Intensive systolic blood pressure control (SBP <120 mm Hg) in patients receiving VEGFR TKIs was feasible and reduced SBP by 12.2 mm Hg (95% CI, -18.1 to -7.0) at 1 month compared to usual care.
RCT (n=61)
Cluster
Yes
Does intensive systolic blood pressure control (<120 mm Hg) safely improve blood pressure management compared to usual care (<140 mm Hg) in patients with renal cell or thyroid cancer receiving VEGFR tyrosine kinase inhibitors?
Intensive systolic blood pressure control (<120 mm Hg) is feasible, safe, and tolerable in patients with active cancer receiving VEGFR tyrosine kinase inhibitors, achieving significantly lower blood pressure than usual care.
Effect estimate: Mean difference -12.2 mm Hg (95% CI -18.1 to -7.0)
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04467021.
Ky et al. (Wed,) conducted a rct in Renal cell or thyroid cancer (n=61). Intensive systolic blood pressure control vs. Usual care (SBP <140 mm Hg) was evaluated on Systolic blood pressure difference at 1 month (Mean difference -12.2 mm Hg, 95% CI -18.1 to -7.0). Intensive systolic blood pressure control (SBP <120 mm Hg) in patients receiving VEGFR TKIs was feasible and reduced SBP by 12.2 mm Hg (95% CI, -18.1 to -7.0) at 1 month compared to usual care.