About: CNS Irradiation in Pediatric Acute Myleoid Leukemia: Equal Results by 12 or 18 Gy in Studies AML-BFM98 and 2004     Goto   Sponge   Distinct   Permalink

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  • 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. (en)
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 (en)
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 (en)
skos:notation
  • RIV/00064203:_____/11:7275!RIV12-MZ0-00064203
http://linked.open...avai/riv/aktivita
http://linked.open...avai/riv/aktivity
  • I, Z(MSM0021620813)
http://linked.open...iv/cisloPeriodika
  • 6
http://linked.open...vai/riv/dodaniDat
http://linked.open...aciTvurceVysledku
http://linked.open.../riv/druhVysledku
http://linked.open...iv/duvernostUdaju
http://linked.open...titaPredkladatele
http://linked.open...dnocenehoVysledku
  • 190695
http://linked.open...ai/riv/idVysledku
  • RIV/00064203:_____/11:7275
http://linked.open...riv/jazykVysledku
http://linked.open.../riv/klicovaSlova
  • AML; clinical trials; leukemia; molecular diagnosis and therapy; outcomes research; radiation therapy (en)
http://linked.open.../riv/klicoveSlovo
http://linked.open...odStatuVydavatele
  • US - Spojené státy americké
http://linked.open...ontrolniKodProRIV
  • [EEC2CD916439]
http://linked.open...i/riv/nazevZdroje
  • Pediatric Blood & Cancer
http://linked.open...in/vavai/riv/obor
http://linked.open...ichTvurcuVysledku
http://linked.open...cetTvurcuVysledku
http://linked.open...UplatneniVysledku
http://linked.open...v/svazekPeriodika
  • 57
http://linked.open...iv/tvurceVysledku
  • Bourquin, J. P.
  • Creutzig, U.
  • Dworzak, MN
  • Fleischhack, G.
  • Reinhardt, D.
  • Ritter, J.
  • Sander, A.
  • Schrauder, A.
  • Starý, Jan
  • Zimmermann, M.
  • von Neuhoff, C.
  • von Stackelberg, A.
http://linked.open...ain/vavai/riv/wos
  • 000295257700016
http://linked.open...n/vavai/riv/zamer
issn
  • 1545-5009
number of pages
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