Subtype analysis from the GEICAM/2003-02 study: High-risk, node-negative breast cancer patients treated with adjuvant fluorouracil, doxorubicin, and cyclophosphamide (FAC) versus FAC followed by weekly paclitaxel.

Authors

null

Federico Rojo

Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain

Federico Rojo , Ana Lluch , Amparo Ruiz , Manuel Ruiz-Borrego , Agusti Barnadas , Lourdes Calvo , Sonia Gonzalez , Mireia Margeli , Alvaro Rodriguez-Lescure , Antonio Anton , Miguel Angel Seguí , Montserrat Munoz-Mateu , Joan Dorca , Jose Manuel Lopez-Vega , Carlos Jara-Sanchez , Nuria Martin , Maribel Casas , Eva Maria Carrasco , Rosalia Caballero , Miguel Martin

Organizations

Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain, Hospital Clinico Universitario de Valencia, Valencia, Spain, Instituto Valenciano de Oncología, Valencia, Spain, Hospital Universitario Virgen del Rocío de Sevilla, Seville, Spain, Hospital Sant Pau, Barcelona, Spain, Complejo Hospitalario Universitario de A Coruña, A Coruna, Spain, Hosp Mutua Terrassa, Barcelona, Spain, Institut Català d'Oncologia - Hospital Germans Trias i Pujol, Badalona, Spain, Hospital General Universitario de Alicante, Elche, Spain, Hospital Universitario Miguel Servet, Zaragoza, Spain, Corporación Sanitaria Parc Taulí, Barcelona, Spain, Hospital Clinico de Barcelona, Barcelona, Spain, Institut Catala d'Oncologia Girona, Girona, Spain, Hospital Universitario Marques de Valdecilla, Cantabria, Spain, Fundacion Hospital Alcorcon, Madrid, Spain, GEICAM, Madrid, Spain, Instituto de Investigación Sanitaria Gregorio Marañón, Madrid, Spain

Research Funding

No funding sources reported

Background: Adding taxanes to standard anthracycline-based adjuvant therapy improves survival outcome in node-negative breast cancer (BC) patients (pts) with high risk of recurrence. Due to the small magnitude of the benefit and to avoid toxicity, biomarker analyses aimed to identify subpopulations benefiting the most from taxanes are warranted. Methods: After surgery, 1,925 node-negative BC pts with at least one high-risk factor for recurrence (St. Gallen 1998 criteria) were randomly assigned to receive 6 FAC cycles or 4 FAC cycles followed by 8 weekly paclitaxel doses (FAC-wP); 108 out of the 181 HER2+ pts did not receive trastuzumab. With a median follow-up of 63.3 months, 93% and 90.3% of pts receiving FAC-wP or FAC, respectively, remained disease free (hazard ratio [HR]: 0.73; 95% CI: 0.54-0.99; log-rank p= 0.04; Martin JCO 2013). We performed central immunohistochemistry (IHC) for ER, PR, Ki-67 and HER2/FISH; pts were grouped in intrinsic BC subtypes according to the Prat et al. classification (JCO 2012): Luminal A: RE+, PR>20%, HER2-, Ki67<14%; Luminal B1: RE+, HER2-, PR≤20% and/or Ki67≥14%; Luminal B2: RE+, PR+/-, HER2+; HER2: RE-, PR-, HER2+; TN: RE-, PR-, HER2-. We report here the correlation between these variables and Distant Metastases-Free Survival (DMFS). Cox regression and log-rank test were used for analysis. Results: Central biomarker expression and subtype classification is currently available for 1,084 and 946 pts, respectively. DMFS in the 1,084 pts were 97.8% vs 94.8% (HR: 0.52; 95% CI: 0.28-0.97; p=0.035). In the univariate analysis, FAC-wP therapy, ER and PR positive status, low Ki67 proliferation and Luminal A and B1 subtypes were significantly associated with better DMFS. Absence of PR and Luminal B1 were predictive for FAC-wP benefit. The multivariate analysis showed that intrinsic subtype classification was predictive of DMFS (p=0.010). Conclusions: Our study suggests that IHC-based intrinsic subtypes provide prognostic value and could identify a subpopulation of node-negative BC pts (the luminal B1) who obtains more benefit from FAC-wP adjuvant therapy.

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2014 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Tumor Biology

Track

Tumor Biology

Sub Track

Molecular Diagnostics and Imaging

Citation

J Clin Oncol 32:5s, 2014 (suppl; abstr 11107)

DOI

10.1200/jco.2014.32.15_suppl.11107

Abstract #

11107

Poster Bd #

389

Abstract Disclosures