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Statements

Subject Item
n2:RIV%2F00064203%3A_____%2F11%3A7275%21RIV12-MZ0-00064203
rdf:type
skos:Concept n18:Vysledek
rdfs:seeAlso
http://www.ncbi.nlm.nih.gov/pubmed/21480469
dcterms:description
Background. The impact of preventive central nervous system irradiation (CNS-RT) in childhood acute myeloid leukemia (AML) is still discussed. As results of study AML-BFM87 revealed an increased risk for relapse when CNS-RT was not performed, studies AML-BFM98 and -2004 randomized CNS-RT of 18 or 12 Gy in order to evaluate the efficacy of the lower dose and to reduce late effects. Procedures. To achieve a power of 80% for non-inferiority (range 11%) 240 patients per group were required. Out of 722 eligible patients, 486 patients < 18 years were randomized to receive 12 Gy (n = 249) or 18 Gy (n = 237). Since this was a non-inferiority study, the analysis was performed for treated (12 Gy: n = 252 and 18 Gy: n = 219). Results. Five-year survival, event-free survival and cumulative incidence of relapse were similar in patients who received 12 or 18 Gy, respectively (82 +/- 3% vs. 79 +/- 3%, 68 +/- 3% vs. 63 +/- 3%, and 30 +/- 3% vs. 34 +/- 3%). The lower limit of the one-sided confidence interval for the 5% difference in 5-years pEFS was 2%. There were six relapses with CNS involvement (one in the 12 Gy, and five in the 18 Gy group). Conclusion. Results demonstrate no disadvantage for patients irradiated with a reduced CNS dose of 12 Gy. Background. The impact of preventive central nervous system irradiation (CNS-RT) in childhood acute myeloid leukemia (AML) is still discussed. As results of study AML-BFM87 revealed an increased risk for relapse when CNS-RT was not performed, studies AML-BFM98 and -2004 randomized CNS-RT of 18 or 12 Gy in order to evaluate the efficacy of the lower dose and to reduce late effects. Procedures. To achieve a power of 80% for non-inferiority (range 11%) 240 patients per group were required. Out of 722 eligible patients, 486 patients < 18 years were randomized to receive 12 Gy (n = 249) or 18 Gy (n = 237). Since this was a non-inferiority study, the analysis was performed for treated (12 Gy: n = 252 and 18 Gy: n = 219). Results. Five-year survival, event-free survival and cumulative incidence of relapse were similar in patients who received 12 or 18 Gy, respectively (82 +/- 3% vs. 79 +/- 3%, 68 +/- 3% vs. 63 +/- 3%, and 30 +/- 3% vs. 34 +/- 3%). The lower limit of the one-sided confidence interval for the 5% difference in 5-years pEFS was 2%. There were six relapses with CNS involvement (one in the 12 Gy, and five in the 18 Gy group). Conclusion. Results demonstrate no disadvantage for patients irradiated with a reduced CNS dose of 12 Gy.
dcterms:title
CNS Irradiation in Pediatric Acute Myleoid Leukemia: Equal Results by 12 or 18 Gy in Studies AML-BFM98 and 2004 CNS Irradiation in Pediatric Acute Myleoid Leukemia: Equal Results by 12 or 18 Gy in Studies AML-BFM98 and 2004
skos:prefLabel
CNS Irradiation in Pediatric Acute Myleoid Leukemia: Equal Results by 12 or 18 Gy in Studies AML-BFM98 and 2004 CNS Irradiation in Pediatric Acute Myleoid Leukemia: Equal Results by 12 or 18 Gy in Studies AML-BFM98 and 2004
skos:notation
RIV/00064203:_____/11:7275!RIV12-MZ0-00064203
n18:predkladatel
n19:ico%3A00064203
n3:aktivita
n17:Z n17:I
n3:aktivity
I, Z(MSM0021620813)
n3:cisloPeriodika
6
n3:dodaniDat
n13:2012
n3:domaciTvurceVysledku
n5:4977939
n3:druhVysledku
n6:J
n3:duvernostUdaju
n16:S
n3:entitaPredkladatele
n12:predkladatel
n3:idSjednocenehoVysledku
190695
n3:idVysledku
RIV/00064203:_____/11:7275
n3:jazykVysledku
n4:eng
n3:klicovaSlova
AML; clinical trials; leukemia; molecular diagnosis and therapy; outcomes research; radiation therapy
n3:klicoveSlovo
n7:AML n7:leukemia n7:molecular%20diagnosis%20and%20therapy n7:outcomes%20research n7:radiation%20therapy n7:clinical%20trials
n3:kodStatuVydavatele
US - Spojené státy americké
n3:kontrolniKodProRIV
[EEC2CD916439]
n3:nazevZdroje
Pediatric Blood & Cancer
n3:obor
n14:FD
n3:pocetDomacichTvurcuVysledku
1
n3:pocetTvurcuVysledku
12
n3:rokUplatneniVysledku
n13:2011
n3:svazekPeriodika
57
n3:tvurceVysledku
Fleischhack, G. Sander, A. Starý, Jan Reinhardt, D. Schrauder, A. von Stackelberg, A. Zimmermann, M. Bourquin, J. P. Creutzig, U. Ritter, J. von Neuhoff, C. Dworzak, MN
n3:wos
000295257700016
n3:zamer
n11:MSM0021620813
s:issn
1545-5009
s:numberOfPages
7