Table V-YProstate Cancer. HER2 Measurement Methods

StudyAssays (Name)Criteria for PositivitvTest Results (%)Comments
1320, Nishio et al., 2006SerumSerumPos
Equiv
Neg
FISHFISHPos
Equiv
Neg
IHCK5205 (Dako HercepTest)IHCweak to moderate or strong complete membrane staining in > 10% of tumor cells (> 1+) Pos42
Equiv2
Neg56
16450, Arai et al., 1997SerumSV2-61Y and 6G10 (Eiken Chemical Co. Tokyo, Japan)Serum> 3.7 ng/mLPos3071 treated pts had serum assay data plus 161 additional patients
Equiv
Neg70
FISHFISHPos
Equiv
Neg
IHCIHCPos
Equiv
Neg
18080, Fox et al., 1994SerumSerumPos
Equiv
Neg
FISHFISHPos
Equiv
Neg
IHCCB11(Novacostra Lab)IHCmembrane or cytoplasmic staining in > 10% of tumor cellsPos36
Equiv
Neg64

From: Appendix C. Evidence Data Abstraction Tables

Cover of HER2 Testing to Manage Patients With Breast Cancer or Other Solid Tumors
HER2 Testing to Manage Patients With Breast Cancer or Other Solid Tumors.
Evidence Reports/Technology Assessments, No. 172.
Seidenfeld J, Samson DJ, Rothenberg BM, et al.

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