Conveying genomic recurrence risk estimates to patients with early‐stage breast cancer: oncologist perspectives

Spellman, Elizabeth; Sulayman, Nadiyah; Eggly, Susan; Peshkin, Beth N.; Isaacs, Claudine; Schwartz, Marc D.; O’Neill, Suzanne C.

doi:10.1002/pon.3264

Cited by 19 publications

(26 citation statements)

References 49 publications

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“…Their opinions of the evidence appeared to affect their views of gep test results in decision-making, with several oncologists using test results as one piece of a larger puzzle rather than relying more heavily on the results, as was the case for other oncologists. Our findings are similar to those of Spellman et al 28 , who found that oncologists were concerned that too much weight was given to test results rather than to other clinical data.…”

Section: Discussionsupporting

confidence: 81%

Uptake of a 21-Gene Expression Assay in Breast Cancer Practice: Views of Academic and Community-Based Oncologists

et al. 2017

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Purpose Advances in personalized medicine have produced novel tests and treatment options for women with breast cancer. Relatively little is known about the process by which such tests are adopted into oncology practice. The objectives of the present study were to understand the experiences of medical oncologists with multigene expression profile (gep) tests, including their adoption into practice in early-stage breast cancer, and the perceptions of the oncologists about the influence of test results on treatment decision-making. MethodsWe conducted a qualitative descriptive study involving interviews with medical oncologists from academic and community cancer centres or hospitals in 8 communities in Ontario. A 21-gene breast cancer assay was used as the example of gep testing. Qualitative analytic techniques were used to identify the main themes. ResultsOf 28 oncologists who were approached, 21 (75%) participated in the study [median age: 43 years; 12 women (57%)]. Awareness and knowledge of gep testing were derived from several sources: international scientific meetings, participation in clinical studies, discussions with respected colleagues, and manufacturer-sponsored meetings. Oncologists observed that incorporating gep testing into their clinical practice resulted in several changes, including longer consultation times, second visits, and taking steps to minimize treatment delays. Oncologists expressed divergent opinions about the strength of evidence and added value of gep testing in guiding treatment decisions.Conclusions Incorporation of gep testing into clinical practice in early-stage breast cancer required oncologists to make changes to their usual routines. The opinions of oncologists about the quality of evidence underpinning the test affected how much weight they gave to test results in treatment decision-making.

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Section: Discussionsupporting

confidence: 81%

Uptake of a 21-Gene Expression Assay in Breast Cancer Practice: Views of Academic and Community-Based Oncologists

et al. 2017

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“…Qualitative studies with oncologists suggest they take a number of factors into consideration when ordering testing. These factors include not only clinical variables, but also patients’ pre-test preferences for chemotherapy 32 and the degree of uncertainty regarding their recommendation for chemotherapy. 33 Additional multi-method research is needed to further understand oncologists’ decision making processes about the use of GEP testing, and precision medicine more broadly, as well as how they involve patients in this process.…”

Section: Resultsmentioning

confidence: 99%

Adoption of Gene Expression Profiling for Breast Cancer in US Oncology Practice for Women Younger Than 65 Years

O’Neill¹,

Isaacs²,

Chao³

et al. 2015

J Natl Compr Canc Netw

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Background Four practice guidelines incorporate the use of gene expression profiling (GEP) tests for early-stage, hormone-receptor positive, HER2 negative breast tumors. Few studies describe factors associated with GEP testing in US oncology practice. We assessed the relationship between clinical, demographic, and group-level socioeconomic variables and test use in women under age 65. Patients and Methods Data from five state cancer registries were linked with insurance claims data and GEP test results. We assessed rates of testing and variables associated with test use in an incident cohort of 9444 commercially-insured women under age 65, newly-diagnosed with Stage I or II hormone-receptor positive breast cancer from 2006–2012. Results Rates of testing for women with N0 disease increased from 20.4% in 2006 to 35.2% in 2011. Variables associated with higher rates of testing, beyond clinical factors such as nodal status (P < .001), included being diagnosed from 2008–2012 vs. 2006–2007 (adjusted odds ratio, 1.67; 95% CI, 1.47 to 1.90), having preexisting comorbidities (adjusted odds ratio, 1.35; 95% CI, 1.14 to 1.59), and higher out-of-pocket pharmacy costs (adjusted odds ratio, 1.66; 95% CI, 1.40 to 1.97). Women under age 50 were more likely to be tested if they had Stage I vs. Stage II disease (P < .0001). Conclusions In an insured population of women under age 65, GEP testing increased following its inclusion in guidelines and mounting evidence. Additional research is needed to better understand oncologists’ decision not to order GEP testing for their patients who are otherwise eligible.

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“…42,44 Explanation and discussion of intermediate risk are very challenging, and decisions are ultimately made by incorporating consideration of other clinical factors as well as patients' views and preferences. 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.…”

Section: Contextual Issues Important To the Recommendationmentioning

confidence: 99%

“…Studies have begun to document how medical and surgical oncologists use the test, how they communicate results to patients, how well patients understand the information, and how they use it in decision making. [42][43][44][45] Although studies to date are too small to allow firm conclusions, their findings indicated that physicians generally assume the test has clinical utility and many use it as a primary tool in discussing risks and benefits of chemotherapy with women who have HR+ early breast cancer, often by directly sharing with them the report provided by Genomic Health. 42,44 Explanation and discussion of intermediate risk are very challenging, and decisions are ultimately made by incorporating consideration of other clinical factors as well as patients' views and preferences.…”

Section: Contextual Issues Important To the Recommendationmentioning

confidence: 99%

“…[42][43][44][45] Although studies to date are too small to allow firm conclusions, their findings indicated that physicians generally assume the test has clinical utility and many use it as a primary tool in discussing risks and benefits of chemotherapy with women who have HR+ early breast cancer, often by directly sharing with them the report provided by Genomic Health. 42,44 Explanation and discussion of intermediate risk are very challenging, and decisions are ultimately made by incorporating consideration of other clinical factors as well as patients' views and preferences. 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.…”

Section: Contextual Issues Important To the Recommendationmentioning

confidence: 99%

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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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Conveying genomic recurrence risk estimates to patients with early‐stage breast cancer: oncologist perspectives

Cited by 19 publications

References 49 publications

Uptake of a 21-Gene Expression Assay in Breast Cancer Practice: Views of Academic and Community-Based Oncologists

Uptake of a 21-Gene Expression Assay in Breast Cancer Practice: Views of Academic and Community-Based Oncologists

Adoption of Gene Expression Profiling for Breast Cancer in US Oncology Practice for Women Younger Than 65 Years

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?

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