Sensitivity to Endocrine Therapy Index Predicts Benefit from Weekly Adjuvant Paclitaxel for Hormone Receptor-Positive Breast Cancer in the GEICAM/9906 Trial.

Fecha de publicación: 01/09/2026

Autores de IIS La Fe

Ana Santaballa Bertrán

Autor

Participantes ajenos a IIS La Fe

Martín M
Rodriguez-Lescure A
Reboredo C
Chen E
Ruiz-Borrego M
Rodríguez CA
Martinez-Jañez N
Alba E
Tran K
Pelaez Fernandez I
Álvarez I
Seguí MA
de la Cruz A
Valero V
Antón-Torres A
Andrés R
Amillano K
Ponce-Lorenzo JJ
Dominguez Fernandez S
Herranz J
Rincon R
Caballero R
Guerrero-Zotano A
Rojo F
Symmans WF

Grupos

Grupo de Investigación en tumores ginecológicos, cáncer de mama y cáncer hereditario

Abstract

PURPOSE: To independently validate that low endocrine transcriptional activity measured by the sensitivity to endocrine therapy (SETER/PR) index in hormone receptor-positive (HR+) breast cancer predicts benefit from dose-dense paclitaxel chemotherapy within a second prospective-retrospective biomarker study. EXPERIMENTAL DESIGN: We conducted a blinded, prospective-retrospective biomarker analysis within the GEICAM/9906 trial (NCT00129922), which compared adjuvant 5-fluorouracil, epirubicin, and cyclophosphamide (FEC) followed by weekly paclitaxel (P) versus six cycles of FEC in lymph node-positive breast cancer. The SETER/PR index was measured in all available HR+/HER2- tumor RNA samples using a prespecified cut point (<0.75). The primary endpoint was the distant recurrence-free interval (DRFI); secondary endpoints were overall survival (OS) and breast cancer-specific survival (BCSS). RESULTS: Of 647 HR+/HER2- tumors, 567 (87.6%) passed assay quality control (279 FEC + P; 288 FEC). A low SETER/PR index was identified in 92 tumors (16.2%). There was a significant interaction between SETER/PR status and treatment on DRFI (P = 0.046). Among patients with a low SETER/PR index, FEC + P significantly improved DRFI [hazard ratio (HR), 0.46; 95% confidence interval (CI), 0.22-0.95; P = 0.035], with similar results after adjustment (HR, 0.48; 95% CI, 0.24-1; P = 0.049). No treatment benefit was observed for SETER/PR =0.75 (HR, 1.02; 95% CI, 0.70-1.47; P = 0.931). Differences in OS and BCSS did not reach significance. CONCLUSIONS: Low endocrine transcriptional activity predicts benefit from adding weekly paclitaxel to anthracycline-based adjuvant chemotherapy in HR+/HER2- breast cancer. These findings independently validate the SETER/PR index as a predictive biomarker for paclitaxel-based chemotherapy and support its potential role in guiding regimen selection.

Datos de la publicación

ISSN/ISSNe:: 1078-0432, 1557-3265
Tipo:: Article
Páginas:: 3870-3879
DOI:: 10.1158/1078-0432.CCR-26-0177
PubMed:: 42189890
Factor de Impacto:: 4,399 SCImago ℠
Cuartil:: Q1 SCImago ℠

Documentos

No hay documentos

Métricas

Filiaciones

Martín M:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Medical Oncology Department, Hospital General Universitario Gregorio Marañon Instituto de Investigacion Sanitaria Gregorio Marañon, Universidad Complutense, Madrid, Spain
Rodriguez-Lescure A:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Medical Oncology Department, Hospital General Universitario de Elche, Elche, Spain. ROR: https://ror.org/01jmsem62
Reboredo C:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Department of Medical Oncology, INIBIC, A Coruña University Hospital, A Coruña, Spain
Ruiz-Borrego M:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Medical Oncology Department, Hospital Universitario Virgen del Rocio, Sevilla, Spain. ROR: https://ror.org/04vfhnm78
Santaballa Bertran A:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Instituto de Investigación. Medical Oncology Department, La Fe Health Research Institute (IISLaFe), La Fe University Hospital, Valencia, Spain
Rodríguez CA:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Oncology Department, Hospital Universitario de Salamanca, IBSAL, Salamanca, Spain
Martinez-Jañez N:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Medical Oncology Department, Hospital Ramon y Cajal, Madrid, Spain
Alba E:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Unidad de Gestion Clinica Intercentros de Oncologia Medica, Hospitales Universitarios Regional y Virgen de la Victoria, Malaga, Spain

The Biomedical Research Institute of Malaga, Malaga, Spain

Oncology Biomedical Research National Network (CIBERONC-ISCIII), Madrid, Spain
Pelaez Fernandez I:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Medical Oncology Department, Hospital Universitario de Cabueñes, Gijon, Spain
Álvarez I:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Medical Oncology, Hospital Universitario Donostia-Biodonostia, San Sebastian, Spain
Seguí MA:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Medical Oncology Department, Consorcio Hospital Universitario Parc Tauli, Sabadell, Spain
de la Cruz A:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Surgical Pathology Service, Centro Oncologico de Galicia, La Coruña, Spain. ROR: https://ror.org/00swmft88
Antón-Torres A:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Universidad de Zaragoza, Instituto Investigacion Sanitaria Aragon, Hospital Universitario Miguel Servet, Zaragoza, Spain. ROR: https://ror.org/01r13mt55
Andrés R:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Medical Oncology Department, University Hospital Lozano Blesa, Zaragoza, Spain
Amillano K:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Medical Oncology Department, Hospital Universitari Sant Joan de Reus, Reus, Spain. ROR: https://ror.org/04f7pyb58
Ponce-Lorenzo JJ:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Medical Oncology Department, Dr. Balmis General University Hospital, Alicante Institute for Health and Biomedical Research (ISABIAL), Alicante, Spain
Dominguez Fernandez S:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Medical Oncology Department, Hospital Universitario Araba - Txagorritxu, Vitoria, Spain
Herranz J:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711
Rincon R:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711
Caballero R:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711
Guerrero-Zotano A:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Instituto Valenciano de Oncologia (IVO), Valencia, Spain
Rojo F:: GEICAM, Spanish Breast Cancer Group , Madrid, Spain. ROR: https://ror.org/05ygm7711

Department of Pathology, Fundacion Jimenez Diaz University Hospital Health Research Institute (IIS-FJD, UAM)-CIBERONC, Madrid, Spain

Sensitivity to Endocrine Therapy Index Predicts Benefit from Weekly Adjuvant Paclitaxel for Hormone Receptor-Positive Breast Cancer in the GEICAM/9906 Trial.

Autores de IIS La Fe

Ana Santaballa Bertrán