PMID- 16813731
OWN - NLM
STAT- MEDLINE
DCOM- 20061122
LR  - 20220420
IS  - 1540-1405 (Print)
IS  - 1540-1405 (Linking)
VI  - 4 Suppl 3
DP  - 2006 Jul
TI  - HER2 testing in breast cancer: NCCN Task Force report and recommendations.
PG  - S1-22; quiz S23-4
AB  - The NCCN HER2 Testing in Breast Cancer Task Force was convened to critically 
      evaluate the ability of the level of HER2 expression or gene amplification in 
      breast cancer tumors to serve as a prognostic and a predictive factor in the 
      metastatic and adjuvant settings, to assess the reliability of the methods of 
      measuring HER2 expression or gene amplification in the laboratory, and to make 
      recommendations regarding the interpretation of test results. The Task Force is a 
      multidisciplinary panel of 24 experts in breast cancer representing the 
      disciplines of medical oncology, pathology, radiation oncology, surgical 
      oncology, epidemiology, and patient advocacy. Invited members included members of 
      the NCCN Breast Cancer Panel and other needed experts selected solely by the 
      NCCN. During a 2-day meeting, individual task force members provided didactic 
      presentations critically evaluating important aspects of HER2 biology and 
      epidemiology: HER2 as a prognostic and predictive factor; results from clinical 
      trials in which trastuzumab was used as a targeted therapy against HER2 in the 
      adjuvant and metastatic settings; the available testing methodologies for HER2, 
      including sensitivity, specificity, and ability to provide prognostic and 
      predictive information; and the principles on which HER2 testing should be based. 
      Each task force member was charged with identifying evidence relevant to their 
      specific expertise and presentation. Following the presentations, an 
      evidence-based consensus approach was used to formulate recommendations relating 
      to the pathologic and clinical application of the evidence to breast cancer 
      patient evaluation and care. In areas of controversy, this process extended 
      beyond the meeting to achieve consensus. The Task Force concluded that accurate 
      assignment of the HER2 status of invasive breast cancer is essential to clinical 
      decision making in the treatment of breast cancer in both adjuvant and metastatic 
      settings. Formal validation and concordance testing should be performed and 
      reported by laboratories performing HER2 testing for clinical purposes. If 
      appropriate quality control/assurance procedures are in place, either 
      immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) methods 
      may be used. A tumor with an IHC score of 0 or 1+, an average HER2 
      gene/chromosome 17 ratio of less than 1.8, or an average number of HER2 gene 
      copies/cell of 4 or less as determined by FISH is considered to be HER2 negative. 
      A tumor with an IHC score of 3+, an average HER2 gene/chromosome 17 ratio of 
      greater than 2.2 by FISH, or an average number of HER2 gene copies/cell of 6 or 
      greater is considered HER2 positive. A tumor with an IHC score of 2+ should be 
      further tested using FISH, with HER2 status determined by the FISH result. Tumor 
      samples with an average HER2 gene/chromosome ratio of 1.8 to 2.2 or average 
      number of HER2 gene copies/cell in the range of greater than 4 to less than 6 are 
      considered to be borderline, and strategies to assign the HER2 status of such 
      samples are proposed.
FAU - Carlson, Robert W
AU  - Carlson RW
AD  - Stanford Hospital and Clinics.
FAU - Moench, Susan J
AU  - Moench SJ
FAU - Hammond, M Elizabeth H
AU  - Hammond ME
FAU - Perez, Edith A
AU  - Perez EA
FAU - Burstein, Harold J
AU  - Burstein HJ
FAU - Allred, D Craig
AU  - Allred DC
FAU - Vogel, Charles L
AU  - Vogel CL
FAU - Goldstein, Lori J
AU  - Goldstein LJ
FAU - Somlo, George
AU  - Somlo G
FAU - Gradishar, William J
AU  - Gradishar WJ
FAU - Hudis, Clifford A
AU  - Hudis CA
FAU - Jahanzeb, Mohammad
AU  - Jahanzeb M
FAU - Stark, Azadeh
AU  - Stark A
FAU - Wolff, Antonio C
AU  - Wolff AC
FAU - Press, Michael F
AU  - Press MF
FAU - Winer, Eric P
AU  - Winer EP
FAU - Paik, Soonmyung
AU  - Paik S
FAU - Ljung, Britt-Marie
AU  - Ljung BM
CN  - NCCN HER2 Testing in Breast Cancer Task Force
LA  - eng
PT  - Journal Article
PT  - Practice Guideline
PT  - Review
PL  - United States
TA  - J Natl Compr Canc Netw
JT  - Journal of the National Comprehensive Cancer Network : JNCCN
JID - 101162515
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  - Advisory Committees
MH  - Antibodies, Monoclonal/pharmacology
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Agents/pharmacology
MH  - Breast Neoplasms/drug therapy/*genetics
MH  - Genetic Testing/*standards
MH  - Humans
MH  - Immunohistochemistry/methods
MH  - In Situ Hybridization, Fluorescence
MH  - Prognosis
MH  - Quality Assurance, Health Care
MH  - Receptor, ErbB-2/*genetics
MH  - Trastuzumab
RF  - 129
EDAT- 2006/07/04 09:00
MHDA- 2006/12/09 09:00
CRDT- 2006/07/04 09:00
PHST- 2006/07/04 09:00 [pubmed]
PHST- 2006/12/09 09:00 [medline]
PHST- 2006/07/04 09:00 [entrez]
PST - ppublish
SO  - J Natl Compr Canc Netw. 2006 Jul;4 Suppl 3:S1-22; quiz S23-4.