Patients’ Perceptions of Gene Expression Profiling in Breast Cancer Treatment Decisions

Bombard, Yvonne; Rozmovits, Linda; Trudeau, Maureen; Leighl, Natasha B.; Deal, Ken; Marshall, Deborah A.

doi:10.3747/co.21.1524

Cited by 28 publications

(34 citation statements)

References 22 publications

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“…It used qualitative methods and a discrete-choice experiment that aimed to estimate the utility of the gep test relative to other factors, as described elsewhere 18 . The research ethics boards at St. Joseph's Hospital, Sunnybrook Health Sciences Centre, and Princess Margaret Hospital approved the study.…”

Section: Methodsmentioning

confidence: 99%

Access to Personalized Medicine: Factors Influencing the Use and Value of Gene Expression Profiling in Breast Cancer Treatment

et al. 2014

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Section: Methodsmentioning

confidence: 99%

Access to Personalized Medicine: Factors Influencing the Use and Value of Gene Expression Profiling in Breast Cancer Treatment

et al. 2014

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“…44 Careful presentation of test results is important 42 because approximately one-third of patients have been found to not fully understand the test and its implications, 43 and there is some evidence that patients may overestimate the accuracy of the test. 46 • Other molecular prognostic tests that have been developed for predicting recurrence risk in early-stage breast cancer patients have also been evaluated in systematic reviews, 18,19 and recent studies have added to the evidence base for these tests. 29,30,47 Two of the tests-MammaPrint (Agendia Laboratories) and the NanoString Technologies Prosigna test (which uses the PAM50 microarray set)-have received FDA marketing approval.…”

Section: Contextual Issues Important To the Recommendationmentioning

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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“…Participants had minimal levels of knowledge about genetic testing, mirroring past research, 3,8 which may involve failure to understand potential disadvantages, such as receiving incidental findings, or experiencing adverse psychological reactions. 22,12,18 Participants also appeared to rate privacy concerns lower than United States participants, reflecting possible cultural or healthcare differences. 17,22 Despite few privacy concerns, adequate patient education regarding implications of potential test results for survivors' future health and life insurance applications is essential.…”

Section: Willingness-to-paymentioning

confidence: 99%

“…11 The potential psychological impacts, along with concerns regarding family planning, fertility, lifestyle choices and health management, 5,12 indicate individualized management and genetic counseling should remain a priority. 3,10 A large body of research has investigated public [13][14][15][16][17] and patient 1,3,[18][19][20][21][22] perceptions of genetic testing, and reported that despite low levels of understanding, perceived benefits outweigh the risks. Patients' most highly-rated benefits include increased knowledge, better outcomes, and more effective prevention strategies.…”

Section: Introductionmentioning

confidence: 99%

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Genetic testing for the risk of developing late effects among survivors of childhood cancer: Consumer understanding, acceptance, and willingness to pay

Georgiou

Wakefield

McGill

et al. 2016

Cancer

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BACKGROUND Genetic testing to determine cancer survivors' risk of developing late effects from their cancer treatment will be increasingly used in survivorship care. This 2‐stage study with 64 survivors of childhood cancer and their parents investigated the preferences and acceptability of testing among those who may be at risk of developing late effects. METHODS The first stage (Stage 1) identified the most commonly perceived benefits and concerns regarding genetic testing for the risk of late effects among 24 participants. In Stage 2, during interviews, 20 survivors (55% of whom were female; mean age, 26.0 years [range, 18‐39 years]; standard deviation [SD], 0.80) and 20 parents (55% of whom were male; mean age of child survivor, 14.2 years [range, 10‐19 years]; SD, 0.79) rated the 7 most common benefits and concerns from those identified in Stage 1. Interviews were transcribed verbatim and analyzed. Decisional balance ratios were calculated by dividing the participants' average concerns scores with the average benefits scores. RESULTS Genetic testing for late effects was highly acceptable: 95% of participants leaned toward testing, and the majority (65.9%) would pay up to Australian $5000. The majority (97.2%) reported it was acceptable to wait for up to 6 months to receive results, and to be offered testing immediately after treatment or when the survivor reached adulthood (62.9%). Survivors and parents had a highly positive decisional balance (Mean (M), 0.5 [SD, 0.38] and M, 0.5 [SD, 0.39], respectively), indicating that perceived benefits outweighed concerns. CONCLUSIONS Although to our knowledge clinical efficacy has yet to be clearly demonstrated, survivors and parents described positive interest in genetic testing for the risk of developing late effects. Perceived benefits outweighed harms, and the majority of participants would be willing to pay, and wait, for testing. Cancer 2016. © 2016 American Cancer Society. Cancer 2016;122:2876–2885. © 2016 American Cancer Society

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Patients’ Perceptions of Gene Expression Profiling in Breast Cancer Treatment Decisions

Abstract: results identify a need to better support patient understanding of the test and its limitations. Findings illustrate the deep emotional investment patients make in gep test results and the impact of that investment on their treatment decisions.

Cited by 28 publications

References 22 publications

Access to Personalized Medicine: Factors Influencing the Use and Value of Gene Expression Profiling in Breast Cancer Treatment

Access to Personalized Medicine: Factors Influencing the Use and Value of Gene Expression Profiling in Breast Cancer Treatment

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?

Genetic testing for the risk of developing late effects among survivors of childhood cancer: Consumer understanding, acceptance, and willingness to pay

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