Source:http://linkedlifedata.com/resource/pubmed/id/15486066
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| Predicate | Object |
|---|---|
| rdf:type | |
| lifeskim:mentions | |
| pubmed:issue |
3
|
| pubmed:dateCreated |
2005-1-20
|
| pubmed:abstractText |
In the Non-Hodgkin Lymphoma-Berlin-Frankfurt-Münster 95 (NHL-BFM95) study, we tested by randomization whether for patients with B-cell neoplasms methotrexate as intravenous infusion over 4 hours (MTX-4h) is not inferior to, but less toxic than, a 24-hour intravenous infusion (MTX-24h). Second, we investigated against the historical control of study NHL-BFM90, whether for patients with moderate tumor mass MTX can be reduced from 5 g/m(2) to 1 g/m(2). Patients received 2 5-day therapy courses in risk group R1 (resected), 4 in R2 (lactate dehydrogenase [LDH] < 500 U/L), 5 in R3 (LDH > 500 to < 1000 U/L) and 6 in R4 (LDH > 1000 U/L and/or central nervous system [CNS] disease). Courses contained MTX 1 g/m(2) in R1 + R2 and 5 g/m(2) in R3 + R4. Of 505 patients (April 1996 to March 2001), 364 were randomized to receive MTX-4h or MTX-24h. Failure-free survival (pFFS, 1 year) for arm MTX-4h versus MTX-24h, respectively, was 95% +/- 5% (n = 20) versus 100% (n = 19) in R1, 94% +/- 2% (n = 88) versus 96% +/- 2% (n = 95) in R2, and 77% +/- 5% (n = 62) versus 93% +/- 3% (n = 69) in R3 +/- R4 (per-protocol analysis). Incidence of mucositis grade III/IV was significantly lower with MTX-4h in all risk groups. For patients in R2, event-free survival (pEFS) was 95% +/- 2% (n = 222) in NHL-BFM95 (MTX 1 g/m(2)) and 97% +/- 1% (n = 154) in NHL-BFM90 (MTX 5 g/m(2)). In conclusion, MTX-4h was less toxic than MTX-24h. MTX-4h was noninferior to MTX-24h for limited stage B-cell non-Hodgkin lymphoma (B-NHL) but not for advanced disease. For limited disease, MTX 1 g/m(2) is noninferior to 5 g/m(2).
|
| pubmed:language |
eng
|
| pubmed:journal | |
| pubmed:citationSubset |
AIM
|
| pubmed:chemical | |
| pubmed:status |
MEDLINE
|
| pubmed:month |
Feb
|
| pubmed:issn |
0006-4971
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| pubmed:author |
pubmed-author:BFM Group,
pubmed-author:BurkhardtBirgitB,
pubmed-author:GadnerHelmutH,
pubmed-author:GrafNorbertN,
pubmed-author:GruhnBerndB,
pubmed-author:JuergensHeribertH,
pubmed-author:KlingebielThomasT,
pubmed-author:LudwigWolf-DieterWD,
pubmed-author:MannGeorgG,
pubmed-author:NiggliFelixF,
pubmed-author:OschliesIlskeI,
pubmed-author:ParwareschRezaR,
pubmed-author:ReiterAlfredA,
pubmed-author:RiehmHansjoergH,
pubmed-author:SchrappeMartinM,
pubmed-author:SeidemannKathrinK,
pubmed-author:WoessmannWilhelmW,
pubmed-author:ZimmermannMartinM
|
| pubmed:issnType |
Print
|
| pubmed:day |
1
|
| pubmed:volume |
105
|
| pubmed:owner |
NLM
|
| pubmed:authorsComplete |
Y
|
| pubmed:pagination |
948-58
|
| pubmed:dateRevised |
2006-11-15
|
| pubmed:meshHeading |
pubmed-meshheading:15486066-Adolescent,
pubmed-meshheading:15486066-Adult,
pubmed-meshheading:15486066-Antineoplastic Combined Chemotherapy Protocols,
pubmed-meshheading:15486066-Child,
pubmed-meshheading:15486066-Child, Preschool,
pubmed-meshheading:15486066-Disease-Free Survival,
pubmed-meshheading:15486066-Drug Administration Schedule,
pubmed-meshheading:15486066-Female,
pubmed-meshheading:15486066-Follow-Up Studies,
pubmed-meshheading:15486066-Humans,
pubmed-meshheading:15486066-Infant,
pubmed-meshheading:15486066-Lymphoma, B-Cell,
pubmed-meshheading:15486066-Male,
pubmed-meshheading:15486066-Methotrexate,
pubmed-meshheading:15486066-Survival Analysis,
pubmed-meshheading:15486066-Time Factors
|
| pubmed:year |
2005
|
| pubmed:articleTitle |
The impact of the methotrexate administration schedule and dose in the treatment of children and adolescents with B-cell neoplasms: a report of the BFM Group Study NHL-BFM95.
|
| pubmed:affiliation |
Department of Pediatric Hematology and Oncology, Justus-Liebig-University, D-35385 Giessen, Germany.
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| pubmed:publicationType |
Journal Article,
Clinical Trial,
Randomized Controlled Trial,
Research Support, Non-U.S. Gov't
|