Economic impact of 21-gene recurrence score testing on early-stage breast cancer in Ireland
- 382 Downloads
The 21-gene test is a validated multi-gene diagnostic test that predicts chemotherapy (CT) benefit in oestrogen receptor positive (ER+), lymph node-negative (N0) breast cancer (BC) patients (pts). Ireland was the first public health care system to reimburse this test in Europe. Study objectives were to assess the impact of this test on decision-making and to analyse the economic impact of testing. Between October 2011 and February 2013, a national, retrospective, cross-sectional observational study of ER+, N0 BC pts tested with the 21-gene test was conducted. Surveyed breast medical oncologists, provided the assumption for the decision impact analysis that grade (G) 1 pts would not have received CT before testing and G2/3 pts would have received CT before testing. Descriptive statistical analyses were performed. 592 pts were identified; Low, intermediate and high recurrence score were identified in 53, 36 and 10 % pts, respectively. 384 (70 %) pts had G2, 129 (22 %) G3 and 76 (13 %) G1 tumours. Post testing, 345 pts (59 %) experienced a change in CT decision; 339 changed to hormone therapy alone and 6 advised to receive CT. 172 (30 %) pts received CT, 12 (3.9 %) of pts with low scores, 108 (50.9 %) of intermediate risk and 50 (90.9 %) of pts with high risk scores. Net reduction in CT use was 58 % and net savings achieved were €793,565. Since public reimbursement, the introduction of the 21-gene test has resulted in a significant reduction in chemotherapy administration and cost savings for the Irish public healthcare system.
KeywordsBreast cancer Adjuvant chemotherapy Recurrence score Oncotype DX 21-Gene test Economic evaluation
The data management staff of each cancer centre in Ireland contributed significantly to this work. The authors have disclosed that they have no financial or commercial interests with the manufacturers of any products discussed in this article or their competitors. This article was produced by employees of the Irish health service.
This study was funded by Genomic health.
Compliance with ethical standards
Conflict of interest
The authors JW and MJK declare consultant roles for Roche and Genomic Health, respectively. The authors KV and OS declare funding from Pharmerit GmbH. All other authors declare that they have no conflict of interest.
- 1.Cancer in Ireland 2013: Annual report of the National Cancer Registry, 2013Google Scholar
- 2.National Cancer Registry C, Ireland (2012): Breast cancer incidence, mortality, treatment and survival in Ireland: 1994–2009Google Scholar
- 3.Fisher B, Brown AM, Dimitrov NV, Poisson R, Redmond C, Margolese RG, Bowman D, Wolmark N, Wickerham DL, Kardinal CG et al (1990) Two months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with 6 months of cyclophosphamide, methotrexate, and fluorouracil in positive-node breast cancer patients with tamoxifen-nonresponsive tumors: results from the National Surgical Adjuvant Breast and Bowel Project B-15. J Clin Oncol 8(9):1483–1496PubMedGoogle Scholar
- 6.Fisher B, Jeong JH, Bryant J, Anderson S, Dignam J, Fisher ER, Wolmark N (2004) 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 364(9437):858–868CrossRefPubMedGoogle Scholar
- 11.Palazzi M, De Tomasi D, D’Affronto C, Richetti A, Valli MC, Meregalli S, Asnaghi D, Arienti V, Cavallini D, Pradella R et al (2002) Are international guidelines for the prescription of adjuvant treatment for early breast cancer followed in clinical practice? Results of a population-based study on 1547 patients. Tumori 88(6):503–506PubMedGoogle Scholar
- 20.Eiermann W, Rezai M, Kummel S, Kuhn T, Warm M, Friedrichs K, Schneeweiss A, Markmann S, Eggemann H, Hilfrich J et al (2013) The 21-gene recurrence score assay impacts adjuvant therapy recommendations for ER-positive, node-negative and node-positive early breast cancer resulting in a risk-adapted change in chemotherapy use. Ann Oncol 24(3):618–624PubMedCentralCrossRefPubMedGoogle Scholar
- 23.Lo SS, Mumby PB, Norton J, Rychlik K, Smerage J, Kash J, Chew HK, Gaynor ER, Hayes DF, Epstein A et al (2010) Prospective multicenter study of the impact of the 21-gene recurrence score assay on medical oncologist and patient adjuvant breast cancer treatment selection. J Clin Oncol 28(10):1671–1676CrossRefPubMedGoogle Scholar
- 25.Albanell J GJ, Holt S, Blohmer J, Eiermann W, Svedman C (2011) Meta-analysis of Prospective European Studies Assessing the Impact of Using the 21-Gene Recurrence Score Assay on Clinical Decision Making in Women with ER-positive, HER2-negative Early Stage Breast Cancer Presented at the San Antonio Breast Cancer Symposium (SABCS) San Antonio, TX, 6-10 Dec, 2011Google Scholar
- 26.Hornberger J, Chien R (2010) Abstract P2-09-06: meta-analysis of the decision impact of the 21-gene breast cancer Recurrence Score in clinical practice. Cancer Res 70:P2-09-06Google Scholar
- 27.Albanell J, Gonzalez A, Ruiz-Borrego M, Alba E, Garcia-Saenz JA, Corominas JM, Burgues O, Furio V, Rojo A, Palacios J et al (2012) Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER+) node-negative breast cancer. Ann Oncol 23(3):625–631CrossRefPubMedGoogle Scholar
- 28.Yamauchi H, Nakagawa C, Takei H, Chao C, Yoshizawa C, Yagata H, Yoshida A, Hayashi N, Hell S, Nakamura S (2014) Prospective study of the effect of the 21-gene assay on adjuvant clinical decision-making in Japanese women with estrogen receptor-positive, node-negative, and node-positive breast cancer. Clin Breast Cancer 14(3):191–197CrossRefPubMedGoogle Scholar
- 31.Kondo M, Hoshi SL, Yamanaka T, Ishiguro H, Toi M (2011) Economic evaluation of the 21-gene signature (Oncotype DX) in lymph node-negative/positive, hormone receptor-positive early-stage breast cancer based on Japanese validation study (JBCRG-TR03). Breast Cancer Res Treat 127(3):739–749CrossRefPubMedGoogle Scholar
- 32.Ireland NCfPN: Cost-effectiveness of Oncotype DX® to target chemotherapy use in lymph-node-negative, oestrogen-receptor-positive, early-stage breast cancer in Ireland. July 2011Google Scholar
- 36.Fisher B, Redmond C, Fisher ER, Caplan R (1988) Relative worth of estrogen or progesterone receptor and pathologic characteristics of differentiation as indicators of prognosis in node negative breast cancer patients: findings from National Surgical Adjuvant Breast and Bowel Project Protocol B-06. J Clin Oncol 6(7):1076–1087PubMedGoogle Scholar
- 38.Oratz R, Kim B, Chao C, Skrzypczak S, Ory C, Bugarini R, Broder M (2011) Physician survey of the effect of the 21-gene recurrence score assay results on treatment recommendations for patients with lymph node-positive, estrogen receptor-positive breast cancer. J Oncol Pract 7(2):94–99PubMedCentralCrossRefPubMedGoogle Scholar
- 39.Holt S, Bertelli G, Humphreys I, Valentine W, Durrani S, Pudney D, Rolles M, Moe M, Khawaja S, Sharaiha Y et al (2013) A decision impact, decision conflict and economic assessment of routine Oncotype DX testing of 146 women with node-negative or pNImi, ER-positive breast cancer in the U.K. Br J Cancer 108(11):2250–2258PubMedCentralCrossRefPubMedGoogle Scholar
- 42.Bayt T BE, Rothney M, Sing AP. The 21-Gene Breast Cancer Assay: a roadmap of clinical evidence. In Abstract P248. St. Gallen International Breast Cancer Conference—Vienna, Austria, 2015Google Scholar
- 45.Joh JE, Esposito NN, Kiluk JV, Laronga C, Lee MC, Loftus L, Soliman H, Boughey JC, Reynolds C, Lawton TJ et al (2011) 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. Oncologist 16(11):1520–1526PubMedCentralCrossRefPubMedGoogle Scholar
- 48.Bargallo JE, Lara F, Shaw-Dulin R, Perez-Sanchez V, Villarreal-Garza C, Maldonado-Martinez H, Mohar-Betancourt A, Yoshizawa C, Burke E, Decker T et al (2015) A study of the impact of the 21-gene breast cancer assay on the use of adjuvant chemotherapy in women with breast cancer in a Mexican public hospital. J Surg Oncol 111(2):203–207CrossRefPubMedGoogle Scholar
- 49.Bodmer A HA, Diebold Berger S, Favet L, Guetty Alberto M, Exquis B. Abstract P241. St. Gallen International Breast Cancer Conference—Vienna, Austria 2015: Usefulness of the 21-Gene Assay to Guide Adjuvant Chemotherapy Decision-Making: Geneva ExperienceGoogle Scholar
- 50.Davidson JA, Cromwell I, Ellard SL, Lohrisch C, Gelmon KA, Shenkier T, Villa D, Lim H, Sun S, Taylor S et al (2013) A prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene Recurrence Score(R) assay in oestrogen receptor positive node negative breast cancer. Eur J Cancer (Oxford, England : 1990) 49(11):2469–2475CrossRefGoogle Scholar