title: A randomized trial of amifostine as a cytoprotective agent in patients receiving chemotherapy for small cell lung cancer.
abstract: A randomized trial was conducted to determine whether administration of Amifostine with chemotherapy for small cell lung cancer could decrease the toxicity. 84 patients with small cell lung cancer of favourable prognosis (limited disease, performance status 0-1; limited disease with performance status 2 but normal sodium and alkaline phosphatase, or extensive disease with performance status 0-1, normal sodium and alkaline phosphatase) received treatment with Ifosfamide 3 g/m(2)intravenously, Carboplatin (Glomerular filtration rate + 25) x6 mg intravenously, Etoposide 50 mg orally, twice daily, for 7 days, every 3 weeks. Patients were randomized to receive amifostine 740 mg/m(2)immediately prior to the intravenous drugs (n = 42) or to receive chemotherapy alone (n = 42). The two groups were similar with respect to baseline prognostic factors. There was no significant difference in the occurrence of grade III or IV neutropenia or thrombocytopenia between the two groups, nor in the response rate or overall survival, for which the median was 11 months in the chemotherapy only group and 14 months in the group treated with amifostine. This study has not shown a protective effect from the use of amifostine with this regimen and there does not appear to be any effect upon the efficacy of treatment.
authors.affiliation: ICRF Cancer Medicine Research Unit, St James's University Hospital, Beckett Street, Leeds, UK.
authors.forename: P W
authors.initials: PW
authors.lastname: Johnson
authors.forename: M F
authors.initials: MF
authors.lastname: Muers
authors.forename: M D
authors.initials: MD
authors.lastname: Peake
authors.forename: K M
authors.initials: KM
authors.lastname: Poulter
authors.forename: E M
authors.initials: EM
authors.lastname: Gurney
authors.forename: V V
authors.initials: VV
authors.lastname: Napp
authors.forename: P M
authors.initials: PM
authors.lastname: Hepburn
authors.forename: J M
authors.initials: JM
authors.lastname: Brown
mesh_terms: D000328:Adult; D000368:Aged; D004999:Amifostine / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000401:mortality; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced / Q000517:prevention & control*; D016019:Survival Analysis; D013921:Thrombocytopenia / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D005047:Etoposide; D016190:Carboplatin; D004999:Amifostine; D007069:Ifosfamide