Primary pharmacologic prevention of symptomatic venous thromboembolic events (VTEs) in outpatients with advanced pancreatic cancer is highly efficacious and feasible, a recent study published in the Journal of Clinical Oncology has shown.1
Uwe Pelzer, MD, PhD, from Charité – Universitätsmedizin Berlin in Germany, and colleagues enrolled 312 patients with histologically proven advanced pancreatic cancer and randomly assigned them 1:1 to receive ambulant first-line chemotherapy and prophylactic use of enoxaparin 1 mg/kg subcutaneously daily or chemotherapy alone.1
Chemotherapy either consisted of gemcitabine monotherapy 1 g/m2 intravenously on days 1, 8, and 15 in 28-day cycles, or gemcitabine 1 g/m2 intravenously plus fluorouracil 750 mg/m2 continuous intravenous infusion, folinic acid 200 mg/m2 intravenously, and cisplatin 30 mg/m2 intravenously on days 1 and 8 in 21-day cycles.1
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After 3 months, all patients received gemcitabine alone with or without enoxaparin 40 mg daily. Enoxaparin was dose-adjusted based on patients’ platelet count and kidney function.1
Results of the study showed that within the first 3 months, 15 of 152 patients randomly assigned to the observation group experienced symptomatic VTEs compared with two of the 160 patients in the enoxaparin group (HR 0.12; 95% CI: 0.03, 0.52; P = 0.001).1
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In addition, five of the 152 patients in the observation are experienced major bleeding events versus seven of 160 patients in the enoxaparin arm (HR 1.4; 95% CI: 0.35,3.72; P = 1.0).1
The overall cumulative incidence rates of symptomatic VTEs were 15.1% and 6.4% in the observation and enoxaparin groups, respectively (HR 0.40; 95% CI: 0.19, 0.83; P = 0.01). Researchers found no difference in progression-free survival (P = 0.64) and overall survival (P = 0.44) between the two treatment arms.1
