Surveillance of the eye and vision in clinical trials of CP-675,206 for metastatic melanoma.
Am J Ophthalmol
; 143(6): 958-969, 2007 Jun.
Article
em En
| MEDLINE
| ID: mdl-17434437
ABSTRACT
PURPOSE:
To determine the ocular safety of CP-675,206 (Pfizer, New York, New York, USA), a fully human anti-cytotoxic T lymphocyte-associated antigen 4 monoclonal antibody in clinical trials of immunotherapy of metastatic melanoma.DESIGN:
Prospective, nonrandomized study of the eye and vision in phase I/II clinical trials of CP-675,206 in metastatic melanoma conducted at the University of California, Los Angeles.METHODS:
Patients with regional or distant metastatic melanoma were enrolled in phase I/II clinical trials evaluating the safety and antitumor efficacy of CP-675,206 alone or in combination with melanoma antigen peptide-pulsed dendritic cell vaccines. Ophthalmic evaluation was performed at the onset of CP-675,206 immunotherapy (baseline evaluation), two months or more after the onset of CP-675,206 immunotherapy (end-study evaluation), and at two- to three-month intervals thereafter in patients who continued to receive CP-675,206 immunotherapy (poststudy evaluation). Baseline and end-study evaluations included comprehensive ophthalmic examination, psychophysical and electrophysiologic visual function assessment, fundus photography, fluorescein angiography, and visual function assessment.RESULTS:
Twenty patients with metastatic melanoma arising from the skin, mucosa, eye, or unknown site were evaluated. Systemic toxicity attributed to CP-675,206 included dermatologic manifestations, diarrhea, and autoimmune hepatitis with panhypopituitarism. A subset of patients receiving CP-675,206 demonstrated antitumor efficacy with partial response or complete response of metastatic melanoma. Comparison of ophthalmic baseline with end-study evaluations in all 20 patients and limited-term poststudy evaluations showed no adverse effect of CP-675,206 immunotherapy on the eye or vision.CONCLUSIONS:
In this study, CP-675,206 immunotherapy for metastatic melanoma did not adversely affect the eye or vision.
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Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Visão Ocular
/
Imunoconjugados
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Anticorpos Bloqueadores
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Imunoterapia
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Melanoma
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Anticorpos Monoclonais
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Neoplasias
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Fenômenos Fisiológicos Oculares
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Risk_factors_studies
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Screening_studies
Limite:
Adult
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Aged
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Aged80
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Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Am J Ophthalmol
Ano de publicação:
2007
Tipo de documento:
Article
País de afiliação:
Estados Unidos