Randomized controlled study of gemcitabine plus S-1 combination chemotherapy versus gemcitabine for unresectable pancreatic cancer

被引：59

作者：

Sudo, Kentaro ^{[1
]}

Ishihara, Takeshi ^{[2
]}

Hirata, Nobuto ^{[3
]}

Ozawa, Fumiaki ^{[4
]}

Ohshima, Tadashi ^{[5
]}

Azemoto, Ryosaku ^{[6
]}

Shimura, Kenji ^{[7
]}

Nihei, Takeshi ^{[8
]}

Nishino, Takayoshi ^{[9
]}

Nakagawa, Akihiko ^{[10
]}

Nakamura, Kazuyoshi ^{[1
]}

Hara, Taro ^{[1
]}

Tada, Motohisa ^{[2
]}

Mikata, Rintaro ^{[2
]}

Tawada, Katsunobu ^{[2
]}

Yokosuka, Osamu ^{[2
]}

Nakaji, So ^{[3
]}

Yamaguchi, Taketo ^{[1
]}

机构：

[1] Chiba Canc Ctr, Dept Gastroenterol, Chuo Ku, Chiba 2608717, Japan

[2] Chiba Univ, Grad Sch Med, Dept Gastroenterol & Nephrol, Chiba, Japan

[3] Kameda Med Ctr, Dept Gastroenterol, Kamogawa, Japan

[4] Saitama Med Univ, Dept Hepatobiliary Pancreat Surg, Saitama Med Ctr, Kawagoe, Saitama, Japan

[5] Saitama Red Cross Hosp, Dept Gastroenterol, Saitama, Japan

[6] Kimitsu Chuo Hosp, Dept Gastroenterol, Kisarazu, Japan

[7] Asahi Gen Hosp, Dept Gastroenterol, Asahi, Japan

[8] Mito Saiseikai Gen Hosp, Dept Internal Med, Mito, Ibaraki, Japan

[9] Tokyo Womens Med Univ, Dept Gastroenterol, Yachiyo Med Ctr, Tokyo, Japan

[10] Numazu City Hosp, Dept Gastroenterol, Numazu, Japan

来源：

CANCER CHEMOTHERAPY AND PHARMACOLOGY | 2014年 / 73卷 / 02期

关键词：

Pancreatic cancer; S-1; Gemcitabine; Randomized controlled study; PHASE-II TRIAL; ORAL S-1; 5-FLUOROURACIL; THERAPY; FLUOROURACIL; CARCINOMA; CISPLATIN; ACID;

D O I：

10.1007/s00280-013-2368-6

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The aim of this study was to evaluate efficacy and safety of gemcitabine plus S-1 (GS) combination chemotherapy in patients with unresectable pancreatic cancer. Patients were randomly assigned to receive GS (oral S-1 60 mg/m(2) daily on days 1-15 every 3 weeks and gemcitabine 1,000 mg/m(2) on days 8 and 15) or gemcitabine (1,000 mg/m(2) on days 1, 8, and 15 every 4 weeks). The primary endpoint was progression-free survival (PFS). One hundred and one patients were randomly assigned. PFS was significantly longer in the GS arm with an estimated hazard ratio (HR) of 0.65 (95 % CI 0.43-0.98; P = 0.039; median 5.3 vs 3.8 months). Objective response rate (ORR) was also better in the GS arm (21.6 vs 6 %, P = 0.048). Median survival was 8.6 months for GS and 8.6 months for GEM (HR 0.93; 95 % CI 0.61-1.41; P = 0.714). Grade 3-4 neutropenia (44 vs 19.6 %, P = 0.011) and thrombocytopenia (26 vs 8.7 %, P = 0.051) were more frequent in the GS arm. GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer.

引用

页码：389 / 396

页数：8

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