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

共 27 条

[11]

Nakahira S, 2008, ANTICANCER RES, V28, P179

[12] A multicentre randomised phase II trial of gemcitabine alone vs gemcitabine and S-1 combination therapy in advanced pancreatic cancer: GEMSAP study [J].

Nakai, Y. ;

Isayama, H. ;

Sasaki, T. ;

Sasahira, N. ;

Tsujino, T. ;

Toda, N. ;

Kogure, H. ;

Matsubara, S. ;

Ito, Y. ;

Togawa, O. ;

Arizumi, T. ;

Hirano, K. ;

Tada, M. ;

Omata, M. ;

Koike, K. .

BRITISH JOURNAL OF CANCER, 2012, 106 (12) :1934-1939

[13] Phase II trial of oral S-1 combined with gemcitabine in metastatic pancreatic cancer [J].

Nakamura, K. ;

Yamaguchi, T. ;

Ishihara, T. ;

Sudo, K. ;

Kato, H. ;

Saisho, H. .

BRITISH JOURNAL OF CANCER, 2006, 94 (11) :1575-1579

[14] Phase I trial of oral S-1 combined with gemcitabine in metastatic pancreatic cancer [J].

Nakamura, K ;

Yamaguchi, T ;

Ishihara, T ;

Kobayashi, A ;

Tadenuma, H ;

Sudo, K ;

Kato, H ;

Saisho, H .

BRITISH JOURNAL OF CANCER, 2005, 92 (12) :2134-2139

[15] A late phase II study of S-1 for metastatic pancreatic cancer [J].

Okusaka, Takuji ;

Funakoshi, Akihiro ;

Furuse, Junji ;

Boku, Narikazu ;

Yamao, Kenji ;

Ohkawa, Shinichi ;

Saito, Hiroshi .

CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2008, 61 (04) :615-621

[16] Randomized phase II study of gemcitabine and S-1 combination versus gemcitabine alone in the treatment of unresectable advanced pancreatic cancer (Japan Clinical Cancer Research Organization PC-01 study) [J].

Ozaka, Masato ;

Matsumura, Yuji ;

Ishii, Hiroshi ;

Omuro, Yasushi ;

Itoi, Takao ;

Mouri, Hisatsugu ;

Hanada, Keiji ;

Kimura, Yasutoshi ;

Maetani, Iruru ;

Okabe, Yoshinobu ;

Tani, Masaji ;

Ikeda, Takaaki ;

Hijioka, Susumu ;

Watanabe, Ryouhei ;

Ohoka, Shinya ;

Hirose, Yuki ;

Suyama, Masafumi ;

Egawa, Naoto ;

Sofuni, Atsushi ;

Ikari, Takaaki ;

Nakajima, Toshifusa .

CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2012, 69 (05) :1197-1204

[17]

Rauchwerger DR, 2000, CANCER RES, V60, P6075

[18] Gemcitabine versus cisplatin, epirubicin, fluorouracil, and gemcitabine in advanced pancreatic cancer: a randomised controlled multicentre phase III trial [J].

Reni, M ;

Cordio, S ;

Milandri, C ;

Passoni, P ;

Bonetto, E ;

Oliani, C ;

Luppi, G ;

Nicoletti, R ;

Galli, L ;

Bordonaro, R ;

Passardi, A ;

Zerbi, A ;

Balzano, G ;

Aldrighetti, L ;

Staudacher, C ;

Villa, E ;

Di Carlo, V .

LANCET ONCOLOGY, 2005, 6 (06) :369-376

[19] Randomized Phase II Study of Two Different Schedules of Gemcitabine and Oral S-1 in Chemo-naive Patients with Advanced Non-small Cell Lung Cancer [J].

Satouchi, Miyako ;

Kotani, Yoshikazu ;

Katakami, Nobuyuki ;

Shimada, Temiko ;

Urata, Yoshiko ;

Yoshimura, Sho ;

Funada, Yasuhiro ;

Hata, Akito ;

Ando, Masahiko ;

Negoro, Shunichi .

JOURNAL OF THORACIC ONCOLOGY, 2010, 5 (05) :696-701

[20] Development of a novel form of an oral 5-fluorouracil derivative (S-1) directed to the potentiation of the tumor selective cytotoxicity of 5-fluorouracil by two biochemical modulators [J].

Shirasaka, T ;

Shimamato, Y ;

Ohshimo, H ;

Yamaguchi, M ;

Kato, T ;

Yonekura, K ;

Fukushima, M .

ANTI-CANCER DRUGS, 1996, 7 (05) :548-557

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