Impact of the Intermediate Oncotype DX Recurrence Score results on adjuvant treatment recommendations in hormone receptor-positive early breast cancer in a single center.

Vicente, Borja Lopez De San; Novas, Patricia; Calvo, E.; Arrazubi, Virginia; Sala, María; Fernández, Sara Rafael; Arévalo, Alberto; Arango, Juan Fernando; Zumarraga, Ane; Sande, L. De; Perez-Hoyos, Maria Teresa; Abad, Teresa; Prado, Purificación Martínez del

doi:10.1200/jco.2015.33.15_suppl.e11560

Cited by 1 publication

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“…The percentage of patients with any change in treatment recommendation or decision (either to or from chemotherapy) among UK studies was 29% to 49% across four oncotype DX studies, 62,[139][140][141][142]144 37% in one EndoPredict study 159 and 27% in one IHC4+C study. 163 Ranges across European (non-UK) studies were 5% to 70% for oncotype DX, [146][147][148][149][150][151][152][153][154][155][156][157] 38% to 41% for EndoPredict, [160][161][162] 14% to 41% for Prosigna [164][165][166] and 13% to 51% for MammaPrint. 81,[167][168][169][170][171]173 The net changes in the percentage of patients with a chemotherapy recommendation or decision (pre test to post test) among UK studies were a reduction of 8% to 23% across four oncotype DX studies, [141][142][143][144] an increase of 1% in one EndoPredict study 159 and a reduction of between 2% and 26% in one IHC4+C study (unclear owing to category definitions).…”

Section: Summary and Discussion Of Decision Impact Studiesmentioning

confidence: 99%

“…81,[167][168][169][170][171]173 The net changes in the percentage of patients with a chemotherapy recommendation or decision (pre test to post test) among UK studies were a reduction of 8% to 23% across four oncotype DX studies, [141][142][143][144] an increase of 1% in one EndoPredict study 159 and a reduction of between 2% and 26% in one IHC4+C study (unclear owing to category definitions). 163 Net changes across European (non-UK) studies were a reduction of 0% to 64% for oncotype DX, [146][147][148][149][151][152][153][154][155][156][157][158] a reduction of 13% to 26% for EndoPredict, [160][161][162] a reduction of 2% to an increase of 9% for Prosigna [164][165][166] and a reduction of 31% to an increase of 8% for MammaPrint. 81,[167][168][169]171,173 Anxiety and health-related quality of life Six studies (reported in seven publications) 159,164,166,[174][175][176]…”

Section: Summary and Discussion Of Decision Impact Studiesmentioning

confidence: 99%

“…NIHR Journals Library www.journalslibrary.nihr.ac.uk Five UK studies [139][140][141][142][143][144][145] and 12 other European studies [146][147][148][149][150][151][152][153][154][155][156][157][158] assessed the decision impact of oncotype DX (see Report Supplementary Material 9, Table 1); the results of one further study were provided as commercial in confidence and could not be presented here. 62 One UK study 159 and three other European studies [160][161][162] assessed the decision impact of EndoPredict (EPClin) (see Report Supplementary Material 9, Table 2).…”

Section: Clinical Evidencementioning

confidence: 99%

“…Among four UK studies, [139][140][141][142][143][144] the percentage of patients with any change in treatment recommendation or decision (either to or from chemotherapy) ranged from 29% to 49% (Table 26). Across 11 European (non-UK) studies, [146][147][148][149][150][151][152][153][154][155][156][157] the percentage of patients with any change in treatment recommendation or decision ranged from 5% to 70%. There was little clear difference in results in accordance with LN status.…”

Section: Oncotype DXmentioning

confidence: 99%

“…141,142,144 Two further UK studies 139,140,145 reported changes from pre-test chemotherapy recommendation to the post-test decision, which may overestimate the net change: one reported a reduction of 23% in chemotherapy use 139,140 and the other assessed only patients with an initial recommendation for chemotherapy so it is misleading to calculate the absolute change. 145 Across 11 European (non-UK) studies, [146][147][148][149][151][152][153][154][155][156][157][158] the net reduction in chemotherapy recommendations or decisions ranged from 0% to 64%. Again, there was little clear difference in results in accordance with LN status.…”

Section: Oncotype DXmentioning

confidence: 99%

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Tumour profiling tests to guide adjuvant chemotherapy decisions in early breast cancer: a systematic review and economic analysis

Harnan

Tappenden

Cooper

et al. 2019

Health Technol Assess

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Background Breast cancer and its treatment can have an impact on health-related quality of life and survival. Tumour profiling tests aim to identify whether or not women need chemotherapy owing to their risk of relapse. Objectives To conduct a systematic review of the effectiveness and cost-effectiveness of the tumour profiling tests oncotype DX® (Genomic Health, Inc., Redwood City, CA, USA), MammaPrint® (Agendia, Inc., Amsterdam, the Netherlands), Prosigna® (NanoString Technologies, Inc., Seattle, WA, USA), EndoPredict® (Myriad Genetics Ltd, London, UK) and immunohistochemistry 4 (IHC4). To develop a health economic model to assess the cost-effectiveness of these tests compared with clinical tools to guide the use of adjuvant chemotherapy in early-stage breast cancer from the perspective of the NHS and Personal Social Services. Design A systematic review and health economic analysis were conducted. Review methods The systematic review was partially an update of a 2013 review. Nine databases were searched in February 2017. The review included studies assessing clinical effectiveness in people with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative, stage I or II cancer with zero to three positive lymph nodes. The economic analysis included a review of existing analyses and the development of a de novo model. Results A total of 153 studies were identified. Only one completed randomised controlled trial (RCT) using a tumour profiling test in clinical practice was identified: Microarray In Node-negative Disease may Avoid ChemoTherapy (MINDACT) for MammaPrint. Other studies suggest that all the tests can provide information on the risk of relapse; however, results were more varied in lymph node-positive (LN+) patients than in lymph node-negative (LN0) patients. There is limited and varying evidence that oncotype DX and MammaPrint can predict benefit from chemotherapy. The net change in the percentage of patients with a chemotherapy recommendation or decision pre/post test ranged from an increase of 1% to a decrease of 23% among UK studies and a decrease of 0% to 64% across European studies. The health economic analysis suggests that the incremental cost-effectiveness ratios for the tests versus current practice are broadly favourable for the following scenarios: (1) oncotype DX, for the LN0 subgroup with a Nottingham Prognostic Index (NPI) of > 3.4 and the one to three positive lymph nodes (LN1–3) subgroup (if a predictive benefit is assumed); (2) IHC4 plus clinical factors (IHC4+C), for all patient subgroups; (3) Prosigna, for the LN0 subgroup with a NPI of > 3.4 and the LN1–3 subgroup; (4) EndoPredict Clinical, for the LN1–3 subgroup only; and (5) MammaPrint, for no subgroups. Limitations There was only one completed RCT using a tumour profiling test in clinical practice. Except for oncotype DX in the LN0 group with a NPI score of > 3.4 (clinical intermediate risk), evidence surrounding pre- and post-test chemotherapy probabilities is subject to considerable uncertainty. There is uncertainty regarding whether or not oncotype DX and MammaPrint are predictive of chemotherapy benefit. The MammaPrint analysis uses a different data source to the other four tests. The Translational substudy of the Arimidex, Tamoxifen, Alone or in Combination (TransATAC) study (used in the economic modelling) has a number of limitations. Conclusions The review suggests that all the tests can provide prognostic information on the risk of relapse; results were more varied in LN+ patients than in LN0 patients. There is limited and varying evidence that oncotype DX and MammaPrint are predictive of chemotherapy benefit. Health economic analyses indicate that some tests may have a favourable cost-effectiveness profile for certain patient subgroups; all estimates are subject to uncertainty. More evidence is needed on the prediction of chemotherapy benefit, long-term impacts and changes in UK pre-/post-chemotherapy decisions. Study registration This study is registered as PROSPERO CRD42017059561. Funding The National Institute for Health Research Health Technology Assessment programme.

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