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Evaluation of the correlation of baseline blood pressure (BP) and plasma renin activity (PRA) with bevacizumab (B)-mediated hypertension in patients with early-stage breast cancer.

602 Background: Although hypertension (HTN) develops in 20-30% of bevacizumab (B)-treated cancer patients, no accurate clinical predictors of B-mediated HTN have been identified. We evaluated baseline blood pressure (BP) and plasma renin activity (PRA) as potential predictors of B-mediated HTN among breast cancer patients enrolled in an adjuvant chemotherapy-B study.


METHODS
In this phase II study, B was administered concurrently (10 mg/kg IV q2wk x 8) with pegfilgrastim-supported chemotherapy (AC at 60/600 mg/m2 q2wk x4 then nab-paclitaxel at 260 mg/m2 q2wk x4) and continued at 15 mg/kg q3wk thereafter for a total one year of B therapy. The primary endpoint was cardiac safety. A secondary endpoint was the prospective exploration of PRA as a predictor of HTN. Patients with baseline BP >150/100 mmHg were excluded from the study. Peripheral blood for PRA was collected at baseline, week 8, week 16 and every 3 months during B administration. In this preliminary analysis, baseline data was available for 65 of the 80 enrolled patients. Baseline BP and PRA values for those who did and did not develop grade 2-4 HTN were evaluated by Wilcoxon rank sum test.


RESULTS
The baseline characteristic medians are: age 45y (27-75), baseline diastolic BP 70 mmHg (52-95), baseline systolic BP 120 mmHg (90-146), and number of B cycles administered 20 (1-21). Twenty-one patients (32%) developed grade 2-4 HTN. Median diastolic and systolic BP among patients with grade 2-4 HTN was 78 and 124 mmHg, respectively, versus 70 and 115.5 mm Hg, respectively, among patients without grade 2-4 HTN (p = 0.0256 and p = 0.0228). There was no significant association between baseline PRA values and the development of grade 2-4 HTN versus not (p = 0.2917).


CONCLUSIONS
At the time of this preliminary analysis, both baseline diastolic and systolic BP appear to positively predict the development of B-mediated grade 2-4 HTN while baseline PRA does not. Studies exploring the relationship between serial PRAs and the development of HTN for all study participants are ongoing. [Table: see text].