Recommendations from the EGAPP Working Group: can tumor gene expression profiling improve outcomes in patients with breast cancer?

Berg, Alfred O.; Armstrong, Katrina; Botkin, Jeffrey R.; Calonge, Ned; Haddow, James E.; Hayes, Maxine; Kaye, Celia I.; Phillips, Kathryn A.; Piper, Margaret; Richards, C. Sue; Scott, Joan A.; Strickland, Ora L.; Teutsch, Steven M.

doi:10.1097/gim.0b013e3181928f56

Cited by 120 publications

(51 citation statements)

References 29 publications

(56 reference statements)

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“…In fact, over the past 7 years, independent panels such as the U.S. Preventive Services Task Force and the EGAPP Working Group only made a few evidence-based recommendations for use of genomic applications in practice [33,34]. Two recent evidence reviews of promising genomics applications yielded inconclusive evidence of clinical utility for their use in practice [35,36]. …”

Section: Discussionmentioning

confidence: 99%

Translational Research in Cancer Genetics: The Road Less Traveled

Schully¹,

Benedicto²,

Gillanders³

et al. 2009

Public Health Genomics

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Gene discoveries in cancer have the potential for clinical and public health applications. To take advantage of such discoveries, a translational research agenda is needed to take discoveries from the bench to population health impact. To assess the current status of translational research in cancer genetics, we analyzed the extramural grant portfolio of the National Cancer Institute (NCI) from Fiscal Year 2007, as well as the cancer genetic research articles published in 2007. We classified both funded grants and publications as follows: T0 as discovery research; T1 as research to develop a candidate health application (e.g., test or therapy); T2 as research that evaluates a candidate application and develops evidence-based recommendations; T3 as research that assesses how to integrate an evidence-based recommendation into cancer care and prevention; and T4 as research that assesses health outcomes and population impact. We found that 1.8% of the grant portfolio and 0.6% of the published literature was T2 research or beyond. In addition to discovery research in cancer genetics, a translational research infrastructure is urgently needed to methodically evaluate and translate gene discoveries for cancer care and prevention.

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Section: Discussionmentioning

confidence: 99%

Translational Research in Cancer Genetics: The Road Less Traveled

Schully¹,

Benedicto²,

Gillanders³

et al. 2009

Public Health Genomics

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“…As an example, Blue Cross Health Tec Assessment [5] and the American Society of Clinical Oncology [6] have endorsed gene expression profiling as a means to characterize breast cancer prognosis and inform chemotherapy decisions. By contrast, the Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group, an evaluation group sponsored by CDC, reviewed the same evidence and found it insufficient to recommend for or against such testing [7]. Similarly, experts have disagreed about whether the available evidence is sufficient to recommend pharmacogenetic testing to guide the use of the anticoagulant warfarin [8,9,10,11].…”

Section: Evidence Thresholds For Genetic Test Usementioning

confidence: 99%

Debating Clinical Utility

Burke

Laberge

Press

2010

Public Health Genomics

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The clinical utility of genetic tests is determined by the outcomes following test use. Like other measures of value, it is often contested. Stakeholders may have different views about benefits and risks and about the importance of social versus health outcomes. They also commonly disagree about the evidence needed to determine whether a test is effective in achieving a specific outcome. Questions may be presented as factual disagreements, when they are actually debates about what information matters or how facts should be interpreted and used in clinical decision-making. Defining the different issues at stake is therefore an important element of policy-making. Key issues include evidence standards for test use, and in particular, the circumstances under which prospective controlled data should be required, as well as evidence on feasibility, cost and equitable delivery of testing; the goals of population-based screening programs, and in particular, the role of social outcomes in evaluating test value; and the appropriate uses and funding of tests that inform non-medical actions. Addressing each of these issues requires attention to stakeholder values and methods for effective deliberation that incorporate consumer as well as health professional perspectives.

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“…Subsequent statistical analysis and modeling narrowed this list down to 21 candidate genes, of which 16 were cancer-related and primarily focused on the components of the estrogen receptor pathway and proliferation, and five reference genes, which were used for normalization of the gene-expression of the cancer-related genes (Paik et al, 2004). The Oncotype DX has been analytically and clinically validated in multiple studies in the past and diverse patient cohorts (Cronin et al, 2007;Esteva et al, 2005;Habel et al, 2006;Paik et al, 2006). The test result is presented as a recurrence score (RS), ranging from 0 to 100, which predicts recurrence in earlystage, node-negative ER+ disease and benefit from chemotherapy after breast surgery (Arpino et al, 2013;Brenton et al, 2005;Cobleigh et al, 2005;Daly et al, 2005;Simon et al, 2003;Stec et al, 2005).…”

Section: Introductionmentioning

confidence: 99%

Signatures of breast cancer metastasis at a glance

Karagiannis

Goswami

Jones

et al. 2016

Journal of Cell Science

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Gene expression profiling has yielded expression signatures from which prognostic tests can be derived to facilitate clinical decision making in breast cancer patients. Some of these signatures are based on profiling of whole tumor tissue (tissue signatures), which includes all tumor and stromal cells. Prognostic markers have also been derived from the profiling of metastasizing tumor cells, including circulating tumor cells (CTCs) and migratory–disseminating tumor cells within the primary tumor. The metastasis signatures based on CTCs and migratory–disseminating tumor cells have greater potential for unraveling cell biology insights and mechanistic underpinnings of tumor cell dissemination and metastasis. Of clinical interest is the promise that stratification of patients into high or low metastatic risk, as well as assessing the need for cytotoxic therapy, might be improved if prognostics derived from these two types of signatures are used in a combined way. The aim of this Cell Science at a Glance article and accompanying poster is to navigate through both types of signatures and their derived prognostics, as well as to highlight biological insights and clinical applications that could be derived from them, especially when they are used in combination.

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Recommendations from the EGAPP Working Group: can tumor gene expression profiling improve outcomes in patients with breast cancer?

Abstract: The EWG reviewed economic studies that used modeling to predict potential effects of using gene profiling, and judged the evidence inadequate.

Cited by 120 publications

References 29 publications

Translational Research in Cancer Genetics: The Road Less Traveled

Translational Research in Cancer Genetics: The Road Less Traveled

Debating Clinical Utility

Signatures of breast cancer metastasis at a glance

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