Phase II study of trastuzumab and cisplatin as first-line therapy in patients with HER2-positive advanced gastric or gastroesophageal junction cancer
Clin. transl. oncol. (Print)
; 13(3): 179-184, mar. 2011. ilus, tab
Artigo
em Inglês
| IBECS
| ID: ibc-124633
Biblioteca responsável:
ES1.1
Localização: BNCS
ABSTRACT
INTRODUCTION:
HER2 over-expression and/or amplification are present in 9-38% of gastric or gastroesophageal junction (GEJ) cancers and are correlated to poor outcome. We conducted a multicentre phase II trial to evaluate trastuzumab in combination with cisplatin in patients with untreated HER2-positive advanced gastric or GEJ cancer. MATERIALS ANDMETHODS:
Chemo-naïve patients with measurable, non-resectable, advanced or metastatic gastric or GEJ adenocarcinoma, with HER2 over-expression and/or amplification (IHC 3+, or IHC 2+ and FISH+), age ≥18 years, ECOG ≤2, left ventricle ejection fraction ≥50% and adequate organ function were eligible. Treatment consisted of trastuzumab (8 mg/kg on cycle 1 day 1 as loading; 6 mg/kg in subsequent cycles) and cisplatin (75 mg/m(2)), both intravenously on day 1, every 21 days.RESULTS:
Twenty-two out of 228 patients (10%) were HER2- positive and were included in this phase II trial. The median age was 66 years and ECOG 0/1 was 41%/59%. The median number of cycles was 4 (range 1-41). The confirmed ORR was 32% and disease control was achieved in 64% of patients. Median time to progression was 5.1 months. Grade 3 adverse events included asthenia (27%), neutropenia (18%), anorexia (14%), diarrhoea (9%) and abdominal pain (9%). There were no grade 4 toxicities or treatment-related deaths. Higher baseline HER extracellular domain (ECD) levels were associated with better outcome in terms of response and survival.CONCLUSIONS:
Trastuzumab in combination with cisplatin is an active regimen and has a favourable toxicity profile in advanced HER2-positive gastric or gastroesophageal cancers (AU)
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Coleções:
Bases de dados nacionais
/
Espanha
Contexto em Saúde:
Doenças Negligenciadas
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ODS3 - Meta 3.3 Acabar com as doenças tropicais negligenciadas e combater as doenças transmissíveis
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ODS3 - Meta 3.4 Reduzir as mortes prematuras devido doenças não transmissíveis
Problema de saúde:
Diarreia
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Infecções Diarreicas
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Doenças do Sistema Digestório
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Neoplasia Esofágica
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Neoplasia do Estômago
Base de dados:
IBECS
Assunto principal:
Neoplasias Gástricas
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Neoplasias Esofágicas
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Adenocarcinoma
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Protocolos de Quimioterapia Combinada Antineoplásica
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Genes erbB-2
Limite:
Idoso
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Feminino
/
Humanos
/
Masculino
Idioma:
Inglês
Revista:
Clin. transl. oncol. (Print)
Ano de publicação:
2011
Tipo de documento:
Artigo
Instituição/País de afiliação:
Hosiptal Miguel Servet/Spain
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Hospital Carlos Haya/Spain
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Hospital Josep Trueta/Spain
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Hospital Severo Ochoa/Spain
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Hospital Virgen de la Victoria/Spain
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MD Anderson Care Center España/Spain
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University Hospital 12 de Octubre/Spain
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University Hospital La Princesa/Spain
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University Hospital Marqués de Valdecilla/Spain
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University Hospital San Carlos/Spain