Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
9
pubmed:dateCreated
2001-2-9
pubmed:abstractText
This phase I study was designed to determine the optimal dosages of a novel repetitive high-dose therapy regimen for patients with metastatic breast cancer (MBC). The planned treatment was three cycles of high-dose cyclophosphamide, thiotepa and docetaxel delivered every 35 days with progressive dose-escalation in successive cohorts. Each cycle was supported by peripheral blood progenitor cells (PBPC) and filgrastim. Eighteen patients were entered into this trial. Of the planned 54 treatment cycles, 44 were delivered and 11 patients completed all three cycles. The dose-limiting toxicities were interstitial pneumonitis and mucositis with moderately severe diarrhea (n = 3) and rash (n = 3). There were no treatment-related deaths. Of the 17 patients with evaluable disease, 16 patients responded with six patients achieving a complete remission and an additional four patients achieving no detectable disease (negative restaging including PET scan) but a persistently abnormal bone scan. At a median follow-up of 12 months, median progression-free survival was 11 months with the median overall survival not reached. The recommended doses for phase II/III studies are cyclophosphamide (4 g/m2), thiotepa (300 mg/m2) and docetaxel (100 mg/m2).
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Nov
pubmed:issn
0268-3369
pubmed:author
pubmed:issnType
Print
pubmed:volume
26
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
955-61
pubmed:dateRevised
2011-11-17
pubmed:meshHeading
pubmed-meshheading:11100274-Adult, pubmed-meshheading:11100274-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:11100274-Breast Neoplasms, pubmed-meshheading:11100274-Cyclophosphamide, pubmed-meshheading:11100274-Diarrhea, pubmed-meshheading:11100274-Disease Progression, pubmed-meshheading:11100274-Female, pubmed-meshheading:11100274-Granulocyte Colony-Stimulating Factor, pubmed-meshheading:11100274-Hematopoietic Stem Cell Transplantation, pubmed-meshheading:11100274-Humans, pubmed-meshheading:11100274-Lung Diseases, Interstitial, pubmed-meshheading:11100274-Middle Aged, pubmed-meshheading:11100274-Neoplasm Metastasis, pubmed-meshheading:11100274-Neutropenia, pubmed-meshheading:11100274-Paclitaxel, pubmed-meshheading:11100274-Recombinant Proteins, pubmed-meshheading:11100274-Remission Induction, pubmed-meshheading:11100274-Stomatitis, pubmed-meshheading:11100274-Survival Analysis, pubmed-meshheading:11100274-Taxoids, pubmed-meshheading:11100274-Thiotepa, pubmed-meshheading:11100274-Thrombocytopenia, pubmed-meshheading:11100274-Transplantation Conditioning
pubmed:year
2000
pubmed:articleTitle
Repetitive high-dose therapy with cyclophosphamide, thiotepa and docetaxel with peripheral blood progenitor cell and filgrastim support for metastatic and locally advanced breast cancer: results of a phase I study.
pubmed:affiliation
Blood and Marrow Transplant Service, Peter MacCallum Cancer Institute, Victoria, Australia.
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, Non-U.S. Gov't, Clinical Trial, Phase I