A prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene Recurrence Score® assay in oestrogen receptor positive node negative breast cancer

Davidson, James; Cromwell, Ian; Ellard, Susan L.; Lohrisch, Caroline A.; Gelmon, Karen A.; Shenkier, Tamara; Villa, Diego; Lim, Howard John; Sun, Sophie; Taylor, Sara; Taylor, Morag; Czerkawski, Barbara; Hayes, Malcolm; Ionescu, Diana N.; Yoshizawa, Carl N.; Chao, Calvin; Peacock, Stuart; Chia, Stephen

doi:10.1016/j.ejca.2013.03.009

Cited by 49 publications

(32 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…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: 74%

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

View full text Add to dashboard Cite

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%

show abstract

Section: Discussionmentioning

confidence: 74%

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

View full text Add to dashboard Cite

show abstract

“…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.

View full text Add to dashboard Cite

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.

show abstract

“…We are aware that the Irish Healthcare system has procured this test at a lower price but this commercially sensitive information was not available to us. Notably this analysis, as with others, have not been able to apply a monetary value to the societal costs associated with chemotherapy administration such as child care, absenteeism from work, social benefit costs and the improvement in quality of life through decreased patient anxiety in avoiding chemotherapy [23,50,53].…”

Section: Discussionmentioning

confidence: 96%

“…Cost-effective analyses performed across global healthcare settings have predominantly shown 21-gene testing to be cost saving or cost-effective, regardless of variation in chemotherapy prescribing and costs [29,39,[50][51][52]. We estimated that 21-gene testing and its associated cost during the study period led to €793,565 in net savings to the Irish health service during the 1.5-year study period.…”

Section: Discussionmentioning

confidence: 97%

Economic impact of 21-gene recurrence score testing on early-stage breast cancer in Ireland

Smyth

Watson

Walsh

et al. 2015

Breast Cancer Res Treat

View full text Add to dashboard Cite

The 21-gene test is a validated multi-gene diagnostic test that predicts chemotherapy (CT) benefit in oestrogen receptor positive (ER+), lymph node-negative (N0) breast cancer (BC) patients (pts). Ireland was the first public health care system to reimburse this test in Europe. Study objectives were to assess the impact of this test on decision-making and to analyse the economic impact of testing. Between October 2011 and February 2013, a national, retrospective, cross-sectional observational study of ER+, N0 BC pts tested with the 21-gene test was conducted. Surveyed breast medical oncologists, provided the assumption for the decision impact analysis that grade (G) 1 pts would not have received CT before testing and G2/3 pts would have received CT before testing. Descriptive statistical analyses were performed. 592 pts were identified; Low, intermediate and high recurrence score were identified in 53, 36 and 10 % pts, respectively. 384 (70 %) pts had G2, 129 (22 %) G3 and 76 (13 %) G1 tumours. Post testing, 345 pts (59 %) experienced a change in CT decision; 339 changed to hormone therapy alone and 6 advised to receive CT. 172 (30 %) pts received CT, 12 (3.9 %) of pts with low scores, 108 (50.9 %) of intermediate risk and 50 (90.9 %) of pts with high risk scores. Net reduction in CT use was 58 % and net savings achieved were €793,565. Since public reimbursement, the introduction of the 21-gene test has resulted in a significant reduction in chemotherapy administration and cost savings for the Irish public healthcare system.

show abstract

A prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene Recurrence Score® assay in oestrogen receptor positive node negative breast cancer

Cited by 49 publications

References 23 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

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

Economic impact of 21-gene recurrence score testing on early-stage breast cancer in Ireland

Contact Info

Product

Resources

About