Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER+) node-negative breast cancer

Albanell, Joan; González, Antonio; Ruíz‐Borrego, Manuel; Alba, Emilio; García-Sáenz, José Ángel; Corominas, Josep M.; Burgués, Octavio; Furio, V.; Rojo, A.; Palacios, José; Bermejo, B.; Martinez-García, Maria; Limón, María Luisa; Muñoz, Alfonso Sánchez; Martín, Miguel; Tusquets, Ignasi; Rojo, Federico; Colomer, Ramón; Faull, Iris; Lluch, Aña

doi:10.1093/annonc/mdr278

Cited by 110 publications

(125 citation statements)

References 27 publications

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“…13 Current evidence is based on a few impact studies with relatively small numbers of patients, predominantly describing a hypothesized decrease in the administration of adjuvant CT after 70-GS use in early breast cancer patients. 12,14 Similar results were reported regarding the impact of the 21-gene Recurrence Score (OncotypeDx) on the administration of adjuvant CT. [15][16][17] In addition, high compliance rates with the test results in patients with early-stage ER+, node-negative breast cancer have been reported. 18 Yet, to our knowledge, there are no nationwide studies assessing the impact on the administration of adjuvant CT for either OncotypeDx or the 70-GS.…”

Section: Discussionmentioning

confidence: 99%

Using a gene expression signature when controversy exists regarding the indication for adjuvant systemic treatment reduces the proportion of patients receiving adjuvant chemotherapy: a nationwide study

Kuijer

Bommel

Drukker

et al. 2016

Genetics in Medicine

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Methods:Patients within a national guideline directed indication area for 70-GS use who were surgically treated between November 2011 and April 2013 were selected from the Netherlands Cancer Registry database. The effect of 70-GS use on the administration of CT was evaluated in guideline-and age-delineated subgroups addressing potential effect of bias by linear mixed-effect modeling and instrumental variable (IV) analyses.Results: A total of 2,043 patients within the indicated area for 70-GS use were included, of whom 298 received a 70-GS. Without use of the 70-GS, 45% of patients received CT. The 70-GS use was associated with a 9.5% decrease in CT administration (95% confidence interval (CI): −15.7 to −3.3%) in linear mixed-effect model analyses and IV analyses showed similar results (−9.9%; 95% CI: −19.3 to −0.4). Conclusion:In patients in whom the Dutch national guidelines suggest the use of a gene-expression profile, 70-GS use is associated with a 10% decrease in the administration of adjuvant CT. Genet Med advance online publication 19 November 2015

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Section: Discussionmentioning

confidence: 99%

Using a gene expression signature when controversy exists regarding the indication for adjuvant systemic treatment reduces the proportion of patients receiving adjuvant chemotherapy: a nationwide study

Kuijer

Bommel

Drukker

et al. 2016

Genetics in Medicine

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“…64,70 A number of studies (e.g. Ademuyiwa et al 71 and Albanell et al 72 ), including two conducted within the UK, 73,74 have shown that the use of Oncotype DX leads to changes in chemotherapy decisions in about one-third of patients, although these studies involve small sample sizes and often have poorly described protocols.…”

Section: Individual Multiparameter Assaysmentioning

confidence: 99%

OPTIMA prelim: a randomised feasibility study of personalised care in the treatment of women with early breast cancer

Stein

Dunn²,

Bartlett

et al. 2016

Health Technol Assess

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This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (www.publicationethics.org/).Editorial contact: nihredit@southampton.ac.ukThe full HTA archive is freely available to view online at www.journalslibrary.nihr.ac.uk/hta. Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: www.journalslibrary.nihr.ac.uk Criteria for inclusion in the Health Technology Assessment journalReports are published in Health Technology Assessment (HTA) if (1) they have resulted from work for the HTA programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors.Reviews in Health Technology Assessment are termed 'systematic' when the account of the search appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others. HTA programmeThe HTA programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care.The journal is indexed in NHS Evidence via its abstracts included in MEDLINE and its Technology Assessment Reports inform National Institute for Health and Care Excellence (NICE) guidance. HTA research is also an important source of evidence for National Screening Committee (NSC) policy decisions.For more information about the HTA programme please visit the website: http://www.nets.nihr.ac.uk/programmes/hta This reportThe research reported in this issue of the journal was funded by the HTA programme as project number 10/34/01. The contractual start date was in May 2012. The draft report began editorial review in May 2014 and was accepted for publication in September 2015. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors' report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health. Background: There i...

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“…The Recurrence Score has also been validated as a predictive marker for the magnitude of adjuvant chemotherapy benefit [2,11] with a significant benefit in patients with high Recurrence Score values (28% absolute benefit in 10-year risk of distant recurrence) and minimal, if any, benefit from chemotherapy in patients with low values. In patients with intermediate values (Recurrence Scores of [18][19][20][21][22][23][24][25][26][27][28][29][30], the available data cannot rule out that some patients may benefit from chemotherapy [2,11].…”

Section: Introductionmentioning

confidence: 99%

Prospective Clinical Utility Study of the Use of the 21-Gene Assay in Adjuvant Clinical Decision Making in Women With Estrogen Receptor-Positive Early Invasive Breast Cancer: Results From the SWITCH Study

et al. 2015

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Background. The 21-gene Oncotype DX Recurrence Score assay is a validated assay to help decide the appropriate treatment for estrogen receptor-positive (ER1), early-stage breast cancer (EBC) in the adjuvant setting. The choice of adjuvant treatments might vary considerably in different countries according to various treatment guidelines. This prospective multicenter study is the first to assess the impact of the Oncotype DX assay in the French clinical setting. Methods. A total of 100 patients with ER1, human epidermal growth factor receptor 2-negative EBC, and node-negative (pN0) disease or micrometastases in up to 3 lymph nodes (pN1mi) were enrolled.Treatment recommendations, physicians' confidence before and after knowing the Recurrence Score value, and physicians' perception of the assay were recorded. Results. Of the 100 patients, 95 were evaluable (83 pN0, 12 pN1mi). Treatment recommendations changed in 37%

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Prospective transGEICAM study of the impact of the 21-gene Recurrence Score assay and traditional clinicopathological factors on adjuvant clinical decision making in women with estrogen receptor-positive (ER+) node-negative breast cancer

Cited by 110 publications

References 27 publications

Using a gene expression signature when controversy exists regarding the indication for adjuvant systemic treatment reduces the proportion of patients receiving adjuvant chemotherapy: a nationwide study

Using a gene expression signature when controversy exists regarding the indication for adjuvant systemic treatment reduces the proportion of patients receiving adjuvant chemotherapy: a nationwide study

OPTIMA prelim: a randomised feasibility study of personalised care in the treatment of women with early breast cancer

Prospective Clinical Utility Study of the Use of the 21-Gene Assay in Adjuvant Clinical Decision Making in Women With Estrogen Receptor-Positive Early Invasive Breast Cancer: Results From the SWITCH Study

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