The advanced carcinoma of pancreas still remains an untreatable disease. Both chemotherapy and hormono-therapy seem not to prolong the survival time. Also immunotherapy with IL-2 has been shown to have no efficacy. Our experimental studies suggested the possibility of enhancing the antitumor activity of IL-2 by the administration of immunomodulating neurohormones, such as melatonin (MLT). This study was carried out to evaluate the efficacy of IL-2 plus MLT in advanced cancer of the pancreas. Fifty patients, with advanced adenocarcinoma of the pancreas, were randomized to receive chemotherapy consisting of 5-FU plus folates, endocrine therapy with LHRH and somatostatin analogues, supportive care alone or immunotherapy with subcutaneous low-dose IL-2 plus MLT. A partial response was obtained in 1/13 patients treated with chemotherapy and in 2/12 patients receiving immunotherapy; no tumor regression was seen in the other groups. The percent of survival at 1 year achieved in patients treated with immunotherapy was significantly higher than in the other groups tested (3/12 vs 1/38; p<0.02). This preliminary study would suggest that the immunotherapy with IL-2 plus MLT may represent a new promising treatment of advanced pancreatic adenocarcinoma.

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