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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152 Scopus citations


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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Rini, B. I., Schiller, J. H., Fruehauf, J. P., Cohen, E. E. W., Tarazi, J. C., Rosbrook, B., Bair, A. H., Ricart, A. D., Olszanski, A. J., Letrent, K. J., Kim, S., & Rixe, O. (2011). Diastolic blood pressure as a biomarker of axitinib efficacy in solid tumors. Clinical Cancer Research, 17(11), 3841-3849. https://doi.org/10.1158/1078-0432.CCR-10-2806