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

Surmont, V.; Aerts, J.G.; Pouw, E.; Tan, K.Y.; Vernhout, R.; Gras, J.; Salomé, J.; Pronk, T.; Schmitz, P.I.M.; Hoogsteden, H.; van Klaveren, R.J.

doi:10.1016/j.lungcan.2009.02.016

« Previous Next »Lung Cancer
Volume 66, Issue 3 , Pages 333-337, December 2009

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

V. Surmont
- Department of Pulmonology, Erasmus MC-Daniel Den Hoed Cancer Center, Groene Hilledijk 301, 3075 EA Rotterdam, The Netherlands
- Corresponding author. Tel.: +31 10 7041437; fax: +31 10 7041044.
J.G. Aerts
- Department of Pulmonology, Erasmus MC-Daniel Den Hoed Cancer Center, Groene Hilledijk 301, 3075 EA Rotterdam, The Netherlands
- Department of Pulmonology, Amphia Hospital, 4800 RK Breda, The Netherlands
E. Pouw
- Department of Pulmonology, Groene Hartziekenhuis, 2803 HH Gouda, The Netherlands
K.Y. Tan
- Department of Pulmonology, Sint-Franciscus Gasthuis, 3045 PM Rotterdam, The Netherlands
R. Vernhout
- Department of Trials and Statistics, Erasmus MC-Daniel Den Hoed Cancer Center, 3075 EA Rotterdam, The Netherlands
J. Gras
- Department of Trials and Statistics, Erasmus MC-Daniel Den Hoed Cancer Center, 3075 EA Rotterdam, The Netherlands
J. Salomé
- Department of Pulmonology, Sint-Franciscus Gasthuis, 3045 PM Rotterdam, The Netherlands
T. Pronk
- Department of Pulmonology, Erasmus MC-Daniel Den Hoed Cancer Center, Groene Hilledijk 301, 3075 EA Rotterdam, The Netherlands
P.I.M. Schmitz
- Department of Trials and Statistics, Erasmus MC-Daniel Den Hoed Cancer Center, 3075 EA Rotterdam, The Netherlands
H. Hoogsteden
- Department of Pulmonology, Erasmus MC-Daniel Den Hoed Cancer Center, Groene Hilledijk 301, 3075 EA Rotterdam, The Netherlands
R.J. van Klaveren
- Department of Pulmonology, Erasmus MC-Daniel Den Hoed Cancer Center, Groene Hilledijk 301, 3075 EA Rotterdam, The Netherlands

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.

Keywords: Oral treatment, UFT, Etoposide, Recurrent, Non-small cell lung cancer