Paediatric Oncology and Haematology Research Institute N.N.Blokhin Russian Cancer Research Center Moscow Rituximab in children with B-NHL on top of BFM95 protocol Т.Т.Valiev, A.V.Popa, G.L.Mentkevich.
Download ReportTranscript Paediatric Oncology and Haematology Research Institute N.N.Blokhin Russian Cancer Research Center Moscow Rituximab in children with B-NHL on top of BFM95 protocol Т.Т.Valiev, A.V.Popa, G.L.Mentkevich.
Slide 1
Paediatric Oncology and Haematology Research Institute
N.N.Blokhin Russian Cancer Research Center
Moscow
Rituximab in children with
B-NHL on top of BFM95
protocol
Т.Т.Valiev, A.V.Popa, G.L.Mentkevich
Slide 2
Results of multicenter studies on
III/IV stages childhood B-NHL
Protocol
EFS (3-5y)
Authors
BFM90
69.1%
Meng JH et al. 2012
POG Total
79%
B-ALL – 65%
Bowman WP et al.
1996
CCG Hybrid
60% incl B-ALL
Cairo MS et al. 2002
NHL-BFM90
73%
B-ALL 74%
Reiter A et al. 1999
NHL-BFM95
81%
B-ALL 77%
Woesserman W. et al.
2005
FAB/LMB96
79%
Patte C. et al. 2007
Slide 3
EFS in pediatric pts with B-NHL in Russia (2004)
В
е
р
о
я
т
н
о
с
т
ь
Р=0,035
Е.В.Самочатова, Н.В.Мякова и др. Гематология и трансфузиология»,2004,№1,с.3;
годы
Slide 4
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
Slide 5
Overall response rate 41%
Rituximab toxicity (grade III/IV)
-General condition 15%
-Fatigue 13%
-ALT/AST 8%
-Anaphylaxis 7%
-Infection 3%
Slide 6
B-NHL-BFM 95 protocol modification
(Italian experience)
(A.Rosolen, M.Pillon, L.Mussolin 2012)
Slide 7
Modified B-NHL BFM95 protocol
(rituximab regimen) 2007-2010
4 risk group
AA
BB
3 risk group
CC
AA
АА
СС
АА
ВВ
BB
ВВ
CC
Slide 8
Patients characteristics
R+
(n=28)
R(n=25)
Age
3-17y (median 8,2y)
3-16 y (median 7,8y)
m/f
23/5
22/3
BL
23 (82%)
21 (84%)
DLBCL
2 (7%)
2 (8%)
PMBCL
3 (11%)
2 (8%)
III
19 (68%)
15 (60%)
IV
9 (32%)
10 (40%)
3
12 (43%)
11 (44%)
4
16 (57%)
14 (56%)
BM+
12 (43%)
8 (32%)
CNS+
3 (11%)
2 (8%)
CD20+
28 (100%)
25 (100%)
Stage
Risk group
Slide 9
Results of modified B-NHL BFM95 protocol
(rituximab regimen)
EFS= 94,4+/-4,3%
R+ (n=28)
(median 73,7+/-4,3 мo)
EFS= 74,8+/-9,7%
R- (n=25)
(median 119,8+/-8,7 мo)
Slide 10
EFS in group with M1 – 91,9%
EFS in group without M1 – 92,5%
Slide 11
Modified B-NHL BFM95
(rituximab regimen, block reduction)
2010-…
4 risk group
AA
BB
3 risk group
CC
AA
АА
СС
АА
ВВ
BB
ВВ
Slide 12
Comparative analysis of block reduction
and standard block therapy with
rituximab
Block reduction
R+
(n=10)
Standard block
therapy R+
(n=23)
10 (100%)
23 (100%)
III
6
14
IV
4
9
0
8
10 (100%)
15
9/10
(24 mo)
22/23
(72 mo)
Relapse
0
0
Progression
1
0
Induction death
1
1
BL
Stage
Risk group 3
4
Alive
(duration)
Slide 13
Treatment failure for B-NHL BFM95
protocol (rituximab regimen)
Failure
Progression
R+
(n=38)
1 (3%)
R(n=25)
2 (8%)
Relapse
0 (0%)
1 (4%)
TRD
2 (5%)
3 (12%)
Slide 14
Treatment toxicity for B-NHL BFM95
protocol (rituximab regimen)
Toxicity
R+
(n=38)
37 (97%)
R(n=25)
23 (92%)
Transfusions
36 (95%)
22 (88%)
Mucositis
grade 3/4ст
38 (100%)
24 (96%)
Febrile neutropenia
38 (100%)
25 (100%)
Haematologic
grade ¾
Slide 15
Conclusions
1.
Rituximab with B-NHL BFM95 protocol as a first-line
treatment in children with B-NHL (unfavorable stages
and risk groups) increased EFS significantly
2.
Toxicity profile of rituximab regimen was comparable
with standard B-NHL BFM95 protocol
3.
It is possible to reduce block number for pts with BNHL R4 with early complete response from six to five
Slide 16
Thank You
for attention!
Paediatric Oncology and Haematology Research Institute
N.N.Blokhin Russian Cancer Research Center
Moscow
Rituximab in children with
B-NHL on top of BFM95
protocol
Т.Т.Valiev, A.V.Popa, G.L.Mentkevich
Slide 2
Results of multicenter studies on
III/IV stages childhood B-NHL
Protocol
EFS (3-5y)
Authors
BFM90
69.1%
Meng JH et al. 2012
POG Total
79%
B-ALL – 65%
Bowman WP et al.
1996
CCG Hybrid
60% incl B-ALL
Cairo MS et al. 2002
NHL-BFM90
73%
B-ALL 74%
Reiter A et al. 1999
NHL-BFM95
81%
B-ALL 77%
Woesserman W. et al.
2005
FAB/LMB96
79%
Patte C. et al. 2007
Slide 3
EFS in pediatric pts with B-NHL in Russia (2004)
В
е
р
о
я
т
н
о
с
т
ь
Р=0,035
Е.В.Самочатова, Н.В.Мякова и др. Гематология и трансфузиология»,2004,№1,с.3;
годы
Slide 4
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
Slide 5
Overall response rate 41%
Rituximab toxicity (grade III/IV)
-General condition 15%
-Fatigue 13%
-ALT/AST 8%
-Anaphylaxis 7%
-Infection 3%
Slide 6
B-NHL-BFM 95 protocol modification
(Italian experience)
(A.Rosolen, M.Pillon, L.Mussolin 2012)
Slide 7
Modified B-NHL BFM95 protocol
(rituximab regimen) 2007-2010
4 risk group
AA
BB
3 risk group
CC
AA
АА
СС
АА
ВВ
BB
ВВ
CC
Slide 8
Patients characteristics
R+
(n=28)
R(n=25)
Age
3-17y (median 8,2y)
3-16 y (median 7,8y)
m/f
23/5
22/3
BL
23 (82%)
21 (84%)
DLBCL
2 (7%)
2 (8%)
PMBCL
3 (11%)
2 (8%)
III
19 (68%)
15 (60%)
IV
9 (32%)
10 (40%)
3
12 (43%)
11 (44%)
4
16 (57%)
14 (56%)
BM+
12 (43%)
8 (32%)
CNS+
3 (11%)
2 (8%)
CD20+
28 (100%)
25 (100%)
Stage
Risk group
Slide 9
Results of modified B-NHL BFM95 protocol
(rituximab regimen)
EFS= 94,4+/-4,3%
R+ (n=28)
(median 73,7+/-4,3 мo)
EFS= 74,8+/-9,7%
R- (n=25)
(median 119,8+/-8,7 мo)
Slide 10
EFS in group with M1 – 91,9%
EFS in group without M1 – 92,5%
Slide 11
Modified B-NHL BFM95
(rituximab regimen, block reduction)
2010-…
4 risk group
AA
BB
3 risk group
CC
AA
АА
СС
АА
ВВ
BB
ВВ
Slide 12
Comparative analysis of block reduction
and standard block therapy with
rituximab
Block reduction
R+
(n=10)
Standard block
therapy R+
(n=23)
10 (100%)
23 (100%)
III
6
14
IV
4
9
0
8
10 (100%)
15
9/10
(24 mo)
22/23
(72 mo)
Relapse
0
0
Progression
1
0
Induction death
1
1
BL
Stage
Risk group 3
4
Alive
(duration)
Slide 13
Treatment failure for B-NHL BFM95
protocol (rituximab regimen)
Failure
Progression
R+
(n=38)
1 (3%)
R(n=25)
2 (8%)
Relapse
0 (0%)
1 (4%)
TRD
2 (5%)
3 (12%)
Slide 14
Treatment toxicity for B-NHL BFM95
protocol (rituximab regimen)
Toxicity
R+
(n=38)
37 (97%)
R(n=25)
23 (92%)
Transfusions
36 (95%)
22 (88%)
Mucositis
grade 3/4ст
38 (100%)
24 (96%)
Febrile neutropenia
38 (100%)
25 (100%)
Haematologic
grade ¾
Slide 15
Conclusions
1.
Rituximab with B-NHL BFM95 protocol as a first-line
treatment in children with B-NHL (unfavorable stages
and risk groups) increased EFS significantly
2.
Toxicity profile of rituximab regimen was comparable
with standard B-NHL BFM95 protocol
3.
It is possible to reduce block number for pts with BNHL R4 with early complete response from six to five
Slide 16
Thank You
for attention!