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3/2024
vol. 28
 
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Original paper

The utility of the 21-gene Oncotype DX Breast Recurrence Score® assay in node-negative breast cancer patients – the final analysis of the Polish real life survey PONDx

Michał Jarząb
1
,
Maria Litwiniuk
2, 3
,
Paige Innis
4
,
Aleksandra Łacko
5
,
Gesine Enderle
6
,
Bogumiła Czartoryska-Arłukowicz
7
,
Małgorzata Talerczyk
8
,
Joanna Streb
9, 10
,
Piotr Wysocki
9, 10
,
Grażyna Suchodolska
11
,
Bartosz Szymanowski
12
,
Renata Duchnowska
12

  1. Breast Cancer Centre, Maria Skłodowska-Curie National Research Institute of Oncology, Gliwice Branch, Gliwice, Poland
  2. Department of Clinical Oncology and Immuno-oncology, Greater Poland Cancer Centre, Poznań, Poland
  3. Department of Cancer Pathology and Prevention, Poznań University of Medical Sciences, Poznań, Poland
  4. Exact Sciences Corporation, Redwood City, CA, USA
  5. Lower Silesian Oncology Centre, Medical University of Wrocław, Wrocław, Poland
  6. Exact Sciences International GmbH, Baar, Switzerland
  7. M. Skłodowska-Curie Bialystok Oncology Centre, Białystok, Poland
  8. West Pomeranian Oncology Centre in Szczecin, Szczecin, Poland
  9. Department of Oncology, Jagiellonian University Medical College, Kraków, Poland
  10. Department of Oncology, Krakow University Hospital, Kraków, Poland
  11. Department of Oncology and Radiotherapy, Medical University of Gdańsk, Gdańsk, Poland
  12. Department of Oncology, Military Institute of Medicine – National Research Institute, Warsaw, Poland
Contemp Oncol (Pozn) 2024; 28 (3): 245–252
DOI: https://doi.org/10.5114/wo.2024.144222
Online publish date: 2024/10/15
Article file
- The utility of the 21-gene (1).pdf  [0.11 MB]
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1. Partridge AH, Rumble RB, Carey LA, et al. Chemotherapy and targeted therapy for women with human epidermal growth factor receptor 2-negative (or unknown) advanced breast cancer: Ame- rican Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol 2014; 32: 3307-3329.
2. Wojciechowska U, Barańska K, Miklewska M, Didkowska JA. Cancer incidence and mortality in Poland in 2020. NOWOTWORY J Oncol 2023; 73: 129-145.
3. Roth MY, Elmore JG, Yi-Frazier JP, Reisch LM, Oster NV, Miglioret- ti DL. Self-detection remains a key method of breast cancer detection for U.S. women. J Womens Health (Larchmt) 2011; 20: 1135-1139.
4. Barni S, Cognetti F, Petrelli F. Is the oncotype DX test useful in elderly breast cancer patients: a subgroup analysis of real-life Ita- lian PONDx study. Breast Cancer Res Treat 2022; 191: 477-480.
5. Syed YY. Oncotype DX Breast Recurrence Score(®): a review of its use in early-stage breast cancer. Mol Diagn Ther 2020; 24: 621-632.
6. Skapek SX, Ferrari A, Gupta AA, et al. Rhabdomyosarcoma. Nat Rev Dis Primer 2019; 5: 1.
7. Female breast cancer subtypes – cancer stat facts. SEER. Available from: https://seer.cancer.gov/statfacts/html/breast-subtypes.html (accessed: 05.06.2024).
8. Fisher B, Jeong JH, Bryant J, et al Treatment of lymph-node-negative, oestrogen-receptor-positive breast cancer: long-term fin-dings from National Surgical Adjuvant Breast and Bowel Project randomised clinical trials. Lancet 2004; 364: 858-868.
9. Peto R, Davies C, Godwin J, et al. Comparisons between different polychemotherapy regimens for early breast cancer: meta- analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet 2012; 379: 432-444.
10. Schaafsma E, Zhang B, Schaafsma M, Tong CY, Zhang L, Cheng C. Impact of Oncotype DX testing on ER+ breast cancer treatment and survival in the first decade of use. Breast Cancer Res 2021; 23: 74.
11. Pearce A, Haas M, Viney R, et al. Incidence and severity of self-reported chemotherapy side effects in routine care: A prospective cohort study. PLoS One 2017; 12: e0184360.
12. Cheng R, Kong X, Wang X, Fang Y, Wang J. Oncotype DX Breast Recurrence Score Distribution and Chemotherapy Benefit among women of different age groups with HR-positive, HER2-negative, node-negative breast cancer in the SEER database. Front Oncol 2020; 10: 1583.
13. Santa-Maria CA, Camp M, Cimino-Mathews A, Harvey S, Wright J, Stearns V. Neoadjuvant therapy for early-stage breast cancer: current practice, controversies, and future directions. Oncology (Williston Park) 2015; 29: 828-838.
14. Excellence. NIfHaC. Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer. Available from: https: //www.nice.org.uk: National Institute for Health and Care Excellence (accessed: 10.06.2024).
15. Network. NCC. NCCN clinical practice guidelines in oncology (NCCN Guidelines): breast cancer, version 3. Available from: https : //www.nccn.org: National Comprehensive Cancer Network (accessed: 10.06.2024).
16. 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: 2817-2826.
17. Habel LA, Shak S, Jacobs MK, et al. A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients. Breast Cancer Res 2006; 8: R25.
18. 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: 111-121.
19. Markopoulos C, van de Velde C, Zarca D, Ozmen V, Masetti R. Clinical evidence supporting genomic tests in early breast cancer: Do all genomic tests provide the same information? Eur J Surg Oncol 2017; 43: 909-920.
20. Fayanju OM, Park KU, Lucci A. Molecular genomic testing for breast cancer: utility for surgeons. Ann Surg Oncol 2018; 25: 512-519.
21. Hochheiser L, Hornberger J, Turner M, Lyman GH. Multi-gene assays: effect on chemotherapy use, toxicity and cost in estrogen receptor-positive early stage breast cancer. J Comp Eff Res 2019; 8: 289-304.
22. Varga Z, Sinn P, Seidman AD. Summary of head-to-head comparisons of patient risk classifications by the 21-gene Recurrence Score® (RS) assay and other genomic assays for early breast cancer. Int J Cancer 2019; 145: 882-893.
23. 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 2020; 6: 367-374.
24. Sparano JA, Gray RJ, Ravdin PM, et al. Clinical and genomic risk to guide the use of adjuvant therapy for breast cancer. N Engl J Med 2019; 380: 2395-405.
25. 25. Kalinsky K, Barlow WE, Gralow JR, et al. 21-gene assay to inform chemotherapy benefit in node-positive breast cancer. N Engl J Med 2021; 385: 2336-2347.
26. Lux MP, Minartz C, Müller-Huesmann H, Sandor MF, Radeck-Knorre S, Neubauer AS. Budget impact of the Oncotype DX Breast Recurrence Score® test in patients with early primary hormone-receptor- positive, HER2-negative, node-positive breast cancer in Germany. Breast Care 2023; 19: 27-33.
27. Bravaccini S, Mazza M, Maltoni R. No more disparities among regions in Italy: recent approval of genomic test reimbursability for early breast cancer patients in the country. Breast Cancer Res Treat 2023; 201: 1-3.
28. Smyth L, Watson G, Walsh EM, et al. Economic impact of 21-gene recurrence score testing on early-stage breast cancer in Ireland. Breast Cancer Res Treat 2015; 153: 573-582.
29. Plaud MG, Helk E, Ecker T, Herrmann KH. PCN254 assment and reimbursement of GENE Expression TESTS in breast cancer in Europe – a comparative policy analysis. Value in Health 2020; 23: S468.
30. Fisher B, Jeong JH, Bryant J, et al . Treatment of lymph-node-negative, oestrogen-receptor-positive breast cancer: long-term findings from National Surgical Adjuvant Breast and Bowel Project randomised clinical trials. Lancet 2004; 364: 858-868.
31. Faragalla H, Plotkin A, Barnes P, et al. Ki67 in breast cancer assay: an ad hoc testing recommendation from the Canadian Association of Pathologists Task Force. Curr Oncol 2023; 30: 3079-3090.
32. Inwald E, Klinkhammer-Schalke M, Hofstädter F, et al. Ki-67 is a prognostic parameter in breast cancer patients: results of a large population-based cohort of a cancer registry. Breast Cancer Res Treat 2013; 139: 539-552.
33. Petrelli F, Viale G, Cabiddu M, Barni S. Prognostic value of different cut-off levels of Ki-67 in breast cancer: a systematic review and meta-analysis of 64,196 patients. Breast Cancer Res Treat 2015; 153: 477-491.
34. Felts JL, Zhu J, Han B, Smith SJ, Truica CI. An analysis of Oncotype DX Recurrence Scores and clinicopathologic characteristics in invasive lobular breast cancer. Breast J 2017; 23: 677-686.
35. Bae SJ, Ahn SG, Ji JH, et al. Application of the 21-Gene Recurrence Score in patients with early HR-positive/HER2-negative breast cancer: chemotherapy and survival rate according to clinical risk. Cancers (Basel) 2021; 13.
36. Cognetti F, Masetti R, Fabi A, et al. PONDx: real-life utilization and decision impact of the 21-gene assay on clinical practice in Italy. NPJ Breast Cancer 2021; 7: 47.
37. Curtit E, Vannetzel JM, Darmon JC, et al. Results of PONDx, a prospective multicenter study of the Oncotype DX® breast cancer assay: real-life utilization and decision impact in French clinical practice. Breast 2019; 44: 39-45.
38. Chiru ED, Oseledchyk A, Schoetzau A, et al . Application of a 21-Gene Recurrence Score in a Swiss Single-Center Breast Cancer Population: a comparative analysis of treatment administration before and after TAILORx. Diagnostics (Basel) 2023; 14.
39. Group EBCTC. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100 000 women in 123 randomised trials. Lancet 2012; 379: 432-444.
40. Swain SM, Jeong JH, Geyer Jr CE, et al. Longer therapy, iatrogenic amenorrhea, and survival in early breast cancer. N En J Med 2010; 362: 2053-2065.
41. 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: 1829-1834.
42. 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: 3726-3734.
43. Orucevic A, Heidel RE, Bell JL. Utilization and impact of 21-gene recurrence score assay for breast cancer in clinical practice across the United States: lessons learned from the 2010 to 2012 National Cancer Data Base analysis. Breast Cancer Res Treat 2016; 157: 427-435.
44. LeVasseur N, Sun J, Fenton D, et al. Impact of the 21-Gene Recurrence Score assay on the treatment of estrogen receptor-positive, HER2-negative, breast cancer patients with 1-3 positive nodes: a prospective clinical utility study. Clin Breast Cancer 2022; 22: e74-e9.
45. Hassan S, Younan R, Patocskai E, et al. Impact of the 21-gene recurrence score assay on treatment decisions and cost in patients with node-positive breast cancer: a multicenter study in Quebec. Oncologist 2022; 27: 822-831.
46. Dieci MV, Guarneri V, Zustovich F, et al. Impact of 21-gene breast cancer assay on treatment decision for patients with T1-T3, N0-N1, estrogen receptor-positive/human epidermal growth receptor 2-negative breast cancer: final results of the prospective multicenter ROXANE study. Oncologist 2019; 24: 1424-1431.
47. Davidson JA, Cromwell I, Ellard SL, et al. A prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene Recurrence Score® assay in oestrogen receptor positive node negative breast cancer. Eur J Cancer 2013; 49: 2469-2475.
48. Torres S, Trudeau M, Gandhi S, et al. Prospective evaluation of the impact of the 21-gene recurrence score assay on adjuvant treatment decisions for women with node-positive breast cancer in Ontario, Canada. Oncologist 2018; 23: 768-775.
49. Lux MP, Minartz C, Muller-Huesmann H, et al. Budget impact of the Oncotype DX(R) test compared to other gene expression tests in patients with early breast cancer in Germany. Cancer Treat Res Commun 2022; 31: 100519.
Copyright: © 2024 Termedia Sp. z o. o. This is an Open Access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International (CC BY-NC-SA 4.0) License (http://creativecommons.org/licenses/by-nc-sa/4.0/), allowing third parties to copy and redistribute the material in any medium or format and to remix, transform, and build upon the material, provided the original work is properly cited and states its license.
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