A RANDOMIZED STUDY WITH THE PINEAL HORMONE MELATONIN VERSUS SUPPORTIVE CARE ALONE IN PATIENTS WITH BRAIN METASTASES DUE TO SOLID NEOPLASMS

Background. Unresectable brain metastases remain an untreatable diseas e. Because of its antitumor cytostatic action and its anticonvulsant e ffect, the pineal hormone melatonin could constitute a new effective a gent in the treatment of brain metastases. The current study was perfo rmed to evaluate the effect of melatonin on the survival time in patie nts with brain metastases due to sold neoplasms. Methods. The study in cluded 50 patients, who were randomized to be treated with supportive care alone (steroids plus anticonvulsant agents) or with supportive ca re plus melatonin (20 mg/day at 8:00 p.m. orally). Results. The surviv al at 1 year, free-from-brain-progression period, and mean survival ti me were significantly higher in patients treated with melatonin than i n those who received the supportive care alone. Conversely, steroid-in duced metabolic and infective complications were significantly more fr equent in patients treated with supportive care alone than in those co ncomitantly treated with melatonin. Conclusions. The pineal hormone me latonin may be able to improve the survival time and the quality of li fe in patients with brain metastases due to solid tumors.