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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Adjuvant Treatment
• Intervention / Treatment: Genetic: Oncotype DX® Assay; Other: Cost

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.

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04112080
      • Andre Mattar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with early stage breast cancer, positive ER and negative HER2 with negative lymph node or positive lymph node.

Description

Inclusion Criteria:

Women ≥ 18 years Early stage breast cancer, ER and/or PR positive with HER2 negative breast cancer.

Exclusion Criteria:

More than one operable primary breast tumor; Multifocal or multicentric tumors; 4 or more lymph node involvement; Metastatic breast cancer; Previous history of breast cancer; Invasive tumor <2 mm ; Performance status > 2 and / or other clinical factors that would make the patient a non-viable candidate for adjuvant chemotherapy; Previous hormonal or chemotherapy treatment; Current medical condition that would interfere with their ability to consent (psychiatric illness, for example)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Single arm; All patients will have the test

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of patients whose choice of treatment is changed as a result of Oncotype Test Low risk	Changes based on initial clinical measures	up to 3 weeks
Economic evaluation	The costs of each scenario	up to 5 years

Collaborators and Investigators

• Sponsor: Hospital Perola Byington
• Collaborators: Fleury Laboratory

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 8, 2018
• Primary Completion (ACTUAL): February 4, 2019
• Study Completion (ACTUAL): February 4, 2019

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: October 17, 2021
• First Posted (ACTUAL): October 29, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 1/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All data will be available upon request
• IPD Sharing Time Frame: The data will be available when the paper is published upon request
• IPD Sharing Access Criteria: described above
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes