Assessment of exposure-response relationship for bevacizumab in patients with metastatic colorectal cancer

Biomedicine & Pharmacotherapy

Ana Royuela Vicente¹  Ana Peña-Cabia²  Ruth Ramos Díaz³  Isabel Siso García⁴  Benito García Díaz⁵  Fernando Gutiérrez Nicolás⁶  Irene Iglesias-Peinado⁷  Ricardo Hitt Sabag⁸  Concepción García Lacalle⁸  Silvia Peña-Cabia⁹  Ana López-Martín⁹  Ángela Peñalver Vera^1,10 

[1] Correspondence to: Hospital Universitario Severo Ochoa, Avda. Orellana s/n 28914, Leganés, Madrid, Spain.;Biochemistry Unit, Severo Ochoa University Hospital, Madrid, Spain;Biostatistics Unit, Puerta de Hierro Biomedical Research Institute (IDIPHISA), CIBERESP, Madrid, Spain;Clinical Trial Unit, Severo Ochoa University Hospital, Madrid, Spain;Department of Pharmacology, Pharmacognosy and Botany, Faculty of Pharmacy, Complutense University of Madrid, Madrid, Spain;Foundation Health Research Institute of Canary (FIISC), University Hospital Complex of Canary (CHUC), Tenerife, Spain;Medical Laboratory Unit, Virgen de la Luz Hospital, Cuenca, Spain;Medical Oncology Unit, Severo Ochoa University Hospital, Madrid, Spain;Pharmacy Unit, Severo Ochoa University Hospital, Madrid, Spain;Research Unit, University Hospital Complex of Canary (CHUC), Tenerife, Spain;

关键词: Bevacizumab;    Colorectal neoplasms;    Drug monitoring;    Exposure-response relationship;    Treatment outcome;   

DOI  :  

来源: DOAJ

【 摘 要 】

Limited literature is available for bevacizumab exposure-response relationship and there is not a concentration threshold associated with an optimal disease control. This prospective observational study in patients with metastatic colorectal cancer (mCRC) aims to evaluate, in a real-life setting, the relationship between bevacizumab through concentrations at steady state (Ctrough, SS) and disease control. Ctrough, SS were drawn, coinciding with the radiological evaluation of the response (progression or clinical benefit). Generalized estimating equations (GEE) analysis was performed. To test the association between Ctrough, SS in each patient with overall survival (OS) or progression-free survival (PFS), Cox proportional hazard models were developed. Data included 50 bevacizumab Ctrough, SS from 27 patients. The GEE model did not suggest any positive association between bevacizumab Ctrough, SS and clinical benefit (OR 0.99, 95% CI: 0.98–1.02, p = 0.863). The Cox regression showed association between higher median Ctrough, SS with better OS (HR 0.86, 95% CI: 0.73–1.01, p = 0.060), but not with PFS. We cannot confirm a relationship between bevacizumab Ctrough, SS and clinical benefit but this is the first real-world study trying to show a relationship between bevacizumab Ctrough, SS and disease control in mCRC. It was conducted in a small sample size which reduces the level of evidence. Further controlled randomized studies with a sufficient number of patients are required.

【 授权许可】

Unknown