Efficacy of trastuzumab in Japanese patients with HER2-positive advanced gastric or gastroesophageal junction cancer: a subgroup analysis of the Trastuzumab for Gastric Cancer (ToGA) study

被引：98

作者：

Sawaki, Akira ^{[1
]}

Ohashi, Yasuo ^{[2
]}

Omuro, Yasushi ^{[3
]}

Satoh, Taroh ^{[4
]}

Hamamoto, Yasuo

Boku, Narikazu ^{[5
]}

Miyata, Yoshinori ^{[6
]}

Takiuchi, Hiroya ^{[7
]}

Yamaguchi, Kensei ^{[8
]}

Sasaki, Yasutsuna ^{[9
]}

Nishina, Tomohiro ^{[10
]}

Satoh, Atsushi ^{[11
]}

Baba, Eishi ^{[12
]}

Tamura, Takao ^{[13
]}

Abe, Takashi ^{[14
]}

Hatake, Kiyohiko ^{[15
]}

Ohtsu, Atsushi ^{[16
]}

机构：

[1] Nagoya Daini Red Cross Hosp, Div Oncol, Shouwa Ku, Nagoya, Aichi 4668650, Japan

[2] Publ Hlth Res Fdn, Dept Biostat, Tokyo, Japan

[3] Komagome Hosp, Dept Chemotherapy, Tokyo Metropolitan Canc & Infect Dis Ctr, Tokyo, Japan

[4] Kinki Univ, Dept Med Oncol, Fac Med, Osaka, Japan

[5] Shizuoka Canc Ctr, Div Gastrointestinal Oncol, Shizuoka, Japan

[6] Saku Cent Hosp, Dept Gastroenterol, Nagano, Japan

[7] Osaka Med Coll, Dept Internal Med 2, Osaka, Japan

[8] Saitama Canc Ctr, Div Gastroenterol, Saitama, Japan

[9] Saitama Med Univ, Ctr Comprehens Canc, Saitama Int Med Ctr, Dept Med Oncol, Saitama, Japan

[10] Natl Hosp Org, Shikoku Canc Ctr, Dept Gastroenterol, Shikoku, Ehime, Japan

[11] Showa Univ, Sch Med, Toyosu Hosp, Dept Internal Med, Tokyo 142, Japan

[12] Kyushu Univ Hosp, Dept Hematol & Oncol, Fukuoka 812, Japan

[13] Kobe Univ, Div Diabet Digest & Kidney Dis, Dept Clin Mol Med, Grad Sch Med, Kobe, Hyogo, Japan

[14] Yamagata Prefectural Cent Hosp, Yamagata, Japan

[15] Ariake Hosp, JFCR Canc Inst, Tokyo, Japan

[16] Natl Canc Ctr Hosp E, Res Ctr Innovat Oncol, Chiba, Japan

来源：

GASTRIC CANCER | 2012年 / 15卷 / 03期

关键词：

Trastuzumab; Drug therapy; Stomach neoplasms; Randomized controlled trial; PHASE-III; CHEMOTHERAPY; CISPLATIN; CAPECITABINE; THERAPY;

D O I：

10.1007/s10120-011-0118-1

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

The Trastuzumab for Gastric Cancer (ToGA) study is the first international trial to include Japanese patients with human epidermal growth factor 2 (HER2) positive advanced/metastatic gastric or gastroesophageal junction cancer. ToGA showed that trastuzumab plus chemotherapy (capecitabine/cisplatin or 5-fluorouracil/cisplatin) improved overall survival in the overall population (hazard ratio 0.74). Regional differences in outcome in favor of Japanese populations were observed in other studies; therefore, subgroup analyses of ToGA may contribute to the evaluation of the potential benefits of this regimen in Japanese patients. We performed subgroup analyses on 101 Japanese patients enrolled into ToGA (trastuzumab plus chemotherapy, n = 51; chemotherapy, n = 50). Median overall survival in the Japanese subgroup was 15.9 months (95% confidence interval 12-25) for trastuzumab plus chemotherapy and 17.7 months (95% confidence interval 12-24) for chemotherapy (hazard ratio 1.00; 95% confidence interval 0.59-1.69). After adjusting for prespecified covariates, the estimated hazard ratio for overall survival was 0.68 (95% confidence interval 0.36-1.27). Further post hoc and exploratory examinations supported the robustness of the adjusted hazard ratios. After adjusting for imbalanced patient backgrounds between arms, overall survival of Japanese patients with human epidermal growth factor 2 positive advanced/metastatic gastric or gastroesophageal junction cancer who received trastuzumab plus chemotherapy was improved compared with patients who received chemotherapy alone.

引用

页码：313 / 322

页数：10

共 19 条

[1]

Adachi Y, 2000, CANCER-AM CANCER SOC, V89, P1418

[2]

[Anonymous], 2010, CANC STAT JAP 2010

[3]

Bang YJ, 2010, LANCET, V376, P1302

[4] Fluorouracil versus combination of irinotecan plus cisplatin versus S-1 in metastatic gastric cancer: a randomised phase 3 study [J].

Boku, Narikazu ;

Yamamoto, Seiichiro ;

Fukuda, Haruhiko ;

Shirao, Kuniaki ;

Doi, Toshihiko ;

Sawaki, Akira ;

Koizumi, Wasaburo ;

Saito, Hiroshi ;

Yamaguchi, Kensei ;

Takiuchi, Hiroya ;

Nasu, Junichiro ;

Ohtsu, Atsushi .

LANCET ONCOLOGY, 2009, 10 (11) :1063-1069

[5]

Burzykowski T, 2009, J CLIN ONCOL, V27

[6] Multivariate prognostic factor analysis in locally advanced and metastatic esophago-gastric cancer-pooled analysis from three multicenter, randomized, controlled trials using individual patient data [J].

Chou, I ;

Norman, AR ;

Cunningham, D ;

Waters, JS ;

Oates, J ;

Ross, PJ .

JOURNAL OF CLINICAL ONCOLOGY, 2004, 22 (12) :2395-2403

[7] Capecitabine and oxaliplatin for advanced esophagogastric cancer [J].

Cunningham, David ;

Starling, Naureen ;

Rao, Sheela ;

Iveson, Timothy ;

Nicolson, Marianne ;

Coxon, Fareeda ;

Middleton, Gary ;

Daniel, Francis ;

Oates, Jacqueline ;

Norman, Andrew Richard .

NEW ENGLAND JOURNAL OF MEDICINE, 2008, 358 (01) :36-46

[8] Drug therapy: Trastuzumab - Mechanism of action and use in clinical practice [J].

Hudis, Clifford A. .

NEW ENGLAND JOURNAL OF MEDICINE, 2007, 357 (01) :39-51

[9] S-1 plus cisplatin versus S-1 alone for first-line treatment of advanced gastric cancer (SPIRITS trial): a phase III trial [J].

Koizumi, Wasaburo ;

Narahara, Hiroyuki ;

Hara, Takuo ;

Takagane, Akinori ;

Akiya, Toshikazu ;

Takagi, Masakazu ;

Miyashita, Kosei ;

Nishizaki, Takashi ;

Kobayashi, Osamu ;

Takiyama, Wataru ;

Toh, Yasushi ;

Nagaie, Takashi ;

Takagi, Seiichi ;

Yamamura, Yoshitaka ;

Yanaoka, Kimihiko ;

Orita, Hiroyuki ;

Takeuchi, Masahiro .

LANCET ONCOLOGY, 2008, 9 (03) :215-221

[10] Combination chemotherapy with capecitabine (X) and cisplatin (P) as first line treatment in advanced gastric cancer: Experience of 223 patients with prognostic factor analysis [J].

Lee, Sung Sook ;

Lee, Jae-Lyun ;

Ryu, Min-Hee ;

Chang, Heung Moon ;

Kim, Tae Won ;

Kang, Hye-Jin ;

Kim, Woo Kun ;

Lee, Jung Shin ;

Kang, Yoon-Koo .

JAPANESE JOURNAL OF CLINICAL ONCOLOGY, 2007, 37 (01) :30-37

← 1 2 →