PROLONGED ADMINISTRATION OF ORAL ETOPOSIDE ALONE OR WITH INTRAVENOUS CARBOPLATIN IN STAGE-IV NONSMALL CELL LUNG-CANCER - A RANDOMIZED TRIAL

Background: To investigate whether the addition of intravenous carbopl atin (CBDCA) to prolonged oral administration of etoposide improves tr eatment results over that obtained with the same etoposide given alone in patients with Stage IV non small-cell lung cancer (NSCLC). Materia l and methods: Patients, 120 were randomized to receive either 400 mg/ m(2) of CBDCA, day 1 and 50 mg/m(2) of etoposide, days 1-21 (Group I) or the same etoposide alone (Group II). Cycles were repeated every 4 w eeks for up to 6 cycles or until tumor progression was noted. Results: Patients, 117 were fully evaluable for this report. Patients in Group I achieved better response rate than those in Group II (31 versus 20% , P = 0.19). They also had longer median survival time and higher 1- a nd 2-year survival rates than those in Group II (9 versus 5 months, re spectively; 38 and 12% versus 24 and 5%, respectively; P = 0.015). The re were no treatment-related deaths. Leukopenia (P = 0.047) and trombo cytopenia (P = 0.000) were more frequent in Group I, but only 15 (26%) patients in Group and 7 (12%) patients in Group II experienced high-g rade (greater than or equal to 3) hematological toxicity. Apart from a lopecia (P = 0.000), other non-hematological toxicity was not differen t between the two treatment Groups. Conclusion: Results of this study showed improvement in survival for the two-drug regimen. Together with mild to moderate toxicity anti low cost, they may warrant further stu dies comparing it with other approaches in patients with Sta,ee IV NSC LC. (C) 1997 Elsevier Science Ireland Ltd.