Please use this identifier to cite or link to this item:
Título : Granulocyte colony-stimulating factor in the treatment of high-risk febrile neutropenia: a multicenter randomized trial.
Autor : García-Carbonero, Rocío
Mayordomo, Jose Ignacio
Tornamira, María V
López-Brea, Marta
Rueda Domínguez, Antonio
Guillém, Vicente
Arcediano, Alberto
Yubero, Alfonso
Ribera, Fernando
Gómez, Carlos
Trés, Alejandro
Pérez-Gracia, José L
Lumbreras, Carlos
Hornedo, Javier
Cortés-Funes, Hernan
Paz-Ares, Luis
Filiación: [García-Carbonero,R; Tornamira,MV; Arcediano,A; Gómez,C; Pérez-Gracia,JL; Hornedo,J; Cortés-Funes,H; Paz-Ares,L] Division of Medical Oncology, Hospital Universitario Doce de Octubre, Madrid, Spain. [Mayordomo,JI; Yubero,A; Trés,A] Division of Medical Oncology, Hospital Clínico, Zaragoza, Spain. [López-Brea,M; Rivera,F] Division of Medical Oncology, Hospital M. Valdecilla, Santander, Spain. [Rueda Domínguez,A] Division of Medical Oncology, Hospital Universitario Virgen de la Victoria, Málaga, Spain. [Guillém,V] Division of Medical Oncology, Instituto Valenciano de Oncologia, Valencia, Spain. [Lumbreras,C] Division of Infectious Diseases, Hospital Universitario Doce de Octubre, Madrid, Spain.
Palabras clave : Antibacterianos
Protocolos de Quimioterapia Combinada Antineoplásica
Análisis Costo-Beneficio
Esquema de Medicación
Factor Estimulante de Colonias de Granulocitos
Tiempo de Internación
Modelos de Riesgos Proporcionales
Análisis de Supervivencia
Factores de Tiempo
Resultado del Tratamiento
MeSH: Medical Subject Headings::Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Anti-Bacterial Agents
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Clinical Protocols::Antineoplastic Protocols::Antineoplastic Combined Chemotherapy Protocols
Medical Subject Headings::Health Care::Health Care Economics and Organizations::Economics::Costs and Cost Analysis::Cost-Benefit Analysis
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Administration Schedule
Medical Subject Headings::Check Tags::Female
Medical Subject Headings::Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Body Temperature Changes::Fever
Medical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::Cytokines::Hematopoietic Cell Growth Factors::Colony-Stimulating Factors::Granulocyte Colony-Stimulating Factor
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Health Care::Health Care Facilities, Manpower, and Services::Health Services::Patient Care::Hospitalization::Length of Stay
Medical Subject Headings::Check Tags::Male
Medical Subject Headings::Named Groups::Persons::Age Groups::Adult::Middle Aged
Medical Subject Headings::Diseases::Neoplasms
Medical Subject Headings::Diseases::Hemic and Lymphatic Diseases::Hematologic Diseases::Leukocyte Disorders::Leukopenia::Agranulocytosis::Neutropenia
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Models, Statistical::Proportional Hazards Models
Medical Subject Headings::Geographicals::Geographic Locations::Europe::Spain
Medical Subject Headings::Health Care::Health Care Quality, Access, and Evaluation::Quality of Health Care::Health Care Evaluation Mechanisms::Statistics as Topic::Survival Analysis
Medical Subject Headings::Phenomena and Processes::Physical Phenomena::Time::Time Factors
Medical Subject Headings::Health Care::Health Services Administration::Quality of Health Care::Outcome and Process Assessment (Health Care)::Outcome Assessment (Health Care)::Treatment Outcome
Medical Subject Headings::Named Groups::Persons::Age Groups::Adult::Aged
Fecha de publicación : 3-Jan-2001
Editorial : Oxford University Press
Cita Bibliográfica: García-Carbonero R, Mayordomo JL, Tornamira MV, López-Brea M, Rueda Domínguez A, Guillém V, et al. Granulocyte colony-stimulating factor in the treatment of high-risk febrile neutropenia: a multicenter randomized trial. J. Natl. Cancer Inst.. 2001; 93(1):31-8
Abstract: BACKGROUND Granulocyte colony-stimulating factors (G-CSFs) have been shown to help prevent febrile neutropenia in certain subgroups of cancer patients undergoing chemotherapy, but their role in treating febrile neutropenia is controversial. The purpose of our study was to evaluate-in a prospective multicenter randomized clinical trial-the efficacy of adding G-CSF to broad-spectrum antibiotic treatment of patients with solid tumors and high-risk febrile neutropenia. METHODS A total of 210 patients with solid tumors treated with conventional-dose chemotherapy who presented with fever and grade IV neutropenia were considered to be eligible for the trial. They met at least one of the following high-risk criteria: profound neutropenia (absolute neutrophil count <100/mm(3)), short latency from previous chemotherapy cycle (<10 days), sepsis or clinically documented infection at presentation, severe comorbidity, performance status of 3-4 (Eastern Cooperative Oncology Group scale), or prior inpatient status. Eligible patients were randomly assigned to receive the antibiotics ceftazidime and amikacin, with or without G-CSF (5 microg/kg per day). The primary study end point was the duration of hospitalization. All P values were two-sided. RESULTS Patients randomly assigned to receive G-CSF had a significantly shorter duration of grade IV neutropenia (median, 2 days versus 3 days; P = 0.0004), antibiotic therapy (median, 5 days versus 6 days; P = 0.013), and hospital stay (median, 5 days versus 7 days; P = 0.015) than patients in the control arm. The incidence of serious medical complications not present at the initial clinical evaluation was 10% in the G-CSF group and 17% in the control group (P = 0.12), including five deaths in each study arm. The median cost of hospital stay and the median overall cost per patient admission were reduced by 17% (P = 0.01) and by 11% (P = 0.07), respectively, in the G-CSF arm compared with the control arm. CONCLUSIONS Adding G-CSF to antibiotic therapy shortens the duration of neutropenia, reduces the duration of antibiotic therapy and hospitalization, and decreases hospital costs in patients with high-risk febrile neutropenia.
Descripción : Presented in part at the 35th American Society of Clinical Oncology meeting. Atlanta (GA); 1999. Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't;
Versión del editor :
DOI: 10.1093/jnci/93.1.31
ISSN : 1460-2105 (Online)
0027-8874 (Print)
Appears in Collections:01- Artículos - Hospital Virgen de la Victoria

Files in This Item:
File Description SizeFormat 
Garcia_Granulocyte.pdfArtículo publicado146,92 kBAdobe PDFView/Open

This item is licensed under a Creative Commons License Creative Commons