PMID- 21671702
OWN - NLM
STAT- MEDLINE
DCOM- 20111012
LR  - 20151119
IS  - 1744-8379 (Electronic)
IS  - 1473-7167 (Linking)
VI  - 11
IP  - 3
DP  - 2011 Jun
TI  - Clinical and health economic outcomes of alternative HER2 test strategies for 
      guiding adjuvant trastuzumab therapy.
PG  - 325-41
LID - 10.1586/erp.11.25 [doi]
AB  - AIM: To evaluate the clinical outcomes and cost-effectiveness of human epidermal 
      growth factor receptor 2 (HER2) testing strategies to guide adjuvant trastuzumab 
      (AT) therapy in women with HER2-positive breast cancer. METHODS: A literature 
      review produced 72 studies comparing HER2 test methods, and we computed 
      concordance (assuming fluorescence in situ hybridization [FISH] as a reference 
      assay) to assess performance relative to American Society of Clinical 
      Oncology/College of American Pathologists (ASCO/CAP) guidelines. An economic 
      analysis provided cost-effectiveness of alternative strategies, including a Monte 
      Carlo simulation to vary key assumptions such as test price and performance. 
      RESULTS: Of 46 studies comparing immunohistochemistry (IHC) and FISH, only seven 
      met the ASCO/CAP guideline of 95% or better concordance. A total of 14 out of 21 
      studies comparing chromogenic in situ hybridization and three out of five studies 
      comparing silver-enhanced in situ hybridization met the guideline. Confirmation 
      of IHC 2+ and 3+ and primary FISH strategies are likely to reduce costs and 
      improve quality of life relative to confirmation of IHC 2+ only. Initial testing 
      with a gene amplification-based assay is probably a cost-effective alternative to 
      confirmation of IHC 2+ and 3+. The results are not sensitive to varying test 
      price but are sensitive to test accuracy below 98%. CONCLUSION: Using a primary 
      gene amplification-based assay to guide AT therapy for HER2-positive breast 
      cancer probably results in lower US medical costs, increased life-years and 
      increased quality of life compared with confirmation of IHC 2+ with a gene 
      amplification-based assay. We recommend the ASCO/CAP guidelines reflect 98% or 
      greater concordance relative to a reference assay. Additional research regarding 
      therapy response is required to further differentiate between gene 
      amplification-based assays.
FAU - Lee, James A
AU  - Lee JA
AD  - Altarum Institute, 3520 Green Court, Suite 300, Ann Arbor, MI 48105, USA. 
      jim.lee@altarum.org
FAU - Shaheen, Megan
AU  - Shaheen M
FAU - Walke, Thomas
AU  - Walke T
FAU - Daly, Matt
AU  - Daly M
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PL  - England
TA  - Expert Rev Pharmacoecon Outcomes Res
JT  - Expert review of pharmacoeconomics & outcomes research
JID - 101132257
RN  - 0 (Antibodies, Monoclonal)
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Antineoplastic Agents)
RN  - EC 2.7.10.1 (Receptor, ErbB-2)
RN  - P188ANX8CK (Trastuzumab)
SB  - IM
MH  - Antibodies, Monoclonal/administration & dosage/economics/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Agents/administration & dosage/economics/therapeutic use
MH  - Breast Neoplasms/*drug therapy/economics
MH  - Chemotherapy, Adjuvant/economics/methods
MH  - Cost-Benefit Analysis
MH  - Female
MH  - Gene Amplification
MH  - Humans
MH  - Immunohistochemistry/economics/methods
MH  - In Situ Hybridization, Fluorescence/economics/methods
MH  - Practice Guidelines as Topic
MH  - Quality of Life
MH  - Receptor, ErbB-2/*metabolism
MH  - Trastuzumab
EDAT- 2011/06/16 06:00
MHDA- 2011/10/13 06:00
CRDT- 2011/06/16 06:00
PHST- 2011/06/16 06:00 [entrez]
PHST- 2011/06/16 06:00 [pubmed]
PHST- 2011/10/13 06:00 [medline]
AID - 10.1586/erp.11.25 [doi]
PST - ppublish
SO  - Expert Rev Pharmacoecon Outcomes Res. 2011 Jun;11(3):325-41. doi: 
      10.1586/erp.11.25.