Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
6
pubmed:dateCreated
1996-11-5
pubmed:abstractText
To verify whether the association of granulocyte-macrophage colony-stimulating factor (GM-CSF) and erythropoietin (EPO) would allow both the acceleration and the dose escalation of the cyclophosphamide/epidoxorubicin/5-fluorouracil (CEF) regimen as first-line therapy in advanced breast cancer patients, we conducted a dose-finding study. Cohorts of three consecutive patients received cyclophosphamide (Ctx, dose range 800-1400 mg/m2), epidoxorubicin (Epidx, dose range 70-100 mg/m2), and 5-fluorouracil (5-Fu, 600 mg/m2, fixed dose) given as an intravenous bolus on day 1 every 14 days; GM-CSF at 5 micrograms/kg given as a subcutaneous injection from day 4 to day 11; and EPO at 150 IU/kg given as a subcutaneous injection three times a week. In no single patient was any dose escalation allowed. A total of 14 patients entered the study. At the 4th dose level (Ctx 1400 mg/m2, Epidx 100 mg/m2, 5-Fu 600 mg/m2), two patients had dose-limiting mucositis and one patient developed dose-limiting neutropenia. Therefore, the 3rd cohort received the maximum tolerated dose, i.e. Ctx at 1200 mg/m2, Epidx at 90 mg/m2, and 5-Fu at 600 mg/m2, given every 18.5 (+/-2.5) days. Toxicity was moderate and manageable in an outpatient setting. Only 1 admission at the 4th dose level was required. Throughout the 4 dose levels there was no toxicity-related death; grade IV leukopenia ranged from 24% to 75% of cycles and grade IV thrombocytopenia ranged from 6% to 8%. No grade IV anemia was recorded. Increasing the doses of Ctx and Epidx while maintaining a fixed dose of 5-Fu with the support of both EPO and GM-CSF allows safe acceleration and dose escalation of CEF chemotherapy. Further controlled studies will evaluate the activity and efficacy of this strategy.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0344-5704
pubmed:author
pubmed:issnType
Print
pubmed:volume
38
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
487-94
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:8823488-Adult, pubmed-meshheading:8823488-Aged, pubmed-meshheading:8823488-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:8823488-Bone Marrow, pubmed-meshheading:8823488-Breast Neoplasms, pubmed-meshheading:8823488-Cohort Studies, pubmed-meshheading:8823488-Cyclophosphamide, pubmed-meshheading:8823488-Dose-Response Relationship, Drug, pubmed-meshheading:8823488-Doxorubicin, pubmed-meshheading:8823488-Epirubicin, pubmed-meshheading:8823488-Erythropoietin, pubmed-meshheading:8823488-Female, pubmed-meshheading:8823488-Fluorouracil, pubmed-meshheading:8823488-Granulocyte-Macrophage Colony-Stimulating Factor, pubmed-meshheading:8823488-Humans, pubmed-meshheading:8823488-Middle Aged, pubmed-meshheading:8823488-Outpatients, pubmed-meshheading:8823488-Pilot Projects, pubmed-meshheading:8823488-Treatment Outcome
pubmed:year
1996
pubmed:articleTitle
Erythropoietin and granulocyte-macrophage colony-stimulating factor allow acceleration and dose escalation of cyclophosphamide/epidoxorubicin/5-fluorouracil chemotherapy: a dose-finding study in patients with advanced breast cancer.
pubmed:affiliation
Oncologia Medica 1, Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.
pubmed:publicationType
Journal Article, Research Support, Non-U.S. Gov't