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. Invest New Drugs 2014 Aug;32(4):717-22
Date
04/26/2014Pubmed ID
24764123DOI
10.1007/s10637-014-0104-7Scopus ID
2-s2.0-84904461273 (requires institutional sign-in at Scopus site) 3 CitationsAbstract
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.
Author List
Bilen MA, Durand JB, McQuinn L, Hess KR, Fu S, Falchook GS, Hong DS, Wheler JJ, Said R, Ewer MS, Kurzrock R, Naing AAuthor
Razelle Kurzrock MD Center Associate Director, Professor in the Medicine department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
AdolescentAdult
Aged
Aged, 80 and over
Angiogenesis Inhibitors
Antihypertensive Agents
Blood Pressure
Child
Female
Humans
Male
Middle Aged
Neoplasms
Retrospective Studies
Vascular Endothelial Growth Factor A
Young Adult