Oral treatment with uracil-tegafur, etoposide and leucovorin in non-Asian patients with recurrent non-small cell lung cancer: A non-randomized, phase II study

Abstract

19019 Background: Maintenance of good quality of life is a very important aspect in the treatment of patients with recurrent advanced NSCLC. Therefore, out-patient treatment regimens with few side-effects are appealing. Purpose of our study was to investigate the activity and toxicity of oral etoposide, UFT and leucovorin in second or third line for non-Asian patients with advanced NSCLC. Methods: Patients with stage IIIB or IV NSCLC treated with one or two prior chemotherapy regimens were eligible. Patients were treated in a non-randomised phase II study with oral etoposide 50 mg/m2/d, Uracil-Tegafur 250 mg/m2/d and leucovorin 90 mg/d (fixed dose) in a 21 day cycle: 14 days treatment followed by 7 days of rest. Treatment was continued until PD. Primary endpoint was RR, secondary endpoints were toxicity and TTP. Minimum RR below which treatment is of no interest was set at 5%. The 2-phase Simon design was used. Results: Of the 35 patients entered in the study (mean age 60.4 yrs, range 42- 79.4 yrs) 25 were evaluable for response: 5 had PD, 17 SD and 3 PR (ORR 9%). Grade 3/4 neutropenia and thrombocytopenia occurred in 11% and 14%, respectively. No febrile neutropenia was observed. Grade 3 non-hematological toxicity included elevated transaminases (2/35), lethargy (5/35), diarrhea (1/35) and nausea (1/35). One patient developed treatment related peripheral arterial ischemia. For all participants the median TTP was 85 days (range 5–723days), for patients treated in 2nd line (18/35) 121 days (range 26–349), whereas for 3rd line patients (17/35) it was 91.5 days (range 5–723). Conclusions: The present study is the first to demonstrate activity of UFT combined with etoposide in 2nd or 3rd line treatment for advanced NSCLC in a non-Asian population. The TTP is comparable with other 2nd or 3rd line treatments, the combination is well tolerated and toxicity is mild. Randomized studies comparing the cost-effectiveness of UFT-etoposide with one of the other registered 2nd or 3rd line treatment are warranted. No significant financial relationships to disclose.