Clinical and economic impact of the 21-gene recurrence score assay in adjuvant therapy decision making in patients with early-stage breast cancer: pooled analysis in 4 Basque Country university hospitals

Abstract

PurposeThe 21-gene recurrence score (RS) is a genomic test developed as a prognostic and predictive tool to improve the treatment decision making in cases of estrogen receptor-positive and human epidermal growth factor receptor 2-negative early-stage breast cancer. This study examined the clinical and economic impact of its use in 4 Basque Country university hospitals.MethodsTaking into consideration the RS result, we recorded the recommended initial systemic adjuvant therapy (endocrine therapy with or without chemotherapy) according to standard clinicopathologic factors and the final decision about chemotherapy. Then, if the RS was high, chemotherapy was recommended; it was not recommended if the RS was low; for those with an intermediate RS, clinicopathologic factors were considered, and the initial recommendation based on those factors was maintained. In addition, the probability of switching treatment was calculated. Then, we developed an economic evaluation by measuring the treatment’s incremental short-term budget impact from both the societal perspective and that of the Basque Health System. Patients’ characteristics and chemotherapy use were analyzed using logistic regressions and receiver operating characteristic curves.ResultsWithout an RS, chemotherapy would have been prescribed to 56% of 401 patients, but, with RS use, that percentage decreased to 25. The overall rate of decision change was 35.4%. Test inclusion led to a reduction in chemotherapy costs of €922 per patient in the total population. Although this reduction did not entirely offset the cost of the test, the productivity loss per patient was reduced by €1,977.ConclusionThe 21-gene RS test significantly changed the indication for chemotherapy. As chemotherapy treatments with no benefit were avoided, patients’ quality of life was improved. The short-term economic impact was negative for the Basque Health Service, but savings resulted when sick-leave costs were included.

Direct and Indirect Costs of Breast Cancer and Associated Implications: A Systematic Review

“…Studies in the US ( n = 19; 36%) [ 19 – 37 ] and Canada ( n = 9; 17%) [ 38 – 46 ] made up the majority of our identified studies ( n = 28; 53%), followed collectively by the Western European countries ( n = 22; 42%). In Western Europe, most studies were in Italy ( n = 5; 9%) [ 47 – 51 ], then Spain ( n = 4; 8%) [ 52 – 55 ], France ( n = 4; 8%) [ 56 – 59 ], Netherlands ( n = 3; 6%) [ 60 – 62 ], UK ( n = 3; 6%) [ 63 – 65 ], Sweden ( n = 2; 4%) [ 66 , 67 ], and Germany ( n = 1; 2%) [ 68 ]. Three (6%) studies were in Australia [ 69 – 71 ].…”

Personalised medicine and the decision to withhold chemotherapy in early breast cancer with intermediate risk of recurrence – a systematic review and meta-analysis

“…Given the results in the present review, it may be surprising that the guidelines update in 2017 [ 55 ], but not in 2019 [ 17 ], emphasised that node-positive patients should be informed of the potential benefits from chemotherapy. Indeed, an internationally used “objective” test result may have a large impact on chemotherapy decision making, which is illustrated by the fact that several studies have been performed in patients with intermediate clinical risk of recurrence, in which the chemotherapy decision was based solely on the results of the gene expression assay [ 26 , 45 , 56 ]. Conversely, our results suggest that many oncologists and patients take clinical parameters into account, also when the gene expression assay shows a low/intermediate risk of recurrence.…”

“…It may be argued that the introduction of gene expression assays will reduce the provision of chemotherapy, thereby reducing the costs to justify a potential worse patient outcome. However, chemotherapy decision making studies in the relevant patient group have reported both increased [44][45][46][47] and decreased [48][49][50][51] administration of chemotherapy when gene expression assay results are provided, and none of these studies had a randomised design. Also, from an ethical perspective, withholding an established treatment may be more problematic than introducing a new one.…”

Identification of Patients with Early HR+ HER2− Breast Cancer at High Risk of Recurrence

“…Although choice of adjuvant treatments in treatment guidelines can differ among countries, the association between using molecular profiling assays and a change in treatment decisions and an overall reduction in chemotherapy use is consistent 22 , 121 , 122 , 123 . By avoiding chemotherapy treatments, improvements in patientsʼ quality of life and overall cost savings for health systems can be achieved, despite the negative economic impact in the short term caused by the cost of the molecular tests 124 , 125 .…”