title: Feasibility study of gemcitabine and cisplatin combination chemotherapy for patients with refractory biliary tract cancer.
abstract: Gemcitabine and cisplatin combination chemotherapy have been shown to have promising efficacy for the treatment of advanced biliary tract cancer (BTC) as a first-line chemotherapy. However, this treatment has not been approved for clinical practice in Japan. Oral fluoropyrimidines (e.g., S-1 and capecitabine) are also promising agents that are widely used with or without gemcitabine. Unfortunately, there is no standard chemotherapy for patients refractory to gemcitabine and oral fluoropyrimidine. We conducted a feasibility study of gemcitabine and cisplatin combination chemotherapy for patients with advanced BTC who are refractory to gemcitabine and S-1. Gemcitabine (1,000 mg/m(2)) and cisplatin (25 mg/m(2)) were administered intravenously on days 1 and 8, and this regimen was repeated every 3 weeks. Tumor response was assessed every two cycles using the Response Evaluation Criteria in Solid Tumors version 1.0. Twenty patients with pathologically confirmed BTC were enrolled. Gemcitabine and cisplatin combination chemotherapy was administered as a second-line chemotherapy in thirteen patients and as a third-line chemotherapy in seven patients. Tumor response did not occur in any of the cases. Fourteen patients demonstrated stable diseases, and the disease control rate was 70%. Median overall survival and time-to-progression were 5.9 months (95% CI, 3.9-11.3 months) and 3.6 months (95% CI, 2.2-4.2 months), respectively. Grade 3/4 toxicities included leucopenia (35%), neutropenia (35%), anemia (20%), and thrombocytopenia (15%). Two patients treated for approximately 1 year developed cisplatin-related toxicities. In conclusion, gemcitabine and cisplatin combination chemotherapy produces a limited tumor response in BTC, but may prolong patient's survival.
authors.affiliation: Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-8655, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Sasaki
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Isayama
authors.forename: Yousuke
authors.initials: Y
authors.lastname: Nakai
authors.forename: Suguru
authors.initials: S
authors.lastname: Mizuno
authors.forename: Keisuke
authors.initials: K
authors.lastname: Yamamoto
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Yagioka
authors.forename: Yoko
authors.initials: Y
authors.lastname: Yashima
authors.forename: Kazumichi
authors.initials: K
authors.lastname: Kawakubo
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Kogure
authors.forename: Osamu
authors.initials: O
authors.lastname: Togawa
authors.forename: Saburo
authors.initials: S
authors.lastname: Matsubara
authors.forename: Naoki
authors.initials: N
authors.lastname: Sasahira
authors.forename: Kenji
authors.initials: K
authors.lastname: Hirano
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tsujino
authors.forename: Minoru
authors.initials: M
authors.lastname: Tada
authors.forename: Masao
authors.initials: M
authors.lastname: Omata
authors.forename: Kazuhiko
authors.initials: K
authors.lastname: Koike
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine