当前位置： SCI文献检索 > CANCER CHEMOTHERAPY AND PHARMACOLOGY期刊下所有文献 > A multi-institution phase II study of gemcitabine/cisplatin/S-1 (GCS) combination chemotherapy for patients with advanced biliary tract cancer (KHBO 1002).

A multi-institution phase II study of gemcitabine/cisplatin/S-1 (GCS) combination chemotherapy for patients with advanced biliary tract cancer (KHBO 1002).

Abstract：

PURPOSE:Gemcitabine/cisplatin combination therapy has been the standard palliative chemotherapy for patients with advanced biliary tract cancer (BTC). We aimed to evaluate the efficacy and safety of adding S-1 to gemcitabine/cisplatin combination therapy for patients with advanced BTC. METHODS:Patients with histologically or cytologically confirmed unresectable or recurrent BTC were eligible for inclusion. The primary end point was overall survival. Based on the results of our preceding phase I study, gemcitabine and cisplatin were administered intravenously at doses of 1,000 or 25 mg/m(2), respectively, on day 1, and oral S-1 was administered daily at a dose of 80 mg/m(2) on days 1-7 every 2 weeks. This study was registered with ClinicalTrials.gov (NCT01284413) and the UMIN Clinical Trials Registry (ID 000004468). RESULTS:Fifty patients enrolled between October 2011 and August 2012 were evaluated. After a median follow-up of 15.1 months (range 2.4-24.4 months), the median overall survival time was 16.2 months [95% confidence interval (CI) 10.2-22.2 months], and the one-year overall survival rate was 59.9% (95% CI 46.2-73.5%). The grade 3-4 hematological toxicities were as follows: neutropenia (32%), anemia (32%), thrombocytopenia (10%), and febrile neutropenia (4%). The common grade 3-4 non-hematological toxicities were biliary tract infection (14%), anorexia/nausea (10%), and fatigue (8%). CONCLUSIONS:Gemcitabine/cisplatin/S-1 combination chemotherapy offered a promising survival benefit with manageable toxicity in patients with advanced BTC. A randomized phase III trial to investigate the efficacy of this regimen compared to gemcitabine/cisplatin combination therapy in patients with advanced BTC is now underway (UMIN000014371/NCT02182778).

journal_name

Cancer Chemother Pharmacol

journal_title

Cancer chemotherapy and pharmacology

authors

Kanai M,Hatano E,Kobayashi S,Fujiwara Y,Marubashi S,Miyamoto A,Shiomi H,Kubo S,Ikuta S,Yanagimoto H,Terajima H,Ikoma H,Sakai D,Kodama Y,Seo S,Morita S,Ajiki T,Nagano H,Ioka T

doi

10.1007/s00280-014-2648-9

subject

Has Abstract

pub_date

2015-02-01 00:00:00

pages

293-300

issue

eissn

0344-5704

issn

1432-0843

journal_volume

pub_type

杂志文章,多中心研究

在线工具

A multi-institution phase II study of gemcitabine/cisplatin/S-1 (GCS) combination chemotherapy for patients with advanced biliary tract cancer (KHBO 1002).