Risk of Recurrence and Chemotherapy Benefit for Patients With Node-Negative, Estrogen Receptor–Positive Breast Cancer: Recurrence Score Alone and Integrated With Pathologic and Clinical Factors

Tang, Gong; Cuzick, Jack; Costantino, Joseph P.; Dowsett, Mitch; Forbes, John F.; Crager, Michael; Mamounas, Eleftherios P.; Shak, Steven; Wolmark, Norman

doi:10.1200/jco.2011.35.3714

Cited by 122 publications

(106 citation statements)

References 15 publications

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“…Incorporating clinical data (tumour stage, grade and age) for patients with node-negative disease into the test improves its performance as a prognostic test but crucially does not improve its ability to predict chemotherapy sensitivity. 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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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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“…23,[26][27][28]31 In a meta-analysis of combined data sets from the NSABP and TransATAC trials, a prognostic score that combined RS with selected clinicopathological features provided improved risk assessment over RS alone (P < 0.001) and classified fewer patients as intermediate risk. 32 • A recent meta-analysis of four studies using a fixedeffects model found a hazard ratio of 2.97 (95% CI 2.19-4.0) for a high RS versus an intermediate or low RS. However, this analysis combined studies on nodenegative and node-positive patients and included one study in which the outcome was locoregional rather than distant recurrence.…”

Section: Clinical Validitymentioning

confidence: 99%

“…(Table 3) 31 or a score that combined RS with selected clinicopathological factors. 32 • When evaluated by the GRADE criteria, the quality of evidence indicating that Oncotype DX RS has clinical utility was assessed as very low. 21 Low quality was not due to conflicting studies or studies demonstrating lack of benefit.…”

Section: Clinical Utilitymentioning

confidence: 99%

Recommendations from the EGAPP Working Group: does the use of Oncotype DX tumor gene expression profiling to guide treatment decisions improve outcomes in patients with breast cancer?

2015

Genet Med

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Summary of Recommendations:The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group found insufficient evidence to recommend for or against the use of Oncotype DX testing to guide chemotherapy treatment decisions in women with hormone receptor-positive, lymph node-negative, or lymph node-positive early breast cancer who are receiving endocrine therapy. This recommendation statement updates a 2009 EGAPP statement on the use of gene expression profiling tests in breast cancer. Evidence of clinical validity for Oncotype DX was confirmed as adequate. With regard to clinical utility, although there was evidence from prospective retrospective studies that the Oncotype DX test predicts benefit from chemotherapy, and there was adequate evidence that the use of Oncotype DX gene expression profiling in clinical practice changes treatment decisions regarding chemotherapy, no direct evidence was found that the use of Oncotype DX testing leads to improved clinical outcomes. Rationale:In women with early-stage invasive breast cancer, gene expression profiling is increasingly being used as an aid to estimate the likely benefit from chemotherapy treatment. In a previous recommendation statement, the EGAPP Working Group (EWG) found adequate evidence for clinical validity of some gene expression profiling tests in predicting distant disease recurrence in women with early-stage, hormone receptor-positive, lymph-node-negative breast cancer who are treated with tamoxifen, but insufficient evidence that use of these tests for decisions about chemotherapy treatment has clinical utility. The current recommendation statement updates these findings for Oncotype DX and extends them to the population of women with lymph node-positive disease, using evidence from recent systematic reviews and other sources. Analytic validity:The previous recommendation statement found that evidence was inadequate to enable quantitative determination of the analytic validity of Oncotype DX. Analytic validity was not reconsidered in the updated recommendation statement because there remains no gold-standard test for comparison. Clinical validity: The EWG found that new evidence published since the original evidence review supports the clinical validity of Oncotype DX in predicting risk of distant metastases in women with hormone receptor-positive, early-stage breast cancer that is either node-negative or node-positive. Clinical utility: No direct evidence was found that use of Oncotype DX tumor gene expression profiling to guide treatment decisions improves clinical outcomes in women with early breast cancer. There is indirect evidence, from prospective retrospective studies on archived tissue samples from randomized controlled trials, that the Oncotype DX test can predict benefit from chemotherapy. Large, prospective, randomized, controlled trials currently in progress may provide evidence of clinical utility. Contextual issues: Until definitive evidence for clinical utility is available, clinicians must decide on a case-by-cas...

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“…This test has been shown to have predictive value in identifying women with either node-positive or node-negative breast cancer who are unlikely to respond to adjuvant chemotherapy and so may choose to forgo adjuvant chemotherapy. 30,31 This test is eligible for review with our tool, is based on its ability to predict drug response (as well as recurrence risk), and proceeds through clinical review to economic review. OncotypeDx has potentially large budget impact, reasonable prevalence (greater than 20% of women have actionable results), and a relatively high price for a test.…”

Section: Q10mentioning

confidence: 99%

Improving the Efficiency and Quality of the Value Assessment Process for Companion Diagnostic Tests: The Companion test Assessment Tool (CAT)

Canestaro

Pritchard²,

Garrison³

et al. 2015

JMCP

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Risk of Recurrence and Chemotherapy Benefit for Patients With Node-Negative, Estrogen Receptor–Positive Breast Cancer: Recurrence Score Alone and Integrated With Pathologic and Clinical Factors

Abstract: RSPC refines the assessment of distant recurrence risk and reduces the number of patients classified as intermediate risk. Adding clinicopathologic measures did not seem to enhance the value of RS alone nor the individual biology RS identifies in predicting chemotherapy benefit.

Cited by 122 publications

References 15 publications

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

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

Recommendations from the EGAPP Working Group: does the use of Oncotype DX tumor gene expression profiling to guide treatment decisions improve outcomes in patients with breast cancer?

Improving the Efficiency and Quality of the Value Assessment Process for Companion Diagnostic Tests: The Companion test Assessment Tool (CAT)

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