135P - ACE and CXCL10 as predictive biomarkers in the LEA study

Date 10 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Translational Research
Presenter Juan De la Haba
Citation Annals of Oncology (2016) 27 (6): 15-42. 10.1093/annonc/mdw363
Authors J. De la Haba1, E. Aranda Aguilar1, S. Morales2, J.A. García-Sáenz3, A. Guerrero4, N. Martínez5, A. Antón6, M. Muñoz7, M. Ramos8, M. Gil-Gil9, M. Margelí10, S. Servitja11, B. Bermejo12, J. Cruz13, A. Rodríguez Lescure14, M. Casas15, M. Sánchez-Aragó15, R. Caballero15, E. Carrasco15, M. Martin16
  • 1Medical Oncology Dpto, University Hospital Reina Sofia, 14004 - Cordoba/ES
  • 2Medical Oncology, Hospital Universitario Arnau Vilanova de Lleida, Lerida/ES
  • 3Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid/ES
  • 4Medical Oncology, Fundación Instituto Valenciano de Oncología, 46008 - Valencia/ES
  • 5Medical Oncology, Hospital Universitario Ramon y Cajal, Madrid/ES
  • 6Medical Oncology, Hospital Miguel Servet, 50009 - Zaragoza/ES
  • 7Medical Oncology, Hospital Clinic y Provincial de Barcelona, Barcelona/ES
  • 8Medical Oncology, Fundacion Centro Oncologico de Galicia, A Coruna/ES
  • 9Medical Oncology, ICO L'Hospitalet, Barcelona/ES
  • 10Medical Oncology, Hospital Germans Trias i Pujol, Barcelona/ES
  • 11Medical Oncology, University Hospital del Mar, Barcelona/ES
  • 12Serv. Hematologia Y Oncologia Medica, Hospital Clinico Universitario de Valencia, 46010 - Valencia/ES
  • 13Medical Oncology, Hospital Universitario de Canarias, Santa Cruz/ES
  • 14Medical Oncology, Hospital General Universitario de Elche, Alicante/ES
  • 15GEICAM (Spanish Breast Cancer Research Group), Madrid/ES
  • 16Medical Oncology, Hospital General Universitario Gregorio Marañon, Madrid/ES

Abstract

Background

LEA Study (GEICAM/2006-11/GBG51), is a randomized clinical trial comparing bevacizumab in combination with endocrine therapy (ET + B) with endocrine therapy (ET) in postmenopausal women with advanced or metastatic HR-positive/HER2-negative breast cancer (BC) with indication of hormonotherapy as first-line treatment. Patients with secondary hypertension had better progression-free survival (PFS) and overall survival (OS). We have evaluated the role of two hypertension-related biomarkers, Angiotensin-Converting Enzyme (ACE) and Small-Inducible Cytokine B10 (CXCL10) as prognostic and/or predictive biomarkers of benefit to bevacizumab in the first line metastatic disease.

Methods

From 380 patients, 266 were included in 33 Spanish sites. Median age was 64 years, 63.5% had measurable disease, 97.4% were metastatic at randomization, 51.5% had visceral disease and 52.6% received previous chemotherapy. PFS was 14.3 months (range 0.8-61.1), OS was 34 months (range 0.8-71.6) and 93 patients had Objective Response (OR). We analyzed 124 plasma samples collected before treatment (52 from ET and 72 from ET + B arms). Circulating levels of ACE and CXCL10 were determined by ELISA. ACE levels of 115ng/ml and 135ng/ml were pre-defined as cutoff values. CXCL10 was explored as a quantitative variable.

Results

PFS was 15.1 months (range 1.4-61.1), OS was 31.1 months (range 2.8-61.1) and 40.3% had OR. OR was significantly different between treatment arms (p 

Conclusions

ACE levels could be considered a prognostic and a bevacizumab predictive biomarker of PFS. CXCL10 could be prognostic of OS. Confirmatory studies are warranted.

Clinical trial identification

EUDRACT 2007-002841-19

Legal entity responsible for the study

Spanish Breast Cancer Group (GEICAM) & Instituto Maimonides de Investigacion Biomedica, Cordoba

Funding

Instituto de Salud Carlos III

Disclosure

All authors have declared no conflicts of interest.