Table IV-CHER2 Measurement Methods

StudyAssays (Name)Criteria for PositivityTest Results (%)Comments
Gasparini et al. 2007Serum:Bayer ADVIA Centaur, at baselineSerum> 15 ng/mlPosNo info on % SHER2+/-
Equiv
FISHFISHNeg
Pos
Equiv
IHC:HercepTestIHC3+Neg
2+Pos68.3
Equiv31.7
Neg
Im et al. 2005Serum:Oncogene ELISASerum≥ 15Pos14.8sHER2 tested in 27 of 40
Equiv
Neg85.2
FISHFISHPos
Equiv
Neg
IHC:Biogenix CB11 AbIHC≥ 10% tumor cells with intense membrane stainingPos
Equiv
Neg
Fornier et al. 2005Serum:Bayer Immuno 1Serum>15Pos69
Equiv
Neg31
FISHPathVysion (in 44 of 55)FISH≥ 2Pos41
Equiv
Neg59
IHC:HercepTest/CB11IHC2+/3+, Hercep TestPos47
Equiv
Neg53
2+/3+, CB11Pos36
Equiv
Neg64
Muller et al. 2004Serum:Oncogene Science ELISASerum≥ 15Pos37
Equiv
Neg63
FISHFISHPos
Equiv
Neg
IHC:CB11IHC3+Pos31tHER2 tested in 29 of 103
Equiv
Neg69
Luftner et al. 2004Serum:Oncogene ScienceSerum≥ 15Pos63
Equiv
Neg37
FISHFISHPos
Equiv
Neg
IHC:IHCPos
Equiv
Neg
Sandri et al. 2004Serum:Bayer Immuno 1Serum≥ 15Pos?
Equiv
Neg?
FISHFISHPos
Equiv
Neg
IHC:Dako HercepTestIHC> 10% cancer cells with intense to moderate stainingPos35tHER2 tested in 20 of 39
Equiv
Neg65
Colomer et al. 2004Serum:Oncogene ELISASerum≥ 30 ng/mlPos29.3
Equiv
Neg70.7
FISHFISHPos
Equiv
Neg
IHC:IHCPos
Equiv
Neg
Burstein et al. 2003Serum:Oncogene ScienceSerumPos?
Equiv
Neg?
FISH?FISHPos18
Equiv
Neg
IHC:?IHC3+Pos80
Equiv2
Neg
Lipton et al. 2003Serum:Immuno 1 assaySerum≥ 15Pos29.2
Equiv
FISHFISHNeg70.8
Pos
Equiv
-Neg
IHC:IHCPos
Equiv
Neg
Esteva et al. 2002Serum:Immuno 1Serum≥ 15Pos70
Equiv
FISHPathVysionFISH+Neg30FISH done in 28 of 30
Pos85.7
Equiv
Neg14.3
IHC:Neomarkers mAb e2-4001IHC3+Pos79.2IHC done in 24 of 30
Equiv
0–2+Neg20.8
Colomer et al. 2000Serum:Calbiochem ELISASerum450 fmol/mlPos43.6sHER2 done in 55 of 58
Equiv
Neg56.4
FISHFISHPos
Equiv
Neg
IHC:CB11IHCPos27.5IHC done in 40 of 58
Equiv
Neg72.5
Colomer et al. 2006Serum:Oncogene Science ELISASerum>30Pos29.8
Equiv
Neg70.2
FISHFISHPos
Equiv
Neg
IHC:IHCPos
Equiv
Neg
Yamauchi et al. 1997Serum:Oncogene Science ELISASerum≥ 5000 U/mlPos34
Equiv
Neg66
FISHFISHPos
Equiv
Neg
IHC:IHCPos
Equiv
Neg

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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