Gemcitabine and cisplatin combination
therapy (GC) is accepted as a standard treatment for advanced biliary tract cancer (BTC). However, little information
is available regarding such treatment in the clinical practice setting in
Japan. We retrospectively examined the clinical data of patients with
unresectable or recurrent BTC who received GC as first-line treatment. The
regimen consisted of cisplatin (25 mg/m2) and gemcitabine (1000 mg/m2)
administered intravenously on days 1 and 8 of repeated 3-week cycles. Twenty
patients were analyzed. A total of 148 cycles of GC was administered, with a
median of 8 and a range of 1 to 18 cycles. Treatment delay and dose reduction
were noted in 35 (24%) and 41 (28%) of the 148 cycles, respectively. The major
adverse events of grade 3 or 4 included neutropenia (50%), leukopenia (45%), anemia
(30%), and thrombocytopenia (15%). Nonhematologic toxicities included nausea
(10%), appetite loss (10%), and fatigue (10%). Median progression-free and
overall survival times were 6.9 and 12.3 months, respectively. Gallbladder
cancer showed a significantly higher response rate than did other types of BTC
(chi-squaretest, P = 0.002). GC was
thus effective and well tolerated as first-line chemotherapy for Japanese
patients with advanced BTC in the clinical practice setting.
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