P241 Usefulness of the 21-gene assay to guide adjuvant chemotherapy decision-making: Geneva experience

Bodmer, Alexandre; Hügli, Anne; Berger, Sylvie; Favet, Laurence; Alberto, Matos; Exquis, B.

doi:10.1016/s0960-9776(15)70273-0

Cited by 2 publications

(6 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…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%

“…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%

See 3 more Smart Citations

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

View full text Add to dashboard Cite

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.

show abstract

Section: Summary and Discussion Of Decision Impact Studiesmentioning

confidence: 99%

Section: Clinical Evidencementioning

confidence: 99%

Section: Oncotype DXmentioning

confidence: 99%

Section: Oncotype DXmentioning

confidence: 99%

See 2 more Smart Citations

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

View full text Add to dashboard Cite

show abstract

“…Applying, albeit an informed, assumption to the study population is likely to account for our higher change (59 %) in treatment recommendation compared with most contemporaneous studies (*30 %). Notably, however, a recently reported prospective study did similarly demonstrate a relatively high (47 %) rate of change in CT decision post testing [49].…”

Section: Discussionmentioning

confidence: 83%

Economic impact of 21-gene recurrence score testing on early-stage breast cancer in Ireland

Smyth

Watson

Walsh

et al. 2015

Breast Cancer Res Treat

View full text Add to dashboard Cite

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.

show abstract

P241 Usefulness of the 21-gene assay to guide adjuvant chemotherapy decision-making: Geneva experience

Cited by 2 publications

References 0 publications

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

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

Economic impact of 21-gene recurrence score testing on early-stage breast cancer in Ireland

Contact Info

Product

Resources

About