Prolonged administration of oral etoposide alone or with intravenous carboplatin in stage IV non-small cell lung cancer: a randomized trial.

BACKGROUND

To investigate whether the addition of intravenous carboplatin (CBDCA) to prolonged oral administration of etoposide improves treatment results over that obtained with the same etoposide given alone in patients with Stage IV non small-cell lung cancer (NSCLC).

MATERIAL AND

METHODS

Patients, 120 were randomized to receive either 400 mg/m2 of CBDCA, day 1 and 50 mg/m2 of etoposide, days 1-21 (Group I) or the same etoposide alone (Group II). Cycles were repeated every 4 weeks 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- and 2-year survival rates than those in Group II (9 versus 5 months, respectively; 38 and 12% versus 24 and 5%, respectively; P = 0.015). There were no treatment-related deaths. Leukopenia (P = 0.047) and thrombocytopenia (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-grade (> or = 3) hematological toxicity. Apart from alopecia (P = 0.000), other non-hematological toxicity was not different 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 and low cost, they may warrant further studies comparing it with other approaches in patients with Stage IV NSCLC.