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. 2018 May 4;18(1):526.
doi: 10.1186/s12885-018-4331-8.

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)

Frédérique Penault-Llorca  1 , Thomas Filleron  2 , Bernard Asselain  3 , Frederick L Baehner  4   5 , Pierre Fumoleau  6 , Magali Lacroix-Triki  7 , Joseph M Anderson  4 , Carl Yoshizawa  4 , Diana B Cherbavaz  4 , Steven Shak  4 , Lise Roca  8 , Christine Sagan  9 , Jérôme Lemonnier  10 , Anne-Laure Martin  10 , Henri Roché  11
Affiliations

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)

Frédérique Penault-Llorca et al. BMC Cancer. .

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.

Keywords: Adjuvant chemotherapy; Breast cancer; Docetaxel; Epirubicin; Hormone receptor-positive; Lymph node-positive; Oncotype DX® 21-gene assay; Recurrence score® result; Tamoxifen.

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Conflict of interest statement

Ethics approval and consent to participate

The PACS-01 protocol was reviewed and approved by the French Ethics Committee/Institutional Review Board (CCPPRB of Toulouse, France). Written informed consent was obtained before randomization. The informed consent of the parent PACS-01 trial mentioned that tumoral tissues could be prospectively analyzed for research purpose.

Competing interests

FLB, JMA, CY, DBC and SS are employees of Genomic Health, Inc. The other authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Modified REMARK diagram resulting in the final sample size of 530 patients. HR-, hormone-receptor negative; FPET, fixed paraffin embedded tumor; RNA, ribonucleic acid; qPCR, quantitative real-time polymerase chain reaction
Fig. 2
Fig. 2
a Distribution of Recurrence Score results by (a) age, (b) tumor size, (c) tumor grade, and (d) Ki-67 expression
Fig. 3
Fig. 3
Disease outcome according to Recurrence Score group: (a) freedom from distant recurrence, and (b) disease-free survival
Fig. 4
Fig. 4
Disease outcome according to Recurrence Score group and chemotherapy treatment arm: (a) freedom from distant recurrence, (b) disease-free survival in patients treated with FEC100, (c) freedom from distant recurrence, and (d) disease-free survival in patients treated with FEC-D
Fig. 5
Fig. 5
Forest plot of 5-year distant recurrence according to prognostic factors
See this image and copyright information in PMC

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