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Published in: BMC Cancer 1/2018

Open Access 01-12-2018 | Research article

The 21-gene Recurrence Score® 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)

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

Published in: BMC Cancer | Issue 1/2018

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Abstract

Background

The 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).

Methods

The 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).

Results

There 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).

Conclusions

After adjustment for clinical covariates, the 21-gene RS result is a significant prognostic factor in N+/HR+ patients receiving adjuvant chemoendocrine therapy.

Trial registration

Not applicable.
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Metadata
Title
The 21-gene Recurrence Score® 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)
Authors
Frédérique Penault-Llorca
Thomas Filleron
Bernard Asselain
Frederick L. Baehner
Pierre Fumoleau
Magali Lacroix-Triki
Joseph M. Anderson
Carl Yoshizawa
Diana B. Cherbavaz
Steven Shak
Lise Roca
Christine Sagan
Jérôme Lemonnier
Anne-Laure Martin
Henri Roché
Publication date
01-12-2018
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2018
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/s12885-018-4331-8

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