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

August 1, 2005

NEW YORK-The combinationof UFT (an oral fluoropyrimidineconsisting of tegafur plus uracil) andleucovorin “is tolerable and efficacious”and “an excellent alternative to

NEW YORK-The combinationof UFT (an oral fluoropyrimidineconsisting of tegafur plus uracil) andleucovorin "is tolerable and efficacious"and "an excellent alternative tofluorouracil/leucovorin, according tothe results of a phase II multicentertrial (abstract 3608). "Prolonged administrationof UFT/leucovorin has asimilar toxicity profile to infusional 5-FU," the investigators concluded. Theyalso noted that UFT/leucovorin "comparesfavorably with other oral fluoropyrimidines"and saw "no disadvantagein treating the very elderly" (olderthan age 75).The principal toxicities were diarrheaand neutropenia. Grade 3/4 diarrheaoccurred in 23% of patients andgrade 3/4 neutropenia, in 5%. Othertoxicities included fatigue in 14.3%and nausea (but no grade 4 events) in10.7%. No cases of hand-foot syndromewere observed.Treatment Every 8 HoursA total of 58 patients were enrolledin the Eastern Cooperative OncologyGroup (ECOG) study 1299. The medianage of patients was 81 years (range75-90 years). Performance status was0 for 14 patients (24%), 1 for 31 patients(56%), and 2 for 13 patients(20%). Patients had undergone noprior chemotherapy for metastaticdisease, but 13 patients had undergoneprior adjuvant chemotherapy.

Treatment was administered asUFT (300 mg/m2) plus leucovorin (30mg) every 8 hours for 28 days, with 7days of rest. CT scans were performedevery 2 weeks.Similar Results toSingle-Agent 5-FUAccording to updated data presentedby Elizabeta C. Popa, MD, of NewYork University Cancer Institute, thebest confirmed responses among the55 treated patients were a completeresponse in 1 patient and a partialresponse in 11 patients. Eighteen patientshad stable disease and 16 hadprogressive disease. Nine patients werenot evaluable (Table 1).Results are similar to the 22% responserate and 13-month median survivalreported for single-agent 5-FU."Phase III studies comparing bolus IV5-FU and oral UFT/leucovorin haveshown similar response rates and survivaloutcomes to our study," Dr. Popaadded.The investigators said that additionalstudies comparing infusional 5-FU with oral UFT/leucovorin, as wellas phase II studies using UFT/leucovorinin combination with newer agents,such as oxaliplatin (Eloxatin), irinotecan(Camptosar), and biologics, "arewarranted to establish maximal utilityof this oral fluoropyrimidine."