Chemoneuroendocrine therapy of metastatic breast cancer with persistent thrombocytopenia with weekly low-dose epirubicin plus melatonin: A phase II study

Thrombocytopenia is a frequent complication of cancer and constitutes an ab solute contraindication for chemotherapy. Recent studies have demonstrated that platelet generation may be influenced by both cytokines and neurohormo nes. In particular, the pineal indole melatonin has been proven to enhance platelet number in patients with thrombocytopenia due to different reasons. On this basis, we have evaluated the effects of a concomitant administrati on of melatonin in thrombocytopenic cancer patients undergoing chemotherapy . The study was performed in 14 metastatic breast cancer women treated by w eekly epirubicin. Each cycle consisted of epirubicin at 25 mg/m(2) i.v. at weekly intervals. Melatonin was given orally at 20 mg/day in the evening ev ery day, starting 7 days prior to chemotherapy. Patients were considered as evaluable when they received at least four cycles of chemotherapy. Evaluab le patients were 12/14. The induction phase with melatonin induced a normal ization of platelet number in 9/12 evaluable patients, and no further plate let decline occurred on chemotherapy. Objective tumor regression was achiev ed in 5/12 (41%) patients. This preliminary study would suggest that melato nin may be effective in the treatment of cancer-related thrombocytopenia an d to prevent chemotherapy-induced platelet decline. Until now, melatonin th erapy of cancer has been generally considered as an alternative treatment t o chemotherapy. In contrast. this study would suggest that melatonin may co ntribute to the realization of chemotherapy in metastatic cancer patients u nable to tolerate the chemotherapeutic approach because of persistent throm bocytopenia.