Journal Article
. 2010 Jun; 116(13):3112-8.
doi: 10.1002/cncr.25206.

Clinical significance of the 21-gene signature (Oncotype DX) in hormone receptor-positive early stage primary breast cancer in the Japanese population

Masakazu Toi 1 Hiroji Iwata  Takeharu Yamanaka  Norikazu Masuda  Shinji Ohno  Seigo Nakamura  Takahiro Nakayama  Masahiro Kashiwaba  Shunji Kamigaki  Katsumasa Kuroi  Japan Breast Cancer Research Group-Translational Research Group  
Affiliations
  • PMID: 20564629
  •     33 citations

Abstract

Background: The 21-gene signature has been intensively studied and incorporated into major guidelines for treatment decision in early breast cancer. However, it remains to be examined whether this system is applicable to Asian populations.

Methods: The authors collected 325 tumor tissues from estrogen receptor (ER)-positive primary breast cancer patients who had undergone surgery and were treated with tamoxifen between 1992 and 1998. The tissues were analyzed for the 21-gene signature, and the patients were classified into groups of low, intermediate, or high risk based on the Recurrence Score.

Results: A total of 280 patients were eligible, with adequate reverse transcription polymerase chain reaction profiles for the Recurrence Score. Of those, 200 and 80 patients had lymph node-negative and lymph node-positive disease, respectively. The proportions of lymph node-negative patients categorized as being at low, intermediate, or high risk were 48%, 20%, and 33%, respectively. In lymph node-negative patients, the Kaplan-Meier estimates of the distant recurrence rate at 10 years were 3.3% (95% confidence interval [95% CI], 1.1-10.0%), 0%, and 24.8% (95% CI, 15.7-37.8%) for those in the low-risk, intermediate-risk, and high-risk groups, respectively. The risk of distant recurrence in the low-risk group was significantly lower than that in the high-risk group when the entire Kaplan-Meier plots were compared (P < .001, log-rank test). There was a significant difference for overall survival between the low-risk and the high-risk groups (P = .008, log-rank test).

Conclusions: This is the first report to show that the 21-gene signature has value in providing prognostic information in Asian populations with ER-positive, lymph node-negative breast cancer.

The effect of Oncotype DX recurrence score on treatment recommendations for patients with estrogen receptor-positive early stage breast cancer and correlation with estimation of recurrence risk by breast cancer specialists.
Jennifer E Joh, Nicole N Esposito, +10 authors, Geza Acs.
Oncologist, 2011 Oct 22; 16(11). PMID: 22016474    Free PMC article.
PBX1 genomic pioneer function drives ERα signaling underlying progression in breast cancer.
Luca Magnani, Elizabeth B Ballantyne, Xiaoyang Zhang, Mathieu Lupien.
PLoS Genet, 2011 Nov 30; 7(11). PMID: 22125492    Free PMC article.
Early developments in gene-expression profiling of breast tumors: potential for increasing black-white patient disparities in breast cancer outcomes?
Donna H Odierna, Aimee Afable-Munsuz, +5 authors, Ninez A Ponce.
Per Med, 2011 Dec 23; 8(6). PMID: 22190978    Free PMC article.
Gene expression profiling for guiding adjuvant chemotherapy decisions in women with early breast cancer: an evidence-based and economic analysis.
Medical Advisory Secretariat.
Ont Health Technol Assess Ser, 2010 Jan 01; 10(23). PMID: 23074401    Free PMC article.
An overview of the Japan Breast Cancer Research Group (JBCRG) activities.
Shinji Ohno, Katsumasa Kuroi, Masakazu Toi.
Breast Cancer, 2013 Mar 16; 20(4). PMID: 23494592    Free PMC article.
Review.
The impact of the 21-gene Recurrence Score assay on clinical decision-making in node-positive (up to 3 positive nodes) estrogen receptor-positive breast cancer patients.
Salomon M Stemmer, Shmuel H Klang, +7 authors, Nicky Lieberman.
Breast Cancer Res Treat, 2013 Jun 27; 140(1). PMID: 23801158    Free PMC article.
The impact of the Oncotype DX Recurrence Score on treatment decisions and clinical outcomes in patients with early breast cancer: the Maccabi Healthcare Services experience with a unified testing policy.
Nava Siegelmann-Danieli, Barbara Silverman, +3 authors, Avi Porath.
Ecancermedicalscience, 2014 Jan 05; 7. PMID: 24386009    Free PMC article.
The application of Oncotype DX in early-stage lymph-node-positive disease.
Sarika Jain, William J Gradishar.
Curr Oncol Rep, 2014 Jan 21; 16(1). PMID: 24442572
Review.
Treatment decisions in estrogen receptor-positive early breast cancer patients with intermediate oncotype DX recurrence score results.
Georgeta Fried, Mor Moskovitz.
Springerplus, 2014 Feb 26; 3. PMID: 24567880    Free PMC article.
Diagnostic tests based on gene expression profile in breast cancer: from background to clinical use.
Laura Zanotti, Alberto Bottini, +2 authors, Maria Rosa Cappelletti.
Tumour Biol, 2014 Jul 23; 35(9). PMID: 25048969
Review.
Societal cost-effectiveness analysis of the 21-gene assay in estrogen-receptor-positive, lymph-node-negative early-stage breast cancer in Japan.
Hideko Yamauchi, Chizuko Nakagawa, +9 authors, Seigo Nakamura.
BMC Health Serv Res, 2014 Sep 06; 14. PMID: 25190451    Free PMC article.
A Prospective Comparison of the 21-Gene Recurrence Score and the PAM50-Based Prosigna in Estrogen Receptor-Positive Early-Stage Breast Cancer.
Michael D Alvarado, Che Prasad, +5 authors, Christos J Markopoulos.
Adv Ther, 2015 Nov 28; 32(12). PMID: 26610383    Free PMC article.
Fertility Preservation for the Young Breast Cancer Patient.
Shari B Goldfarb, Sabrina A Kamer, +6 authors, Mary L Gemignani.
Ann Surg Oncol, 2016 Jan 23; 23(5). PMID: 26790670    Free PMC article.
Comprehensive Histologic Scoring to Maximize the Predictability of Pathology-generated Equation of Breast Cancer Oncotype DX Recurrence Score.
Thaer Khoury, Xiao Huang, +3 authors, Mateusz Opyrchal.
Appl Immunohistochem Mol Morphol, 2016 Jan 26; 24(10). PMID: 26808126    Free PMC article.
The impact of the 21-gene assay on adjuvant treatment decisions in oestrogen receptor-positive early breast cancer: a prospective study.
Anna Kuchel, Tim Robinson, +8 authors, Jeremy P Braybrooke.
Br J Cancer, 2016 Mar 10; 114(7). PMID: 26954715    Free PMC article.
The analytical validation of the Oncotype DX Recurrence Score assay.
Frederick L Baehner.
Ecancermedicalscience, 2016 Oct 13; 10. PMID: 27729940    Free PMC article.
Estimating the OncotypeDX score: validation of an inexpensive estimation tool.
Anne A Eaton, Catherine E Pesce, +5 authors, Mahmoud El-Tamer.
Breast Cancer Res Treat, 2016 Dec 09; 161(3). PMID: 27928699    Free PMC article.
Adjuvant treatment recommendations for patients with ER-positive/HER2-negative early breast cancer by Swiss tumor boards using the 21-gene recurrence score (SAKK 26/10).
Bernhard C Pestalozzi, Christoph Tausch, +17 authors, Swiss Group for Clinical Cancer Research (SAKK).
BMC Cancer, 2017 Apr 15; 17(1). PMID: 28407750    Free PMC article.
Prognostic cancer gene signatures share common regulatory motifs.
Ying Wang, Steve Goodison, Xiaoman Li, Haiyan Hu.
Sci Rep, 2017 Jul 08; 7(1). PMID: 28684851    Free PMC article.
Clinical outcomes in ER+ HER2 -node-positive breast cancer patients who were treated according to the Recurrence Score results: evidence from a large prospectively designed registry.
Salomon M Stemmer, Mariana Steiner, +13 authors, Noa Ben-Baruch.
NPJ Breast Cancer, 2017 Sep 14; 3. PMID: 28900632    Free PMC article.
Clinical outcomes in patients with node-negative breast cancer treated based on the recurrence score results: evidence from a large prospectively designed registry.
Salomon M Stemmer, Mariana Steiner, +21 authors, Nicky Liebermann.
NPJ Breast Cancer, 2017 Sep 14; 3. PMID: 28900633    Free PMC article.
Gene expression profiling in prognosis of distant recurrence in HR-positive and HER2-negative breast cancer patients.
Tzu-Ting Huang, Nicolas Pennarun, +3 authors, Skye Hung-Chun Cheng.
Oncotarget, 2018 May 26; 9(33). PMID: 29796180    Free PMC article.
Panoptic View of Prognostic Models for Personalized Breast Cancer Management.
Geetanjali Saini, Karuna Mittal, +3 authors, Ritu Aneja.
Cancers (Basel), 2019 Sep 11; 11(9). PMID: 31500225    Free PMC article.
Review.
21-Gene recurrence score influences the chemotherapy decision for patients with breast cancer of different luminal subtypes.
Wei Wang, Lin Lin, +11 authors, Kunwei Shen.
Oncol Lett, 2019 Oct 04; 18(4). PMID: 31579428    Free PMC article.
Adjuvant chemotherapy and survival among patients 70 years of age and younger with node-negative breast cancer and the 21-gene recurrence score of 26-30.
Seho Park, Yunan Han, +7 authors, Yikyung Park.
Breast Cancer Res, 2019 Oct 18; 21(1). PMID: 31619259    Free PMC article.
Decision of Adjuvant Systemic Treatment in HR+ HER2- Early Invasive Breast Cancer: Which Biomarkers Could Help?
Marie Alexandre, Aurélie Maran-Gonzalez, +6 authors, Séverine Guiu.
Cancer Manag Res, 2019 Dec 19; 11. PMID: 31849525    Free PMC article.
Review.
A preliminary report of head-to-head comparison of 18-gene-based clinical-genomic model and oncotype DX 21-gene assay for predicting recurrence of early-stage breast cancer.
Po-Sheng Yang, Yi-Hsuan Lee, +9 authors, Chiun-Sheng Huang.
Jpn J Clin Oncol, 2019 Jul 10; 49(11). PMID: 31287883    Free PMC article.
Breast cancer: an update on treatment-related infertility.
Erica Silvestris, Miriam Dellino, +3 authors, Stella D'Oronzo.
J Cancer Res Clin Oncol, 2020 Feb 02; 146(3). PMID: 32006118
Review.
Community clinical practice patterns and mortality in patients with intermediate oncotype DX recurrence scores: Who benefits from chemotherapy?
Abiola F Ibraheem, David J Press, Olufunmilayo I Olopade, Dezheng Huo.
Cancer, 2018 Nov 06; 125(2). PMID: 30387876    Free PMC article.
A new clinical-genomic model to predict 10-year recurrence risk in primary operable breast cancer patients.
Tzu-Ting Huang, Lei Lei, +3 authors, Skye Hung-Chun Cheng.
Sci Rep, 2020 Mar 19; 10(1). PMID: 32184406    Free PMC article.
A DNA Methylation-Based Panel for the Prognosis and Dagnosis of Patients With Breast Cancer and Its Mechanisms.
Xiao-Ping Liu, Jinxuan Hou, +3 authors, Sheng Li.
Front Mol Biosci, 2020 Aug 01; 7. PMID: 32733914    Free PMC article.
Adipophilin expression is an independent marker for poor prognosis of patients with triple-negative breast cancer: An immunohistochemical study.
Katsuhiro Yoshikawa, Mitsuaki Ishida, +3 authors, Tomoharu Sugie.
PLoS One, 2020 Nov 18; 15(11). PMID: 33201923    Free PMC article.
Predicting chemosensitivity using drug perturbed gene dynamics.
Joshua D Mannheimer, Ashok Prasad, Daniel L Gustafson.
BMC Bioinformatics, 2021 Jan 09; 22(1). PMID: 33413081    Free PMC article.