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Rini BI, Schiller JH, Fruehauf JP, Cohen EE, Tarazi JC, Rosbrook B, Bair AH, Ricart AD, Olszanski AJ, Letrent KJ, Kim S, Rixe O
Diastolic Blood Pressure as a Biomarker of Axitinib Efficacy in Solid Tumors
Clinical Cancer Research (2011) 17:3841-3849.
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 >= 90mmHg. 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 <90mmHg [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. Clin Cancer Res; 17(11); 3841-9. (C)2011 AACR.
Note
Publication Date: 2011-06-01.
PMCID: not NIH funded
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