A PROSPECTIVE RANDOMIZED STUDY IN LIMITED DISEASE SMALL-CELL CARCINOMA-DOXORUBICIN AND VINCRISTINE PLUS EITHER CYCLOPHOSPHAMIDE OR ETOPOSIDE

A prospective randomised study was undertaken in patients with limited disease small cell carcinoma of the lung (SCCL), which compared doxorubicin, 50 mg/m(2), and vincristine, 2 mg i.v. (intravenously) on day 1, with either cyclophosphamide, 800 mg/m(2) on day 1 (CAV) or etoposide, 60 mg/m(2) i.v. on day 1 and 120 mg/m(2) orally on days 2-5 (AVE). Responding patients were to receive six cycles of chemotherapy at 3 weekly intervals followed after 2 weeks by mediastinal irradiation. Response rates and toxicity were evaluated by the chi square or Fisher's exact test and survival by the logrank test. 81 patients were entered into the study, 38 of whom received CAV and 43 received AVE. In the patients treated with CAV and AVE, the overall response rate was 61% (confidence limit (CL), 45-71%) and 74% (CL, 61-87%) respectively, the complete response rate was 32% (CL, 17-47%) and 51% (CL, 36-66%), respectively (P = 0.07) and the median survival was 12 and 14.5 months, respectively (P = 0.15). In the patients treated with CAV and AVE, the incidence of grade 3 and 4 leucopenia was 29% (CL, 15-43%) and 9% (CL, 0-18%), respectively (P = 0.025). No patient developed doxorubicin cardiomyopathy. These findings support the role of etoposide in first line chemotherapy for SCCL. AVE is among the more efficacious regimens for SCCL and also has a relatively low toxicity.