Linked Life Data

10552939

Source:http://linkedlifedata.com/resource/pubmed/id/10552939

Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
10
pubmed:dateCreated
1999-11-30
pubmed:abstractText
We showed in a phase I trial that the maximum tolerated dose of the ProMACE-CytaBOM regimen in patients with aggressive lymphoma was 200% (Gordon et al, J Clin Oncol 14:1275, 1996). Based on these observations, we initiated a phase II trial designed to determine response, toxicity, and dose intensity using this regimen. We analyzed 74 patients with advanced-stage (III or IV) or bulky stage II aggressive lymphoma. The overall complete response rate was 69% (72% in evaluable patients). With a median follow-up of 4.5 years, the median survival has not yet been reached. The 4-year survival rate is 73% (95% confidence interval [CI] 62, 83%) and no difference was observed among International Prognostic Index (IPI) groups. The 4-year disease-free survival was 71% (95% CI 58, 84%) with no statistical difference between patients with IPI 0 to 1 versus 2 to 4. The toxicity was acceptable, though the grade 4 hematologic toxicity rate for this regimen was 100%. Grade 4 nonhematologic toxicity was 36%. Three cases of either myelodysplastic syndrome or acute leukemia occurred at 7 months, 3.4 years, and 4.2 years after registration. Cytogenic analysis was available in two cases, showing inv(16) without French American British classification (FAB) M4 EO histology in one patient and a 5q-syndrome in the other. These data suggest that 200% ProMACE-CytaBOM with either granulocyte-macrophage colony-stimulating factor (GM-CSF) or G-CSF results in a high complete remission rate and a disease-free survival comparable to any prior risk-based analysis in aggressive lymphoma. Before using this regimen in general practice, phase III clinical trials should be conducted.
pubmed:grant
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
AIM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Nov
pubmed:issn
0006-4971
pubmed:author
pubmed:issnType
Print
pubmed:day
15
pubmed:volume
94
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
3307-14
pubmed:dateRevised
2007-11-14
pubmed:meshHeading
pubmed-meshheading:10552939-Adult, pubmed-meshheading:10552939-Aged, pubmed-meshheading:10552939-Antineoplastic Combined Chemotherapy Protocols, pubmed-meshheading:10552939-Bleomycin, pubmed-meshheading:10552939-Cohort Studies, pubmed-meshheading:10552939-Cyclophosphamide, pubmed-meshheading:10552939-Cytarabine, pubmed-meshheading:10552939-Disease-Free Survival, pubmed-meshheading:10552939-Doxorubicin, pubmed-meshheading:10552939-Etoposide, pubmed-meshheading:10552939-Female, pubmed-meshheading:10552939-Humans, pubmed-meshheading:10552939-Lymphoma, Non-Hodgkin, pubmed-meshheading:10552939-Male, pubmed-meshheading:10552939-Methotrexate, pubmed-meshheading:10552939-Middle Aged, pubmed-meshheading:10552939-Prednisone, pubmed-meshheading:10552939-Treatment Failure, pubmed-meshheading:10552939-Treatment Outcome, pubmed-meshheading:10552939-Vincristine
pubmed:year
1999
pubmed:articleTitle
A phase II trial of 200% ProMACE-CytaBOM in patients with previously untreated aggressive lymphomas: analysis of response, toxicity, and dose intensity.
pubmed:affiliation
Northwestern University Medical School, Chicago, IL 60611-3008, USA.
pubmed:publicationType
Journal Article, Clinical Trial, Research Support, U.S. Gov't, P.H.S., Clinical Trial, Phase II