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Table 6. Relationship Between Tyrosine Kinase Genotype and Response to Imatinib Therapya

 European Phase I/IIb Trial, % (n) [31] B-2222 Phase IIc Trial, % (n) [32] European/Australasian Phase IIId Trial, % (n) [18] North American CLB-80004 Phase IIIe Trial, % (n) [33] 
Study participants(N = 37)(N = 127)(N= 377)(N = 324)
Objective responsef
KIT exon 1183 (24)83g (85)70g (248)67g (211)
KIT exon 925 (4)48 (23)35 (58)40 (25)
Wild-type33 (6)0 (9)25 (52)39 (33)
Progressive disease
KIT exon 11453NR
KIT exon 901717NR
Wild-type335619NR

N = number in sample, number of observations; NR = not reported.
aAnnual review of pathology by ANNUAL REVIEWS, INC. Reproduced with permission of ANNUAL REVIEWS, INC., in the format Internet posting via Copyright Clearance Center.[3]
b[Level of evidence: 1iiA, 1iiDii, 1iiDiv (Phase 1) and 2A; 2Div (Phase II)]
c[Level of evidence: 1iiDiv]
d[Level of evidence: 1iiA and 1iiDiii]
e[Level of evidence: 1iiDiv]
fDefined as complete or partial response by Southwest Oncology Group (SWOG) criteria for B-2222 or RECIST (Response Evaluation Criteria in Solid Tumors) for all other trials; excludes nonevaluable patients.
gStatistically significant difference compared with KIT 9 and wild-type (no KIT or PDGFRA mutation) groups.

References

  1. Corless CL, Heinrich MC: Molecular pathobiology of gastrointestinal stromal sarcomas. Annu Rev Pathol 3: 557-86, 2008.  [PUBMED Abstract]

  2. Debiec-Rychter M, Sciot R, Le Cesne A, et al.: KIT mutations and dose selection for imatinib in patients with advanced gastrointestinal stromal tumours. Eur J Cancer 42 (8): 1093-103, 2006.  [PUBMED Abstract]

  3. Debiec-Rychter M, Dumez H, Judson I, et al.: Use of c-KIT/PDGFRA mutational analysis to predict the clinical response to imatinib in patients with advanced gastrointestinal stromal tumours entered on phase I and II studies of the EORTC Soft Tissue and Bone Sarcoma Group. Eur J Cancer 40 (5): 689-95, 2004.  [PUBMED Abstract]

  4. Heinrich MC, Corless CL, Demetri GD, et al.: Kinase mutations and imatinib response in patients with metastatic gastrointestinal stromal tumor. J Clin Oncol 21 (23): 4342-9, 2003.  [PUBMED Abstract]

  5. Heinrich MC, Shoemaker JS, Corless CL, et al.: Correlation of target kinase genotype with clinical activity of imatinib mesylate (IM) in patients with metastatic GI stromal tumors (GISTs) expressing KIT (KIT+). [Abstract] J Clin Oncol 23 (Suppl 16): A-7, 3s, 2005.