Cluster randomized trial of intensive systolic blood pressure control in patients with renal cell or thyroid cancer receiving VEGFR tyrosine kinase inhibitors: ECOG-ACRIN EAQ191

Authors

• Bonnie Ky, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (B.K., K.B.M., N.B.H., C.D., V.K.N., A.M.S., N.S.W., R.R.T.).
• Tao Liu, Department of Biostatistics, ECOG-ACRIN Biostatistics Center, Brown University, Providence, RI (T.L.).
• Kenneth B. Margulies, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (B.K., K.B.M., N.B.H., C.D., V.K.N., A.M.S., N.S.W., R.R.T.).
• Joshua D. Mitchell, Washington University at St. Louis, MO (J.D.M.).
• Naomi B. Haas, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (B.K., K.B.M., N.B.H., C.D., V.K.N., A.M.S., N.S.W., R.R.T.).
• Ilana F. Gareen, Center for Biostatistics and Health Data Science, Brown University School of Public Health, Providence, RI (T.L., I.F.G., M.T., J.D.S.).
• Maryanne Thangarajah, Center for Biostatistics and Health Data Science, Brown University School of Public Health, Providence, RI (T.L., I.F.G., M.T., J.D.S.).
• JoRean D. Sicks, Center for Biostatistics and Health Data Science, Brown University School of Public Health, Providence, RI (T.L., I.F.G., M.T., J.D.S.).
• Chris Domenico, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (B.K., K.B.M., N.B.H., C.D., V.K.N., A.M.S., N.S.W., R.R.T.).
• Vivek K. Narayan, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (B.K., K.B.M., N.B.H., C.D., V.K.N., A.M.S., N.S.W., R.R.T.).
• Amanda M. Smith, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (B.K., K.B.M., N.B.H., C.D., V.K.N., A.M.S., N.S.W., R.R.T.).
• Nicholas S. Wilcox, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (B.K., K.B.M., N.B.H., C.D., V.K.N., A.M.S., N.S.W., R.R.T.).
• Kriti Mittal, University of Massachusetts Medical Center, Worcester (K.M.).
• June-Wha Rhee, City of Hope Comprehensive Cancer Center, Duarte, CA (J.-W.R., S.H.A.).
• Saro H. Armenian, City of Hope Comprehensive Cancer Center, Duarte, CA (J.-W.R., S.H.A.).
• Thomas Saphner, Advocate Health - MidwestFollow
• Asit K. Paul, Virginia Commonwealth University, Richmond (A.K.P.).
• Benjamin A. Gartrell, Montefiore Einstein Comprehensive Cancer Center, Bronx, NY (B.A.G.).
• Vlad G. Zaha, UT Southwestern, Dallas, TX (V.G.Z.).
• Fern Anari, Fox Chase Cancer Center, Philadelphia, PA (F.A.).
• Risa L. Wong, University of Pittsburgh Medical Center, PA (R.L.W.).
• Raymond R. Townsend, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia (B.K., K.B.M., N.B.H., C.D., V.K.N., A.M.S., N.S.W., R.R.T.).
• Lynne I. Wagner, University of North Carolina, Chapel Hill (L.I.W.).

Recommended Citation

Ky B, Liu T, Margulies KB, et al. Cluster Randomized Trial of Intensive Systolic Blood Pressure Control in Patients With Renal Cell or Thyroid Cancer Receiving VEGFR Tyrosine Kinase Inhibitors: ECOG-ACRIN EAQ191. Hypertension. Published online May 20, 2026. doi:10.1161/HYPERTENSIONAHA.125.26016

Affiliations

Aurora Health Care Madison

Abstract

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.

Document Type

Article

PubMed ID

42158981