title: Chemoneuroendocrine therapy of metastatic breast cancer with persistent thrombocytopenia with weekly low-dose epirubicin plus melatonin: a phase II study.
abstract: Thrombocytopenia is a frequent complication of cancer and constitutes an absolute contraindication for chemotherapy. Recent studies have demonstrated that platelet generation may be influenced by both cytokines and neurohormones. 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 administration of melatonin in thrombocytopenic cancer patients undergoing chemotherapy. The study was performed in 14 metastatic breast cancer women treated by weekly epirubicin. Each cycle consisted of epirubicin at 25 mg/m2 i.v. at weekly intervals. Melatonin was given orally at 20 mg/day in the evening every day, starting 7 days prior to chemotherapy. Patients were considered as evaluable when they received at least four cycles of chemotherapy. Evaluable patients were 12/14. The induction phase with melatonin induced a normalization of platelet number in 9/12 evaluable patients, and no further platelet decline occurred in chemotherapy. Objective tumor regression was achieved in 5/12 (41%) patients. This preliminary study would suggest that melatonin may be effective in the treatment of cancer-related thrombocytopenia and to prevent chemotherapy-induced platelet decline. Until now, melatonin therapy of cancer has been generally considered as an alternative treatment to chemotherapy. In contrast, this study would suggest that melatonin may contribute to the realization of chemotherapy in metastatic cancer patients unable to tolerate the chemotherapeutic approach because of persistent thrombocytopenia.
authors.affiliation: Divisione di Radioterapia Oncologica, Ospedale S. Gerardo, Milan, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Lissoni
authors.forename: G
authors.initials: G
authors.lastname: Tancini
authors.forename: F
authors.initials: F
authors.lastname: Paolorossi
authors.forename: M
authors.initials: M
authors.lastname: Mandalà
authors.forename: A
authors.initials: A
authors.lastname: Ardizzoia
authors.forename: F
authors.initials: F
authors.lastname: Malugani
authors.forename: L
authors.initials: L
authors.lastname: Giani
authors.forename: S
authors.initials: S
authors.lastname: Barni
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D019046:Bone Marrow Neoplasms / Q000556:secondary; D001943:Breast Neoplasms / Q000150:complications* / Q000188:drug therapy*; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D015251:Epirubicin / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000556:secondary; D008175:Lung Neoplasms / Q000556:secondary; D008550:Melatonin / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D008875:Middle Aged; D010976:Platelet Count / Q000187:drug effects; D012074:Remission Induction; D013921:Thrombocytopenia / Q000139:chemically induced / Q000188:drug therapy* / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D015251:Epirubicin; D008550:Melatonin