A phase I study of combination chemotherapy with gemcitabine and oral UFT for advanced non-small cell lung cancer

A phase I study was carried out to determine the optimal dose and administration schedule for combined UFT plus gemcitabine therapy in patients with non-small cell lung cancer. Twenty-four patients (including 11 patients previously treated with cisplatin as the key drug) received oral UFT 400 mg m(−2) on days 1 to 14 with intravenous infusions of gemcitabine (800 mg m(−2) on days 8 and 15, or 900 mg m(−2) on days 8 and 15, or 900 mg m(−2) on days 1, 8 and 15). The most appropriate dosing option appeared to be 400 mg m(−2) per day of oral UFT for 14 consecutive days with 900 mg m(−2) gemcitabine on days 8 and 15. Eight of the 24 patients achieved partial response. The combination chemotherapy UFT and gemcitabine was well tolerated and may benefit patients with advanced non-small cell lung cancer. A multicentre phase II study using a 3-weekly regimen is in progress. British Journal of Cancer (2002) 86, 1701–1704. doi:10.1038/sj.bjc.6600337 www.bjcancer.com © 2002 Cancer Research UK