Validation of gene profiling of breast tumors using the 21-gene panel for use in a population of patients treated in the Unified Health System (SUS).

• Grant number: 25/12182-3
• Support Opportunities: Scholarships in Brazil - Scientific Initiation
• Start date: April 01, 2026
• End date: March 31, 2027
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Auro del Giglio
• Grantee: Beatris Lucio Galete
• Host Institution: Centro Universitário FMABC (FMABC). Santo André , SP, Brazil
• Associated research grant: 23/11927-0 - Validation of gene profiling of breast tumors using the 21-gene panel for use in a population of patients treated in the Unified Health System (SUS), AP.R

Abstract

Gene expression profiling using the 21-gene panel known as Oncotype® is currently used routinely for prognostic stratification of patients with hormone receptor-positive, Her2/neu-negative breast tumors, typically with negative axillary lymph nodes. For patients with scores above 25 in postmenopausal women or above 20 in premenopausal women, Oncotype is used to guide the indication of adjuvant chemotherapy. The Oncotype score is not only prognostic but also predictive of chemotherapy sensitivity. However, despite being considered cost-effective in several healthcare settings, the high cost of this molecular test is prohibitive for its widespread use in the Brazilian Unified Health System (SUS). Our group has reproduced this test based on the same 21 genes, using multiplex PCR, achieving a significantly lower cost and promising prognostic performance. The national version of the test, in addition to enabling access through the SUS, also promotes greater integration with local healthcare systems, allowing for faster and more personalized treatment decisions. For its implementation, it is necessary to validate the correspondence between our score and the original Oncotype score, as well as to assess its ability to stratify recurrence risk in patients with early-stage, hormone receptor-positive, node-negative breast cancer-a subgroup that was underrepresented in our previous studies. (AU)