Preliminary results of a randomized trial of adjuvant immunotherapy in patients with malignant melanoma who have lymph node metastases.

This study evaluates the effect of adjuvant immunotherapy with BCG alone, or combined with melanoma cell vaccine, on the recurrence and survival rates of patients with metastatic melanoma in the regional lymph nodes who were treated by lymphadenectomy. Patients were prospectively randomized and stratified on the basis of age, sex, site of primary tumour, and clinical estimate of the regional nodes. During the past four years, 134 patients were entered into this trial, and to date, the incidence of recurrence among the two arms mentioned and the control arm is not significantly different; however, patients receiving BCG alone had longer survival than those in either the tumour cell vaccine or control groups. The improved survival in the BCG-only group was found to be due to the fact that patients survived longer with their recurrent disease than the patients in the other two groups. At the present time, these differences do not appear to be significant enough to justify routine adjuvant immunotherapy in patients with melanoma metastatic to regional nodes. Longer follow-up will be necessary to evaluate the role of adjuvant immunotherapy of Stage II melanoma.

RCT Entities:   Population Interventions Outcomes