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

被引：54

作者：

Kanai, Masashi ^{[1
]}

Hatano, Etsuro ^{[2
]}

Kobayashi, Shogo ^{[3
]}

Fujiwara, Yutaka ^{[4
]}

Marubashi, Shigeru ^{[5
]}

Miyamoto, Atsushi ^{[6
]}

Shiomi, Hisanori ^{[7
]}

Kubo, Shoji ^{[8
]}

Ikuta, Shinichi ^{[9
]}

Yanagimoto, Hiroaki ^{[10
]}

Terajima, Hiroaki ^{[11
]}

Ikoma, Hisashi ^{[12
]}

Sakai, Daisuke ^{[13
]}

Kodama, Yuzo ^{[14
]}

Seo, Satoru ^{[2
]}

Morita, Satoshi ^{[15
]}

Ajiki, Tetsuo ^{[16
]}

Nagano, Hiroaki ^{[3
]}

Ioka, Tatsuya ^{[17
]}

机构：

[1] Kyoto Univ, Grad Sch Med, Dept Clin Oncol & Pharmacogen, Sakyo Ku, Kyoto 6068507, Japan

[2] Kyoto Univ, Grad Sch Med, Dept Surg, Kyoto 6068507, Japan

[3] Osaka Univ, Grad Sch Med, Dept Surg, Osaka, Japan

[4] Natl Canc Ctr, Dept Expt Therapeut, Exploratory Oncol Res & Clin Trial Ctr, Tokyo, Japan

[5] Osaka Med Ctr Canc & Cardiovasc Dis, Dept Surg, Osaka, Japan

[6] Osaka Natl Hosp, Natl Hosp Org, Dept Surg, Osaka, Japan

[7] Shiga Univ Med Sci, Dept Surg, Otsu, Shiga, Japan

[8] Osaka City Univ, Grad Sch Med, Dept Hepatobiliary Pancreat Surg, Osaka 558, Japan

[9] Meiwa Gen Hosp, Dept Surg, Kobe, Hyogo, Japan

[10] Kansai Med Univ, Dept Surg, Osaka, Japan

[11] Kitano Hosp, Dept Gastroenterol Surg & Oncol, Osaka, Japan

[12] Kyoto Prefectural Univ Med, Dept Surg, Div Digest Surg, Kyoto 602, Japan

[13] Osaka Univ, Grad Sch Med, Dept Frontier Sci Canc & Chemotherapy, Osaka, Japan

[14] Kyoto Univ Hosp, Dept Gastroenterol & Hepatol, Grad Sch Med, Kyoto 606, Japan

[15] Kyoto Univ, Grad Sch Med, Dept Biomed Stat & Bioinformat, Kyoto 6068507, Japan

[16] Kobe Univ Hosp, Grad Sch Med, Dept Surg, Kobe, Hyogo, Japan

[17] Osaka Med Ctr Canc & Cardiovasc Dis, Dept Hepatobiliary & Pancreat Oncol, Osaka, Japan

来源：

CANCER CHEMOTHERAPY AND PHARMACOLOGY | 2015年 / 75卷 / 02期

关键词：

Biliary; Gemcitabine; Cisplatin; S-1; Chemotherapy; S-1 PLUS CISPLATIN; CELL LUNG-CANCER; 1ST-LINE TREATMENT; GEMCITABINE; TRIAL; OXALIPLATIN; MULTICENTER; CARCINOMA;

D O I：

10.1007/s00280-014-2648-9

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. 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). 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 %). 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).

引用

页码：293 / 300

页数：8

共 25 条

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