A randomized trial of amifostine as a cytoprotective agent in patients receiving chemotherapy for small cell lung cancer

A randomized trial was conducted to determine whether administration of Ami fostine with chemotherapy for small cell lung cancer could decrease the tox icity. 84 patients with small cell lung cancer of favourable prognosis (lim ited disease, performance status 0-1; limited disease with performance stat us 2 but normal sodium and alkaline phosphatase, or extensive diseas with p erformance status 0-1, normal sodium and alkaline phosphatase) received tre atment with Ifosfamide 3 g/m(2) intravenously, Carboplatin (Glomerular filt ration 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 recei ve chemotherapy alone (n = 42). The two groups were similar with respect to baseline prognostic factors. There was no significant difference in the oc currence 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 tr eated with amifostine, This study has not shown a protective effect from th e use of amifostine with this regimen and there does not appear to be any e ffect upon the efficacy of treatment. (C) 2001 Cancer Research Campaign htt p://www.bjcancer.com.