Table II-ETime to Event Outcomes

StudyTime to Event Outcomes
HER2 Discrepant, Adjuvant Therapy
Paik et al. 2007;
Kim et al, in preparation;
Romond et al. 2005

FISH+ IHC- (0, 1+, 2+) by central lab
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSTx
Cx
RFI*Tx56Cox prop hazards0.110.35 (0.10–1.28)adjusted for ER and nodal status
Cx69
PFSTx
Cx
RFSTx
Cx
DFSTx56Cox prop hazards0.0640.30 (0.08–1.07)adjusted for ER and nodal status
Cx69
DSSTx
Cx
Paik et al. 2007;
Kim et al, in preparation;
Romond et al. 2005

FISH- IHC 3+ by central lab
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSTx
Cx
RFI*Tx10Cox prop hazards0.940.91 (0.08–10)adjusted for ER and nodal status
Cx21
PFSTx
Cx
RFSTx
Cx
DFSTx10Cox prop hazards0.940.91 (0.08–10)adjusted for ER and nodal status
Cx21
DSSTx
Cx
Perez et al. 2007;
Perez et al. 2006;
Romond et al. 2005
DFSGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
FISH+Tx123???0.970.98 (0.33–2.91)pools IHC 2+ with 0, 1+
IHC<3+Cx95
FISH-Tx23???0.570.61 (0.11–3.29)
IHC3+Cx30
Paik et al. 2007;
Kim et al, in preparation;
Romond et al. 2005

FISH- IHC 1+, 2+ by central lab
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSTx
Cx
RFI*Tx69Cox prop hazards0.0410.31(0.10–0.95)adjusted for ER and nodal status
Cx80
PFSTx
Cx
RFSTx
Cx
DFSTx69~98%~95%~90%~90%~86%Cox prop hazards0.020.30 (0.11–0.83)adjusted for ER and nodal status
Cx80~90%~79%~75%~70%~62%
DSSTx
Cx
Paik et al. 2007;
Kim et al, in preparation;
Romond et al. 2005

FISH- IHC-(0, 1+, 2+) by central lab
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSTx
Cx
RFI*Tx82Cox prop hazards0.0340.36 (0.14–0.92adjusted for ER and nodal status
Cx92
PFSTx
Cx
RFSTx
Cx
DFSTx82~97%~90%~87%~87%~84%Cox prop hazards0.0140.34 (0.14–0.80)adjusted for ER and nodal status
Cx92~92%~80%~76%~72%~65%
DSSTx
Cx
Perez et al. 2007;
Perez et al. 2006;
Romond et al. 2005

FISH- IHC- (0, 1+, 2+) by central lab
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSTx
Cx
TTPTx
Cx
PFSTx
Cx
RFSTx
Cx
DFSTx59???0.130.51 (0.21–1.2)
Cx44
DSSTx
Cx
HER2 Negative, Therapy for Metastasis
CALGB 9840
Seidman et al. 2004

IHC2+/FISH- or
IHC 0, 1+
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSTx11321.6~75%~40%~25%???0.67
Cx11519.6~70%~37%~22%
TTPTx1137.3~30%~18%~10%???0.088
Cx1155.5~25%~10%~10%
PFSTx
Cx
RFSTx
Cx
DFSTx
Cx
DSSTx
Cx
CALGB 150002
Kaufman et al. 2007

central FISH- with polysomy 17 from CALGB 9840
OutcomeGrpNMed (mos)1 yr2 yr3 yr4 yr5 yrTestpHR (95%CI)Comments
OSTx19~30~90%~65%~30%???0.538
Cx19~23~69%~48%~30%
TTPTx19~12~50%~15%0???0.888
Cx19~6~29%~23%~17%
PFSTx
Cx
RFSTx
Cx
DFSTx
Cx
DSSTx
Cx
*

RFI = recurrence-free interval

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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