A new study demonstrated similar results for bleeding rates in pediatric patients with cancer and venous thromboembolism (VTE) who received either direct oral anticoagulants (DOACs) or low-molecular-weight heparin (LMWH). Study findings were presented at the 2021 American Society of Pediatric Hematology/Oncology (ASPHO) meeting.
The standard of care in treating VTE is LMWH, but adult patients have experienced promising efficacy and safety outcomes with DOACs. Research on DOACs in pediatric patients is limited, especially among the population with cancer, so the study investigators had an objective of determining the safety and efficacy of DOACs in this patient population.
This retrospective cohort study included patients seen at Children’s Wisconsin in Milwaukee, Wisconsin, who were up to 18 years of age and who had VTE and a malignancy. The primary safety endpoint of the study involved a comparison of significant bleeding events. Primary efficacy endpoints concerned thrombosis progression during treatment and resolution of thrombosis upon completion of planned therapy.
In this study, 14 patients were analyzed who had cancer and a VTE that was treated with a DOAC. These patients were matched with 27 patients who received LMWH, with matching based on age and diagnosis. The average ages of each treatment group were 15.5 years for those receiving DOACs and 13.0 years for those receiving LMWH.
Among patients in the DOAC group, VTE occurred in an extremity in 9 cases, in pulmonary embolisms in 2, and in the cerebral region in 3. Among patients receiving LMWH, VTE occurred in an extremity in 22 cases, as pulmonary embolisms in 3, and as cerebral VTEs in 2.
Analysis of the primary safety endpoint showed no significant differences between DOACs and LMWH regarding major bleeding in this analysis. Thrombosis progression and resolution also did not differ between anticoagulant therapies.
“In conclusion, based on this small study, DOACs seem to have similar efficacy and bleeding risk in pediatric cancer patients when compared to the standard of care,” study author Amanda Scheuermann, DO said during an audio summary accompanying the poster presentation.
Scheuermann also said the research team believes DOACs should be a potential treatment option for this patient population, and that they hope use of this agent may improve both medication adherence and quality of life in this patient population. This study was a pilot study, which the research team expects will be followed by a larger study.
Scheuermann A, Malec L. Safety and efficacy of direct oral anticoagulants compared to low molecular weight heparin for treatment of venous thromboembolism in pediatric oncology patients. Poster presented at: 2021 American Society of Pediatric Hematology/Oncology meeting; April 21-23, 2021; virtual.