Gynecologic Cancer: Apixaban effective oral option for post-surgery thromboprophylaxis
USA: Oral apixaban may be a safer alternative to subcutaneous enoxaparin for thromboprophylaxis after surgery for gynecologic cancer, according to a recent study in the JAMA Network Open. Oral apixaban is easier and less painful for patients to take.
Gynecologic cancers (uterine, ovarian, cervical, and vulvar) affect approximately 100 000 women in the US each year. The standard of care for nearly all gynecologic cancers (early and advanced stage) remains aggressive surgical debulking with resection of all visible disease.
Current guidelines recommend a 28-day course of enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. However, previous studies have shown enoxaparin to have low adherence rates in addition to its high cost. Saketh R. Guntupalli, University of Colorado School of Medicine at Denver, Aurora, and colleagues investigate the safety and efficacy of an oral treatment alternative for thromboprophylaxis in postoperative patients with gynecologic cancer.
For the purpose, the researchers conducted a patient-based, multicenter, open-label, blinded, endpoint, randomized clinical trial between May 2015 to March 2019 in outpatient and inpatient gynecologic oncology settings. It included women undergoing surgery for suspected or confirmed gynecologic cancer. The trial compared rates of major bleeding and clinically relevant nonmajor bleeding events during a 90-day follow-up period in patients taking apixaban or enoxaparin for postoperative thromboprophylaxis using a modified intent-to-treat analysis.
The study enrolled 400 women, of which 204 received apixaban (2.5 mg orally twice daily) and 196 received enoxaparin (40 mg subcutaneously daily).
The primary outcome was major bleeding and clinically relevant nonmajor bleeding events.
Key findings of the study include:
- Treatment groups did not differ in terms of race/ethnicity, cancer stage, or surgery modality (open vs robotic).
- There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%]; OR, 1.88), venous thromboembolic events (2 patients [1.0%] vs 3 patients [1.5%]; OR, 1.57), adverse events, medication adherence, or quality of life between the groups.
- Participant satisfaction was significantly greater in the apixaban group with regard to ease of taking the medication (186 patients [98.9%] vs 110 patients [58.8%]; OR, 0.06) and pain associated with taking the medication (4 patients [2.1%] vs 92 patients [49.2%]; OR, 9.20).
"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. The efficacy of apixaban to prevent venous thromboembolic events is hypothesized as being equivalent," concluded the authors.
The study, "Safety and Efficacy of Apixaban vs Enoxaparin for Preventing Postoperative Venous Thromboembolism in Women Undergoing Surgery for Gynecologic Malignant Neoplasm: A Randomized Clinical Trial," is published in the JAMA Network Open.
