# Adjuvant chemotherapy in T1a/bN0 breast cancer with a high 21-gene recurrence score (> 25): a 10-year follow-up in a real-world cohort

## TL;DR

This study examines whether chemotherapy improves outcomes for small, early-stage breast cancer patients with high genetic risk scores.

## Contribution

The study evaluates adjuvant chemotherapy benefits in T1a/bN0 breast cancer patients with high 21-gene scores in a real-world setting.

## Key findings

- Adjuvant chemotherapy did not improve invasive disease-free survival in T1a/bN0 breast cancer patients with high 21-gene scores.
- Distant recurrence rates were similar between patients who received chemotherapy and those who did not.
- The 21-gene recurrence score did not predict improved outcomes in this specific patient group.

## Abstract

In ER + /HER2- early breast cancer (BC), 21-Gene Recurrence Score (RS) > 25 indicates high-risk of distant-recurrence and predicts benefit from adjuvant chemotherapy (aCT) regardless of tumor-size. However, T1a/b (≤ 1 cm) node-negative (N0) tumors, regarded as of low risk of recurrence, were under-represented in the RS trials. We therefore aimed to investigate the benefit of aCT in patients with T1a/bN0 BC, RS > 25, where clinical and genomic risk indicators are discordant.

This retrospective observational cohort study utilized Israel’s national Oncotest database to identify Clalit Health Services (CHS) members, diagnosed with T1a/bN0 HR + /HER2- BC, who underwent RS testing between February 2006, and December 2019. Patients with RS > 25 who received aCT were matched 1:1 by propensity-scoring to similar patients receiving no aCT. Invasive disease-free survival (iDFS) and distant recurrence were the study endpoints. Patient demographic and clinical data were obtained from CHS’s centralized database. Kaplan––Meier analysis with log-rank testing was used for comparing outcomes.

During the study period, high-risk RS result (> 25) was identified in 156/9858 patients of the study cohort. aCT was administered to 74 (47.4%) and median follow-up was 121 months. Within the 148 matched-cases, eighteen iDFS-events occurred, nine (12.1%) in each group (χ2 = 0.72, p = 0.39). Four (5.4%) of the aCT treated and three (4.0%) of the untreated patients were diagnosed with distant recurrence (χ2 = 0.22, p = 0.64).

In this study cohort, patients with T1a/bN0 BC, RS > 25 that received aCT, did not have improved outcomes and the 21-Gene RS > 25 was not found to be predictive, possibly due to the low number of events observed.