A decision impact, decision conflict and economic assessment of routine Oncotype DX testing of 146 women with node-negative or pNImi, ER-positive breast cancer in the UK

Holt, Simon; Bertelli, Gianfilippo; Humphreys, Ian; Valentine, William J.; Durrani, Sajid; Pudney, Delia; Rolles, Martin; Moe, Maung; Khawaja, Saira; Sharaiha, Yousef; Brinkworth, Elaine; Whelan, Sarah; Jones, Simon; Bennett, Hayley; Phillips, Ceri

doi:10.1038/bjc.2013.207

Cited by 93 publications

(96 citation statements)

References 22 publications

(23 reference statements)

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“…In this cohort 46 (48%) results were categorized as Low risk (<18), 30 (31%) were Intermediate risk (18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30), and 20 (21%) had High risk (!31) results (Table II). A sizable proportion of both N0 and Nþ patients were classified as Low risk.…”

Section: Patients and Tumor Characteristicsmentioning

confidence: 99%

“…Multiple studies have shown that use of the Oncotype DX Breast Cancer Assay affects treatment recommendations [14][15][16][17][18][19][20][21][22][23][24][25][26]. These studies demonstrated that analysis of treatment decisions before and after receipt of Recurrence Score information showed approximately a 30% decrease in chemotherapy recommendations [27].…”

Section: Introductionmentioning

confidence: 99%

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A study of the impact of the 21‐gene breast cancer assay on the use of adjuvant chemotherapy in women with breast cancer in a Mexican public hospital

Lara

Shaw-Dulin

et al. 2014

J. Surg. Oncol.

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Background: The majority of breast cancer patients in Mexico are treated through the public health system and >80% receive adjuvant chemotherapy. The aim of this prospective study was to characterize the impact of the Oncotype DX assay on adjuvant therapy decision making and the confidence in those decisions amongst public sector physicians in Mexico. Methods: Ninety-eight consecutive patients with ERþ, HER2À, stage I-IIIa, N0/N1-3 node-positive breast cancer from the Instituto Nacional de Cancerología were eligible for the study. The primary endpoint was the overall change in treatment recommendations after receiving the assay results. Results: Of 96 patients, 48% received a chemohormonal therapy recommendation prior to testing. Following receipt of results, treatment decisions changed for 31/96 (32%) patients, including 17/62 (27%) node-negative patients and 14/34 (41%) node-positive patients. The proportion of patients with a chemotherapy-based recommendation decreased from 48% pre-to 34% post-assay (P ¼ 0.024). 92% of physicians agreed that they were more confident in their treatment recommendation after ordering the assay. Conclusions: These results suggest that use of the 21-gene assay in the Mexican public health system has a meaningful impact on adjuvant treatment recommendations that may reduce the overall use of chemotherapy.

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Section: Patients and Tumor Characteristicsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

A study of the impact of the 21‐gene breast cancer assay on the use of adjuvant chemotherapy in women with breast cancer in a Mexican public hospital

Lara

Shaw-Dulin

et al. 2014

J. Surg. Oncol.

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“…[37][38][39] One of these studies also found that testing reduced patient anxiety but did not affect overall quality of life.…”

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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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“…The results of the Trial Assigning Individualized Options for Treatment (TAILORx) are awaited to help clarify the recommendations for the intermediate group [19] . There have been several studies suggesting that Oncotype-DX is cost effective as a prognostic test [20] . Furthermore, this assay has been recommended by a number of regulatory bodies [11,21] .…”

Section: Oncotype-dxmentioning

confidence: 99%

“…EP has achieved CE certification, and has been included in German guidelines [35] . In addition to reliably identifying patients who can be safely treated with adjuvant endocrine therapy only, EP has other potential applications including further stratification of tumours with intermediate RS (18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31) in order to make final recommendations regarding the need for chemothery and selection of patients for 5 years vs 10 of adjuvant endocrine therapy. Finally, the hybrid score EpClin is applicable to patients with node positive ERpositive breast cancer.…”

mentioning

confidence: 99%

Emerging gene-based prognostic tools in early breast cancer: First steps to personalised medicine

Wazir

Mokbel

2014

WJCO

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Breast cancer remains a major cause of neoplastic disease in much of the developed world. The majority of cases are diagnosed with oestrogen receptor (ER)-positive and human epidermal growth factor receptor-2 negative invasive ductal carcinoma and are treated predominantly by surgery which includes sentinel node biopsy and adjuvant endocrine therapy ± adjuvant radiotherapy. It is believed that an indeterminate subset of the patient population is needlessly incurring chemotherapy related morbidity without attaining any increase in survival due to therapy. Furthermore in the era of extended adjuvant endocrine therapy it is important to identify those patients who can be safely treated with 5 years rather than 10 years of endocrine therapy thus optimising the benefit-risk balance. This perception has propelled the development of more personalised prognostic tools for newly diagnosed cases of ER-positive breast cancer. In this article, we shall review the evidence regarding the currently available gene assays for human breast cancer.

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A decision impact, decision conflict and economic assessment of routine Oncotype DX testing of 146 women with node-negative or pNImi, ER-positive breast cancer in the UK

Cited by 93 publications

References 22 publications

A study of the impact of the 21‐gene breast cancer assay on the use of adjuvant chemotherapy in women with breast cancer in a Mexican public hospital

A study of the impact of the 21‐gene breast cancer assay on the use of adjuvant chemotherapy in women with breast cancer in a Mexican public hospital

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?

Emerging gene-based prognostic tools in early breast cancer: First steps to personalised medicine

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