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Diastolic Blood Pressure as a Biomarker of Axitinib Efficacy in Solid Tumors.
MedLine Citation:
PMID:  21531811     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
PURPOSE: To evaluate if diastolic blood pressure (dBP) ≥90 mm Hg during axitinib treatment is a marker of efficacy. EXPERIMENTAL DESIGN: The relationship between dBP ≥90 mm Hg and efficacy was retrospectively explored across five phase II studies of single-agent axitinib for the treatment of four different tumor types. All patients had baseline BP ≤140/90 mm Hg and were stratified into two groups based upon in-clinic BP measurements after initiating therapy: those with dBP <90 mm Hg throughout therapy and those with at least one 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 significantly longer mOS than those with dBP <90 mm Hg (30.1 versus 10.2 months; adjusted hazard ratio [HR] [95% confidence interval (CI)] = 0.55 [0.39, 0.77]; P < 0.001); mPFS was twofold longer in patients with dBP ≥90 mm Hg (13.1 versus 5.8 months; HR [95% CI] = 0.76 [0.54, 1.06], P = 0.107), and ORR was significantly higher (43.9% versus 12.0%; P < 0.001). In an 8-week landmark analysis, mOS (25.8 versus 14.9 months) and mPFS (10.2 versus 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.
Authors:
Brian I Rini; Joan H Schiller; John P Fruehauf; Ezra Ew Cohen; Jamal C Tarazi; Brad Rosbrook; Angel H Bair; Alejandro D Ricart; Anthony J Olszanski; Kristen J Letrent; Sinil Kim; Olivier Rixe
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2011-4-29
Journal Detail:
Title:  Clinical cancer research : an official journal of the American Association for Cancer Research     Volume:  -     ISSN:  1078-0432     ISO Abbreviation:  -     Publication Date:  2011 Apr 
Date Detail:
Created Date:  2011-5-2     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9502500     Medline TA:  Clin Cancer Res     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Solid Tumor Oncology, Cleveland Clinic Taussig Cancer Institute.
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