CODE (CISPLATIN, VINCRISTINE, DOXORUBICIN, ETOPOSIDE) PLUS GRANULOCYTE-COLONY-STIMULATING FACTOR IN ADVANCED NON-SMALL-CELL LUNG-CANCER - AHOOSIER ONCOLOGY GROUP PHASE-II TRIAL

This phase II trial investigated the activity and toxicity of CODE (ci splatin, vincristine, doxorubicin, etoposide) chemotherapy with the ad dition of granulocyte colony-stimulating factor (G-CSF) in patients wh o had chemotherapy-naive, advanced, or metastatic non-small-cell lung cancer. Treatment consisted of cisplatin, 25 mg/m(2), administered wee ks 1 through 9; vincristine, 1 mg/m(2), weeks 1, 2, 4, 6, and 8; doxor ubicin, 40 mg/m(2), weeks 1, 3, 5, 7, and 9; and etoposide, 80 mg/m(2) intravenously day 1 and 160 mg/m(2) orally, days 2 and 3 on weeks 1, 3, 5, 7, and 9. Granulocyte colony-stimulating factor, 5 mu g/kg, was administered subcutaneously on all days that patients were not receivi ng chemotherapy. From April 1992 through April 1993, 42 patients were entered on study. The principal toxicities were hematologic. Grade 3-4 anemia was seen in 21 patients. Grade 3-4 thrombocytopenia was seen i n 9 patients. Grade 3-4 neutropenia occurred in 29 patients. Eight pat ients experienced a neutropenic febrile episode requiring antibiotics. Nonhematologic toxicities included weight loss and fatigue. Responses were seen in 10 of 42 patients, for an overall response rate of 24% ( 95% confidence interval, 12%-39%) and a median survival of 7.1 months. The CODE chemotherapy regimen has activity similar to other previousl y described cisplatin-based regimens, with a significant amount of bot h hematologic and nonhematologic toxicity. Its continued use in patien ts who have previously untreated nonsmall-cell lung cancer cannot be r ecommended, based on the results of this study.