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Table IIIb-DOutcome Assessment

StudyPrimary OutcomesSecondary OutcomesCriteria for Tumor Response or ProgressionIndependent Response Assessor?F/U Frequency/Duration
Neoadjuvant Hormonal Therapy
None
Adjuvant Hormonal Therapy
Ryden et al 2005Recurrence free survivalNoneNot reportedNot mentionedMedian for pts with no breast cancer event=14 yrs (range: 0–17 yrs). F/U annually for 5 yrs then every 18 mos.
Knoop et al. 2001Disease free survivalNonenot reportednot mentionedNot reported; but 10 year DFS included in tables.
Metastatic Hormonal Therapy
Arpino et al. 2004ResponseTime to failure and overall survivalresponse = cCR or cPR or cSD
cCR: no evidence of disease for ≥6 mos.2
cPR: ≥50% ↓ in cross-sectional area of all measurable lesions2
cSD: <cPR but not cPD2
cPD: ≥25% ↑ in cross-sectional area of all measurable lesions or appearance of new lesions2
not mentioned“Nearly all” tumor blocks >10 years old and some >20 years old.
F/U frequency and duration not reported

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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