Linked Life Data

12425755

Source:http://linkedlifedata.com/resource/pubmed/id/12425755

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
4
pubmed:dateCreated
2002-11-11
pubmed:abstractText
This randomized, double-blind, phase III trial compared granulocyte colony-stimulating factor (G-CSF; filgrastim) and leridistim (formerly myelopoietin), a chimeric dual agonist that binds both G-CSF and interleukin-3 receptors, for the prevention of neutropenic complications in patients with breast cancer receiving TAC (docetaxel/doxorubicin/cyclophosphamide) chemotherapy. Patients with metastatic (44%) or localized breast cancer (56%) were randomized to G-CSF 5 microg/kg subcutaneously (s.c.) daily (n = 135), leridistim 5 microg/kg s.c. daily (n = 139), or leridistim 10 microg/kg s.c. every other day alternating with placebo (n = 139). Following administration of TAC (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2) on day 1, patients received growth factor beginning on day 2 until the postnadir absolute neutrophil count exceeded 1500 cells/ microL. Chemotherapy cycles were repeated every 21 days. The incidence of febrile neutropenia was 7% in the G-CSF arm, 19% in the daily leridistim arm (P = 0.003 for comparison with G-CSF) and 22% in the alternate-day leridistim arm (P < 0.001 for comparison with G-CSF). There was no significant difference between treatment arms in the cumulative percentage of patients experiencing grade 4 neutropenia at some point during therapy (85%-88%). However, grade 4 neutropenia occurred in 53% of cycles in the G-CSF cohort, 61% of cycles in the daily leridistim group (P = 0.063 for comparison with G-CSF), and 63% of cycles in the alternate-day leridistim group (P = 0.015 for comparison with G-CSF). We conclude that G-CSF is superior to leridistim in the prevention of febrile neutropenia in patients with advanced breast cancer receiving TAC chemotherapy. The up-front prophylactic use of G-CSF is a reasonable supportive therapy for patients treated with docetaxel/anthracycline-based combination chemotherapy.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Oct
pubmed:issn
1526-8209
pubmed:author
pubmed:issnType
Print
pubmed:volume
3
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
268-75
pubmed:dateRevised
2011-11-17
pubmed:meshHeading
pubmed-meshheading:12425755-Adult, pubmed-meshheading:12425755-Aged, pubmed-meshheading:12425755-Aged, 80 and over, pubmed-meshheading:12425755-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:12425755-Breast Neoplasms, pubmed-meshheading:12425755-Cyclophosphamide, pubmed-meshheading:12425755-Double-Blind Method, pubmed-meshheading:12425755-Doxorubicin, pubmed-meshheading:12425755-Female, pubmed-meshheading:12425755-Granulocyte Colony-Stimulating Factor, pubmed-meshheading:12425755-Humans, pubmed-meshheading:12425755-Interleukin-3, pubmed-meshheading:12425755-Middle Aged, pubmed-meshheading:12425755-Neoplasm Staging, pubmed-meshheading:12425755-Neutropenia, pubmed-meshheading:12425755-Paclitaxel, pubmed-meshheading:12425755-Recombinant Fusion Proteins, pubmed-meshheading:12425755-Recombinant Proteins, pubmed-meshheading:12425755-Taxoids, pubmed-meshheading:12425755-Treatment Outcome
pubmed:year
2002
pubmed:articleTitle
Phase III trial comparing granulocyte colony-stimulating factor to leridistim in the prevention of neutropenic complications in breast cancer patients treated with docetaxel/doxorubicin/cyclophosphamide: results of the BCIRG 004 trial.
pubmed:affiliation
Cancer Therapy Development Program and Jonsson Comprehensive Cancer Center, University of California-Los Angeles, Peter Ueberroth Building 3360B, 10945 LeConte Avenue, Los Angeles, CA 90095-7077, USA. jean-marc.nabholtz@bcirg.com
pubmed:publicationType
Journal Article, Clinical Trial, Comparative Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Clinical Trial, Phase III