A multi-institution phase II study of gemcitabine/S-1 combination chemotherapy for patients with advanced biliary tract cancer
A multi-institution phase II study of gemcitabine/S-1 combination chemotherapy for patients with advanced biliary tract cancer
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DOI：
10.1007/s00280-010-1443-5
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发表时间：
2011-06-01
影响因子：
3
通讯作者：
Hatano, Etsuro
中科院分区：
文献类型：
--
作者：
Kanai, Masashi;Yoshimura, Kenichi;Hatano, Etsuro
我们的目的是评价吉西他滨/替吉奥联合化疗治疗晚期胆道癌的疗效和安全性。组织学或细胞学证实不能切除或复发的胆道癌患者符合入选条件。主要终点是总生存期。吉西他滨在第1天和第8天以1，000 mg/m2的剂量在30分钟内静脉给药，在第1-14天以60 mg/m2的剂量每日口服S-1。该方案每3周重复一次，直至疾病进展或患者拒绝。2007年10月至2009年1月期间，25例患者入选。肝外胆管癌11例（44%），肝内胆管癌5例（20%），胆囊癌8例（32%），壶腹癌1例（4%）。中位总生存时间为12.7个月（95%CI，8.4-23.5个月），1年生存率为52.0%（95%CI，31.2-69.2%）。在23例具有可评价靶区域的患者中，7例患者出现部分缓解，总体缓解率为30.4%。发生了以下3-4级血液学毒性：中性粒细胞减少症（56%）、白细胞减少症（24%）、贫血（8%）和血小板减少症（4%）。尽管3-4级中性粒细胞减少症的发生率很高，但在本研究中没有患者发生发热性中性粒细胞减少症。3-4级非血液学毒性反应主要为乏力（8%）、厌食（8%）和腹泻（4%），吉西他滨/替吉奥联合化疗方案对晚期胆道癌患者的生存率较高，毒性反应可接受。
We aimed to evaluate the efficacy and safety of gemcitabine/S-1 combination chemotherapy for the treatment of patients with advanced biliary tract cancer.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.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%).Gemcitabine/S-1 combination chemotherapy offered a promising survival benefit with acceptable toxicity in patients with advanced biliary tract cancer.