Molecular characterization of breast cancer needle core biopsy specimens by the 21-gene Breast Recurrence Score test.

COVID-19 pandemic Oncotype DX Recurrence Score result core needle biopsy

Journal

Journal of surgical oncology
ISSN: 1096-9098
Titre abrégé: J Surg Oncol
Pays: United States
ID NLM: 0222643

Informations de publication

Date de publication:
Sep 2020
Historique:
received: 13 05 2020
accepted: 17 05 2020
medline: 5 6 2020
pubmed: 5 6 2020
entrez: 5 6 2020
Statut: ppublish

Résumé

Recent COVID-19 pandemic guidelines recommend genomic assessment of core biopsies to help guide treatment decisions in estrogen receptor (ER)-positive early-stage breast cancer. Herein we characterize biopsy and excisional breast cancer specimens submitted for 21-gene testing. US samples submitted to Genomic Health for 21-gene testing (01/2004-04/2020) were assessed by pathologists and analyzed by a standardized quantitative reverse transcription-polymerase chain reaction. Predefined cutoffs were: ESR1 (positive ≥6.5), PGR (positive ≥5.5), and ERBB2 (negative <10.7). ER status by immunohistochemistry (IHC) and lymph node status were determined locally. Median and interquartile range were reported for continuous variables, and total and percent for categorical variables. Distributions were assessed overall, by age, and by nodal involvement. Of 919 701 samples analyzed, 13% were biopsies and 87% were excisions. Initial assay success rates were 94.5% (biopsies) and 97.3% (excisions). ER IHC concordance with central ESR1 was 96.8% (biopsies) and 97.6% (excisions). Biopsy and excisional medians were: Recurrence Score results 16 (each); ESR1 10.2 (each); PGR 7.7 and 7.6; ERBB2 9.4 and 9.2, respectively. Biopsy submissions for 21-gene testing are common and consistently generate results that are very similar to the experience with excisions. The 21-gene test can be performed reliably on core biopsies.

Sections du résumé

BACKGROUND AND OBJECTIVE OBJECTIVE
Recent COVID-19 pandemic guidelines recommend genomic assessment of core biopsies to help guide treatment decisions in estrogen receptor (ER)-positive early-stage breast cancer. Herein we characterize biopsy and excisional breast cancer specimens submitted for 21-gene testing.
METHODS METHODS
US samples submitted to Genomic Health for 21-gene testing (01/2004-04/2020) were assessed by pathologists and analyzed by a standardized quantitative reverse transcription-polymerase chain reaction. Predefined cutoffs were: ESR1 (positive ≥6.5), PGR (positive ≥5.5), and ERBB2 (negative <10.7). ER status by immunohistochemistry (IHC) and lymph node status were determined locally. Median and interquartile range were reported for continuous variables, and total and percent for categorical variables. Distributions were assessed overall, by age, and by nodal involvement.
RESULTS RESULTS
Of 919 701 samples analyzed, 13% were biopsies and 87% were excisions. Initial assay success rates were 94.5% (biopsies) and 97.3% (excisions). ER IHC concordance with central ESR1 was 96.8% (biopsies) and 97.6% (excisions). Biopsy and excisional medians were: Recurrence Score results 16 (each); ESR1 10.2 (each); PGR 7.7 and 7.6; ERBB2 9.4 and 9.2, respectively.
CONCLUSIONS CONCLUSIONS
Biopsy submissions for 21-gene testing are common and consistently generate results that are very similar to the experience with excisions. The 21-gene test can be performed reliably on core biopsies.

Identifiants

pubmed: 32497318
doi: 10.1002/jso.26050
pmc: PMC7496790
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

611-618

Informations de copyright

© 2020 The Authors. Journal of Surgical Oncology published by Wiley Periodicals LLC.

Références

COVID-19 Pandemic Breast Cancer Consortium. COVID-19 guidelines for triage of breast cancer patients. https://www.facs.org/covid-19/clinical-guidance/elective-case/breast-cancer. Published 2020. Accessed April 9, 2020.
Dietz JR, Moran MS, Isakoff SJ, et al. Recommendations for prioritization, treatment and triage of breast cancer patients during the COVID-19 pandemic. Breast Cancer Res Treat. 2020;181(3):487-497. https://doi.org/10.1016/j.breast.2020.04.006
Ueda M, Martins R, Hendrie PC, et al. Managing cancer care during the COVID-19 pandemic: agility and collaboration toward a common goal. J Natl Compr Canc Netw. 2020;18(4):1-4.
Society of Surgical Oncology. Resource for management options of breast cancer during COVID-19. https://www.surgonc.org/wp-content/uploads/2020/03/Breast-Resource-during-COVID-19-3.30.20.pdf. Published 2020. Accessed April 7, 2020.
The American Society of Breast Surgeons. Performance and practice guidelines for the use of neoadjuvant systemic therapy in the management of breast cancer. https://www.breastsurgeons.org/docs/statements/Performance-and-Practice-Guidelines-for-the-Use-of-Neoadjuvant-Systemic-Therapy-in-the-Management-of-Breast-Cancer.pdf. Published 2017. Accessed April 7, 2020.
National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Breast Cancer (V3.2020). https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf. Published 2020. Accessed April 1, 2020.
Wolff AC, Hammond MEH, Allison KH, et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline focused update. J Clin Oncol. 2018;36(20):2105-2122.
Allison KH, Hammond MEH, Dowsett M, et al. Estrogen and progesterone receptor testing in breast cancer: ASCO/CAP Guideline update. J Clin Oncol, 38(12):1346-1366.
Li S, Yang X, Zhang Y, et al. Assessment accuracy of core needle biopsy for hormone receptors in breast cancer: a meta-analysis. Breast Cancer Res Treat. 2012;135(2):325-334.
You K, Park S, Ryu JM, et al. Comparison of core needle biopsy and surgical specimens in determining intrinsic biological subtypes of breast cancer with immunohistochemistry. J Breast Cancer. 2017;20(3):297-303.
Sharifi S, Peterson MK, Baum JK, et al. Assessment of pathologic prognostic factors in breast core needle biopsies. Mod Pathol. 1999;12(10):941-945.
Daveau C, Baulies S, Lalloum M, et al. Histological grade concordance between diagnostic core biopsy and corresponding surgical specimen in HR-positive/HER2-negative breast carcinoma. Br J Cancer. 2014;110(9):2195-2200.
Harris GC, Denley HE, Pinder SE, et al. Correlation of histologic prognostic factors in core biopsies and therapeutic excisions of invasive breast carcinoma. Am J Surg Pathol. 2003;27(1):11-15.
Burge CN, Chang HR, Apple SK. Do the histologic features and results of breast cancer biomarker studies differ between core biopsy and surgical excision specimens? Breast. 2006;15(2):167-172.
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. 2004;351(27):2817-2826.
Paik S, Tang G, Shak S, et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol. 2006;24(23):3726-3734.
Dowsett M, Cuzick J, Wale C, et al. Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study. J Clin Oncol. 2010;28(11):1829-1834.
Albain KS, Barlow WE, Shak S, et al. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol. 2010;11(1):55-65.
Sparano JA, Gray RJ, Makower DF, et al. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med. 2015;373(21):2005-2014.
Sparano JA, Gray RJ, Makower DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med. 2018;379(2):111-121.
Sparano JA, Gray RJ, Makower DF, et al. Clinical outcomes in early breast cancer with a high 21-gene Recurrence Score of 26 to 100 assigned to adjuvant chemotherapy plus endocrine therapy: a secondary analysis of the TAILORx randomized clinical trial. JAMA Oncol. 2019;6(3):367-374.
Iwata H, Masuda N, Yamamoto Y, et al. Validation of the 21-gene test as a predictor of clinical response to neoadjuvant hormonal therapy for ER+, HER2-negative breast cancer: the TransNEOS study. Breast Cancer Res Treat. 2019;173(1):123-133.
Akashi-Tanaka S, Shimizu C, Ando M, et al. 21-gene expression profile assay on core needle biopsies predicts responses to neoadjuvant endocrine therapy in breast cancer patients. Breast. 2009;18(3):171-174.
Ueno T, Masuda N, Yamanaka T, et al. Evaluating the 21-gene assay Recurrence Score as a predictor of clinical response to 24 weeks of neoadjuvant exemestane in estrogen receptor-positive breast cancer. Int J Clin Oncol. 2014;19(4):607-613.
Gianni L, Zambetti M, Clark K, et al. Gene expression profiles in paraffin-embedded core biopsy tissue predict response to chemotherapy in women with locally advanced breast cancer. J Clin Oncol. 2005;23(29):7265-7277.
Chang JC, Makris A, Gutierrez MC, et al. Gene expression patterns in formalin-fixed, paraffin-embedded core biopsies predict docetaxel chemosensitivity in breast cancer patients. Breast Cancer Res Treat. 2008;108(2):233-240.
Pivot X, Mansi L, Chaigneau L, et al. In the era of genomics, should tumor size be reconsidered as a criterion for neoadjuvant chemotherapy? Oncologist. 2015;20(4):344-350.
Yardley DA, Peacock NW, Shastry M, et al. A phase II trial of ixabepilone and cyclophosphamide as neoadjuvant therapy for patients with HER2-negative breast cancer: correlation of pathologic complete response with the 21-gene Recurrence Score. Breast Cancer Res Treat. 2015;154(2):299-308.
Soran A, Bhargava R, Johnson R, et al. The impact of Oncotype DX(R) Recurrence Score of paraffin-embedded core biopsy tissues in predicting response to neoadjuvant chemotherapy in women with breast cancer. Breast Dis. 2016;36(2-3):65-71.
Pease AM, Riba LA, Gruner RA, Tung NM, James TA. Oncotype DX Recurrence Score as a predictor of response to neoadjuvant chemotherapy. Ann Surg Oncol. 2019;26(2):366-371.
Zelnak AB, Murali S, Styblo TM, et al. Phase II trial evaluating the use of 21-gene Recurrence Score to select preoperative therapy in hormone receptor-positive breast cancer [abstract]. J Clin Oncol. 2013;31(15 suppl):562.
Bear HD, Wan W, Robidoux A, et al. Using the 21-gene assay from core needle biopsies to choose neoadjuvant therapy for breast cancer: a multicenter trial. J Surg Oncol. 2017;115(8):917-923.
Badve S, Gray R, Childs B, et al. ER assessment by central laboratory immunohistochemistry: examination and comparison of percent positive cells and nuclear staining intensity in ECOG breast cancer study E2197 [abstract]. USCAP 98th Annual Meeting; 2009; Boston, MA.
Baehner FL. The analytical validation of the Oncotype DX Recurrence Score assay. Ecancermedicalscience. 2016;10:675.
Badve SS, Baehner FL, Gray RP, et al. Estrogen- and progesterone-receptor status in ECOG 2197: comparison of immunohistochemistry by local and central laboratories and quantitative reverse transcription polymerase chain reaction by central laboratory. J Clin Oncol. 2008;26(15):2473-2481.
Baehner FL, Yoshizawa C, Shak S. Accurate assessment of human epidermal growth factor receptor 2. J Clin Oncol. 2012;30(14):1727-1728.
Spring LM, Gupta A, Reynolds KL, et al. Neoadjuvant endocrine therapy for estrogen receptor-positive breast cancer: a systematic review and meta-analysis. JAMA Oncol. 2016;2(11):1477-1486.
Fennessy M, Bates T, MacRae K, Riley D, Houghton J, Baum M. Late follow-up of a randomized trial of surgery plus tamoxifen versus tamoxifen alone in women aged over 70 years with operable breast cancer. Br J Surg. 2004;91(6):699-704.
Mustacchi G, Ceccherini R, Milani S, et al. Tamoxifen alone versus adjuvant tamoxifen for operable breast cancer of the elderly: long-term results of the phase III randomized controlled multicenter GRETA trial. Ann Oncol. 2003;14(3):414-420.
Stull TS, Goodwin MC, Anderson JM, et al. Comparison of Oncotype DX Recurrence Scores between surgical and core biopsy specimens in breast cancer patients [abstract]. Cancer Res. 2011;71(suppl24):Abstract P3-06-05.
Amat S, Penault-Llorca F, Cure H, et al. Scarff-Bloom-Richardson (SBR) grading: a pleiotropic marker of chemosensitivity in invasive ductal breast carcinomas treated by neoadjuvant chemotherapy. Int J Oncol. 2002;20(4):791-796.
Wang J, Buchholz TA, Middleton LP, et al. Assessment of histologic features and expression of biomarkers in predicting pathologic response to anthracycline-based neoadjuvant chemotherapy in patients with breast carcinoma. Cancer. 2002;94(12):3107-3114.
Petit T, Wilt M, Velten M, et al. Comparative value of tumour grade, hormonal receptors, Ki-67, HER-2 and topoisomerase II alpha status as predictive markers in breast cancer patients treated with neoadjuvant anthracycline-based chemotherapy. Eur J Cancer. 2004;40(2):205-211.
Guarneri V, Broglio K, Kau SW, et al. Prognostic value of pathologic complete response after primary chemotherapy in relation to hormone receptor status and other factors. J Clin Oncol. 2006;24(7):1037-1044.
Petkov VI, Miller DP, Howlader N, et al. Breast-cancer-specific mortality in patients treated based on the 21-gene assay: a SEER population-based study. NPJ Breast Cancer. 2016;2:16017.
Roberts MC, Miller DP, Shak S, Petkov VI. Breast cancer-specific survival in patients with lymph node-positive hormone receptor-positive invasive breast cancer and Oncotype DX Recurrence Score results in the SEER database. Breast Cancer Res Treat. 2017;163(2):303-310.
Cronin M, Sangli C, Liu ML, et al. Analytical validation of the Oncotype DX genomic diagnostic test for recurrence prognosis and therapeutic response prediction in node-negative, estrogen receptor-positive breast cancer. Clin Chem. 2007;53(6):1084-1091.
Geyer CE Jr., Tang G, Mamounas EP, et al. 21-Gene assay as predictor of chemotherapy benefit in HER2-negative breast cancer. NPJ Breast Cancer. 2018;4:37.

Auteurs

Debbie M Jakubowski (DM)

Exact Sciences Corporation, Redwood City, California.

Helen Bailey (H)

Exact Sciences Corporation, Redwood City, California.

John Abran (J)

Exact Sciences Corporation, Redwood City, California.

Andrea Blacklock (A)

Exact Sciences Corporation, Redwood City, California.

Nancy Ciau (N)

Exact Sciences Corporation, Redwood City, California.

Carolyn Mies (C)

Exact Sciences Corporation, Redwood City, California.

Vivian Tan (V)

Exact Sciences Corporation, Redwood City, California.

Rebekah Young (R)

Exact Sciences Corporation, Redwood City, California.

Anna Lau (A)

Exact Sciences Corporation, Redwood City, California.

Frederick L Baehner (FL)

Exact Sciences Corporation, Redwood City, California.

Classifications MeSH