PMID- 12048273
OWN - NLM
STAT- MEDLINE
DCOM- 20020626
LR  - 20220318
IS  - 0027-8874 (Print)
IS  - 0027-8874 (Linking)
VI  - 94
IP  - 11
DP  - 2002 Jun 5
TI  - Real-world performance of HER2 testing--National Surgical Adjuvant Breast and 
      Bowel Project experience.
PG  - 852-4
AB  - Trastuzumab (Herceptin) provides clinical benefits for patients diagnosed with 
      advanced breast cancers that have overexpressed the HER2 protein or have 
      amplified the HER2 gene. The National Surgical Adjuvant Breast and Bowel Project 
      (NSABP) Protocol B-31 is designed to test the advantage of adding Herceptin to 
      the adjuvant chemotherapeutic regimen of doxorubicin and cyclophosphamide 
      followed by paclitaxel (Taxol) in the treatment of stage II breast cancer with 
      HER2 overexpression or gene amplification. Eligibility is based on HER2 assay 
      results submitted by the accruing institutions. We conducted a central review of 
      the first 104 cases entered in this trial on the basis of immunohistochemistry 
      (IHC) results. We found that 18% of the community-based assays, which were used 
      to establish the eligibility of patients to participate in the B-31 study, could 
      not be confirmed by HercepTest IHC or fluorescence in situ hybridization (FISH) 
      by a central testing facility. This report provides a snapshot of the quality of 
      HER2 assays performed in laboratories nationwide.
FAU - Paik, Soonmyung
AU  - Paik S
AD  - National Surgical Adjuvant Breast and Bowel Project (NSABP) Operation Center, 
      Pittsburgh, PA 15212, USA. soon.paik@nsabp.org
FAU - Bryant, John
AU  - Bryant J
FAU - Tan-Chiu, Elizabeth
AU  - Tan-Chiu E
FAU - Romond, Edward
AU  - Romond E
FAU - Hiller, William
AU  - Hiller W
FAU - Park, Kyeongmee
AU  - Park K
FAU - Brown, Ann
AU  - Brown A
FAU - Yothers, Greg
AU  - Yothers G
FAU - Anderson, Steve
AU  - Anderson S
FAU - Smith, Roy
AU  - Smith R
FAU - Wickerham, D Lawrence
AU  - Wickerham DL
FAU - Wolmark, Norman
AU  - Wolmark N
LA  - eng
GR  - U10CA12027/CA/NCI NIH HHS/United States
GR  - U10CA37377/CA/NCI NIH HHS/United States
GR  - U10CA69651/CA/NCI NIH HHS/United States
GR  - U10CA69974/CA/NCI NIH HHS/United States
PT  - Evaluation Study
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - J Natl Cancer Inst
JT  - Journal of the National Cancer Institute
JID - 7503089
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
CIN - J Natl Cancer Inst. 2002 Jun 5;94(11):788-9. PMID: 12048261
CIN - J Natl Cancer Inst. 2003 Apr 16;95(8):628; author reply 628-9. PMID: 12697858
MH  - Antibodies, Monoclonal/*therapeutic use
MH  - Antibodies, Monoclonal, Humanized
MH  - Antineoplastic Agents/therapeutic use
MH  - Breast Neoplasms/*drug therapy/genetics/*metabolism/surgery
MH  - Chemotherapy, Adjuvant
MH  - Clinical Trials as Topic/methods
MH  - Contraindications
MH  - Diagnostic Errors
MH  - Gene Amplification
MH  - Humans
MH  - Immunohistochemistry
MH  - In Situ Hybridization, Fluorescence
MH  - *Patient Selection
MH  - Quality Assurance, Health Care
MH  - Receptor, ErbB-2/*analysis/genetics/metabolism
MH  - Reproducibility of Results
MH  - Trastuzumab
EDAT- 2002/06/06 10:00
MHDA- 2002/06/27 10:01
CRDT- 2002/06/06 10:00
PHST- 2002/06/06 10:00 [pubmed]
PHST- 2002/06/27 10:01 [medline]
PHST- 2002/06/06 10:00 [entrez]
AID - 10.1093/jnci/94.11.852 [doi]
PST - ppublish
SO  - J Natl Cancer Inst. 2002 Jun 5;94(11):852-4. doi: 10.1093/jnci/94.11.852.