la target therapy: cosa ci aspettiamo paolo g. casali [email protected]
TRANSCRIPT
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Imatinib
SCF
Terapia molecolare mirata
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Imatinib
chemioterapia
OS
months
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0 +2 sett
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Le “differenze”
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
1
0 3 6 9 12 15 18 21 24
p <0.05
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Le “differenze”
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
1
0 3 6 9 12 15 18 21 24
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Le “differenze”
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
1
0 3 6 9 12 15 18 21 24
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KIT
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Lasota J et al, Histopathology 2008
esone 9 (~10%)
esone 11 (~70%)
esone 13 (~5%)
esone 17 (~5 %)
PDGFRA (~10%) KIT(~80%) WT (~10%)
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Heinrich MC, J Clin Oncol 2003;21:4342
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KIT exon 9
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KIT esone 9
PDGFRA
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Corless CL, J Clin Oncol 2005, 23: 5357
PDGFRA
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GIST in sindromi
GIST pediatrici 0 – 18+ aa
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Mussi C, Clin Cancer Res 2008;14:4550
Neurofibromatosi, tipo 1
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Agaram NP et al, Clin Cancer Res 2008;14:3204
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Imatinib
SCF
Terapia molecolare mirata
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Negri T al, J Natl Cancer Inst 2009;101:194
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Imatinib 400 mg d
Imatinib 800 mg d
R
EORTC/ISG/AGITG #62005
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(years)
0 1 2 3 4
0
10
20
30
40
50
60
70
80
90
100
400 mg 800 mg
Progression free survival
Overall Logrank test: p=0.108
Casali PG et al, ECCO Ann Meet 2005
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“More is better”?
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Judson I et al, Cancer Chemother Pharmacol 2005;55:379
Farmacocinetica
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Risposta tumorale
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50%
30%
WHO/ECOG
RECIST
Criteri di risposta tumorale
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Choi’s
RECIST
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10%
15%
Choi’s criteria: Risposta tumorale
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5 HU
57 HU39 HU
13 HU
61 HU
15 HU83 HU
36 HU
57 HU9 HU 52 HU
3 HU
- 2 HU
- 18 HU -34 HU
9 HU
5 HU-9 HU
-13 HU
3 HU20 HU
10 HU
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Stacchiotti S et al, Radiology 2009;epub
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PET scan
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0 +3-4 sett +12 mm +18 mm
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50 mg/day, 4 weeks on, 2 weeks off
SUNITINIB
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Van den Abbeele AD et al, ECCO Ann meet 2005
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Progressione intervallare
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t
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BFR14 study
Rstop Imatinib
continue Imatinib
ImatinibCRPRSD
12 mos surgery if feasible
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Resistenza secondaria
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Sunitinib
VEGFR-2
VEGFR-1
VEGFR-3
PDGFR-
KIT
FLT-3PDGFR-
NH
O
NH
F
H3C
CH3
NH
O
N
CH3
CH3
RET
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Imatinib
Sunitinib
Nilotinib
Vatalanib
Sorafenib Dasatanib Masitinib
PKC412
AMG706 IPI504
…..
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Resistenza primaria
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Resistenza secondaria
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Heinrich MC, JCO, 2006;24:4764
Eterogeneità molecolare
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KITPDGRA VEGFR
……..
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KITPDGRA VEGFR
Hsp90
……..
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KITPDGRA VEGFR
PI3K
AKT
mTOR ……..
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Imatinib + Nilotinib
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Il “nodulo nel nodulo”
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0 +1 mm
GIST: rechallenge con Imatinib
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DeMatteo R et al, Lancet 2009
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R
Imatinib x 1 aa
placebo
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OSRFS
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R OSrelapse
RFS
OSImatinib
Imatinib
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R Rrelapse
Rrelapse
Imatinib
Imatinib
Imatinib
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R Rrelapse
Rrelapse
Imatinib
Imatinib
Imatinib
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R Rrelapse
Rrelapse
Imatinib
Imatinib
Imatinib
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R Rrelapse
Rrelapse
Imatinib
Imatinib
Imatinib
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Paolo G. Casali Study Chair & ISG CoordinatorJean-Yves Blay EORTC CoordinatorAxel Le Cesne FSG CoordinatorAndres Poveda GEIS CoordinatorJohn Zalcberg AGITG Coordinator Martine van Glabbeke Study StatisticianSandrine Marraud Coordinating PhysicianAnne Kirkpatrick Study Data Manager
Intermediate and high risklocalized, completely resected,gastrointestinal stromal tumors (GIST) expressing KIT receptor:a controlled randomized trial on adjuvant Imatinib mesylate (Glivec™) versus no further therapy after complete surgery
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R
Imatinib x 2 aa
controllo
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R
Imatinib x 3 aa
Imatinib x 1 aa
German/Scandinavian trial
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Stratificazione del rischiocm M/50HPF gastric jejunal/
ilealduodenal rectal
1 <2 <5 0none
0none
0none
0none
2 >2<5 <5 1.9%very low
4.3%low
8.3%low
8.5% low
3a >5<10 <5 3.6%low
24% moderate
3b >10 <5 12% moderate
52%high
34% high
57% high
4 <2 >5 0 50% 54% high
5 >2<5 >5 16% moderate
73%high
50%high
52%high
6a >5<10 >5 55%high
85% high
6b >10 >5 86%high
90%high
86%high
71%high
Miettinen M. Semin Diagn Pathol 2006; 23: 70
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Terapia citoriduttiva preoperatoria
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Metastatic GIST in response to IM
Followfor
PFS & OS
Imatinib
Imatinib + surgery at best response
(within 1 yr)
EORTC trial with ISG, FSG, SSG, AGITSG
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Surgery of residualprogressive disease
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Surgery of residualresponsive disease
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n = 27
n = 8
Gronchi A, Ann Surg 2007; 245:341
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Raut CP, J Clin Oncol 2006;24:2325
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Il metodo clinico Diagnosi
Early case finding Diagnosi nosografica Staging
Trattamento Decision-making Management del paziente
Valutazione dell’esito Risposta tumorale
clinica patologica
Tossicità Qualità di vita Sopravvivenza
Prognosi Follow-up
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Imatinib
SCF
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chemioterapia