174P - Prediction of recurrence with the recurrence score in pre- and post-menopausal patients from the PACS01 trial

Date 28 September 2014
Event ESMO 2014
Session Poster Display session
Topics Breast Cancer
Translational Research
Presenter Frédérique Penault-Llorca
Citation Annals of Oncology (2014) 25 (suppl_4): iv58-iv84. 10.1093/annonc/mdu326
Authors F. Penault-Llorca1, T. Filleron2, B. Asselain3, F. Baehner4, P. Fumoleau5, M. Lacroix-Triki6, S. Butler7, F. Jamshidian7, D. Cherbavaz8, L. Roca9, C. Sagan10, J. Lemonnier11, A. Martin11, H. Roche12
  • 1Dept. De Pathologie, Centre Jean Perrin, 63011 - Clermont-Ferrand/FR
  • 2Biostatistics, Institut Claudius Regaud, 31052 - Toulouse/FR
  • 3Oncology Department, Institut Curie, 75005 - Paris/FR
  • 4Pathology, Genomic Health, Inc., 94063 - Redwood City/US
  • 5Direction Generale, Centre Georges François Leclerc, 77980 - Dijon/FR
  • 6Oncology Department, Institut Claudius Regaud, 31052 - Toulouse/FR
  • 7Biostatistics, Genomic Health, Inc., 94063 - Redwood City/US
  • 8Genomics Laboratory, Genomic Health, Inc., 94063 - Redwood City/US
  • 9Unité De Biostatistique, Institut régional du Cancer de Montpellier (ICM) - Val d'Aurelle, Montpellier/FR
  • 10Oncology Department, INSTITUT DE CANCEROLOGIE DE L OUEST SITE RENE GAUDUCHEAU, 44805 - SAINT-HERBLAIN/FR
  • 11R&d Dept., R&D UNICANCER, 75013 - Paris/FR
  • 12Oncology Dept, Centre Claudius-Regaud, 31052 - Toulouse CEDEX /FR

Abstract

Aim

The Recurrence Score (RS) predicts outcome in node- and node + , ER+ pts treated with endocrine therapy and chemotherapy (CT) benefit. We studied the prognostic impact of the RS in node + , HR+ pre and post-menopausal pts treated with adjuvant chemohormonal therapy in PACS01 and here present an analysis of the performance of the RS in pre- and post-menopausal pts.

Methods

PACS01 compared FEC with FEC-D in 1999 pts. The current study included 530 pts from the PACS01 parent trial who were central IHC HR+ with sufficient tissue for Oncotype DX. Primary objective was to estimate the association between RS and distant recurrence free interval (DRFI). Secondary endpoints included disease free survival (DFS) and overall survival (OS). Herein we explore the association of the RS in pre- and post-menopausal women. Median follow-up time was 7.7 yrs.

Results

Of 530 pts, 317 were pre-menopausal and 205 were post-menopausal - 209 (39.4%) had low; 159 (30.0%) intermediate; and 162 (30.6%) high RS. Of pre-menopausal, 124 (39.1%) had low; 89 (28.1%) intermediate & 104 (32.8%) high RS. Of post-menopausal 84 (41.0%) had low, 68 (33.2%) intermediate & 53 (25.9%) high RS. 74.2% were treated with tam. In the primary analysis, RS was a significant predictor of DRFI (HR= 4.1 for a 50 point difference, P < 0.001), DFS (HR = 3.3, P < 0.001) and OS (HR = 5.0, P < 0.001). RS provided independent prognostic information beyond age, tumor size, grade, number of + nodes, surgery type, Ki-67 status and treatment (P < 0.001). The performance of the RS was similar in pre- and post-menopausal pts. The 5yr KM estimates and 95% CI for DRFI for low, intermediate and high RS groups in pre- and post-menopausal pts are in the table.

RS Low RS Int RS High Log-rank p-value
All pts n = 530 93.7 (89.4–96.3) 87.3 (81.0–91.6) 69.3 (61.5–75.8) p < 0.001
Pre-meno n = 317 93.5 (87.4–96.7) 89.8 (81.3–94.5) 70.9 (61.1–78.7) p < 0.001
Post-meno n = 205 94.0 (86.2–97.5) 85.2 (74.2–91.7) 64.9 (50.2–76.3) p < 0.001

Conclusions

The 21-gene RS was prognostic in HR + , node+ pts treated with FEC or FEC-D adjuvant CT and the performance was similar in pre- and post-menopausal pts. The data is consistent with those presented from B28 providing further supportive evidence for the assay's validity in pre-menopausal, node+ pts.

Disclosure

F. Penault-Llorca: I have an advisory relationship with Genomic Health Inc, and receive speaker's honoraria from Genomic Health, Inc.; F. Baehner: Frederick Baehner is an employee of Genomic Health, Inc.; P. Fumoleau: Dr Fumoleau has an consultant/advisory relationship with Sanofi, Roche and Novartis.

S. Butler: Mr. Butler is an employee of Genomic Health, Inc.; F. Jamshidian: Mr Jamshidian is an employee of Genomic Health, Inc.; D. Cherbavaz: Mrs Cherbavaz is an employee of Genomic Health, Inc. All other authors have declared no conflicts of interest.