High false-negative rate of HER2 quantitative reverse transcription polymerase chain reaction of the oncotype DX test: An independent quality assurance study

Journal of Clinical Oncology

Volumn 29, Issue 32, 2011, Pages 4279-4285

  Dabbs, David J ^a   Klein, Molly E ^a   Mohsin, Syed K ^c   Tubbs, Raymond R ^d   Shuai, Yongli ^b   Bhargava, Rohit ^a  

^a UNIVERSITY OF PITTSBURGH   (United States)

^b UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^c RIVERSIDE METHODIST HOSPITAL   (United States)

^d CLEVELAND CLINIC LERNER COLLEGE OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANASTROZOLE; ANTINEOPLASTIC AGENT; CARBOPLATIN; CYCLOPHOSPHAMIDE; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; LETROZOLE; TAXANE DERIVATIVE; TRASTUZUMAB;

ARTICLE; BREAST CARCINOMA; CANCER CHEMOTHERAPY; CANCER COMBINATION CHEMOTHERAPY; CONTROLLED STUDY; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST ACCURACY STUDY; FALSE NEGATIVE RESULT; FALSE POSITIVE RESULT; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; GENE AMPLIFICATION; GENOMICS; HUMAN; IMMUNOHISTOCHEMISTRY; LABORATORY; LABORATORY TEST; MAJOR CLINICAL STUDY; PRIORITY JOURNAL; QUALITY CONTROL; QUANTITATIVE ASSAY; REVERSE TRANSCRIPTION POLYMERASE CHAIN REACTION; SENSITIVITY AND SPECIFICITY;

BREAST NEOPLASMS; FALSE NEGATIVE REACTIONS; FEMALE; HUMANS; IMMUNOHISTOCHEMISTRY; IN SITU HYBRIDIZATION, FLUORESCENCE; QUALITY ASSURANCE, HEALTH CARE; RECEPTOR, ERBB-2; REVERSE TRANSCRIPTASE POLYMERASE CHAIN REACTION;

EID: 81155151823     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2011.34.7963     Document Type: Article

References (18)

1. Chia S, Norris B, Speers C, et al.: Human epidermal growth factor receptor 2 overexpression as a prognostic factor in a large tissue microarray series of node-negative breast cancers. J Clin Oncol 26:5697-5704, 2008
2. Slamon DJ, Clark GM, Wong SG, et al.: Human breast cancer: Correlation of relapse and survival with amplification of the HER-2/neu oncogene. Science 235:177-182, 1987 (Pubitemid 17231334)
3. Wolff AC, Hammond ME, Schwartz JN, et al.: American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. J Clin Oncol 25:118-145, 2007 (Pubitemid 350003059)
4. Benohr P, Henkel V, Speer R, et al.: Her-2/neu expression in breast cancer: A comparison of different diagnostic methods. Anticancer Res 25:1895-1900, 2005 (Pubitemid 40904583)
5. Gjerdrum LM, Sorensen BS, Kjeldsen E, et al.: Real-time quantitative PCR of microdissected paraffin-embedded breast carcinoma: An alternative method for HER-2/neu analysis. J Mol Diagn 6:42-51, 2004 (Pubitemid 38208344)
6. Cronin M, Pho M, Dutta D, et al.: Measurement of gene expression in archival paraffin-embedded tissues: Development and performance of a 92-gene reverse transcriptase-polymerase chain reaction assay. Am J Pathol 164:35-42, 2004 (Pubitemid 38364587)
7. Paik S, Shak S, Tang G, et al.: A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 351: 2817-2826, 2004 (Pubitemid 40051905)
8. Baehner FL, Achacoso N, Maddala T, et al.: Human epidermal growth factor receptor 2 assessment in a case-control study: Comparison of fluorescence in situ hybridization and quantitative reverse transcription polymerase chain reaction performed by central laboratories. J Clin Oncol 28:4300-4306, 2010
9. US Food and Drug Administration: Guidance for industry and FDA staff: Statistical guidance on reporting results from studies evaluating diagnostic tests. http://medical.cms.itri.org.tw/pdf/u14.pdf
10. Ross JS, Fletcher JA, Linette GP, et al.: The Her-2/neu gene and protein in breast cancer 2003: Biomarker and target of therapy. Oncologist 8:307-325, 2003 (Pubitemid 36929717)
11. Aubele M, Mattis A, Zitzelsberger H, et al.: Intratumoral heterogeneity in breast carcinoma revealed by laser-microdissection and comparative genomic hybridization. Cancer Genet Cytogenet 110:94-102, 1999 (Pubitemid 29181514)
12. Bohm M, Wieland I, Schutze K, et al.: Microbeam MOMeNT: Non-contact laser microdissection of membrane-mounted native tissue. Am J Pathol 151:63-67, 1997
13. Gjerdrum LM, Lielpetere I, Rasmussen LM, et al.: Laser-assisted microdissection of membranemounted paraffin sections for polymerase chain reaction analysis: Identification of cell populations using immunohistochemistry and in situ hybridization. J Mol Diagn 3:105-110, 2001 (Pubitemid 32771509)
14. Emmert-Buck MR, Bonner RF, Smith PD, et al.: Laser capture microdissection. Science 274:998-1001, 1996 (Pubitemid 26398425)
15. Fend F, Emmert-Buck MR, Chuaqui R, et al.: Immuno-LCM: Laser capture microdissection of immunostained frozen sections for mRNA analysis. Am J Pathol 154:61-66, 1999 (Pubitemid 29031612)
16. Lahr G: RT-PCR from archival single cells is a suitable method to analyze specific gene expression. Lab Invest 80:1477-1479, 2000
17. Schutze K, Lahr G: Identification of expressed genes by laser-mediated manipulation of single cells. Nat Biotechnol 16:737-742, 1998 (Pubitemid 28363754)
18. O'Connor SM, Beriwal S, Dabbs DJ, et al.: Concordance between semiquantitative immunohistochemical assay and Oncotype DX RT-PCR assay for estrogen and progesterone receptors. Appl Immunohistochem Mol Morphol 18:268-272, 2010