Association between elevated blood pressure and clinical response in patients treated with anti-vascular endothelial growth factor (anti-VEGF) therapy in phase I clinical trials.

Abstract

e13506 Background: Relationship between elevated blood pressure and clinical response in patients with advanced cancers treated with anti-VEGF treatment was evaluated. Methods: We performed an analysis of 438 consecutive patients from 19 clinical trials treated with therapy that included an anti-VEGF agent starting January, 2006. Clinical response was determined by RECIST 1.0. Blood pressures (BP) were scored as shown in Table. BP scores were calculated from an average mean BP of all BP readings for each patient, taken at each visit, and then divided into time points: baseline, 4, 8 and 12 months. Other factor included number of medication. Scores at each time point were compared to baseline value and divided into: increasing, decreasing and stable. Chi-square was used to correlate increased BP scores with clinical response. Additional analysis was also done by using CTCAE v4.02 for grading of BP. Results: The median age was 57 years (13 to 88) and 54% were male; 10% of patients received more than one anti-VEGF therapy. The median number of anti-VEGF therapies was 2 (1 to 3). Within the first four months, 52% of patients who achieved partial response (PR) had increased BP scores from baseline compared to 18% of those with progressive disease (PD) and 25% of those with stable disease (SD) (p <0.0001) (CTCAE; p=0.004) but there was no difference between SD and PD (p = 0.11) (CTCAE; p=0.31). The elevation in BP scores was significantly higher in the PR+SD group (31%) compared to PD group (18%) within 4 months (p=0.008) (CTCAE; p=0.07). There is a significant difference in increased BP scores among PR to SD groups within 8 months and 12 months (p=0.04 and p=0.028) (CTCAE; p=0.04 and p=0.107). Conclusions: Increasing BP scores is a positive prognostic indicator for favorable clinical response in patients who received anti-VEGF treatment. [Table: see text]