Multicenter, phase II study of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer

被引:74
作者
Sasaki, Takashi [1 ]
Isayama, Hiroyuki [1 ]
Nakai, Yousuke [1 ]
Ito, Yukiko [2 ]
Kogure, Hirofumi [3 ]
Togawa, Osamu [4 ]
Toda, Nobuo [5 ]
Yasuda, Ichiro [6 ]
Hasebe, Osamu [7 ]
Maetani, Iruru [8 ]
Sasahira, Naoki [1 ]
Hirano, Kenji [1 ]
Tsujino, Takeshi [1 ]
Tada, Minoru [1 ]
Omata, Masao [1 ]
机构
[1] Univ Tokyo, Dept Gastroenterol, Fac Med, Bunkyo Ku, Tokyo 1138655, Japan
[2] Japanese Red Cross Med Ctr, Dept Gastroenterol, Tokyo, Japan
[3] Kanto Cent Hosp, Dept Gastroenterol, Tokyo, Japan
[4] JR Tokyo Gen Hosp, Dept Gastroenterol, Tokyo, Japan
[5] Mitsui Mem Hosp, Dept Gastroenterol, Tokyo 101, Japan
[6] Gifu Univ Hosp, Dept Gastroenterol, Gifu, Japan
[7] Nagano Municipal Hosp, Dept Gastroenterol, Nagano, Japan
[8] Toho Univ, Ohashi Med Ctr, Dept Gastroenterol, Tokyo, Japan
基金
日本学术振兴会;
关键词
Biliary tract cancer; Gemcitabine; S-1; Chemotherapy; METASTATIC PANCREATIC-CANCER; 1ST-LINE CHEMOTHERAPY; CLINICAL-TRIALS; PLUS CISPLATIN; CAPECITABINE; OXALIPLATIN; CARCINOMA; ADENOCARCINOMA; MONOTHERAPY; SYSTEM;
D O I
10.1007/s00280-009-1115-5
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
To evaluate the efficacy and safety of gemcitabine and S-1 combination chemotherapy in patients with advanced biliary tract cancer. Patients with a measurable lesion and no previous history of chemotherapy or radiotherapy were enrolled. Gemcitabine was administered intravenously at a dose of 1,000 mg/m(2) over 30 min on day 1 and 15, repeated every 4 weeks. S-1 was administered orally at a dose of 40 mg/m(2) b.i.d. on days 1-14. Tumor response was assessed every two cycles using Response Evaluation Criteria in Solid Tumors criteria. As much as 35 patients were enrolled between December 2006 and July 2008; 14 patients (40%) with gallbladder cancer and 14 (40%) with intrahepatic cholangiocarcinoma were included and 7 patients (20%) had received previous surgical resection. The overall response rate was 34.3% and the overall disease control rate was 82.9%. The median overall survival time was 11.6 months (95% CI, 7.3-15.6 months), and the median time to progression was 5.9 months (95% CI, 4.0-7.7 months). The grade 3/4 toxicities were leucopenia (23%), neutropenia (34%), anemia (20%), thrombocytopenia (6%) and anorexia (3%). Gemcitabine and S-1 combination chemotherapy has promising efficacy and good tolerability in patients with advanced biliary tract cancer.
引用
收藏
页码:1101 / 1107
页数:7
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