The impact of a genomic assay (Oncotype DX) on adjuvant treatment recommendations in early breast cancer

Boer, Richard H. De; Baker, Caroline; Speakman, David; Chao, Calvin; Yoshizawa, Carl N.; Mann, G. Bruce

doi:10.5694/mja12.11334

Cited by 61 publications

(45 citation statements)

References 18 publications

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“…Studies with a similar design have been reported from other countries [16][17][18][19][20][21][22]. They showed that the initial treatment recommendation is heterogeneous with the initial proportion of patients recommended chemotherapy ranging from 30% to 59%.…”

Section: Discussionmentioning

confidence: 64%

“…The Recurrence Score has also been validated as a predictive marker for the magnitude of adjuvant chemotherapy benefit [2,11] with a significant benefit in patients with high Recurrence Score values (28% absolute benefit in 10-year risk of distant recurrence) and minimal, if any, benefit from chemotherapy in patients with low values. In patients with intermediate values (Recurrence Scores of [18][19][20][21][22][23][24][25][26][27][28][29][30], the available data cannot rule out that some patients may benefit from chemotherapy [2,11].…”

Section: Introductionmentioning

confidence: 99%

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Prospective Clinical Utility Study of the Use of the 21-Gene Assay in Adjuvant Clinical Decision Making in Women With Estrogen Receptor-Positive Early Invasive Breast Cancer: Results From the SWITCH Study

et al. 2015

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Background. The 21-gene Oncotype DX Recurrence Score assay is a validated assay to help decide the appropriate treatment for estrogen receptor-positive (ER1), early-stage breast cancer (EBC) in the adjuvant setting. The choice of adjuvant treatments might vary considerably in different countries according to various treatment guidelines. This prospective multicenter study is the first to assess the impact of the Oncotype DX assay in the French clinical setting. Methods. A total of 100 patients with ER1, human epidermal growth factor receptor 2-negative EBC, and node-negative (pN0) disease or micrometastases in up to 3 lymph nodes (pN1mi) were enrolled.Treatment recommendations, physicians' confidence before and after knowing the Recurrence Score value, and physicians' perception of the assay were recorded. Results. Of the 100 patients, 95 were evaluable (83 pN0, 12 pN1mi). Treatment recommendations changed in 37%

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Section: Discussionmentioning

confidence: 64%

Section: Introductionmentioning

confidence: 99%

Prospective Clinical Utility Study of the Use of the 21-Gene Assay in Adjuvant Clinical Decision Making in Women With Estrogen Receptor-Positive Early Invasive Breast Cancer: Results From the SWITCH Study

et al. 2015

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“…Although many smaller studies have shown that the RS assay influences clinicians' recommendation for chemotherapy, [15][16][17][18] the first nationwide study that involved Medicare beneficiaries recently showed no change in the use of chemotherapy after adoption of the RS assay. 19 The NCCN Clinical Practice Guidelines in Oncology for Breast Cancer contain a footnote suggesting that the RS assay can be considered in select patients with 1 to 3 involved ipsilateral axillary lymph nodes, with ER-positive, HER2-negative EBC to guide the addition of combination chemotherapy to standard hormone therapy.…”

Section: Introductionmentioning

confidence: 99%

The 21-Gene Recurrence Score Assay for Node-Positive, Early-Stage Breast Cancer and Impact of RxPONDER Trial on Chemotherapy Decision-Making: Have Clinicians Already Decided?

Jasem¹,

Fisher²,

Amini³

et al. 2017

J Natl Compr Canc Netw

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Background: The 21-gene recurrence score (RS) assay is retrospectively validated for assessing prognosis and benefit from chemotherapy in hormone receptor-positive, early-stage breast cancer (EBC) with low RS. We hypothesized that oncologists have already incorporated the RS assay for decision-making in higher-risk, node-positive disease, despite the lack of prospective data and contrary to NCCN Guideline recommendations. This study provides the first analysis of trends and differences in RS use and therapeutic implications in a population-based data set of patients with node-positive EBC. It also assesses the impact of the RxPONDER trial on clinicians' chemotherapy recommendations. Methods: Node-positive EBC cases diagnosed during 2010 through 2012 and included in the National Cancer Data Base were used. Multivariate logistic regression was used to estimate test use and impact on chemotherapy recommendations. Results: The RS assay was ordered for 16.5% of the 80,405 identified patients. Of all variables, the RS assay had the strongest association with chemotherapy recommendation, with adjusted odds ratios (AORs) of 19 for scores >30. Odds of chemotherapy recommendation were significantly lower for the group who received the test (AOR, 0.21; 95% CI, 0.20-0.22). When divided based on the cutoff point of 25 adopted by the RxPONDER trial, those with an RS of 18 to 25 had significantly lower odds of chemotherapy recommendation compared with those with an RS of 26 to 30 (AOR, 0.32; 95% CI, 0.26-0.40). Test use was lower for blacks, community centers, uninsured/governmentally insured patients, higher tumor grade, larger tumor size, and more nodes involved. Chemotherapy recommendation was higher for patients of younger age, with private insurance, and with higher tumor grade, size, and number of nodes involved. Black patients had significantly higher RS (AOR, 1.37; 95% CI, 1.25-1.79). Conclusions: The RS assay influences clinicians' chemotherapy recommendation in node-positive EBC. Clinicians are using the inclusion criteria of the RxPONDER trial before its final release. Black patients have higher RS, likely representing worse biology. Significant differences exist in test use and clinical implications based on race, insurance, and facility.

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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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The impact of a genomic assay (Oncotype DX) on adjuvant treatment recommendations in early breast cancer

Abstract: The Oncotype DX recurrence score has a major impact on adjuvant treatment decision making in the MDM setting.

Cited by 61 publications

References 18 publications

Prospective Clinical Utility Study of the Use of the 21-Gene Assay in Adjuvant Clinical Decision Making in Women With Estrogen Receptor-Positive Early Invasive Breast Cancer: Results From the SWITCH Study

Prospective Clinical Utility Study of the Use of the 21-Gene Assay in Adjuvant Clinical Decision Making in Women With Estrogen Receptor-Positive Early Invasive Breast Cancer: Results From the SWITCH Study

The 21-Gene Recurrence Score Assay for Node-Positive, Early-Stage Breast Cancer and Impact of RxPONDER Trial on Chemotherapy Decision-Making: Have Clinicians Already Decided?

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

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