Linked Life Data

9129014

Source:http://linkedlifedata.com/resource/pubmed/id/9129014

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
9
pubmed:dateCreated
1997-6-3
pubmed:abstractText
Thrombocytopenia caused by chemotherapy is an important cause of morbidity and mortality in the treatment of malignant disease. Recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF) is a potent stimulator of megakaryocytopoiesis and prevents chemotherapy-induced thrombocytopenia in preclinical studies. We administered PEG-rHuMGDF with filgrastim after dose-intensive chemotherapy to 41 patients with advanced cancers to determine its safety and effects on hematologic recovery. Carboplatin 600 mg/m2 and cyclophosphamide 1,200 mg/m2 were administered to patients with advanced cancer. Patients were randomly assigned to receive blinded study drug, either PEG-rHuMGDF or placebo (3-to-1 ratio), commencing the day after chemotherapy. PEG-rHuMGDF was given at doses of 0.03, 0.1, 0.3, 1.0, 3.0, and 5.0 microg per kilogram body weight by daily subcutaneous injection for between 7 and 20 days. All patients received concurrent filgrastim 5 microg per kilogram body weight per day until neutrophil recovery. Fifteen patients had received PEG-rHuMGDF alone in a previous phase I study. Platelet function and peripheral blood progenitor cells (PBPC) were assessed. PEG-rHuMGDF enhanced platelet recovery in a dose-related manner when compared with placebo. The platelet nadir occurred earlier in patients given PEG-rHuMGDF (P = .002) but there was no difference in the depth of the nadir. Recovery to baseline platelet count was achieved significantly earlier following PEG-rHuMGDF administration compared with placebo (median, 17 days for PEG-rHuMGDF 0.3 to 5.0 microg/kg versus 22 days for placebo, P = .014). In addition, platelet recovery was faster in patients who had previously received PEG-rHuMGDF, suggesting that pretreatment might be beneficial. Platelet function did not change during or after administration of PEG-rHuMGDF. Levels of PBPC on day 15 after chemotherapy were significantly greater in patients administered PEG-rHuMGDF 0.3 to 5.0 microg/kg and filgrastim compared with those given placebo plus filgrastim. PEG-rHuMGDF was well tolerated at all doses. Two patients given PEG-rHuMGDF had a thrombotic episode. PEG-rHuMGDF accelerates platelet recovery after moderately dose-intensive carboplatin and cyclophosphamide, and is likely to be clinically useful in treatment of chemotherapy-induced thrombocytopenia. Because it enhances mobilization of PBPC by filgrastim, PEG-rHuMGDF might also allow more efficient collection of stem cells for autologous or allogeneic transplantation.
pubmed:commentsCorrections
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
AIM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
May
pubmed:issn
0006-4971
pubmed:author
pubmed:issnType
Print
pubmed:day
1
pubmed:volume
89
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
3118-28
pubmed:dateRevised
2011-11-17
pubmed:meshHeading
pubmed-meshheading:9129014-Adult, pubmed-meshheading:9129014-Aged, pubmed-meshheading:9129014-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:9129014-Blood Platelets, pubmed-meshheading:9129014-Carboplatin, pubmed-meshheading:9129014-Cyclophosphamide, pubmed-meshheading:9129014-Double-Blind Method, pubmed-meshheading:9129014-Drug Administration Schedule, pubmed-meshheading:9129014-Drug Therapy, Combination, pubmed-meshheading:9129014-Female, pubmed-meshheading:9129014-Granulocyte Colony-Stimulating Factor, pubmed-meshheading:9129014-Humans, pubmed-meshheading:9129014-Injections, Subcutaneous, pubmed-meshheading:9129014-Male, pubmed-meshheading:9129014-Middle Aged, pubmed-meshheading:9129014-Neoplasms, pubmed-meshheading:9129014-Placebos, pubmed-meshheading:9129014-Platelet Aggregation, pubmed-meshheading:9129014-Platelet Count, pubmed-meshheading:9129014-Polyethylene Glycols, pubmed-meshheading:9129014-Recombinant Proteins, pubmed-meshheading:9129014-Thrombopoietin
pubmed:year
1997
pubmed:articleTitle
Randomized, blinded, placebo-controlled phase I trial of pegylated recombinant human megakaryocyte growth and development factor with filgrastim after dose-intensive chemotherapy in patients with advanced cancer.
pubmed:affiliation
Centre for Developmental Cancer Therapeutics, Parkville, Victoria, Australia.
pubmed:publicationType
Journal Article, Clinical Trial, Randomized Controlled Trial, Research Support, Non-U.S. Gov't, Multicenter Study, Clinical Trial, Phase I