Cost–Utility Analysis of 21-Gene Assay for Node-Positive Early Breast Cancer

Masucci, Lisa; Torres, Sofía; Eisen, Andrea; Trudeau, Maureen; Tyono, Ivan; Saunders, Hugo; Chan, KH; Isaranuwatchai, Wanrudee

doi:10.3747/co.26.4769

Cited by 8 publications

(7 citation statements)

References 37 publications

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“…However, the savings could actually be greater if the cost of managing short- and long-term toxicities were also considered, including febrile neutropenia, hospitalizations, congestive heart failure, leukemia, and neuropathy. 32-34 Furthermore, while we did not conduct a formal cost-effectiveness model analysis, when incorporating cumulative costs and quality-adjusted life years (QALY), other studies also determined the RS result to be a cost-effective tool. 35 , 36 It is important to note, however, that the selection of our patient cohort may have influenced the magnitude of cost reduction, which could have otherwise been less pronounced among all-comers.…”

Section: Discussionmentioning

confidence: 99%

Impact of the 21-Gene Recurrence Score Assay on Treatment Decisions and Cost in Patients with Node-Positive Breast Cancer: A Multicenter Study in Quebec

et al. 2022

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Background The 21-gene Breast Recurrence Score (RS) assay, “the assay”, has led to a paradigm shift for patients with hormone receptor-positive, node-negative early breast cancer and is emerging as an important tool to assist physician-patient decisions in foregoing chemotherapy in node-positive patients. We wanted to better understand the impact of the RS assay in node-positive patients upon physician treatment decisions and treatment cost in Quebec, Canada. Patients and Methods We conducted a multicenter, prospective observational trial for Estrogen/Progesterone Receptor (ER/PR)- positive, Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer patients with 1-3 positive lymph nodes. Physicians completed a questionnaire indicating treatment choice prior to and post availability of RS results. The primary endpoint was change in the physician’s recommendation for chemotherapy prior to and post assay results. Secondary endpoints included change in physician’s expressed level of confidence, and changes in estimated cost of recommended treatments prior to and post assay results. Results For the entire cohort, physician recommendation for chemotherapy was reduced by an absolute 67.1% by knowledge of the RS assay result (P < .0001). Physician recommendation of chemotherapy was decreased by 75.9% for patients RS result <14 (P < .0001); and 67.5% for patients with RS result 14-25 (P < .0001). Changes in treatment recommendations were associated with an overall reduction in cost by 73.7% per patient, and after incorporating the cost of the RS test, a cost benefit of $823 CAN at 6-month follow-up. Conclusion Altogether, we established that the assay led to a two-third reduction in the use of chemotherapy, and was a cost-effective approach for hormone receptor-positive, node-positive breast cancer.

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Section: Discussionmentioning

confidence: 99%

Impact of the 21-Gene Recurrence Score Assay on Treatment Decisions and Cost in Patients with Node-Positive Breast Cancer: A Multicenter Study in Quebec

et al. 2022

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“…49 Studies which assumed a differential hazard ratio for distant recurrence between RS result subgroups concluded that the 21-gene assay was either dominant or considered to be cost-effective compared to using clinical-pathologic factors alone. 25,[50][51][52][53] Studies which assumed a constant reduction in the rate of distant recurrence with chemotherapy irrespective of RS result were less likely to conclude that the 21-gene assay is costeffective. 54,55 This is consistent with the findings from the prognostic-only scenario in the current analysis which reported an ICER considerably higher than the NICE WTP per QALY threshold, and the prognostic-only base case assumed in the NICE DAR prior to the publication of results from the TAILORx study, which demonstrated that chemotherapy does not provide additional benefit to patients with RS results 11-25.…”

Section: Comparison To Published Evidencementioning

confidence: 99%

Cost-Effectiveness Analysis of the Oncotype DX Breast Recurrence Score® Test in Node-Negative Early Breast Cancer

Berdunov¹,

Millen²,

Paramore³

et al. 2022

CEOR

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The 21-gene assay (the Oncotype DX Breast Recurrence Score ® test) is a validated multigene assay which produces the Recurrence Score ® result (RS) to inform decisions on the use of adjuvant chemotherapy in human epidermal growth factor receptor 2-negative (HER2-), hormone receptor positive (HR+) early invasive breast cancer. A model-based economic evaluation estimated the cost-effectiveness of the 21-gene assay against the use of clinical risk tools alone based on the latest evidence from prospective studies. Methods: The proportion of patients assigned to chemotherapy conditional on their RS result was obtained from retrospective data from the Clalit registry. The probability of distant recurrence with endocrine and chemo-endocrine therapy conditional on RS result was obtained from TAILORx and NSABP B-20 trials. The cost-effectiveness of the 21-gene assay compared to using clinical risk tools alone was estimated in terms of cost per quality-adjusted life-year (QALY) over a lifetime horizon. Results: The 21-gene assay was more effective (0.17 more quality-adjusted life years) at a lower cost (-£519) over a lifetime compared to clinical risk alone. The model results were sensitive to assumptions around the magnitude of benefit of chemotherapy in the high RS result subgroup. Other assumptions underpinning the model, such as the proportion of patients assigned to chemotherapy in the low and mid-range RS result subgroups and long-term distant recurrence probabilities, had a smaller impact on the results. Conclusion:The analysis showed that the cost-effectiveness of the 21-gene assay is sensitive to assumptions for chemotherapy sparing for patients with RS 0-25 whose outcomes with endocrine therapy are no worse compared to chemotherapy-assigned patients, and a chemotherapy benefit in the RS 26-100 group. Future studies need to incorporate a wider set of tumour profiling tests other than the 21-gene assay to allow a direct comparison of their cost-effectiveness.

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“…In recent years, many researchers have been devoted to find and validate molecular alterations to serve as a prognostic and predictive biomarker. One of the validated and widely used multi-gene signature tests is the 21 genes, which is commonly applied for predicting the breast cancer outcomes [ 3 , 4 ]. In addition, there are also studies demonstrating that epigenetic alterations, such as promoter hypermethylation or hypomethylation, can lead to aberrant gene expression in tumor cells [ 5 , 6 ].…”

Section: Introductionmentioning

confidence: 99%

Promoter methylation of transient receptor potential melastatin-related 7 (TRPM7) predicts a better prognosis in patients with Luminal A breast cancers

Wang

Chen

et al. 2022

BMC Cancer

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Breast cancer is the most common female tumors arising worldwide, and genetic and epigenetic events are constantly accumulated in breast tumorigenesis. The melastatin-related transient receptor potential 7 channel (TRPM7) is a nonselective cation channel, mainly maintaining Zn2+, Ca2+ and Mg2+ homeostasis. It is also involved in regulating proliferation and migration in various cancers including breast cancer. However, epigenetic alterations (such as promoter methylation) of TRPM7 and their correlation with clinical outcomes in breast cancer patients remain largely unclear. In this study, we found that TRPM7 was highly expressed in the luminal A subtype of breast cancers but no other subtypes compared with GTEx (Genotype-Tissue Expression Rad) or normal samples by analyzing the TCGA database. Correspondingly, TRPM7 was methylated in 42.7% (93 of 219) of breast cancers. Further studies found that promoter methylation of TRPM7 were significantly associated with better clinical outcomes in breast cancer patients, especially in the Luminal A subtype. Besides, methylated TRPM7 was correlated with less number of metastatic lymph nodes and longer local failure free survival time in this subtype. In summary, our data indicate that promoter methylation of TRPM7 may predict poor prognosis in patients with luminal A breast cancer.

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Cost–Utility Analysis of 21-Gene Assay for Node-Positive Early Breast Cancer

Cited by 8 publications

References 37 publications

Impact of the 21-Gene Recurrence Score Assay on Treatment Decisions and Cost in Patients with Node-Positive Breast Cancer: A Multicenter Study in Quebec

Impact of the 21-Gene Recurrence Score Assay on Treatment Decisions and Cost in Patients with Node-Positive Breast Cancer: A Multicenter Study in Quebec

Cost-Effectiveness Analysis of the Oncotype DX Breast Recurrence Score® Test in Node-Negative Early Breast Cancer

Promoter methylation of transient receptor potential melastatin-related 7 (TRPM7) predicts a better prognosis in patients with Luminal A breast cancers

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