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Hypertension as predictive factor for bevacizumab-containing first-line therapy in metastatic breast and colorectal cancer in BRECOL (GEICAM/2011-04) study.
Rodríguez-Lescure, Álvaro; Gallego, Javier; Garcia-Alfonso, Pilar; Massuti, Bartomeu; Márquez, Raúl; Calvo, Lourdes; Sánchez-Rovira, Pedro; Antón, Antonio; Chacón, José Ignacio; Ciruelos, Eva; Ponce, Jose Juan; Santaballa, Ana; Valladares-Ayerbes, Manuel; Dueñas, María Rosario; Alonso, Vicente; Aparicio, Jorge; Encinas, Sara; Robles, Luis; Escudero, María José; Caballero, Rosalía; Bezares, Susana; de la Haba-Rodriguez, Juan.
Afiliação
  • Rodríguez-Lescure Á; Medical Oncology Department, Hospital General Universitario de Elche, Carrer Almazara, 11, 03203, Elche, Alicante, Spain. alescure@geicam.org.
  • Gallego J; GEICAM Spanish Breast Cancer Group, Madrid, Spain. alescure@geicam.org.
  • Garcia-Alfonso P; Medical Oncology Department, Hospital General Universitario de Elche, Carrer Almazara, 11, 03203, Elche, Alicante, Spain.
  • Massuti B; Instituto de Investigación Sanitaria Gregorio Marañón, Facultad de Medicina de la Universidad Complutense de Madrid, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
  • Márquez R; Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Hospital General Universitario Dr. Balmis, Alicante, Spain.
  • Calvo L; GEICAM Spanish Breast Cancer Group, Madrid, Spain.
  • Sánchez-Rovira P; MD Anderson Cancer Center Madrid, Madrid, Spain.
  • Antón A; GEICAM Spanish Breast Cancer Group, Madrid, Spain.
  • Chacón JI; Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.
  • Ciruelos E; GEICAM Spanish Breast Cancer Group, Madrid, Spain.
  • Ponce JJ; Hospital Universitario de Jaén, Jaén, Spain.
  • Santaballa A; GEICAM Spanish Breast Cancer Group, Madrid, Spain.
  • Valladares-Ayerbes M; Instituto de Investigación Sanitaria de Aragón (IISA), Hospital Universitario Miguel Servet, Universidad de Zaragoza, Saragossa, Spain.
  • Dueñas MR; GEICAM Spanish Breast Cancer Group, Madrid, Spain.
  • Alonso V; Hospital Universitario de Toledo, Toledo, Spain.
  • Aparicio J; GEICAM Spanish Breast Cancer Group, Madrid, Spain.
  • Encinas S; Hospital Universitario, 12 de Octubre, Madrid, Spain.
  • Robles L; GEICAM Spanish Breast Cancer Group, Madrid, Spain.
  • Escudero MJ; Instituto de Investigación Sanitaria y Biomédica de Alicante (ISABIAL), Hospital General Universitario Dr. Balmis, Alicante, Spain.
  • Caballero R; GEICAM Spanish Breast Cancer Group, Madrid, Spain.
  • Bezares S; Hospital Universitario y Politécnico La Fe, Valencia, Spain.
  • de la Haba-Rodriguez J; Complejo Hospitalario Universitario de A Coruña, A Coruña, Spain.
Clin Transl Oncol ; 26(8): 1896-1907, 2024 Aug.
Article em En | MEDLINE | ID: mdl-38578537
ABSTRACT

BACKGROUND:

Retrospective data suggest an association between bevacizumab efficacy and the incidence of arterial hypertension (AHT). Additionally, epigenetic mechanisms have been related to AHT.

METHODS:

This prospective observational study conducted by GEICAM Spanish Breast Cancer Research Group included metastatic breast (MBC) or colorectal (mCRC) cancer patients treated with bevacizumab-containing chemotherapy as first-line treatment. Blood pressure (BP) levels were measured (conventional and 24-h Holter monitoring) at baseline and up to cycle 3. Primary endpoint assessed BP levels increase as predictive factor for progression-free survival (PFS). Germline DNA methylation profile was explored in pre-treatment blood samples; principal component analysis was used to define an epigenetic predictive score for increased BP levels.

RESULTS:

From Oct-2012 to Jul-2016, 143 (78 MBC and 65 mCRC) patients were included. The incidence of AHT according to guidelines was neither predictive of PFS nor of best overall tumor response (BOR). No statistically significant association was observed with systolic BP nor diastolic BP increment for PFS or BOR. Grade 3 and 4 adverse events were observed in 37 and 5% of patients, respectively. We identified 27 sites which baseline methylation status was significantly associated to BP levels increase secondary to bevacizumab-containing chemotherapy.

CONCLUSIONS:

Neither the frequency of AHT nor the increase of BP levels were predictive of efficacy in MBC and mCRC patients treated with bevacizumab-containing chemotherapy. CLINICAL TRIAL REGISTRY ClinicalTrials.gov Identifier NCT01733628.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Mama / Neoplasias Colorretais / Bevacizumab / Hipertensão Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Transl Oncol Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Espanha País de publicação: Itália

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Neoplasias da Mama / Neoplasias Colorretais / Bevacizumab / Hipertensão Limite: Adult / Aged / Aged80 / Female / Humans / Male / Middle aged Idioma: En Revista: Clin Transl Oncol Ano de publicação: 2024 Tipo de documento: Article País de afiliação: Espanha País de publicação: Itália