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Adjuvant BCG immunotherapy for malignant melanoma.

A H Paterson, D J Willans, L M Jerry

    Canadian Medical Association Journal
    |October 1, 1984
    PubMed
    Summary

    This study found that bacille Calmette-Guérin (BCG) immunotherapy did not significantly reduce melanoma recurrence or mortality in patients with stage I malignant melanoma. Adjuvant BCG therapy showed no clear benefit after surgery.

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    Area of Science:

    • Oncology
    • Immunology
    • Clinical Trials

    Background:

    • Malignant melanoma is a significant public health concern.
    • Adjuvant immunotherapy aims to prevent cancer recurrence after primary treatment.
    • Bacille Calmette-Guérin (BCG) has been explored as an adjuvant therapy for various cancers.

    Purpose of the Study:

    • To evaluate the efficacy of local and systemic bacille Calmette-Guérin (BCG) immunotherapy as an adjuvant treatment for stage I malignant melanoma.
    • To assess the impact of BCG on melanoma recurrence and patient survival following surgical excision.

    Main Methods:

    • A prospectively controlled randomized clinical trial involving 199 patients with stage I malignant melanoma (Clark's level 3-5).
    • Patients were randomized to receive either routine follow-up or adjuvant BCG immunotherapy (intradermal and oral administration) for two years.

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  • Stratification by Clark's level and balance of other prognostic factors ensured comparability between groups.

    • Main Results:

    • There were 24 recurrences in the BCG treatment group versus 33 in the control group, a difference that was not statistically significant (p = 0.194).
    • Local/regional recurrences were observed in 13 patients in the BCG group and 21 in the control group, with no significant difference in proportions.
    • Mortality occurred in 17 patients in the BCG group and 24 in the control group, also not a statistically significant difference.

    Conclusions:

    • Adjuvant therapy with bacille Calmette-Guérin (BCG) did not demonstrate a statistically significant benefit in reducing recurrence or improving survival for patients with stage I malignant melanoma.
    • The study suggests that this form of adjuvant BCG therapy offers no clear advantage over routine follow-up for the studied patient population.
    • While minor activity might exist in select individuals, overall efficacy was not confirmed in this trial.