Apixaban a thromboprophylactic alternative after surgery for GYN cancers?
Women undergoing surgery for suspected or confirmed gynaecologic malignant neoplasms* favoured oral apixaban over SC enoxaparin as a prophylactic agent for postoperative venous thromboembolism (VTE**), a study has shown.
The currently recommended course of enoxaparin has been met with adherence issues (ie, cost, pain and bruising at injection site). [Chest 2012;141:7S-47S; Thromb Res 2014;134:774-782] The lengthy treatment required – which could be lifelong should a second VTE develop – is a potential strain on the pocket, noted the researchers.
“[VTE] remains one of the most lethal complications in women who undergo surgery for gynaecologic cancers … [As such,] effective and convenient prophylaxis is critical in reducing this burden,” they said.
“[Our findings show that] satisfaction was substantially higher [with] apixaban … with patients stating ease of use as a major factor in adherence … These findings suggest that oral apixaban is a potentially safe, less painful, and easier-to-take alternative to SC enoxaparin,” they added.
women (median age 58 years) were randomized 1:1 to receive oral apixaban 2.5 mg BID or SC enoxaparin 40 mg daily for 28 days.
(99 percent vs 59 percent; odds ratio [OR], 0.06), with a significantly smaller fraction reporting pain vs those on the injectable agent (2 percent vs 49 percent; OR, 9.2; p<0.001 for both).
“[P]atients taking an oral medication may have higher real-world compliance rates [vs] the known real-world compliance rates for those taking enoxaparin daily for a short period,” they said.
In this setting, the risk of VTE remains even with appropriate anticoagulant use, owing to the proximity of the tumours to lower extremity vessels, as well as the extent of dissection involved in debulking. [Int J Gynecol Cancer 2013;23:1684-1691; Eur J Obstet Gynecol Reprod Biol 2013;170:214-218; In Vivo 2017;31:251-258]
“Surgeons should continue to use appropriate postoperative VTE prophylaxis in high-risk surgical oncology patients to help prevent this potentially life-threatening outcome and may consider at their discretion the safety of thromboprophylaxis options,” they said.
The inclusion of women undergoing laparotomy also suggests that the findings may be extrapolated to other sites (eg, pancreas or colon) requiring extensive abdominal debulking, they added.
A new standard of care?
“[P]reference for an oral medication is clear in the findings … For women who cannot or will not perform self-injection with enoxaparin, [the investigators] have demonstrated that an alternative, oral VTE prevention strategy with apixaban in the postoperative setting is feasible, and possibly as safe with similar VTE outcomes,” said Elisabeth Diver from the Stanford University School of Medicine in California, US, in an editorial.
However, as the study was not primarily designed to evaluate efficacy, Diver called for larger randomized trials to validate the promising findings. “Efficacy is a critical outcome in this population … [A] noninferiority trial designed to assess efficacy of VTE prevention will be required to change standard of care for all women in this patient population … [T]his study provides the scientific rationale to launch such an investigation,” Diver said.
“[With more data], we are likely to see the emergence of a new standard of care for these women that improves patient satisfaction and may improve compliance,” she added.