INTRALYMPHATIC AND REGIONAL SURGICAL ADJUVANT IMMUNOTHERAPY IN HIGH-RISK MELANOMA OF THE EXTREMITIES

Abstract

A prospective, controlled study of surgical adjuvant immunotherapy with intralymphatic methanol-extractable residue (MER) of bacillus Calmette-Guerin (BCG) is preliminarily reported in 25 consecutive patients with high-risk malignant melanoma of the extremities. Patients were allocated on a random basis to receive preoperative intralymphatic immunotherapy with MER-BCG, surgical excision with regional lymphadenectomy and intraoperative infiltration of MER-BCG and postoperative monthly intradermal vacinations wtih BCG; or surgery and lymphadenectomy alone. Twenty patients followed for > 1 yr are the basis of this report. Fifteen patients accepted randomization; 4 patients entered the immunotherapy group and 1 entered the control group at their own insistence. Immunotherapy improved the disease-free survival of patients in this trial. There was 1 recurrence with death in the 13 patients treated with preoperative intralymphatic MER-BCG; 4 of 7 patients in the control group had recurrence (P = 0.015), and all 4 of these patients died during the same interval.