Abstract
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/m 2 ) and gemcitabine (1000 mg/m 2 ) 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.
Highlights
Biliary tract cancer (BTC) is a rare type of cancer worldwide, but it is more common in East Asia and Latin America than in other regions [1]
Tumor assessment by computed tomography of the abdomen and chest was performed at baseline and after two cycles of chemotherapy according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
GC is accepted worldwide as a standard regimen for first-line chemotherapy in patients with advanced biliary tract cancer (BTC), largely on the basis of the results of the first large phase III study (ABC-02) showing the superiority of GC compared with gemcitabine monotherapy for this condition [13]
Summary
Biliary tract cancer (BTC) is a rare type of cancer worldwide, but it is more common in East Asia and Latin America than in other regions [1]. Gemcitabine and cisplatin combination therapy (GC) has shown promising antitumor efficacy in several phase II studies with BTC patients [7,8,9,10,11,12]. Given these results, a phase III trial comparing GC with gemcitabine alone was conductedfor locally advanced or metastatic BTC in the United Kingdom (ABC-02 study). 0.001).The median progression-free survival (PFS) was significantly longer for the GC group than for the gemcitabine group (8.0 versus 5.0 months; HR of 0.63, with a 95% CI of 0.51 to 0.77; P < 0.001) [13]. We report our experience with GC for Japanese patients with BTC in the clinical practice setting
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