title: A randomized study of neuroimmunotherapy with low-dose subcutaneous interleukin-2 plus melatonin compared to supportive care alone in patients with untreatable metastatic solid tumour.
abstract: Recent advances in our knowledge of psychoneuroimmune interactions involved in the control of tumour growth have shown the possibility of manipulating host anticancer defenses through a neuroimmunotherapeutic strategy. In particular, our previous studies have demonstrated that the concomitant administration of the pineal neurohormone melatonin may amplify the antitumour efficacy of interleukin-2 (IL-2) in humans. On this basis, a study was planned to investigate the influence of neuroimmunotherapy with low-dose IL-2 plus melatonin on survival time and on performance status in untreatable metastatic cancer patients. The study included 100 patients with metastatic solid tumours, for whom no standard therapy was available. They were randomized to receive IL-2 (3 x 10(6) IU/day subcutaneously for 4 weeks) plus melatonin (40 mg/day orally) or supportive care alone. Partial tumour regressions were seen in 9/52 (17%) patients treated with the immunotherapy, and in none of the patients treated with supportive care alone. The percentage of survival at 1 year was significantly higher in patients treated with IL-2 and melatonin than in those receiving the supportive care alone (21/52 versus 5/48, P < 0.005). Moreover, the performance status improved in 22/52 patients of the immunotherapy group and in only 8/48 patients treated with supportive care (P < 0.01). This study shows that cancer neuroimmunotherapy with low-dose IL-2 and the pineal hormone melatonin may prolong survival time and improve the quality of life of patients with metastatic solid tumours who do not respond to conventional therapies.
authors.affiliation: Divisione di Radioterapia, Ospedale S. Gerardo, Monza (Milan), Italy.
authors.forename: P
authors.initials: P
authors.lastname: Lissoni
authors.forename: S
authors.initials: S
authors.lastname: Barni
authors.forename: V
authors.initials: V
authors.lastname: Fossati
authors.forename: A
authors.initials: A
authors.lastname: Ardizzoia
authors.forename: M
authors.initials: M
authors.lastname: Cazzaniga
authors.forename: G
authors.initials: G
authors.lastname: Tancini
authors.forename: F
authors.initials: F
authors.lastname: Frigerio
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D004359:Drug Therapy, Combination; D005260:Female; D017051:Hospice Care; D006801:Humans; D007167:Immunotherapy; D007279:Injections, Subcutaneous; D007376:Interleukin-2 / Q000008:administration & dosage / Q000627:therapeutic use*; D017567:Karnofsky Performance Status; D008297:Male; D008550:Melatonin / Q000008:administration & dosage / Q000627:therapeutic use*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009369:Neoplasms / Q000628:therapy*; D015213:Neuroimmunomodulation; D010865:Pilot Projects; D011788:Quality of Life; D015996:Survival Rate
chemical_list: D007376:Interleukin-2; D008550:Melatonin