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Investigational New Drugs

, Volume 32, Issue 4, pp 717–722 | Cite as

Evaluation of a novel blood pressure scoring method and its association with clinical response in cancer patients treated with anti-vascular endothelial growth factor therapy

  • Mehmet Asim Bilen
  • Jean-Bernard Durand
  • Lacey McQuinn
  • Kenneth R. Hess
  • Siqing Fu
  • Gerald S. Falchook
  • David S. Hong
  • Jennifer J. Wheler
  • Rabih Said
  • Michael S. Ewer
  • Razelle Kurzrock
  • Aung NaingEmail author
PHASE I STUDIES

Summary

Background The purposes of this study were to establish a novel blood pressure (BP) scoring method and to correlate it with clinical response in advanced cancer patients treated with anti-vascular endothelial growth factor (VEGF) therapies. Methods We retrospectively analyzed data for 368 patients from 23 clinical trials that included at least one anti-VEGF agent. We determined BP scores using the traditional Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 and our novel method that considers both BP readings and number of anti-hypertensive medications the patient received. BP scores were categorized at baseline and four months. Logistic regression analysis correlated elevated scores with clinical response. Agreement between the CTCAE and the new method was assessed. Results Under the new BP scoring method, partial response rates were 20 % in patients with an elevated score at four months versus 6 % in patients without elevated score (P < 0.001). When adjusted for tumor type, age, sex, history of anti-VEGF treatment, and number of anti-VEGF treatments, elevated BP under the new scoring method had an odds ratio of 3.8 (95 % confidence interval [CI]: 1.8, 8.2; P < 0.001). The kappa statistic for agreement between the CTCAE and new scoring methods was 0.57 (95 % CI: 0.47, 0.67; P < 0.001), indicating significant concordance. Conclusion Using the novel scoring method, an increase in BP scores was a marker for favorable clinical response in patients who received anti-VEGF treatment. This new method ultimately provides information with regard to clinical tumor response over and above that provided by the CTCAE scoring method.

Keywords

Anti-VEGF therapy Hypertension Toxicity Clinical response Scoring method 

Notes

Acknowledgments

We acknowledge Sunita Patterson for scientific editing of the manuscript.

Disclosures

The authors have declared no conflicts of interest.

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Copyright information

© Springer Science+Business Media New York 2014

Authors and Affiliations

  • Mehmet Asim Bilen
    • 1
  • Jean-Bernard Durand
    • 2
  • Lacey McQuinn
    • 3
  • Kenneth R. Hess
    • 4
  • Siqing Fu
    • 3
  • Gerald S. Falchook
    • 3
  • David S. Hong
    • 3
  • Jennifer J. Wheler
    • 3
  • Rabih Said
    • 5
  • Michael S. Ewer
    • 2
  • Razelle Kurzrock
    • 6
  • Aung Naing
    • 3
    Email author
  1. 1.Division of Cancer MedicineThe University of Texas MD Anderson Cancer CenterHoustonUSA
  2. 2.Department of CardiologyThe University of Texas MD Anderson Cancer CenterHoustonUSA
  3. 3.Department of Investigational Cancer TherapeuticsThe University of Texas MD Anderson Cancer CenterHoustonUSA
  4. 4.Department of BiostatisticsThe University of Texas MD Anderson Cancer CenterHoustonUSA
  5. 5.Division of Internal Medicine-OncologyThe University of Texas Health Science CenterHoustonUSA
  6. 6.Division of Hematology-OncologyUC San Diego Moores Cancer CenterLa JollaUSA

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