A multi-institution phase II study of gemcitabine/S-1 combination chemotherapy for patients with advanced biliary tract cancer
Masashi Kanai, Kenichi Yoshimura, Takehiko Tsumura, Masanori Asada, Chihiro Suzuki, Miyuki Niimi, Shigemi Matsumoto, Takafumi Nishimura, Takashi Nitta, Kentaro Yasuchika, Kojiro Taura, Yukiko Mori, Akihiko Hamada, Naoya Inoue, Shinsuke Tada, Kazuhiro Yanagihara, Shujiro Yazumi, Yukio Osaki, Tsutomu Chiba, Iwao Ikai, Masanori Fukushima, Shinji Uemoto, Etsuro Hatano, Masashi Kanai, Kenichi Yoshimura, Takehiko Tsumura, Masanori Asada, Chihiro Suzuki, Miyuki Niimi, Shigemi Matsumoto, Takafumi Nishimura, Takashi Nitta, Kentaro Yasuchika, Kojiro Taura, Yukiko Mori, Akihiko Hamada, Naoya Inoue, Shinsuke Tada, Kazuhiro Yanagihara, Shujiro Yazumi, Yukio Osaki, Tsutomu Chiba, Iwao Ikai, Masanori Fukushima, Shinji Uemoto, Etsuro Hatano
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/m(2) over 30 min on days 1 and 8, and oral S-1 was administered daily at a dose of 60 mg/m(2) 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.
Source: PubMed