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Quantitative Relationship Between AUEC of Absolute Neutrophil Count and Duration of Severe Neutropenia for G-CSF in Breast Cancer Patients.
Li, Liang; Ma, Lian; Schrieber, Sarah J; Rahman, Nam Atiqur; Deisseroth, Albert; Farrell, Ann T; Wang, Yaning; Sinha, Vikram; Marathe, Anshu.
Afiliación
  • Li L; Division of Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Ma L; Division of Clinical Pharmacology V, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Schrieber SJ; Division of Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Rahman NA; Division of Clinical Pharmacology V, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Deisseroth A; Division of Clinical Pharmacology V, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Farrell AT; Division of Hematology Products, Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Wang Y; Division of Hematology Products, Office of Hematology and Oncology Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Sinha V; Division of Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
  • Marathe A; Division of Pharmacometrics, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.
Clin Pharmacol Ther ; 104(4): 742-748, 2018 10.
Article en En | MEDLINE | ID: mdl-29392707
The aim of the study was to evaluate the quantitative relationship between duration of severe neutropenia (DSN, the efficacy endpoint) and area under effect curve of absolute neutrophil counts (ANC-AUEC, the pharmacodynamic endpoint), based on data from filgrastim products, a human granulocyte colony-stimulating factor (G-CSF). Clinical data from filgrastim product comparator and test arms of two randomized, parallel-group, phase III studies in breast cancer patients treated with myelosuppressive chemotherapy were utilized. A zero-inflated Poisson regression model best described the negative correlation between DSN and ANC-AUEC. The models predicted that with 10 × 109 day/L of increase in ANC-AUEC, the mean DSN would decrease from 1.1 days to 0.93 day in Trial 1 and from 1.2 days to 1.0 day in Trial 2. The findings of the analysis provide useful information regarding the relationship between ANC and DSN that can be used for dose selection and optimization of clinical trial design for G-CSF.
Asunto(s)

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Filgrastim / Fármacos Hematológicos / Neutropenia / Neutrófilos / Antineoplásicos Tipo de estudio: Clinical_trials / Diagnostic_studies / Prognostic_studies Límite: Adult / Female / Humans / Middle aged Idioma: En Revista: Clin Pharmacol Ther Año: 2018 Tipo del documento: Article País de afiliación: Estados Unidos

Texto completo: 1 Bases de datos: MEDLINE Asunto principal: Neoplasias de la Mama / Filgrastim / Fármacos Hematológicos / Neutropenia / Neutrófilos / Antineoplásicos Tipo de estudio: Clinical_trials / Diagnostic_studies / Prognostic_studies Límite: Adult / Female / Humans / Middle aged Idioma: En Revista: Clin Pharmacol Ther Año: 2018 Tipo del documento: Article País de afiliación: Estados Unidos