Mammaprint is a test that identifies a profile of a tumor sample that is then used to assess risk. In February 2005, the BlueCross BlueShield Association Technology Evaluation Center (TEC) conducted a technology assessment on gene expression profiling for managing breast cancer treatment.
MammaPrint was added to the St. Gallen’s International Oncology Guidelines for Primary Therapy of Early Breast Cancer(Goldhirsch 2009) and in 2008 MammaPrint was included in The Dutch Institute for Healthcare Improvement CBO Guidelines. The CBO guidelines, drafted in collaboration with the Dutch Association of Comprehensive Cancer Centers (ACCC) and the Dutch National Breast Cancer Consultation Group (NABON). MammaPrint will be offered as standard of care for all eligible early stage breast cancer patients at the Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital (NKI-AVL). In an important change from the previous St Gallen conference and after a long debate, the Panel supported the use of a validated multigene-profiling assay, if readily available, as an adjunct to high-quality phenotyping of breast cancer in cases in which the indication for adjuvant chemotherapy remained uncertain.
Most recently, Hayes Annual Review of MammaPrint® for Prognosis of Breast Cancer Recurrence on June 10, 2013concluded that: “There are some new published studies on this technology. However, our review of the abstracts indicates that the results of these studies will not change the conclusions or ratings in the existing Hayes report (which did not recommend it). However, ASCO recommended it, as follows:
- The use of the MammaPrint assay can be considered to inform decisions on adjuvant systemic chemotherapy in women with estrogen receptor–positive or progesterone receptor–positive, HER2-negative, node-negative breast cancer who are at a high clinical risk of recurrence per MINDACT categorization (details provided in Data Supplement published with this guideline).
- MammaPrint can also be considered in women with estrogen receptor–positive or progesterone receptor–positive, HER2-negative breast cancer with one to three positive lymph nodes who are at a high clinical risk of recurrence.
In 2016, Cardoso published supportive data for Mammaprint. He concluded that Among women with early-stage breast cancer who were at high clinical risk and low genomic risk for recurrence, the receipt of no chemotherapy on the basis of the 70-gene signature led to a 5-year rate of survival without distant metastasis that was 1.5 percentage points lower than the rate with chemotherapy. Given these findings, approximately 46% of women with breast cancer who are at high clinical risk might not require chemotherapy. Nevertheless, these results were not widely adopted in the USA and Mammaprint is not considered med necessary in the USA.
The NCCN recommends Agendia’s MammaPrint® breast cancer test with the highest level of evidence for early-stage breast cancer patients with estrogen receptor-positive, lymph-node negative and lymph-node positive (LN+ 1-3)
Krop I, Ismaila N, Andre F et al. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Focused Update. DOI: 10.1200/JCO.2017.74.0472 Journal of Clinical Oncology – published online before print July 10, 2017
2 Cardoso F, van’t Veer LJ, Bogaerts J et al. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med 2016; 375: 717-29.
Goldhirsch et al, Thresholds for therapies: highlights of the St Gallen International …… Annals of Oncology 20:1319-29, 2009.
F. A. de Snoo, M. Knauer, R. A. Bender, L. Stork-Sloots, E. J. Rutgers, A. M. Glas, S. C. Linn, L. J. Van ‘t VeerJ Outcome prediction by the 70-gene profile in the context of the National Comprehensive Cancer Network (NCCN) guidelines. J Clin Oncol 27:15s, 2009 (suppl; abstr 535)
https://www.ascopost.com/News/57819, accessed 1/2020
National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology. Breast Cancer. http://nccn.org/professionals/physician_gls/PDF/breast.pdf, 2018
Fatima Cardoso, M.D., Laura J. van’t Veer, Ph.D., Jan Bogaerts, Ph.D., Leen Slaets, Ph.D., Giuseppe Viale, M.D., Suzette Delaloge, M.D., Jean-Yves Pierga, M.D., Ph.D., Etienne Brain, M.D., Ph.D., Sylvain Causeret, M.D., Mauro DeLorenzi, Ph.D., Annuska M. Glas, Ph.D., Vassilis Golfinopoulos, M.D., Ph.D., Theodora Goulioti, M.D., Susan Knox, M.A., Erika Matos, M.D., Bart Meulemans, M.Sc., Peter A. Neijenhuis, M.D., Ulrike Nitz, M.D., Ph.D., Rodolfo Passalacqua, M.D., Peter Ravdin, M.D., Isabel T. Rubio, M.D., Mahasti Saghatchian, M.D., Tineke J. Smilde, M.D., Ph.D., Christos Sotiriou, M.D., Ph.D., Lisette Stork, M.Sc., Carolyn Straehle, Ph.D., Geraldine Thomas, Ph.D., Alastair M. Thompson, M.D., Jacobus M. van der Hoeven, M.D., Ph.D., Peter Vuylsteke, M.D., René Bernards, Ph.D., Konstantinos Tryfonidis, M.D., Emiel Rutgers, M.D., Ph.D., and Martine Piccart, M.D., Ph.D., for the MINDACT Investigators,70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer
N Engl J Med 2016; 375:717-729