Table IIIb-FTime to Event Outcome Regression Modeling

StudyDesign/Outcome/ModelCandidate Predictors/Method for Identifying CandidatesUnivariate Results, Variable (p value)Selected Predictors/Methods for Selecting Predictors for Multivariate ModelProportional Hazards Assumption Assessed?/Interactions Considered?Multivariate Model Results, Variable (p value)Discrimination/Validation Methods/ResultsCalibration/Goodness of Fit
Neoadjuvant Hormonal Therapy
None
Adjuvant Hormonal Therapy
Ryden et al 2005CoxNot reportedER+/HER2-(IHC)
P=0.07
ER+/HER2+(IHC)
P=0.2
ER+/PR+/HER2-(IHC), P=0.03 ER+/PR+/HER2+ (IHC), p=0.03
Not certain; prob Age, tumor size, Node status, NHG, HER2 status, TAM, TAM*HER2. Analyzed ER+ and ER+/PR+ tumors Separately.Not reportedER+:
TAM*HER2(IHC)
p=0.4
ER+/PR+
TAM*HER2(IHC)
p=0.3
Not reportedNot reported
Knoop et al. 2001 (among steroid receptor positive pts)CoxTam vs Cx for HR+
Within HER2+ and - subgroups
RR HER2+=0.89
(95% CI: 0.63–1.27)
RR HER2-=0.86
(95% CI: 0.78–0.93)
Tumor size, proportion node pos, histologic grade, p53 status, HER2 status, EGFR status, tamoxifen, and interactions betw. TAM and p53, EGFR, And HER2Interactions includedHER2 and HER2*TAM not significant Not reportedNot reported
Metastatic Hormonal Therapy
Arpino et al. 2004Cox*
single-arm retrospective; TTF & OS
signif predictors of TTF in SWOG 8228, HER 1, HER 2menopausal status, disease-free interval, ER and PR levels; HER1, HER2TTFNot reportedNot reported
 HR1.15
 p.54
OS
 HR.99
 P.97
*

partially non-parametric

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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