pasteur BCC may prolong DFI in resectable lung cancer and warrants further investigation in clinical trials.