ACE and CXCL10 as predictive biomarkers in the LEA study

Date

10 Oct 2016

Session

Poster display

Presenters

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

Author affiliations

  • 1 Medical Oncology Dpto, University Hospital Reina Sofia, 14004 - Cordoba/ES
  • 2 Medical Oncology, Hospital Universitario Arnau Vilanova de Lleida, Lerida/ES
  • 3 Medical Oncology, Hospital Clinico Universitario San Carlos, Madrid/ES
  • 4 Medical Oncology, Fundación Instituto Valenciano de Oncología, 46008 - Valencia/ES
  • 5 Medical Oncology, Hospital Universitario Ramon y Cajal, Madrid/ES
  • 6 Medical Oncology, Hospital Miguel Servet, 50009 - Zaragoza/ES
  • 7 Medical Oncology, Hospital Clinic y Provincial de Barcelona, Barcelona/ES
  • 8 Medical Oncology, Fundacion Centro Oncologico de Galicia, A Coruna/ES
  • 9 Medical Oncology, ICO L'Hospitalet, Barcelona/ES
  • 10 Medical Oncology, Hospital Germans Trias i Pujol, Barcelona/ES
  • 11 Medical Oncology, University Hospital del Mar, Barcelona/ES
  • 12 Serv. Hematologia Y Oncologia Medica, Hospital Clinico Universitario de Valencia, 46010 - Valencia/ES
  • 13 Medical Oncology, Hospital Universitario de Canarias, Santa Cruz/ES
  • 14 Medical Oncology, Hospital General Universitario de Elche, Alicante/ES
  • 15 GEICAM (Spanish Breast Cancer Research Group), Madrid/ES
  • 16 Medical Oncology, Hospital General Universitario Gregorio Marañon, Madrid/ES
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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.

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