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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
2
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pubmed:dateCreated |
1996-9-27
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pubmed:abstractText |
The efficacy of interferon-alpha 2b (IFN alpha) to prolong progression-free (PFS) and/or overall survival (OS) in early B-CLL (Binet stage A) was examined in a risk-adapted phase III study. 99 previously untreated B-CLL patients were recruited. 44 patients with expected high risk for disease progression, defined by non-nodular bone marrow infiltration and lymphocyte doubling time < or = 12 months or serum thymidine kinase levels > or = 5 U/I, were randomized to either receive IFN alpha (group 1, n = 21) or not (group 2, n = 23). 55 low-risk patients were observed to evaluate this risk stratification (group 3). During a median observation time of 36 months, four patients in the IFN alpha group achieved a partial remission (PR), no patient had stable disease (SD), and 17 patients experienced progressive disease (PD). The four responders had less extensive disease at study entry and tended to exhibit a rise in serum IgG levels. In group 2, no PR, seven SD and 16 PD, whereas in group 3, no PR, 37 SD and 18 PD occurred. PFS in group 1 (6.7 months) was not different from group 2 (13.3 months, P = 0.22), but PFS of groups 1 and 2 differed from group 3 (37 months, P < or = 0.001). OS was 44.9 months (group 1), 43.1 months (group 2) and 57.9 months (group 3). OS was not significantly different for group 1 v 2, but was significant between groups 1 and 3 (P = 0.023). The higher percentage of PD in group 2 compared to group 3 (70% v 29%) shows that the selected risk factors allow the definition of CLL stage A patients at risk for disease progression within about a year. In conclusion, our data indicate that IFN alpha does not prolong PFS or OS in stage A CLL patients with high risk for disease progression.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Immunoglobulin A,
http://linkedlifedata.com/resource/pubmed/chemical/Immunoglobulin G,
http://linkedlifedata.com/resource/pubmed/chemical/Immunoglobulin M,
http://linkedlifedata.com/resource/pubmed/chemical/Interferon-alpha,
http://linkedlifedata.com/resource/pubmed/chemical/Recombinant Proteins,
http://linkedlifedata.com/resource/pubmed/chemical/interferon alfa-2b
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pubmed:status |
MEDLINE
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pubmed:month |
Aug
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pubmed:issn |
0007-1048
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
94
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
362-9
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pubmed:dateRevised |
2011-11-17
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pubmed:meshHeading |
pubmed-meshheading:8759897-Aged,
pubmed-meshheading:8759897-Disease Progression,
pubmed-meshheading:8759897-Disease-Free Survival,
pubmed-meshheading:8759897-Female,
pubmed-meshheading:8759897-Follow-Up Studies,
pubmed-meshheading:8759897-Forecasting,
pubmed-meshheading:8759897-Humans,
pubmed-meshheading:8759897-Immunoglobulin A,
pubmed-meshheading:8759897-Immunoglobulin G,
pubmed-meshheading:8759897-Immunoglobulin M,
pubmed-meshheading:8759897-Interferon-alpha,
pubmed-meshheading:8759897-Leukemia, Lymphocytic, Chronic, B-Cell,
pubmed-meshheading:8759897-Male,
pubmed-meshheading:8759897-Middle Aged,
pubmed-meshheading:8759897-Recombinant Proteins,
pubmed-meshheading:8759897-Risk Factors
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pubmed:year |
1996
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pubmed:articleTitle |
Interferon-alpha 2b (IFN alpha) for early-phase chronic lymphocytic leukaemia with high risk for disease progression: results of a randomized multicentre study.
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pubmed:affiliation |
Abteilung für Hämatologie und Onkologie, Klinikum Innenstad, Ludwig-Maximilians-Universität München, Germany.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Randomized Controlled Trial,
Multicenter Study
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