NCT05100277

Impact of Oncotype DX® on Treatment Recommendation and Its Economic Evaluation Under the Brazilian Society Perspective

Impact of Oncotype DX® on Treatment Recommendation of for Early-stage Hormone Receptor-positive Breast Cancer and Its Economic Evaluation Under the Brazilian Society Perspective

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 155 (actual)
• Sponsor: Hospital Perola Byington · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

155 Pérola Byington Hospital patients presenting early stage luminal BC were submitted to Oncotype Dx® evaluation. Changes in treatment recommendations and costs were obtained from Pérola Byington Hospital. Oncotype DX® incorporation in the Brazilian Public Health System should be considered, as it results in high clinical impact for patient and high economic impact for health system, being a tool that safely and accurately delimits the subgroup of patients who really need AC.

Detailed description

Background: It is known that there is significant over administration (and under administration) of adjuvant chemotherapy (AC) when standard clinical parameters (SCP) are used for patients diagnosed with early stage RE+ breast cancer (BC). Although absolute clinical benefit of AC may be modest, its toxicity and economic burden is highly significant; therefore, selecting appropriate patients for AC remains an important issue. Oncotype DX® identifies high-risk patients who are likely to benefit from AC, which otherwise might not be identified through SCP and low-risk patients who will not benefit from AC, thus avoiding toxicities and inherent risks. This study aimed to evaluate the impact of the Oncotype DX® test on treatment decisions in N0 and N1 early-stage breast cancer patients at a Public Brazilian hospital and to estimate the incremental cost-effectiveness ratio (ICER) and budget impact (BI) of incorporating Oncotype DX® under the perspective of the Brazilian Society. Changes in treatment recommendations and costs will be obtained from Pérola Byington Hospital. Additional data will be obtained from literature. Medical costs (test, chemotherapy and adverse events), productivity loss, transportation and employment leave will be considered.

Conditions

• Breast Cancer
• Adjuvant Treatment

Interventions

Type	Name	Description
GENETIC	Oncotype DX® Assay	After surgery, tumoral tissue was used to perform Oncotype Dx®. Patients were evaluated and therapy recommendations - adjuvant chemotherapy (CT) plus hormone therapy (HT) or HT alone - were captured before and after revealing the test results. Results from TAILORx10 were used to guide decisions for or against CT for individual patients. Changes in treatment recommendations were obtained.
OTHER	Cost	Changes in treatment costs were estimated from Pérola Byington Hospital.

Timeline

• Start date: 2018-08-08
• Primary completion: 2019-02-04
• Completion: 2019-02-04
• First posted: 2021-10-29
• Last updated: 2022-01-06

Locations

1 site across 1 country: Brazil