Discordance between original and central laboratories in ER and HER2 results in a diverse, population-based sample
- 240 Downloads
To investigate the discordance between original and central laboratories in estrogen receptor (ER) status, in tumors originally deemed to be ER-negative, and in HER2 status in a diverse population-based sample.
In a follow-up study of 1785 women with Stage I–III breast cancer diagnosed between 2005 and 2007 in the Detroit and Los Angeles County SEER registry catchment areas, participants were asked to consent to reassessment of ER (in tumors originally deemed to be ER-negative) and HER2 status on archival tumor samples approximately four years after diagnosis. Blocks were centrally prepared and analyzed for ER and HER2 using standardized methods and the guidelines of the American Society of Clinical Oncology and the College of American Pathologists. Analyses determined the discordance between original and central laboratories.
132 (31%) of those eligible for ER reassessment and 367 (21%) eligible for HER2 reassessment had archival blocks reassessed centrally. ER discordance was only 6%. HER2 discordance by immunohistochemistry (IHC) was 26%, but final HER2 results—employing FISH in tumors that were IHC 2+ at the central laboratory—were discordant in only 6%. Half of the original laboratories did not perform their own assays.
Discordance between original and central laboratories in two large metropolitan areas was low in this population-based sample compared to previously reported patient samples. Centralization of testing for key pathology variables appears to be occurring in many hospitals. In addition, quality improvement efforts may have preceded the publication and dissemination of specialty society guidelines.
KeywordsBreast cancer Estrogen receptor HER2 SEER registry Pathology
- 1.National Comprehensive Cancer Network (2016) http://www.nccn.org/clinical.asp, Accessed 13 Oct 2016
- 2.Barnes DM, Harris WH, Smith P, Millis RR, Rubens RD (1996) Immunohistochemical determination of oestrogen receptor: comparison of different methods of assessment of staining and correlation with clinical outcome of breast cancer patients. Br J Cancer 74:1445–1451CrossRefPubMedPubMedCentralGoogle Scholar
- 3.Viale G, Regan MM, Maiorano E, Mastropasqua MG, Dell’Orto P, Rasmussen BB, Raffoul J, Neven P, Orosz Z, Braye S, Ohlschlegel C, Thurlimann B, Gelber RD, Castiglione-Gertsch M, Price KN, Goldhirsch A, Gusterson BA, Coates AS (2007) Prognostic and predictive value of centrally reviewed expression of estrogen and progesterone receptors in a randomized trial comparing letrozole and tamoxifen adjuvant therapy for postmenopausal early breast cancer: BIG 1-98. J Clin Oncol 25(25):3846–3852. doi:10.1200/JCO.2007.11.9453 CrossRefPubMedGoogle Scholar
- 5.Rasmussen BB, Regan MM, Lykkesfeldt AE, Dell’Orto P, Del Curto B, Henriksen KL, Mastropasqua MG, Price KN, Mery E, Lacroix-Triki M, Braye S, Altermatt HJ, Gelber RD, Castiglione-Gertsch M, Goldhirsch A, Gusterson BA, Thurlimann B, Coates AS, Viale G (2008) Adjuvant letrozole versus tamoxifen according to centrally-assessed ERBB2 status for postmenopausal women with endocrine-responsive early breast cancer: supplementary results from the BIG 1-98 randomised trial. Lancet Oncol 9:23–28. doi:10.1016/s1470-2045(07)70386-8 CrossRefPubMedGoogle Scholar
- 9.Rhodes A, Jasani B, Barnes DM, Bobrow LG, Miller KD (2000) Reliability of immunohistochemical demonstration of oestrogen receptors in routine practice: interlaboratory variance in the sensitivity of detection and evaluation of scoring systems. J Clin Pathol 53:125–130CrossRefPubMedPubMedCentralGoogle Scholar
- 10.Carlson RW, Moench SJ, Hammond ME, Perez EA, Burstein HJ, Allred DC, Vogel CL, Goldstein LJ, Somlo G, Gradishar WJ, Hudis CA, Jahanzeb M, Stark A, Wolff AC, Press MF, Winer EP, Paik S, Ljung BM (2006) HER2 testing in breast cancer: NCCN Task Force report and recommendations. JNCCN Suppl 3:S1–22Google Scholar
- 11.Wolff AC, Hammond ME, Schwartz JN, Hagerty KL, Allred DC, Cote RJ, Dowsett M, Fitzgibbons PL, Hanna WM, Langer A, McShane LM, Paik S, Pegram MD, Perez EA, Press MF, Rhodes A, Sturgeon C, Taube SE, Tubbs R, Vance GH, van de Vijver M, Wheeler TM, Hayes DF (2007) 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. doi:10.1200/JCO.2006.09.2775 CrossRefPubMedGoogle Scholar
- 12.Wolff AC, Hammond ME, Hicks DG, Dowsett M, McShane LM, Allison KH, Allred DC, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Hayes DF (2013) Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. J Clin Oncol 31(31):3997–4013. doi:10.1200/jco.2013.50.9984 CrossRefPubMedGoogle Scholar
- 13.Thomson TA, Hayes MM, Spinelli JJ, Hilland E, Sawrenko C, Phillips D, Dupuis B, Parker RL (2001) HER-2/neu in breast cancer: interobserver variability and performance of immunohistochemistry with 4 antibodies compared with fluorescent in situ hybridization. Mod Pathol 14:1079–1086. doi:10.1038/modpathol.3880440 CrossRefPubMedGoogle Scholar
- 16.Perez EA, Suman VJ, Davidson NE, Martino S, Kaufman PA, Lingle WL, Flynn PJ, Ingle JN, Visscher D, Jenkins RB (2006) HER2 testing by local, central, and reference laboratories in specimens from the North Central Cancer Treatment Group N9831 intergroup adjuvant trial. J Clin Oncol 24:3032–3038. doi:10.1200/JCO.2005.03.4744 CrossRefPubMedGoogle Scholar
- 17.Bianchi S, Caini S, Paglierani M, Saieva C, Vezzosi V, Baroni G, Simoni A, Palli D (2015) Accuracy and reproducibility of HER2 status in breast cancer using immunohistochemistry: a quality control study in Tuscany evaluating the impact of updated 2013 ASCO/CAP recommendations. Pathol Oncol Res 21:477–485. doi:10.1007/s12253-014-9852-0 CrossRefPubMedGoogle Scholar
- 18.Griggs JJ, Hawley ST, Graff JJ, Hamilton AS, Jagsi R, Janz NK, Mujahid MS, Friese CR, Salem B, Abrahamse PH, Katz SJ (2012) Factors associated with receipt of breast cancer adjuvant chemotherapy in a diverse population-based sample. J Clin Oncol 30:3058–3064. doi:10.1200/JCO.2012.41.9564 CrossRefPubMedPubMedCentralGoogle Scholar
- 19.Friese CR, Pini TM, Li Y, Abrahamse PH, Graff JJ, Hamilton AS, Jagsi R, Janz NK, Hawley ST, Katz SJ, Griggs JJ (2013) Adjuvant endocrine therapy initiation and persistence in a diverse sample of patients with breast cancer. Breast Cancer Res Treat 138:931–939. doi:10.1007/s10549-013-2499-9 CrossRefPubMedPubMedCentralGoogle Scholar
- 20.Minot DM, Kipp BR, Root RM, Meyer RG, Reynolds CA, Nassar A, Henry MR, Clayton AC (2009) Automated Cellular Imaging System III for assessing HER2 status in breast cancer specimens: development of a standardized scoring method that correlates with FISH. Am J Clin Pathol 132:133–138. doi:10.1309/ajcpjv0skaf2pcmy CrossRefPubMedGoogle Scholar
- 21.Hanley KZ, Siddiqui MT, Lawson D, Cohen C, Nassar A (2009) Evaluation of new monoclonal antibodies in detection of estrogen receptor, progesterone receptor, and HER2 protein expression in breast carcinoma cell block sections using conventional microscopy and quantitative image analysis. Diagn Cytopathol 37:251–257. doi:10.1002/dc.20989 CrossRefPubMedGoogle Scholar
- 23.Apple S, Pucci R, Lowe AC, Shintaku I, Shapourifar-Tehrani S, Moatamed N (2011) The effect of delay in fixation, different fixatives, and duration of fixation in estrogen and progesterone receptor results in breast carcinoma. Am J Clin Pathol 135:592–598. doi:10.1309/ajcpb1rit5yxmris CrossRefPubMedGoogle Scholar
- 25.Ma H, Wang Y, Sullivan-Halley J, Weiss L, Burkman RT, Simon MS, Malone KE, Strom BL, Ursin G, Marchbanks PA, McDonald JA, Spirtas R, Press MF, Bernstein L (2009) Breast cancer receptor status: do results from a centralized pathology laboratory agree with SEER registry reports? Cancer Epidemiol Biomarkers Prev 18:2214–2220. doi:10.1158/1055-9965.epi-09-0301 CrossRefPubMedPubMedCentralGoogle Scholar
- 26.Hammond ME, Hayes DF, Dowsett M, Allred DC, Hagerty KL, Badve S, Fitzgibbons PL, Francis G, Goldstein NS, Hayes M, Hicks DG, Lester S, Love R, Mangu PB, McShane L, Miller K, Osborne CK, Paik S, Perlmutter J, Rhodes A, Sasano H, Schwartz JN, Sweep FC, Taube S, Torlakovic EE, Valenstein P, Viale G, Visscher D, Wheeler T, Williams RB, Wittliff JL, Wolff AC (2010) American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. J Clin Oncol 28:2784–2795. doi:10.1200/jco.2009.25.6529 CrossRefPubMedPubMedCentralGoogle Scholar
- 28.Kaufman PA, Bloom KJ, Burris H, Gralow JR, Mayer M, Pegram M, Rugo HS, Swain SM, Yardley DA, Chau M, Lalla D, Yoo B, Brammer MG, Vogel CL (2014) Assessing the discordance rate between local and central HER2 testing in women with locally determined HER2-negative breast cancer. Cancer 120:2657–2664. doi:10.1002/cncr.28710 CrossRefPubMedPubMedCentralGoogle Scholar
- 30.Middleton LP, Price KM, Puig P, Heydon LJ, Tarco E, Sneige N, Barr K, Deavers MT (2009) Implementation of American Society of Clinical Oncology/College of American Pathologists HER2 Guideline Recommendations in a tertiary care facility increases HER2 immunohistochemistry and fluorescence in situ hybridization concordance and decreases the number of inconclusive cases. Arch Pathol Lab Med 133:775–780. doi:10.1043/1543-2165-133.5.775 PubMedGoogle Scholar
- 31.Tubbs RR, Hicks DG, Cook J, Downs-Kelly E, Pettay J, Hartke MB, Hood L, Neelon R, Myles J, Budd GT, Moore HC, Andresen S, Crowe JP (2007) Fluorescence in situ hybridization (FISH) as primary methodology for the assessment of HER2 status in adenocarcinoma of the breast: a single institution experience. Diagn Mol Pathol 16:207–210. doi:10.1097/PDM.0b013e318064c72a CrossRefPubMedGoogle Scholar
- 33.Pogue-Geile KL, Kim C, Jeong JH, Tanaka N, Bandos H, Gavin PG, Fumagalli D, Goldstein LC, Sneige N, Burandt E, Taniyama Y, Bohn OL, Lee A, Kim SI, Reilly ML, Remillard MY, Blackmon NL, Kim SR, Horne ZD, Rastogi P, Fehrenbacher L, Romond EH, Swain SM, Mamounas EP, Wickerham DL, Geyer CE Jr, Costantino JP, Wolmark N, Paik S (2013) Predicting degree of benefit from adjuvant trastuzumab in NSABP trial B-31. J Natl Cancer Inst 105:1782–1788. doi:10.1093/jnci/djt321 CrossRefPubMedPubMedCentralGoogle Scholar