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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)
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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)
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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)
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Journal 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)
2018
Overview
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/m
2
) 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.
Publisher
BioMed Central,BioMed Central Ltd,BMC
Subject
/ Analysis
/ Antineoplastic Combined Chemotherapy Protocols - therapeutic use
/ Biomarkers, Tumor - genetics
/ Biomedical and Life Sciences
/ Breast Neoplasms - drug therapy
/ Breast Neoplasms - pathology
/ Cancer
/ Clinical Trials, Phase III as Topic
/ Female
/ Health Promotion and Disease Prevention
/ Humans
/ Multicenter Studies as Topic
/ Neoplasm Recurrence, Local - diagnosis
/ Neoplasm Recurrence, Local - genetics
/ Oncology
/ Randomized Controlled Trials as Topic
/ Receptors, Estrogen - metabolism
/ Receptors, Progesterone - metabolism
/ Relapse
