The 21-gene recurrence score assay impacts adjuvant therapy recommendations for ER-positive, node-negative and node-positive early breast cancer resulting in a risk-adapted change in chemotherapy use

Eiermann, W.; Rezai, Mahdi; Kümmel, Sherko; Kühn, Thorsten; Warm, M.; Friedrichs, Kay; Schneeweiß, Andreas; Markmann, S.; Eggemann, Holm; Hilfrich, J.; Jackisch, Christian; Witzel, Isabell; Eidtmann, Holger; Bachinger, Andreas; Hell, Susanne; Blohmer, Jens-Uwe

doi:10.1093/annonc/mds512

Cited by 131 publications

(154 citation statements)

References 32 publications

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“…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%

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: 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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“…In recent years, RNA expression-based classification of tumors has become an attractive standardized approach to aiding in the diagnosis and subclassification of tumors [19][20][21][22][23][24][25] and for individualized therapy applications. [26][27][28] In the coming years, gene expressionbased analysis may serve as a complementary approach to genome-wide DNA analysis of tumors for individualized therapy.…”

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confidence: 99%

A 92-gene cancer classifier predicts the site of origin for neuroendocrine tumors

Kerr

Schnabel²,

Sullivan

et al. 2014

Modern Pathology

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A diagnosis of neuroendocrine carcinoma is often morphologically straight-forward; however, the tumor site of origin may remain elusive in a metastatic presentation. Neuroendocrine tumor subtyping has important implications for staging and patient management. In this study, the novel use and performance of a 92-gene molecular cancer classifier for determination of the site of tumor origin are described in a series of 75 neuroendocrine tumors (44 metastatic, 31 primary; gastrointestinal (n ¼ 12), pulmonary (n ¼ 22), Merkel cell (n ¼ 10), pancreatic (n ¼ 10), pheochromocytoma (n ¼ 10), and medullary thyroid carcinoma (n ¼ 11)). Formalinfixed, paraffin-embedded samples passing multicenter pathologist adjudication were blinded and tested by a 92-gene molecular assay that predicts tumor type/subtype based upon relative quantitative PCR expression measurements for 87 tumor-related and 5 reference genes.

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The 21-gene recurrence score assay impacts adjuvant therapy recommendations for ER-positive, node-negative and node-positive early breast cancer resulting in a risk-adapted change in chemotherapy use

Cited by 131 publications

References 32 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?

A 92-gene cancer classifier predicts the site of origin for neuroendocrine tumors

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