Evaluation Study of Hypertension as a Predictor of Efficacy Bevacizumab (BV) in Combination With Chemotherapy (CT) in Metastatic Colorectal Cancer (MCC) and Metastatic Breast Cancer (MBC).
Hypertension (HT) is the most common side effect seen in trials of bevacizumab in
combination with chemotherapy. Based on the hypothesis that the development of hypertension
during treatment would be an indicative of the successful blockade of the VEGF pathway,
different studies have explored retrospectively the relationship between hypertension and
the results of treatment with bevacizumab.
This study aims to demonstrate the association between hypertension (diagnosed optimally)
with efficacy to treatment with bevacizumab prospectively and secondly verify if blood
pressure measures taken at home are a reflection of a diagnosis of hypertension.
Also have been explored different molecular markers involved in the pathway of VEGF which
might be used as predictors of response. Therefore, this study includes the collection of
blood samples (serum or plasma) and tumor tissue of patients included in this study, with
the aim of exploring biomarkers that correlate with treatment efficacy and toxicity.
The diagnosis of hypertension (HT) will be performed using a Holter recording, and standard
blood pressure footage will be collected during the first three cycles of treatment given
the Common Toxicity Criteria of the National Cancer Institute-NCI CTCAE version 4.0 and the
guidelines of the European Society of Cardiology and Hypertension, 2007.
Will be collected a sample of primary tumor and blood for patients who previously have
consented it. Samples will be sent to a central laboratory for analysis of biomarkers.
An interim analysis will be conducted to assess the true incidence of hypertension. Based on
this analysis, will be evaluated the need to recalculate the sample size.
At the end of the study, will be performed an analysis of correlation of data measured by
HTA and Holter recording footage with the SLP standard TA. Moreover will be determined in
serum, plasma and tumor tissue and certain biomarkers to correlate with efficacy to
treatment with bevacizumab.
Observational Model: Case-Only, Time Perspective: Prospective
Blood Pressure will be determined at a baseline, within 14 days before the start of treatment, and on the first day of cycles 1, 2 and 3. Measurement tools for recording blood pressure: Holter o Ambulatory Blood Pressure Monitoring Standard Register Blood Pressure following the guidelines of the European Society of Cardiology and Hypertension, 2007
3 months after the first blood pressure assessment
Alvaro Rodríguez Lescure
Hospital General Universitario de Elche
Spain: Ethic Committee