An open-label, single-arm phase two trial of gefitinib in patients with advanced or metastatic castration-resistant prostate cancer.
Am J Clin Oncol
; 32(4): 338-41, 2009 Aug.
Article
en En
| MEDLINE
| ID: mdl-19363437
ABSTRACT
OBJECTIVE:
To determine whether the oral epidermal growth factor receptor (EGFR) inhibitor gefitinib (ZD1839, Iressa has clinical efficacy in patients with castration-resistant prostate cancer (CRPC).METHODS:
Multicenter open-label phase 2 study. Fifty-one male patients with CRPC and rising PSA levels were enrolled to obtain the target enrollment of 38 patients who completed at least 3 months of treatment with continuous gefitinib 500 mg/d. The primary end point was the prostate-specific antigen (PSA) response rate, as defined by a confirmed 50% decline in serum PSA.RESULTS:
One patient had a confirmed PSA response, giving a response rate of 2.0% (95% CI 0.1-10.4%). The median time to progression was 28 days and the median time on study was 85 days. The majority of patients had a stable performance status while on study. Of the 51 patients who received at least 1 dose of gefitinib, 13 patients had a dose reduction and 9 patients withdrew because of an adverse event.CONCLUSIONS:
There was minimal evidence of single-agent gefitinib activity in CRPC. The treatment was associated with clinically relevant toxicities, which responded to dose interruption or reduction.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
6_ODS3_enfermedades_notrasmisibles
Problema de salud:
6_prostate_cancer
Asunto principal:
Neoplasias de la Próstata
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Quinazolinas
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Testosterona
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Biomarcadores de Tumor
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Antígeno Prostático Específico
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Receptores ErbB
Tipo de estudio:
Clinical_trials
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Etiology_studies
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Prognostic_studies
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Risk_factors_studies
Límite:
Aged
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Aged80
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Am J Clin Oncol
Año:
2009
Tipo del documento:
Article
País de afiliación:
Australia