The 21-gene Recurrence Score\xae assay predicts distant recurrence in lymph node-positive, hormone receptor-positive, breast cancer patients treated with adjuvant sequential epirubicin- and docetaxel-based or epirubicin-based chemotherapy (PACS-01 trial)

Frédérique Penault-Llorca,Carl Yoshizawa,Steven Shak,Thomas Filleron,Frederick L Baehner,Christine Sagan,Pierre Fumoleau,Anne-Laure Martin,Lise Roca,Henri Roché,Joseph M Anderson,Jérôme Lemonnier,Magali Lacroix-Triki,Bernard Asselain,Diana B Cherbavaz

doi:10.1186/s12885-018-4331-8

Abstract

BackgroundThe 21-gene Recurrence Score (RS) result predicts outcome and chemotherapy benefit in node-negative and node-positive (N+), estrogen receptor-positive (ER+) patients treated with endocrine therapy. The purpose of this study was to evaluate the prognostic impact of RS results in N+, hormone receptor-positive (HR+) patients treated with adjuvant chemotherapy (6 cycles of FEC100 vs. 3 cycles of FEC100 followed by 3 cycles of docetaxel 100 mg/m2) plus endocrine therapy (ET) in the PACS-01 trial (J Clin Oncol 2006;24:5664-5671).MethodsThe current study included 530 HR+/N+ patients from the PACS-01 parent trial for whom specimens were available. The primary objective was to evaluate the relationship between the RS result and distant recurrence (DR).ResultsThere were 209 (39.4%) patients with low RS (< 18), 159 (30%) with intermediate RS (18-30) and 162 (30.6%) with high RS (≥ 31). The continuous RS result was associated with DR (hazard ratio = 4.14; 95% confidence interval: 2.67-6.43; p < 0.001), adjusting for treatment. In multivariable analysis, the RS result remained a significant predictor of DR (p < 0.001) after adjustment for number of positive nodes, tumor size, tumor grade, Ki-67 (immunohistochemical status), and chemotherapy regimen. There was no statistically significant interaction between RS result and treatment in predicting DR (p = 0.79).ConclusionsAfter adjustment for clinical covariates, the 21-gene RS result is a significant prognostic factor in N+/HR+ patients receiving adjuvant chemoendocrine therapy.Trial registrationNot applicable.

Highlights

The 21-gene Recurrence Score (RS) result predicts outcome and chemotherapy benefit in nodenegative and node-positive (N+), estrogen receptor-positive (ER+) patients treated with endocrine therapy
We evaluated the ability of the RS to predict the residual risk of distant recurrence (DR) and disease-free survival (DFS) for N+, hormone receptorpositive (HR+) women treated with adjuvant chemoendocrine therapy, from the PACS-01 trial
This study has shown that the 21-gene RS result was an independent predictor of outcome in N+/Hazard ratio (HR)+ breast cancer patients treated with adjuvant chemoendocrine therapy

Summary

Introduction

The 21-gene Recurrence Score (RS) result predicts outcome and chemotherapy benefit in nodenegative and node-positive (N+), estrogen receptor-positive (ER+) patients treated with endocrine therapy. The purpose of this study was to evaluate the prognostic impact of RS results in N+, hormone receptor-positive (HR+) patients treated with adjuvant chemotherapy (6 cycles of FEC100 vs. 3 cycles of FEC100 followed by 3 cycles of docetaxel 100 mg/m2) plus endocrine therapy (ET) in the PACS-01 trial (J Clin Oncol 2006;24:5664-5671)

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