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Rituximab in children with B-NHL on top of BFM95 protocol. Paediatric Oncology and Haematology Research Institute N.N.Blokhin Russian Cancer Research Center Moscow. Т.Т. Valiev , A.V.Popa , G.L.Mentkevich. Results of multicenter studies on III/IV stages childhood B-NHL.
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Rituximab in children with B-NHL on top of BFM95 protocol Paediatric Oncology and Haematology Research Institute N.N.Blokhin Russian Cancer Research Center Moscow Т.Т.Valiev, A.V.Popa, G.L.Mentkevich
Results of multicenter studies on III/IV stages childhood B-NHL
EFS in pediatric pts with B-NHL in Russia (2004) Вероятность Р=0,035 годы • Е.В.Самочатова, Н.В.Мякова и др. Гематология и трансфузиология»,2004,№1,с.3;
Literature data are limited • 3-year EFS in children with B-NHL III/IV stages treated by FAB/LMB96 (R+) - 95% FAB/LMB96 (R-) – 84% • Goldman , ASH, Abstract No 2702, 2011
Overall response rate 41% • Rituximab toxicity (grade III/IV) -General condition 15% -Fatigue 13% -ALT/AST 8% -Anaphylaxis 7% -Infection 3%
B-NHL-BFM 95 protocol modification(Italian experience)(A.Rosolen, M.Pillon, L.Mussolin 2012)
Modified B-NHL BFM95 protocol(rituximab regimen) 2007-2010 4 risk group AA BB CC AA BB CC 3 risk group АА ВВ СС АА ВВ
Results of modified B-NHL BFM95 protocol(rituximab regimen) EFS= 94,4+/-4,3% R+ (n=28) (median73,7+/-4,3 мo) EFS= 74,8+/-9,7% R- (n=25) (median 119,8+/-8,7 мo)
EFS in group with M1 – 91,9% • EFS in group without M1 – 92,5%
Modified B-NHL BFM95(rituximab regimen, block reduction) 2010-… 4 risk group AA BB CC AA BB 3 risk group АА ВВ СС АА ВВ
Comparative analysis of block reduction and standard block therapy with rituximab
Treatment failure for B-NHL BFM95 protocol (rituximab regimen)
Treatment toxicity for B-NHL BFM95 protocol (rituximab regimen)
Conclusions • Rituximab with B-NHL BFM95 protocol as a first-line treatment in children with B-NHL(unfavorable stages and risk groups) increased EFS significantly • Toxicity profile of rituximab regimen was comparable with standard B-NHL BFM95 protocol • It is possible to reduce block number for pts with B-NHL R4 with early complete response from six to five