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Widely-Used Cancer Drug Associated With Significantly Increased Risk of Blood Clots

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Source: American Medical Association (AMA)

Released: Thu 13-Nov-2008, 16:25 ET

http://www.newswise.com/articles/view/546450/?sc=rsmn

Widely-Used Cancer Drug Associated With Significantly Increased Risk of

Blood Clots

Description

An analysis of randomized controlled trials indicates that use of the

cancer drug bevacizumab is associated with an increased risk of venous

thromboembolism (blood clots in the deep veins of the legs or in the

lungs), according to an article in the November 19 issue of JAMA.

Newswise — An analysis of randomized controlled trials indicates that

use of the cancer drug bevacizumab is associated with an increased risk

of venous thromboembolism (blood clots in the deep veins of the legs or

in the lungs), according to an article in the November 19 issue of JAMA.

Angiogenesis, a process involving the proliferation of new blood

vessels, plays a crucial role in the growth and metastasis of cancer.

Bevacizumab, a new, widely-used angiogenesis inhibitor, has shown

benefits in the treatment of many types of malignancy including

colorectal cancer, non–small cell lung cancer (NSCLC), renal cell cancer

and breast cancer. Concerns have arisen regarding the use of bevacizumab

and the risk of venous thromboembolism, one of the leading causes of

illness and death in patients with cancer.

To determine the risk of venous thromboembolism associated with

bevacizumab use, Shobha Rani Nalluri, M.D., of Stony Brook University,

Stony Brook, N.Y., and colleagues conducted a meta-analysis of 15

randomized controlled trials (RCTs), which included a total of 7,956

patients with a variety of advanced solid tumors.

The researchers found that among patients receiving bevacizumab, the

incidence of all-grade venous thromboembolism was 11.9 percent, and for

high-grade venous thromboembolism, it was 6.3 percent. The risk of

developing venous thromboembolism was 33 percent greater with

bevacizumab than with controls. The risk was significantly increased for

both all-grade and high-grade venous thromboembolism. Both high (5 mg/kg

per week) and low (2.5 mg/kg per week) doses of bevacizumab were

associated with a 31 percent increased risk of venous thromboembolism.

The incidence of all-grade venous thromboembolism with bevacizumab

varied among different tumors. The highest incidence was observed among

patients with colorectal cancer (19.1 percent); for patients with NSCLC,

the incidence was 14.9 percent, while for patients with breast cancer,

the incidence of all-grade venous thromboembolism was 7.3 percent. The

lowest incidence was seen in patients with renal cancer at 3.0 percent.

“The association of venous thromboembolism with new agents presents a

challenge for recognition because many RCTs may not be powered to reveal

a significant relationship. Our meta-analysis of 15 RCTs has overcome

this limitation of individual trials and demonstrated that bevacizumab

may be associated with a significantly increased risk of venous

thromboembolism in patients with a variety of metastatic solid tumors.

The increased risk is observed not only for all-grade venous

thromboembolism, but also for clinically significant high-grade venous

thromboembolism. This finding will help physicians and patients to

recognize the risk of venous thromboembolism with the administration of

bevacizumab,” the authors write.

(JAMA. 2008;300[19]:2277-2285. Available pre-embargo to the media at

http://www.jamamedia.org)

Editor’s Note: Please see the article for additional information,

including other authors, author contributions and affiliations,

financial disclosures, funding and support, etc.

--

ne Holden, MS, RD

" Ask the Parkinson Dietitian " http://www.parkinson.org/

" Eat well, stay well with Parkinson's disease "

" Parkinson's disease: Guidelines for Medical Nutrition Therapy "

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