O1-8-4 - Phase 2 Trial of Gemcitabine Plus Uft in Oxaliplatin, Irinotecan and Fluoropyrimidine-Refractory Colorectal Cancer

Abstract

Purpose: To investigate the efficacy of gemcitabine plus UFT (uracil-tegafur) combination chemotherapy as salvage treatment in patients with metastatic or relapsed colorectal cancer (MRCRC).Methods: This single-arm phase 2 study was conducted at 3 institutions in Korea. Patients with MRCRC refractory to fluoropyrimidine, oxaliplatin and irinotecan were enrolled. Gemcitabine 800 mg/m2 was administered intravenously on days 1, 8 and 15. UFT 200 mg/m2/day was taken orally in 3 divided doses on days 1-21. Cycles were repeated every 4 weeks and tumor evaluation was carried out every 8 weeks. The primary endpoint of this study was 8-week progression-free survival (PFS) rate.Results: Forty-one patients were enrolled. Fourteen patients received gemcitabine/UFT as a third-line treatment and 37 patients as a 4th-line or later-line therapy. Toxicities were easily manageable and non-hematologic toxicities of ≥ grade 3 were rare. The most common toxicity of ≥ grade 3 was neutropenia (20.0%). One patient showed partial response (response rate, 2.4%) and 14 (34.1%) showed stable disease. The 8-week PFS rate was 42.3%. The median PFS was 1.7 months [95% confidence interval (CI), 1.6-1.8 months] and the median OS was 9.2 months (95% CI, 5.8-12.6 months).Conclusions: Overall efficacy of gemcitabine/UFT in refractory MRCRC was unsatisfactory. However, we could found a minor proportion of patients who showed prolonged tumor stabilization to gemcitabine/UFT. Further studies are warranted to identify a patient subgroup that might have benefits from gemcitabine/fluoropyrimidine therapy.