ADJUVANT THERAPY WITH THE PINEAL HORMONE MELATONIN IN PATIENTS WITH LYMPH-NODE RELAPSE DUE TO MALIGNANT-MELANOMA

Several experimental studies have shown that melatonin has an oncostat ic action, either by stimulating host antitumor immune defenses or by directly inhibiting the growth of some cancer histotypes, including me lanoma. Our previous clinical studies demonstrated that melatonin may induce stabilization of the disease in untreatable metastatic solid tu mor patients, and these results have been confirmed by others, at leas t in patients with metastatic melanoma. On the contrary, at present th ere are no data related to the possible efficacy of melatonin as an ad juvant endocrine therapy. This study was performed to investigate the impact of melatonin therapy on the disease-free survival (DFS) in mela noma patients surgically treated for regional node recurrence. The stu dy included 30 node-relapsed melanoma patients, who were randomized to receive no treatment or adjuvant therapy of melatonin (20 mg/day oral ly in the evening) every day until disease progression. After a median follow-up of 31 months, the percent of DFS was significantly higher i n melatonin-treated individuals than in controls. The DFS curve was al so significantly longer in melatonin group than in controls. No melato nin-related toxicity was observed. This preliminary study suggests tha t an adjuvant endocrine therapy with melatonin may be effective in pre venting disease progression in node-relapsed melanoma patients.