Abstract
To evaluate if diastolic blood pressure (dBP) ≥90 mm Hg during axitinib treatment is a marker of efficacy. The relationship between dBP ≥90 mm Hg and efficacy was retrospectively explored across 5 phase II studies of single-agent axitinib for the treatment of 4 different tumor types. All patients had baseline BP ≤140/90 mm Hg and were stratified into 2 groups based on in-clinic BP measurements after initiating therapy: those with dBP <90 mm Hg throughout therapy and those with at least 1 dBP ≥90 mm Hg. Median overall survival (mOS), median progression-free survival (mPFS), objective response rate (ORR), and adverse events were evaluated by dBP group in individual and pooled analyses. Two-hundred thirty patients were evaluated. Patients with dBP ≥90 mm Hg had a significantly lower relative risk of death than those with dBP <90 mm Hg [adjusted HR (95% CI) = 0.55 (0.39, 0.77); P < 0.001]. The relative risk of progression was also lower in patients with dBP ≥90 mm Hg [HR (95% CI) = 0.76 (0.54, 1.06), P = 0.107], and ORR was significantly higher (43.9% vs. 12.0%; P < 0.001). In an 8-week landmark analysis, mOS (25.8 vs. 14.9 months) and mPFS (10.2 vs. 7.1 months) were greater for patients in the ≥90 mm Hg group. Adverse events were similar between groups. Axitinib efficacy correlated with dBP ≥90 mm Hg. Further investigation of dBP as a predictive biomarker of efficacy in patients receiving axitinib is warranted.
Highlights
VEGF-targeted agents have contributed to increased success in the treatment of cancer [1], but not all patients benefit from therapy and the prediction of individual benefit remains problematic
Patients with diastolic blood pressure (BP) (dBP) !90 mm Hg had a significantly lower relative risk of death than those with dBP
The relative risk of progression was lower in patients with dBP !90 mm Hg [HR 1⁄4 0.76 (0.54, 1.06), P 1⁄4 0.107], and objective response rate (ORR) was significantly higher (43.9% vs. 12.0%; P < 0.001)
Summary
VEGF-targeted agents have contributed to increased success in the treatment of cancer [1], but not all patients benefit from therapy and the prediction of individual benefit remains problematic. Numerous antiangiogenic biomarkers have been studied; to date no validated biomarker exists for selecting patients for antiangiogenic therapy [1]. The occurrence of increased blood pressure (BP) with the use of VEGF-targeted agents is widely reported [2, 3]. Authors' Affiliations: 1Cleveland Clinic Taussig Cancer Institute, Cleveland, Ohio; 2University of Texas Southwestern Medical Center, Dallas, Texas; 3University of California Irvine Medical Center, Orange, California; 4University of Chicago Medical Center, Chicago, Illinois; 5Pfizer Oncology, San Diego, California; 6Fox Chase Cancer Center, Philadelphia, Pennsylvania; and 7University of Cincinnati Barrett Cancer Institute, Cincinnati, Ohio. Current address for A.J. Olszanski: Pfizer Oncology, 10555 Science Center Drive, San Diego, California
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