SIDEBAR: Clinical Trials of VTE Prophylaxis for Outpatients

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Several studies are investigating low-molecular-weight heparins to reduce the risk of venous thromboembolism (VTE) among patients with cancer. “I enrolled patients in SAVE-ONCO,” Alok Khorana, MD, said, “but that trial used drug called semuloparin, which is not currently available in the United States.”

Two European studies involve patients with pancreatic cancer and are testing the low-molecular-weight heparins enoxoparin (Lovenox) and dalteparin (Fragmin). Both of these agents are available in the United States. “Once we have full information from these studies, I think the guideline committees are going to take a look at the results and make some new recommendations on outpatient prophylaxis,” Dr. Khorana said.

University of Rochester Study

Dr. Khorana’s research group at the University of Rochester is funded by the NIH to study outpatient prophylaxis. They use a risk score system to identify outpatients at higher risk of venous thromboembolism.

“It’s based not just on the type of cancer, but also on other leveraging factors, like white cell count, platelet count, and hemoglobin, as well as body mass index,” Dr. Khorana explained. “If you reach 3 points, either by having a high-risk type of cancer or a combination of these factors, you are at high risk for VTE,” he said.

“In our study, we are randomly assigning just the high-risk patients to observation vs dalteparin, which is a low-molecular-weight heparin. The study is ongoing, and we won’t have results until the end of 2013,” he said. “Right now, the study is open at our institution and at Duke, and we expect more centers to be added in the next month or so.” Total anticipated enrollment is 229. ■

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SIDEBAR: Expect Questions from Your Patients

The current lack of awareness about the high risk of venous thromboembolism (VTE) among people being treated for cancer as outpatients means “there’s a great role for provider education,” Alok Khorana, MD, told The ASCO Post. Here are Dr. Khorana’s answers to some likely questions from patients.