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ORIGINAL RESEARCH

Cost-Effectiveness Analysis of the Oncotype DX Breast Recurrence Score® Test in Node-Negative Early Breast Cancer

Pages 448-633 | Received 26 May 2022, Accepted 13 Aug 2022, Published online: 19 Sep 2022

References

  • Winters S, Martin C, Murphy D, Shokar NK. Breast cancer epidemiology, prevention, and screening. In: Progress in Molecular Biology and Translational Science. Vol. 151. Elsevier B.V.; 2017:1–32. doi:10.1016/bs.pmbts.2017.07.002
  • Ghoncheh M, Pournamdar Z, Salehiniya H. Incidence and mortality and epidemiology of breast cancer in the world. Asian Pacific J Cancer Prev. 2016;17(S3):43–46. doi:10.7314/APJCP.2016.17.S3.43
  • Cancer Research UK. Breast cancer incidence (invasive) statistics. Available from: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast-cancer/incidence-invasive#heading-Zero. Accessed September 15, 2020.
  • Biganzoli L, Wildiers H, Oakman C, et al. Management of elderly patients with breast cancer: updated recommendations of the International Society of Geriatric Oncology (SIOG) and European Society of Breast Cancer Specialists (EUSOMA). Lancet Oncol. 2012;13(4):e148–e160. doi:10.1016/S1470-2045(11)70383-7
  • National Institute for Health and Care Excellence. Early and locally advanced breast cancer: diagnosis and management; 2018.
  • Blows FM, Driver KE, Schmidt MK, et al. Subtyping of breast cancer by immunohistochemistry to investigate a relationship between subtype and short and long term survival: a collaborative analysis of data for 10,159 cases from 12 studies. PLoS Med. 2010;7(5):e1000279. doi:10.1371/journal.pmed.1000279
  • Howlader N, Cronin KA, Kurian AW, Andridge R. Differences in breast cancer survival by molecular subtypes in the United States. Cancer Epidemiol Biomarkers Prev. 2018;27(6):619–626. doi:10.1158/1055-9965.EPI-17-0627
  • Dubsky PC, Jakesz R, Fitzal F, et al. Tamoxifen and anastrozole as a sequencing strategy: a randomized controlled trial in postmenopausal patients with endocrine-responsive early breast cancer from the Austrian Breast and Colorectal Cancer Study Group. J Clin Oncol. 2012;30(7):722–728. doi:10.1200/JCO.2011.36.8993
  • Early Breast Cancer Trialists’ Collaborative Group. Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005;365(9472):1687–1717. doi:10.1016/S0140-6736(05)66544-0
  • Martín M, Ruiz A, Borrego MR, et al. Fluorouracil, doxorubicin, and cyclophosphamide (FAC) versus FAC followed by weekly paclitaxel as adjuvant therapy for high-risk, node-negative breast cancer: results from the GEICAM/2003-02 study. J Clin Oncol. 2013;31:2593–2599. doi:10.1200/JCO.2012.46.9841
  • Martin M, Pienkowski T, Mackey J, et al. Adjuvant docetaxel for node-positive breast cancer. N Engl J Med. 2005;352(22):2302–2313. doi:10.1056/NEJMoa043681
  • Roché H, Fumoleau P, Spielmann M, et al. Sequential adjuvant epirubicin-based and docetaxel chemotherapy for node-positive breast cancer patients: the FNCLCC PACS 01 trial. J Clin Oncol. 2006;24(36):5664–5671. doi:10.1200/JCO.2006.07.3916
  • Caparica R, Bruzzone M, Poggio F, Ceppi M, de Azambuja E, Lambertini M. Anthracycline and taxane-based chemotherapy versus docetaxel and cyclophosphamide in the adjuvant treatment of HER2-negative breast cancer patients: a systematic review and meta-analysis of randomized controlled trials. Breast Cancer Res Treat. 2019;174(1):27–37. doi:10.1007/s10549-018-5055-9
  • Friese CR, Harrison JM, Janz NK, et al. Treatment-associated toxicities reported by patients with early-stage invasive breast cancer. Cancer. 2017;123(11):1925–1934. doi:10.1002/cncr.30547
  • 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. doi:10.1056/NEJMoa1804710
  • Geyer CE, Tang G, Mamounas EP, et al. 21-Gene assay as predictor of chemotherapy benefit in HER2-negative breast cancer. Npj Breast Cancer. 2018;4(1). doi:10.1038/s41523-018-0090-6
  • Sestak I, Buus R, Cuzick J, et al. Comparison of the performance of 6 prognostic signatures for estrogen receptor–positive breast cancer a secondary analysis of a randomized clinical trial. JAMA Oncol. 2018;4(4):545–553. doi:10.1001/jamaoncol.2017.5524
  • Buus R, Sestak I, Kronenwett R, et al. Comparison of endopredict and epclin with oncotype dx recurrence score for prediction of risk of distant recurrence after endocrine therapy. J Natl Cancer Inst. 2016;108:djw149. doi:10.1093/jnci/djw149
  • Loncaster J, Armstrong A, Howell S, et al. Impact of Oncotype DX breast Recurrence Score testing on adjuvant chemotherapy use in early breast cancer: real world experience in Greater Manchester, UK. Eur J Surg Oncol. 2017;43(5):931–937. doi:10.1016/j.ejso.2016.12.010
  • 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. doi:10.1016/j.breast.2018.12.015
  • National Comprehensive Cancer Network. NCCN Guidelines: breast Cancer, Version 2.2021; 2021.
  • National Institute for Health and Care Excellence. Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer; 2018.
  • National Insitute for Health and Care Excellence. Guide to the methods of technology appraisal; 2013.
  • Ward S, Scope A, Rafia R, et al. Gene expression profiling and expanded immunohistochemistry tests to guide the use of adjuvant chemotherapy in breast cancer management: a systematic review and cost-effectiveness analysis. Health Technol Assess (Rockv). 2013;17(44). doi:10.3310/hta17440
  • Hall PS, Smith A, Hulme C, et al. Value of information analysis of multiparameter tests for chemotherapy in early breast cancer: the OPTIMA Prelim Trial. Value Heal. 2017;20(10):1311–1318. doi:10.1016/j.jval.2017.04.021
  • Curtis LA, Burns A. Unit costs of health and social care 2020; 2021. Available from: https://kar.kent.ac.uk/84818/. Accessed August 26, 2022.
  • Stemmer SM, Steiner M, Rizel S, et al. Ten-year clinical outcomes in N0 ER+ breast cancer patients with Recurrence Score-guided therapy. Npj Breast Cancer. 2019;5(1). doi:10.1038/s41523-019-0137-3
  • Petrelli F, Borgonovo K, Cabiddu M, Lonati V, Barni S. Mortality, leukemic risk, and cardiovascular toxicity of adjuvant anthracycline and taxane chemotherapy in breast cancer: a meta-analysis. Breast Cancer Res Treat. 2012;135(2):335–346. doi:10.1007/S10549-012-2121-6
  • Ellis P, Barrett-Lee P, Johnson L, et al. Sequential docetaxel as adjuvant chemotherapy for early breast cancer (TACT): an open-label, Phase III, randomised controlled trial. Lancet. 2009;373(9676):1681–1692. doi:10.1016/S0140-6736(09)60740-6
  • Office for National Statistics. National life tables 2016–2018, United Kingdom; 2019. Available from: https://www.ons.gov.uk/releases/nationallifetablesuk2016to2018. Accessed February 3, 2021.
  • Sledge GW, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor–positive, ERBB2-negative breast cancer that progressed on endocrine therapy—MONARCH 2: a Randomized Clinical Trial. JAMA Oncol. 2020;6(1):116–124. doi:10.1001/JAMAONCOL.2019.4782
  • National Institute for Health and Care Excellence. Liposomal Cytarabine–Daunorubicin for Untreated Acute Myeloid Leukaemia; 2018.
  • 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. doi:10.1007/s10549-017-4162-3
  • Lidgren M, Wilking N, Jönsson B, Rehnberg C. Health related quality of life in different states of breast cancer. Qual Life Res. 2007;16(6):1073–1081. doi:10.1007/s11136-007-9202-8
  • Campbell HE, Epstein D, Bloomfield D, et al. The cost-effectiveness of adjuvant chemotherapy for early breast cancer: a comparison of no chemotherapy and first, second, and third generation regimens for patients with differing prognoses. Eur J Cancer. 2011;47(17):2517–2530. doi:10.1016/j.ejca.2011.06.019
  • Ara R, Brazier J. Deriving an algorithm to convert the eight mean SF-36 dimension scores into a mean EQ-5D preference-based score from published studies (Where Patient Level Data Are Not Available). Value Heal. 2008;11(7):1131–1143. doi:10.1111/j.1524-4733.2008.00352.x
  • Department of Health and Social Care. Drugs and pharmaceutical electronic market information tool (eMIT); 2021. Aailable from: https://www.gov.uk/government/publications/drugs-and-pharmaceutical-electronic-market-information-emit. Accessed January 7, 2022.
  • National Institute for Health and Care Excellence. British national formulary; 2020. Available from: https://bnf.nice.org.uk/. Accessed January 7, 2022.
  • Jasra S, Anampa J. Anthracycline use for early stage breast cancer in the modern era: a review. Curr Treat Options Oncol. 2018;19(6):1–17. doi:10.1007/S11864-018-0547-8
  • London Cancer Alliance West and South. LCA breast cancer clinical guidelines; 2016. Available from: http://rmpartners.cancervanguard.nhs.uk/wp-content/uploads/2017/03/lca-breast-cancer-clinical-guidelines-october-2013-updated-march-2016-.pdf. Accessed February 18, 2022.
  • London Cancer Alliance West and South. Breast pathway group FEC75 in early breast cancer; 2016. Available from: https://rmpartners.nhs.uk/wp-content/uploads/2017/03/LCA-Breast-FEC75-EBC-November-2014.pdf. Accessed February 18, 2022.
  • London Cancer Alliance West and South. Breast pathway group - EC x 4 - Docetaxel x 4: epirubicin & cyclophosphamide followed by docetaxel in early breast cancer; 2016. Available from: https://rmpartners.nhs.uk/wp-content/uploads/2017/03/LCA-Breast-EC-Docetaxel-EBC-November-2014.pdf. Accessed February 18, 2022.
  • NHS Thames Valley. Chemotherapy regimens beast cancer. Available from: http://tvscn.nhs.uk/wp-content/uploads/2018/12/Breast-4.2-November-2018.pdf. Accessed February 18, 2022.
  • National Institute for Health and Care Excellence. Abemaciclib with an aromatose inhibitor for previously untreated, hormone receptor-positive, HER2-negative, locally advanced or metastatic breast cancer; 2019.
  • National Institute for Health and Care Excellence. Advanced breast cancer: diagnosis and treatment; 2017. Available from: https://www.nice.org.uk/guidance/cg81. Accessed August 26, 2022.
  • Kurosky SK, Mitra D, Zanotti G, Kaye JA. Treatment patterns and outcomes of patients with metastatic ER + /HER-2 − breast cancer: a multicountry retrospective medical record review. Clin Breast Cancer. 2018;18(4):e529–e538. doi:10.1016/j.clbc.2017.10.008
  • Zeidan AM, Mahmoud D, Kucmin-Bemelmans IT, et al. Economic burden associated with acute myeloid leukemia treatment. Exp Rev Hematol. 2015;9(1):79–89. doi:10.1586/17474086.2016.1112735
  • 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. doi:10.1200/JCO.2005.04.7985
  • Wang SY, Dang W, Richman I, Mougalian SS, Evans SB, Gross CP. Cost-Effectiveness analyses of the 21-Gene assay in breast cancer: systematic review and critical appraisal. J Clin Oncol. 2018;36(16):1619–1627. doi:10.1200/JCO.2017.76.5941
  • Blohmer JU, Rezai M, Kümmel S, et al. Using the 21-gene assay to guide adjuvant chemotherapy decision-making in early-stage breast cancer: a cost-effectiveness evaluation in the German setting. J Med Econ. 2012;16(1):30–40. doi:10.3111/13696998.2012.722572
  • Masucci L, Torres MS, Eisen A, et al. Cost-utility analysis of 21-gene assay for node-positive early breast cancer. Curr Oncol. 2019;26(5):307–318. doi:10.3747/co.26.4769
  • Kip M, Monteban H, Steuten L. Long-term cost-effectiveness of Oncotype DX® versus current clinical practice from a Dutch cost perspective. J Comp Eff Res. 2015;4(5):433–445. doi:10.2217/CER.15.18
  • Holt S, Bertelli G, Humphreys I, et al. 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. 2013;108(11):2250–2258. doi:10.1038/bjc.2013.207
  • Hannouf MB, Zaric GS, Blanchette P, et al. Cost-effectiveness analysis of multigene expression profiling assays to guide adjuvant therapy decisions in women with invasive early-stage breast cancer. Pharmacogenomics J. 2020;20(1):27–46. doi:10.1038/s41397-019-0089-x
  • Tsoi DT, Inoue M, Kelly CM, Verma S, Pritchard KI. Cost-effectiveness analysis of recurrence score-guided treatment using a 21-gene assay in early breast cancer. Oncologist. 2010;15(5):457–465. doi:10.1634/THEONCOLOGIST.2009-0275
  • Rosenbaum PR, Rubin DB. The central role of the propensity score in observational studies for causal effects. Biometrika. 1983;70(1):41. doi:10.2307/2335942
  • Austin PC. An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav Res. 2011;46(3):399. doi:10.1080/00273171.2011.568786
  • 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(25):2336–2347. doi:10.1056/NEJMOA2108873/SUPPL_FILE/NEJMOA2108873_DATA-SHARING.PDF
  • De Bock GH, Putter H, Bonnema J, Van Der Hage JA, Bartelink H. The impact of loco-regional recurrences on metastatic progression in early-stage breast cancer: a multistate model. Breast Cancer Res Treat. 2009;117(2):401–408. doi:10.1007/s10549-008-0300-2
  • Färkkilä N, Roine R, Jahkola T, et al. PCN137 Health state utilities in breast cancer. Value Heal. 2011;14(7):A459. doi:10.1016/j.jval.2011.08.1238
  • Yousefi M, Najafi S, Ghaffari S, Mahboub-Ahari A, Ghaderi H. Comparison of SF-6D and EQ-5D scores in patients with breast cancer. Iran Red Crescent Med J. 2016;18(5). doi:10.5812/ircmj.23556
  • Ibarrondo O, Álvarez-López I, Freundlich F, et al. Probabilistic cost-utility analysis and expected value of perfect information for the Oncotype multigenic test: a discrete event simulation model. Gac Sanit. 2020;34(1):61–68. doi:10.1016/j.gaceta.2018.07.012