When given a breast cancer diagnosis, the first question in many patients’ minds is “will I need chemotherapy? The treatment side-effects can be debilitating, causing emotional strain and increasing economic costs for many patients. (1) Chemotherapy is an important option for some patients but for many other patients, it provides little or no clinical benefit. (2) A test is available called the Oncotype DX Breast Recurrence Score® test that can identify which patients are most likely to benefit from chemotherapy, potentially sparing patients from unnecessary treatment. (3) (4) (5)
The value of this type of test (known as gene expression test) for the health and medical care system in Sweden is currently has been evaluated by the Swedish Dental and Pharmaceutical Benefits Agency (TLV). This evaluation is a first step towards making the Oncotype DX® test available to Swedish patients in the public healthcare system.
“Exact Sciences has supported the authorities with their evaluations by providing extensive published evidence showing how use of the Oncotype DX® test can enable a more personalised treatment approach for individual patients. We believe that the evidenced based assessment of the Oncotype DX® test undertaken by the Swedish authorities will ensure equity of access for patients and provide the valuable addition of precision medicine to the healthcare system” Neil Yman Nordic Business Lead, Exact Sciences.
Advances in the understanding of cancer mean that clinicians can offer increasingly personalised treatment to patients. Genomics harnesses information about a patient’s tumour, enabling treatments to be tailored to the individual patient. (4) (6) The Oncotype DX® test predicts how likely it is that breast cancer may come back after surgery and the likely benefits of having chemotherapy. (4) (5) It was developed by Exact Sciences, one of the world’s leading provider of genomic-based diagnostic tests that address the overtreatment and optimal treatment of early-stage cancer, one of the greatest issues in healthcare today.
The Oncotype DX® test gives a result, known as the Recurrence Score® result, from 0 to 100. The higher the result, the more likely breast cancer is to come back and the more likely patients will benefit from having chemotherapy as well as hormone therapy. (3) (5) (4)
TAILORx, the largest randomised adjuvant breast cancer trial ever conducted, found that 73 per cent of patients with high clinical risk had Recurrence Score® results of 0-25 and may have been overtreated without the Recurrence Score® result if their treatment had been determined only by clinical risk. 43 per cent of patients with a Recurrence Score® result of 26-100 had low clinical risk and may have been undertreated without the Recurrence Score® result if their treatment had been determined only by clinical risk. The trial, published in 2018, involved more than 10,000 patients in six countries. (3)
The Oncotype DX® test analyses the individual biology of a breast cancer tumour by examining the activity of 21 key genes in the tumour tissue. The test is performed on a small amount of the tissue removed during the original surgery, so the patient does not need to undergo any additional surgical procedures. The tissue is sent to a central laboratory and the results are sent back to the clinician within 7-10 days. Studies suggest that the results of the test change breast cancer treatment decisions in between 30–60 percent of cases. (7) (8)
The test is suitable for some people recently diagnosed with early-stage breast cancer whose tumours are oestrogen receptor positive and HER2 negative. It can be used in cancers that either have or have not spread to the lymph nodes under the arm. (3) (4) (5) (9)
Worldwide, more than one million patients have received the information provided by the Oncotype DX® test in more than 90 countries. (10)
Prominent international breast cancer treatment guidelines recommend the Oncotype DX® test to help guide chemotherapy treatment decisions for early stage breast cancer patients. (6) (11) (12) (13) (14)
“Exact Sciences has established a presence in Sweden and is working with authorities to ensure that the Oncotype DX® test is part of the diagnostic portfolio. Access to the test will help breast cancer patients and their clinicians make more informed chemotherapy treatment decisions. The story from Jane, a patient from the UK, explains how the test helped her and her clinicians plan her treatment.” Neil Yman Nordic Business Lead, Exact Sciences.
Societal costs of chemotherapy in the UK: an incidence-based cost-of-illness model for early breast cancer. Krishnali Parsekar, Stephanie Wilsher, Anna Sweeting, et al. 2021, BMJ Open.
Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100 000 women in 123 randomised trials. (EBCTCG), Early Breast Cancer Trialists’ Collaborative Group. 2012 , Lancet 2012; 379: 432–44, Vol. 379, pp. 432- 44.
Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. JA Sparano, R J Gray, DF. Makower, et al. 2018, N Engl J Med, Vol. 379, pp. 111-121.
Gene expression and benefit of chemotherapy in women with node-negative disease, estrogen recpetor -postive breast cancer. Paik S, Tang, G, & Shak S et al. 23, 2006, Journal of Clinical Oncology , Vol. 24, pp. 3726-3734.
Prognostic and predictive value of the 21-gene recurrence socre assay in postmenopausal women with node-positive, osetorgen-receptor-positive breast cancer on chemotherapy: a retropsective analysis of a randomised trial. Albain KS, Barlow WE, Shak s, et al. 2009, The Lancet Oncology, Vol. 11, pp. 55-65.
(IQWiG), The German Institute for Quality and Efficiency in Health Care. Biomarker tests in breast cancer: New study data indicate advantage for certain patients. IQWiG. [Online] Sept 2018. [Cited: 19 Feb 2019.] https://www.iqwig.de/en/press/press-releases/biomarker-tests-in-breast-cancer-new-study-data-indicate-advantage-for-certain-patients.10059.html.
Real-life Utilization of Genomic Testing for Invasive Breast Cancer Patients in Italy and France Reduces Chemotherapy Recommendations. Barni S, Curtit E, et al. 2018. ESMO. p. P194.
A Pooled Analysis of Observational Studies Evaluating the Impact of Multi-gene Assay Testing on Adjuvant Treatment Decisions in ‘Real-world’ Clinical Practice for Women with Early Breast Cancer. J., Millen S. & Walshe. 2017. St Gallen 2017 . p. p233.
First results from a phase III randomized clinical trial of standard adjuvant endocrine therapy +/- chemotherapy in patients with 1-3 positive nodes, hormone receptor-positive and HER2-negative breast cancer with Recurrence Score ≤25: SWOG S1007 (RxPONDER. Kalinsky K, Barlow WE, Meric-Bernstam F, et al. SABCS : s.n., 2020. GS3-00.
Genomic Helath Inc. Data on file. 1 million patients tested. 2019 .
NICE. NICE DG34: Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer. NICE.org. [Online] 18 December 2018. [Cited: 17 May 2021.] https://www.nice.org.uk/guidance/dg34/chapter/1-Recommendations.
National Comprehensive Cancer Network, Inc. NCCN Guidelines for Breast Cancer V.4.2021. [Online] 2021. [Cited: 17 May 2021.] NCCN.org..
ST Gallen International Consensus Session on the Optimal Primary Treatemnt of Breast Cancer 2017. Panel, Consensus. Viennea : s.n., 2017. 15th St Gallen Breast Cancer Conference .
Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer. Andre F, et al. 2019 : s.n., J Clin Oncol .