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学科主题: 临床医学
题名:
Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial
作者: Bang, Yung-Jue1; Van Cutsem, Eric2; Feyereislova, Andrea3; Chung, Hyun C.4; Shen, Lin5; Sawaki, Akira6; Lordick, Florian7; Ohtsu, Atsushi8; Omuro, Yasushi9; Satoh, Taroh10; Aprile, Giuseppe11; Kulikov, Evgeny12; Hill, Julie13; Lehle, Michaela3; Ruschoff, Josef14; Kang, Yoon-Koo15; ToGA Trial Investigators
刊名: LANCET
发表日期: 2010-08-01
DOI: 10.1016/S0140-6736(10)61121-X
卷: 376, 期:9742, 页:687-697
收录类别: SCI
文章类型: Article
WOS标题词: Science & Technology
类目[WOS]: Medicine, General & Internal
研究领域[WOS]: General & Internal Medicine
关键词[WOS]: METASTATIC BREAST-CANCER ; ADVANCED ESOPHAGOGASTRIC CANCER ; ADJUVANT CHEMOTHERAPY ; GENE AMPLIFICATION ; 1ST-LINE THERAPY ; SUPPORTIVE CARE ; III TRIAL ; PLUS ; HER2 ; FLUOROURACIL
英文摘要:

Background Trastuzumab, a monoclonal antibody against human epidermal growth factor receptor 2 (HER2; also known as ERBB2), was investigated in combination with chemotherapy for first-line treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer.

Methods ToGA (Trastuzumab for Gastric Cancer) was an open-label, international, phase 3, randomised controlled trial undertaken in 122 centres in 24 countries. Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumours showed overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation. Participants were randomly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine plus cisplatin or fluorouracil plus cisplatin given every 3 weeks for six cycles or chemotherapy in combination with intravenous trastuzumak Allocation was by block randomisation stratified by Eastern Cooperative Oncology Group performance status, chemotherapy regimen, extent of disease, primary cancer site, and measurability of disease, implemented with a central interactive voice recognition system. The primary endpoint was overall survival in all randomised patients who received study medication at least once. This trial is registered with ClinicalTrials.gov, number NCT01041404.

Findings 594 patients were randomly assigned to study treatment (trastuzumab plus chemotherapy, n=298; chemotherapy alone, n=296), of whom 584 were included in the primary analysis (n=294; n=290). Median follow-up was 18.6 months (IQR 11-25) in the trastuzumab plus chemotherapy group and 17.1 months (9-25) in the chemotherapy alone group. Median overall survival was 13 8 months (95% Cl 1.2-16) in those assigned to trastuzumab plus chemotherapy compared with 11.1 months (10-13) in those assigned to chemotherapy alone (hazard ratio 0.74; 95% Cl 0.60-0.91; p=0.0046). The most common adverse events in both groups were nausea (trastuzumab plus chemotherapy, 197 [67%] vs chemotherapy alone, 184 [63%]), vomiting (147 [50%] vs 134 [46%]), and neutropenia (157 [53%] vs 165 [57%])} Rates of overall grade 3 or 4 adverse events (201 [68%] vs 198 [68%]) and cardiac adverse events (17 [6%] vs 18 [6%]) did not differ between groups

Interpretation Trastuzumab in combination with chemotherapy can be considered as a new standard option for patients with HER2-positive advanced gastric or gastro-oesophageal junction cancer.

语种: 英语
项目资助者: F Hoffmann-La Roche FL, GA ; Chugal-Roche ; Chugal Pharmaceutical AF
WOS记录号: WOS:000281582900028
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/63644
Appears in Collections:北京大学临床肿瘤学院_期刊论文

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作者单位: 1.Roche Prod Ltd, Dee Why, NSW, Australia
2.Targos Mol Pathol, Kassel, Germany
3.Asan Med Ctr, Seoul, South Korea
4.Seoul Natl Univ, Coll Med, Seoul 110744, South Korea
5.Univ Hosp Gasthuisberg, B-3000 Leuven, Belgium
6.F Hoffmann La Roche, Basel, Switzerland
7.Yonsei Univ, Coll Med, Canc Metastasis Res Ctr, Yonsei Canc Ctr, Seoul, South Korea
8.Peking Univ, Beijing Canc Hosp, Beijing 100871, Peoples R China
9.Aichi Canc Ctr, Aichi, Japan
10.Natl Centrum Tumorerkrankungen, Heidelberg, Germany
11.East Hosp, Natl Canc Ctr, Kashiwa, Chiba, Japan
12.Komagome Gen Hosp, Tokyo Metropolitan Canc & Infect Dis Ctr, Tokyo, Japan
13.Kinki Univ, Sch Med, Osaka 589, Japan
14.Azienda Osped Univ, Udine, Italy
15.Reg Clin Oncol Dispensary, Ryazan, Russia

Recommended Citation:
Bang, Yung-Jue,Van Cutsem, Eric,Feyereislova, Andrea,et al. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial[J]. LANCET,2010,376(9742):687-697.
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