Diastolic blood pressure as a biomarker of axitinib efficacy in solid tumors

Brian I. Rini, Joan H. Schiller, John P. Fruehauf, Ezra E.W. Cohen, Jamal C. Tarazi, Brad Rosbrook, Angel H. Bair, Alejandro D. Ricart, Anthony J. Olszanski, Kristen J. Letrent, Sinil Kim, Olivier Rixe

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179 Scopus citations

Abstract

Purpose: To evaluate if diastolic blood pressure (dBP) ≥90mmHg during axitinib treatment is a marker of efficacy. Experimental Design: 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. Results: 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. Conclusions: Axitinib efficacy correlated with dBP ≥90 mm Hg. Further investigation of dBP as a predictive biomarker of efficacy in patients receiving axitinib is warranted.

Original languageEnglish
Pages (from-to)3841-3849
Number of pages9
JournalClinical Cancer Research
Volume17
Issue number11
DOIs
StatePublished - Jun 1 2011

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