Oral UFT, etoposide and leucovorin in recurrent non-small cell lung cancer: A non-randomized phase II study

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 50 mg/m 2 , UFT 250 mg/m 2 and leucovorin 90 mg (fixed dose) were dosed in 3 gifts approximately 8 h 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 223 mg/m 2 /week (95% CI 213–232) and 1092 mg/m 2 /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.