title: Biological and clinical results of a neuroimmunotherapy with interleukin-2 and the pineal hormone melatonin as a first line treatment in advanced non-small cell lung cancer.
abstract: The metastatic non-small cell lung cancer (NSCLC) still remains an untreatable disease, and the role played by chemotherapy has yet to be defined. The new immunotherapeutic strategies, such as interferon and IL-2, seem to be also less effective, since they generally determine only a stabilisation of disease. On the basis of previous experimental results suggesting a synergistic action between IL-2 and the pineal neurohormone melatonin (MLT), a study was started to evaluate the clinical efficacy and toxicity of a neuroimmunotherapeutic combination consisting of IL-2 plus MLT as a first line therapy in metastatic NSCLC. The study included 20 patients (adenocarcinoma: 10; epidermoid cell carcinoma: 7; large cell carcinoma: 3). MLT was given orally at a dose of 10 mg day-1 at 8.00 pm every day, starting 7 days before the onset of IL-2 administration. IL-2 was given subcutaneously at a dose of 3 x 10(6) IU m-2 every 12 h for 5 days/week for 4 weeks, corresponding to one cycle of immunotherapy. In responder patients or in those with stable disease, a second cycle was given after a rest-period of 21 days. A partial response was achieved in 4/20 (20%) patients. Ten other patients had a stable disease (50%), whereas the last six patients progressed. Toxicity was low in all cases. This study shows that the neuroimmunotherapeutic therapy with IL-2 and the pineal hormone MLT may represent a new effective and well tolerated treatment in metastatic NSCLC, with results comparable to those obtained with chemotherapy, but with an apparent lower biological toxicity.
authors.affiliation: Divisione di Radioterapia Oncologica, Hospital of Monza, Milan, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Lissoni
authors.forename: E
authors.initials: E
authors.lastname: Tisi
authors.forename: S
authors.initials: S
authors.lastname: Barni
authors.forename: A
authors.initials: A
authors.lastname: Ardizzoia
authors.forename: F
authors.initials: F
authors.lastname: Rovelli
authors.forename: R
authors.initials: R
authors.lastname: Rescaldani
authors.forename: D
authors.initials: D
authors.lastname: Ballabio
authors.forename: C
authors.initials: C
authors.lastname: Benenti
authors.forename: M
authors.initials: M
authors.lastname: Angeli
authors.forename: G
authors.initials: G
authors.lastname: Tancini
mesh_terms: D001708:Biopterins / Q000031:analogs & derivatives / Q000097:blood; D002289:Carcinoma, Non-Small-Cell Lung / Q000097:blood / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007376:Interleukin-2 / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000097:blood / Q000276:immunology / Q000473:pathology / Q000628:therapy*; D008297:Male; D008550:Melatonin / Q000627:therapeutic use*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D019798:Neopterin; D015375:Receptors, Interleukin-2 / Q000032:analysis; D013601:T-Lymphocytes / Q000276:immunology; D014409:Tumor Necrosis Factor-alpha / Q000032:analysis
chemical_list: D007376:Interleukin-2; D015375:Receptors, Interleukin-2; D014409:Tumor Necrosis Factor-alpha; D001708:Biopterins; D019798:Neopterin; D008550:Melatonin