Skin tests predict survival after autologous tumor cell vaccination in metastatic melanoma: Experience in 81 patients

Background: Currently there is no standard adjuvant treatment following sur gical resection of metastatic melanoma. We investigated whether surgery fol lowed by autologous tumor cell-BCG vaccination was beneficial for malignant melanoma patients. In this study we focus on the prognostic value of DTH r esponse following vaccination therapy. Patients and methods: Eighty-one patients with AJCC stage III and IV melano ma were selected. Whenever feasible, radical metastasectomy was performed. ASI was initiated by the administration of three weekly intra-cutaneous vac cinations with 10(7) irradiated autologous tumor cells, starting four weeks after surgery. Depending on the size of DTH response to the first three in jections, subsequent vaccinations were planned. The first two vaccines also contained 10(7) BCG organisms as an immune stimulatory adjuvant. Results: Induration as well as erythema correlated strongly with survival ( P < 0.0001 and P = 0.0004). After radical metastasectomy in stage III melan oma patients a five-year survival of 48% was observed. In stage IV disease, a five-year survival of 34% was seen, after radical surgery had been perfo rmed. When macroscopic disease was present at start of vaccination treatmen t, no clinical responses occurred. Apart from transient skin ulceration at the site of BCG-containing vaccinations, no serious side effects were obser ved. Conclusions: This study shows that large-scale preparation of autologous me lanoma cell vaccines is feasible, while vaccination results in DTH response s that correlate significantly with survival. ASI seemed to be beneficial i n stage III and stage IV melanoma when given in the adjuvant setting, while causing only very mild side effects.