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Title: A multi-institution phase II study of gemcitabine/S-1 combination chemotherapy for patients with advanced biliary tract cancer.
Authors: Kanai, Masashi  kyouindb  KAKEN_id
Yoshimura, Kenichi
Tsumura, Takehiko
Asada, Masanori
Suzuki, Chihiro
Niimi, Miyuki
Matsumoto, Shigemi  kyouindb  KAKEN_id
Nishimura, Takafumi
Nitta, Takashi
Yasuchika, Kentaro  kyouindb  KAKEN_id
Taura, Kojiro  kyouindb  KAKEN_id
Mori, Yukiko  kyouindb  KAKEN_id
Hamada, Akihiko
Inoue, Naoya
Tada, Shinsuke
Yanagihara, Kazuhiro
Yazumi, Shujiro
Osaki, Yukio
Chiba, Tsutomu  kyouindb  KAKEN_id
Ikai, Iwao
Fukushima, Masanori
Uemoto, Shinji  kyouindb  KAKEN_id
Hatano, Etsuro
Author's alias: 金井, 雅史
Keywords: Biliary tract cancer
Issue Date: Jun-2011
Publisher: Springer-Verlag
Journal title: Cancer chemotherapy and pharmacology
Volume: 67
Issue: 6
Start page: 1429
End page: 1434
Abstract: Purpose:We aimed to evaluate the efficacy and safety of gemcitabine/S-1 combination chemotherapy for the treatment of patients with advanced biliary tract cancer.  Methods:Patients with histologically or cytologically confirmed unresectable or recurrent biliary tract cancer were eligible for inclusion. The primary endpoint was overall survival. Gemcitabine was administered intravenously at a dose of 1, 000 mg/m2 over 30 min on days 1 and 8, and oral S-1 was administered daily at a dose of 60 mg/m2 on days 1–14. This schedule was repeated every 3 weeks until disease progression or patient refusal.  Results:Twenty-five patients were enrolled between October 2007 and January 2009. Eleven patients (44%) had extrahepatic bile duct cancer, 5 (20%) had intrahepatic bile duct cancer, 8 had gallbladder cancer (32%), and 1 (4%) had ampulla of Vater cancer. The median overall survival time was 12.7 months (95% CI, 8.4–23.5 months), and the 1-year survival rate was 52.0% (95% CI, 31.2–69.2%). Of the 23 patients with evaluable target regions, seven patients experienced a partial response, and an overall response rate was 30.4%. The following grade 3–4 hematological toxicities occurred: neutropenia (56%), leukopenia (24%), anemia (8%) and thrombocytopenia (4%). In spite of the high incidence of grade 3–4 neutropenia, no patients developed febrile neutropenia in the present study. The major grade 3–4 non-hematological toxicities were fatigue (8%), anorexia (8%) and diarrhea (4%).  Conclusions:Gemcitabine/S-1 combination chemotherapy offered a promising survival benefit with acceptable toxicity in patients with advanced biliary tract cancer.
Rights: The final publication is available at
この論文は出版社版でありません。引用の際には出版社版をご確認ご利用ください。This is not the published version. Please cite only the published version.
DOI(Published Version): 10.1007/s00280-010-1443-5
PubMed ID: 20811895
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