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Effect of Leukokine in Patients with Acute Leukemia Receiving Induction Chemotherapy / 대한소아혈액종양학회지
Korean Journal of Pediatric Hematology-Oncology ; : 206-213, 2003.
Artículo en Coreano | WPRIM | ID: wpr-190118
ABSTRACT

PURPOSE:

Neutropenia is common in patients receiving myelotoxic chemotherapy. The aim of this study is to compare the efficacy, safety and adverse events between prophylactically administered Leukokine and Grasin.

METHODS:

An open-label, randomized, phase III study was designed to compare the effects of a subcutaneous injection of Leukokine (CJ Corp.) 100mug/m2 with Grasin (Jeil Pharm. Inc.) in patients receiving induction chemotherapy for acute leukemia. All patients received one dose of G-CSF every day during the study period. Total period of G-CSF injection was not over 14 days. The administration of G-CSF began on day 14 after beginning of chemotherapy under CCG strategy. In other chemotherapies, the injection of G-CSF started on day 1 from end of chemotherapy. Injection of G-CSF stopped after absolute neutrophil count recovery was achieved.

RESULTS:

The median numbers of times of administration were 9.6 (2~14) /cycle for Leukokine and 8.8 (2~14) /cycle for Grasin. The time to needed for neutrophil recovery more than 1, 000/mm3 was 6.6 4.9 day and 4.7 4.8 day of the Leukokine and Grasin, respectively (P=0.14). The mean duration of neutropenia less than 500/mm3 was 7.6 5.6 days for Leukokine and 6.1 6.0 days for Grasin (P=0.28). The results for the two groups were also not significantly different in adverse events, physical examination and laboratory findings.

CONCLUSION:

Leukokine was safe and well tolerated in these patients population. Injection of Leukokine provided neutrophil recovery with safety and efficacy similar to that provided by Grasin.
Asunto(s)

Texto completo: Disponible Índice: WPRIM (Pacífico Occidental) Asunto principal: Examen Físico / Leucemia / Factor Estimulante de Colonias de Granulocitos / Quimioterapia / Quimioterapia de Inducción / Inyecciones Subcutáneas / Neutropenia / Neutrófilos Tipo de estudio: Ensayo Clínico Controlado Límite: Humanos Idioma: Coreano Revista: Korean Journal of Pediatric Hematology-Oncology Año: 2003 Tipo del documento: Artículo

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Texto completo: Disponible Índice: WPRIM (Pacífico Occidental) Asunto principal: Examen Físico / Leucemia / Factor Estimulante de Colonias de Granulocitos / Quimioterapia / Quimioterapia de Inducción / Inyecciones Subcutáneas / Neutropenia / Neutrófilos Tipo de estudio: Ensayo Clínico Controlado Límite: Humanos Idioma: Coreano Revista: Korean Journal of Pediatric Hematology-Oncology Año: 2003 Tipo del documento: Artículo