Development and validation of a prediction index for hand-foot skin reaction in cancer patients receiving sorafenib.
Ann Oncol
; 23(8): 2103-2108, 2012 Aug.
Article
em En
| MEDLINE
| ID: mdl-22228446
ABSTRACT
BACKGROUND:
This study describes a repeated measures prediction index to identify patients at high risk of ≥grade 2 hand-foot skin reaction (HFSR) before each week of sorafenib therapy.METHODS:
Data from 451 patients who received a sorafenib (400 mg bid) as part of a clinical trial were reviewed (Escudier B, Eisen T, Stadler WM et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med 2007; 356 125-134). Generalized estimating equations were used to develop the final risk model. A risk-scoring algorithm (range 0-58) was then derived from the final model coefficients. External validation was then carried out on a new sample of 1145 patients who received sorafenib under an expanded access program.RESULTS:
Pretreatment white blood cell count, female gender, good performance status, presence of lung and liver metastases and number of affected organs were predictors for ≥grade 2 HFSR. A nonlinear association between HFSR risk and treatment duration was also identified where risk was maximized at week 5 followed by a gradual decline. Before each week of therapy, patients with risk scores>40 would be considered at high risk for developing ≥grade 2 HFSR.CONCLUSIONS:
The application and planned continued refinement of this prediction tool will be an important source of patient-specific risk information for the development of moderate to severe HFSR.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Piridinas
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Benzenossulfonatos
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Carcinoma de Células Renais
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Adenocarcinoma de Células Claras
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Síndrome Mão-Pé
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Neoplasias Renais
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Antineoplásicos
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
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Etiology_studies
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Prognostic_studies
/
Risk_factors_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:
Ann Oncol
Assunto da revista:
NEOPLASIAS
Ano de publicação:
2012
Tipo de documento:
Article