Oral Apixaban Preferable for Preventing Postsurgery VTE in Patients With Gynecologic Cancer
Findings from a multi-center clinical trial of patients undergoing surgery for gynecologic cancer showed that oral apixaban was easier and less painful to administer than subcutaneous enoxaparin (JAMA Netw Open. 2020;3:e207410).
“Current guidelines recommend a 28-day course of enoxaparin for thromboprophylaxis after surgery for gynecologic cancer,” wrote Saketh R. Guntupalli, MD, Director of the Division of Gynecologic Oncology, University of Colorado School of Medicine, Denver, and colleagues.
“The high cost of this medication and the low adherence rates observed in prior studies provide an opportunity to benefit patients by demonstrating the safety of a more cost-effective, easier to use thromboprophylactic,” they continued.
A total of 400 women (median age, 58 years) were enrolled in the blinded, open-label study and randomized to receive oral apixaban 2.5 mg twice daily (n = 204) or subcutaneous enoxaparin 40 mg (n = 196). The treatment group did not differ in terms of race/ethnicity, cancer stage, or surgery modality (open vs robotic).
Bleeding and clinically relevant nonmajor bleeding events were the main end points of the study. The secondary outcomes were the incidence of venous thromboembolic events, adverse events, medication adherence, quality of life, and medication satisfaction.
Findings from the study suggest no significant difference between the apixaban and enoxaparin arms with regards to rates of major bleeding events (1 vs 1 patient, respectively; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P >.99), clinically relevant nonmajor bleeding events (12 vs 19 patients, respectively; OR, 1.88; 95% CI, 0.87-4.1; P = .11), and venous thromboembolic events (2 vs 3 patients, respectively; OR, 1.57; 95% CI, 0.26-9.50; P = .68).
In addition, the investigators observed no significant difference in adverse events, medication adherence, or quality of life between the 2 treatment arms.
Patients in the apixaban arm, however, were more satisfied with the ease of taking the medication (186 vs 110 patients in the enoxaparin arm; OR, 0.06; 95% CI, 0.01-0.25; P <.001) and pain associated with the drug (4 vs 92 patients in the enoxaparin arm; OR, 9.20; 95% CI, 2.67-31.82; P <.001).
“These findings suggest that oral apixaban is a potentially safe, less painful, and easier-to-take alternative to subcutaneous enoxaparin for thromboprophylaxis after surgery for gynecologic cancer,” wrote Dr Guntupalli and colleagues.
“The efficacy of apixaban to prevent venous thromboembolic events is hypothesized as being equivalent,” they concluded.—Alexandra Graziano