UFT/Leucovorin: An ‘Excellent Alternative’ to 5-FU/Leucovorin in Colorectal Cancer

NEW YORK-The combination of UFT (an oral fluoropyrimidine consisting of tegafur(Drug information on tegafur) plus uracil) and leucovorin "is tolerable and efficacious" and "an excellent alternative to fluorouracil(Drug information on fluorouracil)/leucovorin, according to the results of a phase II multicenter trial (abstract 3608). "Prolonged administration of UFT/leucovorin has a similar toxicity profile to infusional 5- FU," the investigators concluded. They also noted that UFT/leucovorin "compares favorably with other oral fluoropyrimidines" and saw "no disadvantage in treating the very elderly" (older than age 75). The principal toxicities were diarrhea and neutropenia. Grade 3/4 diarrhea occurred in 23% of patients and grade 3/4 neutropenia, in 5%. Other toxicities included fatigue in 14.3% and nausea (but no grade 4 events) in 10.7%. No cases of hand-foot syndrome were observed. Treatment Every 8 Hours A total of 58 patients were enrolled in the Eastern Cooperative Oncology Group (ECOG) study 1299. The median age of patients was 81 years (range 75-90 years). Performance status was 0 for 14 patients (24%), 1 for 31 patients (56%), and 2 for 13 patients (20%). Patients had undergone no prior chemotherapy for metastatic disease, but 13 patients had undergone prior adjuvant chemotherapy. Treatment was administered as UFT (300 mg/m²) plus leucovorin (30 mg) every 8 hours for 28 days, with 7 days of rest. CT scans were performed every 2 weeks. Similar Results to Single-Agent 5-FU According to updated data presented by Elizabeta C. Popa, MD, of New York University Cancer Institute, the best confirmed responses among the 55 treated patients were a complete response in 1 patient and a partial response in 11 patients. Eighteen patients had stable disease and 16 had progressive disease. Nine patients were not evaluable (Table 1). Results are similar to the 22% response rate and 13-month median survival reported for single-agent 5-FU. "Phase III studies comparing bolus IV 5-FU and oral UFT/leucovorin have shown similar response rates and survival outcomes to our study," Dr. Popa added. The investigators said that additional studies comparing infusional 5- FU with oral UFT/leucovorin, as well as phase II studies using UFT/leucovorin in combination with newer agents, such as oxaliplatin(Drug information on oxaliplatin) (Eloxatin), irinotecan(Drug information on irinotecan) (Camptosar), and biologics, "are warranted to establish maximal utility of this oral fluoropyrimidine."