The influence of a Gene expression profile on breast cancer decisions

Henry, Leonard R.; Stojadinovic, Alexander; Swain, Sandra M.; Prindiville, Sheila A.; Cordes, R.; Soballe, Peter W.

doi:10.1002/jso.21244

Cited by 83 publications

(28 citation statements)

References 15 publications

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“…We, like others [18–20] who have analyzed the use of RS in clinical practice, observed a significantly smaller proportion of RS’s in the high-risk range than that which had been reported in validation cohorts ( p < 0.0001; Fig. 1).…”

Section: Resultssupporting

confidence: 74%

Why does Oncotype DX recurrence score reduce adjuvant chemotherapy use?

Schneider

Khalil

2012

Breast Cancer Res Treat

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The Oncotype DX recurrence score (RS) reduces breast cancer adjuvant treatment utilization, but the reasons for this effect are not straightforward. We performed a retrospective chart review of 89 consecutive node-negative breast cancer patients for whom RS was ordered to facilitate adjuvant treatment decisions. By subtracting the relapse rate predicted by RS from that calculated using the Adjuvant! Online (AOL) web-based instrument, a “prognostic delta” (PΔ) was determined, reflecting the difference between prognoses predicted by these two indices. Clinician interviews were conducted to evaluate the actual effect of RS on treatment decisions and its relation to PΔ. Adjuvant chemotherapy use decreased from 61 to 26 % as a consequence of RS results (p < 0.0001). In multivariate analysis, RS was the only factor significantly associated with the final adjuvant treatment choice. Surprisingly, RS caused chemotherapy to be withheld even when PΔ was negative (i.e., cases in which RS predicted a less favorable outcome than AOL). The prognostic and chemotherapy predictive utilities of the RS do not fully account for its effect in reducing adjuvant chemotherapy use. Further studies are required to more fully elucidate other factors that may be responsible for this effect, including the possibility of unintended influence.

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Section: Resultssupporting

confidence: 74%

Why does Oncotype DX recurrence score reduce adjuvant chemotherapy use?

Schneider

Khalil

2012

Breast Cancer Res Treat

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“…Other studies have supported the ability of the RS assay to change physician treatment recommendations compared with those made on the basis of clinical pathologic characteristics alone, with a shift in recommendations from chemotherapy and hormonal therapy to hormone therapy alone. Reported reductions in chemotherapy use range from 10 to 20 % with use of the assay [17–24], although not all studies have reported declines in chemotherapy use [22]. Using matched analysis, we found an absolute reduction in chemotherapy receipt of 3 % when RS assay was utilized.…”

Section: Discussionmentioning

confidence: 79%

21-Gene recurrence score decreases receipt of chemotherapy in ER+ early-stage breast cancer: an analysis of the NCDB 2010–2013

Parsons

Landercasper

Smith

et al. 2016

Breast Cancer Res Treat

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The purpose of this study was to determine if receipt of chemotherapy was associated with utilization of the 21-gene recurrence score assay (RS assay) or with recurrence score (RS) in eligible patients. Using the National Cancer Data Base (NCDB), we identified female patients eligible for RS assay based on National Comprehensive Cancer Network (NCCN) guidelines: age 18–70, ER-positive and HER2-negative early-stage breast cancer diagnosed during 2010–2013. We excluded patients not meeting testing guidelines. Inclusion required result of RS in patients who underwent RS assay and status for receipt of chemotherapy. Multivariable logistic regression models and propensity matched analysis were used to determine associations between RS assay and RS with receipt of chemotherapy. Among 129,765 patients who were eligible, 74,778 underwent RS assay and had results available. Of these, 59.5 % (44,505) had low-risk, 32.0 % (23,920) had intermediate-risk, and 8.5 % (6353) had high-risk RS. Patients with intermediate- and high-risk RS were more likely to receive chemotherapy [OR 12.9 (CI 12.2–13.6), p <0.001 and OR 87.2 (CI 79.6–95.6), p <0.0001], respectively. In both low- and intermediate-risk groups, increasing RS score was significantly associated with increasing odds of receiving chemotherapy [OR 1.10 (CI 1.09–1.12), p <0.0001 and OR 1.26 (CI 1.25–1.27), p <0.0001, respectively, for each point increase in RS]. Receipt of chemotherapy was more likely in patients who did not undergo RS assay compared to those who did, OR 1.21 (CI 1.175–1.249) p <0.0001. The utilization of RS assay and the RS were both strongly associated with chemotherapy receipt. Patients eligible for chemotherapy, based on NCCN criteria, were more likely to receive chemotherapy if they did not undergo RS assay or they had a high RS.

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“…Three small studies summarized by Smartt et al showed that Oncotype DX led to a reduction in the number of LN− breast cancer patients recommended for treatment with chemotherapy. 27–29 Two additional studies described in the OHTAC review, 30,31 followed by one published report and one conference abstract summarized by Ward et al, 32,33 showed that Oncotype DX had a similar impact on treatment recommendations. Five additional retrospective studies described by Hornberger et al also showed that use of the RS led to an overall reduction in recommendations for chemotherapy.…”

Section: Evidence Overviewmentioning

confidence: 98%

Clinical utility of gene-expression profiling in women with early breast cancer: an overview of systematic reviews

Marrone

Stewart

Dotson

2015

Genetics in Medicine

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Purpose This overview systematically evaluates the clinical utility of using Oncotype DX and MammaPrint gene-expression profiling tests to direct treatment decisions in women with breast cancer. The findings are intended to inform an updated recommendation from the Evaluation of Genomic Applications in Practice and Prevention Working Group. Methods Evidence reported in systematic reviews evaluating the clinical utility of Oncotype DX and MammaPrint, as well as the ability to predict treatment outcomes, change in treatment decisions, and cost-effectiveness, was qualitatively synthesized. Results Five systematic reviews found no direct evidence of clinical utility for either test. Indirect evidence showed Oncotype DX was able to predict treatment effects of adjuvant chemotherapy, whereas no evidence of predictive value was found for MammaPrint. Both tests influenced a change in treatment recommendations in 21 to 74% of participants. The cost-effectiveness of Oncotype DX varied with the alternative compared. For MammaPrint, lack of evidence of the predictive value led to uncertainty in the cost-effectiveness. Conclusion No studies were identified that provided direct evidence that using gene-expression profiling tests to direct treatment decisions improved outcomes in women with breast cancer. Three ongoing studies may provide direct evidence for determining the clinical utility of gene-expression profiling testing.

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The influence of a Gene expression profile on breast cancer decisions

Abstract: RS results were associated with real-world decision changes in 31% of patients and 24% of panel recommendations and increased panel consensus by 10%. However RS did not increase the strength of panelist's recommendations.

Cited by 83 publications

References 15 publications

Why does Oncotype DX recurrence score reduce adjuvant chemotherapy use?

Why does Oncotype DX recurrence score reduce adjuvant chemotherapy use?

21-Gene recurrence score decreases receipt of chemotherapy in ER+ early-stage breast cancer: an analysis of the NCDB 2010–2013

Clinical utility of gene-expression profiling in women with early breast cancer: an overview of systematic reviews

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