Thromboprophylaxis could decrease the likelihood for venous thromboembolism among patients with cancer identified as being at high risk for clotting based on a validated risk score, according to research presented at the ASH Annual Meeting and Exposition.
Prophylaxis with dalteparin (Fragmin, Pfizer) did not impact major bleeding or survival but increased clinically relevant bleeding risk, Alok A. Khorana, MD, director of the gastrointestinal cancer program and the cancer and thrombosis service at Cleveland Clinic, and colleagues from other institutions found.
Alok A. Khorana
After screening a group of patients with a Khorana score ≥ 3 and starting new systemic chemotherapy, the investigators randomized 98 patients (mean age = 59 years; 54% men) to dalteparin (5,000 units per day subcutaneously) or no prophylactic anticoagulation for 3 months.
The most common primary cancers were of the pancreas, gastro-esophageal junction, lung or lymphoma. More than three-fourths of patients in both arms had an Eastern Cooperative Oncology Group functional status of 0 or 1.
The researchers performed lower extremity ultrasounds on all patients at monthly intervals. For primary endpoints, the researchers sought VTE over 12 weeks for efficacy and clinically relevant bleeding over 13 weeks for safety.
VTE occurred in fewer patients on dalteparin (12%, n = 6/50) vs. no prophylactic anticoagulation (21%, n = 10/48) (HR = 0.69; 95% CI, 0.23-1.89). This translated to an absolute risk reduction of 9% and relative risk reduction of 42% (number needed to treat = 12).
Major bleeding was similar between arms (n = 1), but clinically relevant bleeding was higher with dalteparin (n = 7) vs. no prophylactic anticoagulation (n = 1) (HR = 7; 95% CI, 1.2-131.6).
The investigators observed no difference in overall survival.
“First, we should be screening these patients,” Khorana told Healio.com. “If they’re negative, we should be giving them prophylaxis for at least 3 months, the first 3 months that they get chemotherapy.” – by Allegra Tiver
Khorana AA, et al. Abstract 427. Presented at: ASH Annual Meeting and Exposition; Dec. 5-8, 2015; Orlando, Florida.
Disclosure: Khorana reports various financial relationships with Boehringer-Ingelheim, Daiichi Sankyo, Janssen, Leo Pharma, Pfizer and Sanofi.