Skip to main content
NCBI home page
Canadian Medical Association Journal logoLink to Canadian Medical Association Journal
. 1984 Oct 1;131(7):744–748.

Adjuvant BCG immunotherapy for malignant melanoma.

A H Paterson, D J Willans, L M Jerry, J Hanson, T A McPherson
PMCID: PMC1483595  PMID: 6383591

Abstract

A total of 199 patients with stage I malignant melanoma at Clark's level 3 to 5 of invasion were entered into a prospectively controlled randomized clinical trial that attempted to assess the value of local and systemic immunotherapy with BCG (bacille Calmette-Guérin) after surgery. The patients were randomly assigned, with stratification by Clark's level, to receive either routine follow-up or immunotherapy with BCG, administered intradermally with a Heaf gun around the site of wide excision and then given orally for 2 years. Intradermal administration of BCG was repeated after 1 year's oral therapy with BCG. Of the 99 patients in the treatment group 66 had Clark's level 3, 28 had level 4, and 5 had level 5 invasion. Of the 100 patients in the control group, 61 had level 3, 36 had level 4, and 3 had level 5 invasion. Other prognostic factors, such as sex, depth of invasion, histologic features, site of disease and type of surgery, were evenly distributed. There were 57 recurrences of the melanoma, 24 in the treatment group and 33 in the control group. However, this trend was not statistically significant (p = 0.194). The suggestion that BCG may reduce the likelihood of local/regional recurrence has not been confirmed with longer follow-up. There were 13 such recurrences in the BCG group, compared with 21 in the control group; the proportions of patients in each group who had such a recurrence were not significantly different. Of the 199 patients 41 died, 24 in the control group and 17 in the treatment group; again, this difference was not significant. While there may be minor activity in selected patients, there appeared to be no benefit from this form of adjuvant BCG therapy in patients with malignant melanoma.

Full text

PDF
744

Images in this article

745Fig. 1
on p.745

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. Aranha G. V., McKhann C. F., Grage T. B., Gunnarsson A., Simmons R. L. Adjuvant immunotherapy of malignant melanoma. Cancer. 1979 Apr;43(4):1297–1303. doi: 10.1002/1097-0142(197904)43:4<1297::aid-cncr2820430417>3.0.co;2-9. [DOI] [PubMed] [Google Scholar]
  2. Bilgi C., Brown N. E., McPherson T. A., Lentle B. Pulmonary manifestations in patients with malignant melanoma during BCG immunotherapy. A preliminary report. Chest. 1979 Jun;75(6):685–687. doi: 10.1378/chest.75.6.685. [DOI] [PubMed] [Google Scholar]
  3. Clark W. H., Jr, From L., Bernardino E. A., Mihm M. C. The histogenesis and biologic behavior of primary human malignant melanomas of the skin. Cancer Res. 1969 Mar;29(3):705–727. [PubMed] [Google Scholar]
  4. Currie G. A., Lejeune F., Fairley G. H. Immunization with irradiated tumour cells and specific lymphocyte cytotoxicity in malignant melanoma. Br Med J. 1971 May 8;2(5757):305–310. doi: 10.1136/bmj.2.5757.305. [DOI] [PMC free article] [PubMed] [Google Scholar]
  5. Eilber F. R., Morton D. L., Holmes E. C., Sparks F. C., Ramming K. P. Adjuvant immunotherapy with BCG in treatment of regional-lymph-node metastases from malignant melanoma. N Engl J Med. 1976 Jan 29;294(5):237–240. doi: 10.1056/NEJM197601292940501. [DOI] [PubMed] [Google Scholar]
  6. GEHAN E. A. A GENERALIZED WILCOXON TEST FOR COMPARING ARBITRARILY SINGLY-CENSORED SAMPLES. Biometrika. 1965 Jun;52:203–223. [PubMed] [Google Scholar]
  7. Goodnight J. E., Jr, Morton D. L. The role of immunotherapy in the management of patients with malignant melanoma. World J Surg. 1979 Jul 30;3(3):309–320. doi: 10.1007/BF01556582. [DOI] [PubMed] [Google Scholar]
  8. Gutterman J. U., Mavligit G., McBride C., Frei E., 3rd, Freireich E. J., Hersh E. M. Active immunotherapy with B.C.G. for recurrent malignant melanoma. Lancet. 1973 Jun 2;1(7814):1208–1212. doi: 10.1016/s0140-6736(73)90526-6. [DOI] [PubMed] [Google Scholar]
  9. Hansen M. G., McCarten A. B. Tumor thickness and lymphocytic infiltration in malignant melanoma of the head and neck. Am J Surg. 1974 Oct;128(4):557–561. doi: 10.1016/0002-9610(74)90275-x. [DOI] [PubMed] [Google Scholar]
  10. Hellström I., Hellström K. E., Sjögren H. O., Warner G. A. Demonstration of cell-mediated immunity to human neoplasms of various histological types. Int J Cancer. 1971 Jan 15;7(1):1–16. doi: 10.1002/ijc.2910070102. [DOI] [PubMed] [Google Scholar]
  11. Hersh E. M., Gutterman J. U., McBride C. M. Combined modality therapy of malignant melanoma. World J Surg. 1979 Jul 30;3(3):329–343. doi: 10.1007/BF01556586. [DOI] [PubMed] [Google Scholar]
  12. Morton D., Eilber F. R., Malmgren R. A., Wood W. C. Immunological factors which influence response to immunotherapy in malignant melanoma. Surgery. 1970 Jul;68(1):158–164. [PubMed] [Google Scholar]
  13. Nathanson L., Schoenfeld D., Regelson W., Colsky J., Mittelman A. Prospective comparison of intralesional and multipuncture BCG in recurrent intradermal melanoma. Cancer. 1979 May;43(5):1630–1635. doi: 10.1002/1097-0142(197905)43:5<1630::aid-cncr2820430511>3.0.co;2-z. [DOI] [PubMed] [Google Scholar]
  14. O'Connor T. P., Labandter H. P., Hiles R. W., Bodenham D. C. A clinical trial of BCG immunotherapy as an adjunct to surgery in the treatment of primary malignant melanoma. Br J Plast Surg. 1978 Oct;31(4):317–322. [PubMed] [Google Scholar]
  15. Pritchard K. I., Cowan D. H., Baker M. A., Osoba D., Phillips R. A., Clark D. A. The use of oral BCG in the treatment or metastatic malignant melanoma. Med Pediatr Oncol. 1976;2(2):173–181. doi: 10.1002/mpo.2950020207. [DOI] [PubMed] [Google Scholar]
  16. Wallack M. K., Steplewski Z., Koprowski H., Rosato E., George J., Hulihan B., Johnson J. A new approach in specific, active immunotherapy. Cancer. 1977 Feb;39(2):560–564. doi: 10.1002/1097-0142(197702)39:2<560::aid-cncr2820390227>3.0.co;2-m. [DOI] [PubMed] [Google Scholar]
  17. Zbar B., Bernstein I. D., Bartlett G. L., Hanna M. G., Jr, Rapp H. J. Immunotherapy of cancer: regression of intradermal tumors and prevention of growth of lymph node metastases after intralesional injection of living Mycobacterium bovis. J Natl Cancer Inst. 1972 Jul;49(1):119–130. [PubMed] [Google Scholar]

Articles from Canadian Medical Association Journal are provided here courtesy of Canadian Medical Association

RESOURCES