Cluster Randomized Controlled Trial of Intensive Systolic Blood Pressure Control in Patients With Renal Cell or...

The objective of this cluster randomized controlled trial was to determine the feasibility and safety of an intensive (systolic blood pressure [SBP] <120 mm Hg) versus usual care (SBP <140 mm Hg) approach to SBP control in patients with renal cell or thyroid cancer initiating VEGFR (vascular endothelial growth factor)-tyrosine kinase inhibitors.

A phase II site-based cluster randomized controlled trial compared intensive SBP control to usual care, incorporating a centralized BP advisory core to guide BP management. Patients underwent home BP monitoring and study visits at baseline, 1, 2, 3, and 6 months. SBP was compared between the 2 study arms using bootstrapped CIs. Common Terminology Criteria for Adverse Events and patient-reported outcomes were summarized.

Overall, 61 patients with renal cell (n=58) or thyroid cancer (n=3) from 10 sites were enrolled; 30 at 5 sites were randomized to intensive SBP control and 31 at 5 sites to usual care. A lower SBP was observed in the intensive SBP control arm compared with usual care, with mean differences of -12.2 (95% CI, -18.1 to -7.0) mm Hg at 1 month, -7.6 (95% CI, -15.3 to -0.4) mm Hg at 3 months, and -6.9 (95% CI, -19.3 to 6.0) mm Hg at 6 months. In the usual care arm, Grade 3 Common Terminology Criteria for Adverse Events for kidney injury (n=4), hypotension (n=3), and dyspnea (n=2) were numerically greater compared with the intensive SBP control (n=1, 2, and 0, respectively). Patient-reported outcomes were largely similar between the 2 groups.

This first-ever randomized controlled trial of SBP control in an active cancer population demonstrates the feasibility, safety, and tolerability of intensive SBP control with VEGFR tyrosine kinase inhibitors.

URL: https://www.clinicaltrials.gov; Unique identifier: NCT04467021.