Prolonged oral versus high-dose intravenous etoposide in combination with carboplatin for stage IV non-small-cell lung cancer (NSCLC): a randomized trial

In order to investigate whether dose-intensive intravenous (i.v.) etoposide offers an advantage over prolonged oral administration of etoposide when c ombined with carboplatin (CBDCA), between January, 1991 and December, 1994, 171 patients with metastatic (stage IV) non-small cell lung cancer were ra ndomized to receive CBDCA, 400 mg/m(2), day 1 with either oral etoposide, 5 0 mg/m(2), days 1-21 (group I) or i.v. etoposide, 200 mg/m(2), days 1-3 (gr oup II), every 4 weeks for up to six cycles or until tumour progression. Of the patients 168 were fully assessable for response, survival and toxicity . There were three (4%) CR and 16 (19%) PR in group I, and the overall resp onse rate was 23%. There were four (5%) CR and 12 (14%) PR in group II, and the overall response rate was 19% (P = 0.82). The median survival time (MS T) in group I was 8 months, and 1- and 2-year survival rates were 35 and 9. 5%, respectively, while the corresponding figures for group II were 7 month s, and 31 and 7.1%, respectively (P = 0.40). Both haematological and non-ha ematological toxicity was significantly more frequent in group II with six (7%) patients in that group dying of treatment-related infection. Intensive i.v. etoposide combined with CBDCA was similar in efficacy to but more tox ic than prolonged oral etoposide plus carboplatin and we do not recommend i t for further investigation. (C) 1999 Elsevier Science Ireland Ltd. All rig hts reserved.