Efficacy and Safety of Gemcitabine Plus Cisplatin as First-Line Chemotherapy for Advanced Biliary Tract Cancer
Authors: Y. Oka, A. Todaka, A. Fukutomi, T. Tsushima, T. Yokota, N. Machida, K. Yamazaki, Y. Onozawa, N. Boku, H. Yasui
Journal: Annals of Oncology (2013)

Background: Gemcitabine (GEM) plus cisplatin (CDDP) combination (GC) therapy is the standard treatment for advanced biliary tract cancer (BTC) as the results of ABC-02 and BT-22 study.Method: We retrospectively reviewed 36 consective patients with advanced BTC who received GC therapy (GEM 1000 mg/m2, CDDP 25mg/m2, on days 1 and 8, every 3 weeks) as first-line chemotherapy at our institution between July 2002 and August 2012. Inclusion criteria were as follows: age < 75, PS0/1, adequate-organ functions, no massive fluid collection, no critical complication, and no active concomitant malignancy.Results: 27 patients were selected for this analysis. Patients characteristics were as follows: median age 62 years (range, 27-73), male/female 16/11, PS0/1 14/13, gallbladder/intrahepatic bile duct/extrahepatic bile duct/ampulla of Vater 12/8/7/0, primary tumor presence(+)/absence(-) 23/4, metastasis +/- 25/2, measurable lesion +/- 25/2. The median number of administration of GC therapy per patient was 11 (range, 1-22) and median relative dose intensity of GEM/CDDP was 94%/94%. Out of the 25 patients with measurable lesions, 3 patients achieved partial response and 14 patients had stable disease. The response rate was 12% and disease control rate was 68%. The median follow-up time was 11.7 months, and median PFS, median OS and 1-year survival rate were 4.4 months, 8.0 months, and 38.6%, respectively. Grade 3/4 adverse events were leukopenia (41%), neutropenia (44%), anemia (26%), thrombocytopenia (22%), fatigue (11%), anorexia (7%), nausea (7%), and ALT increased (4%). The second-line therapy was administered in 25 patients (93%). In gallbladder/non-gallbladder cancer patients, median PFS was 4.0/6.6 months and median OS was 7.3/13.2 months, respectively.Conclusions: The efficacy of GC therapy in this study was inferior to that of the previous reports. Suggested reason was that the proportions of gall bladder cancer (44%) and the patients with primary tumor (85%) were higher in our analysis. Incidence of grade 3/4 hematotoxicity in this study was as high as that reported in BT-22 study, though higher than that reported in ABC-02 study. Background: Gemcitabine (GEM) plus cisplatin (CDDP) combination (GC) therapy is the standard treatment for advanced biliary tract cancer (BTC) as the results of ABC-02 and BT-22 study. Method: We retrospectively reviewed 36 consective patients with advanced BTC who received GC therapy (GEM 1000 mg/m2, CDDP 25mg/m2, on days 1 and 8, every 3 weeks) as first-line chemotherapy at our institution between July 2002 and August 2012. Inclusion criteria were as follows: age < 75, PS0/1, adequate-organ functions, no massive fluid collection, no critical complication, and no active concomitant malignancy. Results: 27 patients were selected for this analysis. Patients characteristics were as follows: median age 62 years (range, 27-73), male/female 16/11, PS0/1 14/13, gallbladder/intrahepatic bile duct/extrahepatic bile duct/ampulla of Vater 12/8/7/0, primary tumor presence(+)/absence(-) 23/4, metastasis +/- 25/2, measurable lesion +/- 25/2. The median number of administration of GC therapy per patient was 11 (range, 1-22) and median relative dose intensity of GEM/CDDP was 94%/94%. Out of the 25 patients with measurable lesions, 3 patients achieved partial response and 14 patients had stable disease. The response rate was 12% and disease control rate was 68%. The median follow-up time was 11.7 months, and median PFS, median OS and 1-year survival rate were 4.4 months, 8.0 months, and 38.6%, respectively. Grade 3/4 adverse events were leukopenia (41%), neutropenia (44%), anemia (26%), thrombocytopenia (22%), fatigue (11%), anorexia (7%), nausea (7%), and ALT increased (4%). The second-line therapy was administered in 25 patients (93%). In gallbladder/non-gallbladder cancer patients, median PFS was 4.0/6.6 months and median OS was 7.3/13.2 months, respectively. Conclusions: The efficacy of GC therapy in this study was inferior to that of the previous reports. Suggested reason was that the proportions of gall bladder cancer (44%) and the patients with primary tumor (85%) were higher in our analysis. Incidence of grade 3/4 hematotoxicity in this study was as high as that reported in BT-22 study, though higher than that reported in ABC-02 study.