A phase 2 study of cetuximab in combination with docetaxel in chemotherapy-refractory/resistant patients with advanced nonsmall cell lung cancer.
Cancer
; 115(8): 1713-22, 2009 Apr 15.
Article
em En
| MEDLINE
| ID: mdl-19208430
ABSTRACT
BACKGROUND:
Cetuximab in combination with docetaxel was examined in chemotherapy-refractory/resistant patients with advanced nonsmall-cell lung cancer (NSCLC) to determine response rate, survival, safety, and pharmacokinetics (PK).METHODS:
Patients had evidence of epidermal growth factor receptor (EGFR) expression (> or =1 +) and tumor progression during or disease recurrence within 3 months after chemotherapy. Cetuximab was administered weekly (400 mg/m(2) initial; 250 mg/m(2) thereafter). Docetaxel was administered every 3 weeks (75 mg/m(2)). A response in 3 of the first 21 patients was required to continue accrual to the target sample size of 50 patients.RESULTS:
Confirmed responses included 1 complete response (1.8%), 10 partial responses (18.2%), and 20 with stable disease (36.4%). The response rate was 20% (95% confidence interval [CI], 10.4% to 33.0%) and median time to disease progression was 104 days. There were no differences in PK parameters of docetaxel alone or with cetuximab. The most common grade 3 of 4 adverse events were leukopenia (27.3%) and acne (21.8%). Four patients (7.3%) discontinued due to allergic reaction. The median overall survival (OS) was 7.5 months with a 1-year survival of 35%.CONCLUSIONS:
Cetuximab in combination with docetaxel was well tolerated. The response rate supports more definitive evaluation of this combination in the second-line setting.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Protocolos de Quimioterapia Combinada Antineoplásica
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Carcinoma Pulmonar de Células não Pequenas
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Taxoides
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Neoplasias Pulmonares
Tipo de estudo:
Clinical_trials
Limite:
Adult
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Aged
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Cancer
Ano de publicação:
2009
Tipo de documento:
Article