Original Article

Cancer Chemotherapy and Pharmacology

, Volume 67, Issue 6, pp 1429-1434

First online:

A multi-institution phase II study of gemcitabine/S-1 combination chemotherapy for patients with advanced biliary tract cancer

  • Masashi KanaiAffiliated withOutpatient Oncology Unit, Kyoto University Hospital Email author 
  • , Kenichi YoshimuraAffiliated withTranslational Research Center, Kyoto University Hospital
  • , Takehiko TsumuraAffiliated withOsaka Red Cross Hospital
  • , Masanori AsadaAffiliated withKitano Hospital
  • , Chihiro SuzukiAffiliated withTranslational Research Center, Kyoto University Hospital
  • , Miyuki NiimiAffiliated withTranslational Research Center, Kyoto University Hospital
  • , Shigemi MatsumotoAffiliated withOutpatient Oncology Unit, Kyoto University Hospital
  • , Takafumi NishimuraAffiliated withOutpatient Oncology Unit, Kyoto University Hospital
  • , Takashi NittaAffiliated withDepartment of Surgery, Graduate School of Medicine, Kyoto University Hospital
    • , Kentaro YasuchikaAffiliated withDepartment of Surgery, Graduate School of Medicine, Kyoto University Hospital
    • , Kojiro TauraAffiliated withDepartment of Surgery, Graduate School of Medicine, Kyoto University Hospital
    • , Yukiko MoriAffiliated withOutpatient Oncology Unit, Kyoto University Hospital
    • , Akihiko HamadaAffiliated withKyoto Katsura Hospital
    • , Naoya InoueAffiliated withKansai Denryoku Hospital
    • , Shinsuke TadaAffiliated withDepartment of Gastroenterology and Hepatology, Kyoto University Hospital
    • , Kazuhiro YanagiharaAffiliated withOutpatient Oncology Unit, Kyoto University Hospital
    • , Shujiro YazumiAffiliated withKitano Hospital
    • , Yukio OsakiAffiliated withOsaka Red Cross Hospital
    • , Tsutomu ChibaAffiliated withOutpatient Oncology Unit, Kyoto University HospitalDepartment of Gastroenterology and Hepatology, Kyoto University Hospital
    • , Iwao IkaiAffiliated withDepartment of Surgery, Graduate School of Medicine, Kyoto University Hospital
    • , Masanori FukushimaAffiliated withTranslational Research Center, Kyoto University Hospital
    • , Shinji UemotoAffiliated withDepartment of Surgery, Graduate School of Medicine, Kyoto University Hospital
    • , Etsuro HatanoAffiliated withDepartment of Surgery, Graduate School of Medicine, Kyoto University Hospital

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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.

Keywords

Biliary tract cancer Gemcitabine S-1 Chemotherapy