MAYWOOD, IllinoisA novel fixed-dose schedule of uracil/tegafur (UFT)
plus leucovorin (UFT/LV, also known as Orzel, investigational) achieved
significant disease stabilization in advanced breast cancer, according to a
phase II multicenter study reported at ASCO (abstract 240).
UFT/LV is traditionally given by body surface area (BSA)-based oral
dosing two to three times daily for 28 of 35 days. In this trial, a novel
twice-daily fixed-dose schedule was tested in patients and found to be
active. The study was especially encouraging, the investigators noted,
because it showed that a single agent could produce prolonged disease
stabilization in heavily pretreated patients.
Lee Schwartzberg, MD, of the West Cancer Clinic, Memphis, Tennessee, was
lead author. Principal investigator Kathy Albain, MD, of Loyola University
Cardinal Bernardin Cancer Center, Maywood, Illinois, discussed the poster at
"Our intention in evaluating this regimen was that it might be more
palatable, especially for older women or for women who want a simpler
regimen," Dr. Albain said. "We found a response rate that was
modest, but the disease stabilization rate was quite high. Almost 30% of
patients were free of progression at 6 months."
The study included 86 patients who were given 300 mg/m² UFT and 30 mg
leucovorin every 12 hours, Monday through Friday each week. If BSA was 1.5
m2 or less, the UFT dose was reduced to 500 mg/m² for the first 5 weeks of
the study. Almost half the patients had received two prior regimens and had
three sites of metastasis.
A total of 374 cycles were delivered. The number of days the drugs were
withheld due to toxicity was 671 (8%), and the number of days missed for
noncompliance was 135 (2%). (See table below for response rates.)
Median duration of response was 427 days (range, 70 to 616), and median
time to progression was 80 days. Progression-free survival at 6 months was
27% (95% CI 18% to 37%), and median survival was 431 days.