Oral UFT, etoposide and leucovorin in recurrent non-small cell lung cancer: A non-randomized phase II study
Received 31 December 2008; received in revised form 19 February 2009; accepted 19 February 2009. published online 27 March 2009.
Abstract
Background
Oral treatment regimens with few side effects are appealing in the 2nd or 3rd line treatment of non-small cell lung cancer (NSCLC) patients.
Purpose
The aim was to investigate the efficacy and toxicity of the oral combination etoposide, Uracil–Tegafur (UFT) and leucovorin in 2nd or 3rd line in Caucasian patients with advanced NSCLC.
Methods
Etoposide 50mg/m2, UFT 250mg/m2 and leucovorin 90mg (fixed dose) were dosed in 3 gifts approximately 8h apart for 14 days followed by 1 week rest every 3 weeks until progressive disease (PD). Primary endpoint was response rate (RR), secondary endpoints toxicity and time to progression (TTP).
Results
The median number of cycles was 3.5 (95% CI 2–5); 9 patients received ≥6 cycles, 4>10 cycles. The median dose intensities for etoposide and UFT were 223mg/m2/week (95% CI 213–232) and 1092mg/m2/week (95% CI 1032–1167), the relative dose intensities 92% and 90%, respectively. Grade 3/4 neutropenia was observed in 12% (4/32), grade 3/4 thrombocytopenia in 15% (5/32), without febrile neutropenia. Non-hematological toxicity grade 3 included hepatic toxicity (6%), lethargy (15%), diarrhea (3%) and nausea (3%). One patient developed grade 4 arterial ischemia. Fourteen percent (95% CI 4–33%) (4/28) had a confirmed partial response, 57% (95% CI 44–81%) (16/28) stable disease and 28% (95% CI 19–56%) (8/28) progressive disease. The median TTP was 3 months (95% CI 1.3–4.4), the median overall survival 6.7 months (95% CI 4.0–9.3).
Conclusion
The combination of UFT, etoposide and leucovorin is active in 2nd or 3rd line therapy of Caucasian NSCLC patients and because of its favourable toxicity profile this treatment warrants further investigation.
ABSTRACT