Adjuvant immunotherapy with nonviable Mycobacterium smegmatis in resected primary lung carcinoma. A randomized clinical trial of 219 patients

Cancer. 1984 Feb 15;53(4):906-12. doi: 10.1002/1097-0142(19840215)53:4<906::aid-cncr2820530415>3.0.co;2-h.

Abstract

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.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Bacterial Vaccines / therapeutic use*
  • Clinical Trials as Topic
  • Female
  • Humans
  • Lung Neoplasms / surgery
  • Lung Neoplasms / therapy*
  • Male
  • Middle Aged
  • Mycobacterium
  • Neoplasm Metastasis
  • Neoplasm Recurrence, Local
  • Neoplasm Staging
  • Probability
  • Random Allocation

Substances

  • Bacterial Vaccines