Di Nisio Marcello
Dipartimento di Medicina e Scienze dell'Invecchiamento, Università degli Studi "G. d'Annunzio", Chieti.
G Ital Cardiol (Rome). 2018 Sep;19(9 Suppl 1):7S-12S. doi: 10.1714/2989.29922.
Most clinical practice guidelines recommend low molecular weight heparin for the treatment of venous thromboembolism (VTE) in cancer patients. In the Hokusai VTE Cancer study, 1050 patients with cancer and acute VTE were randomized to oral edoxaban or subcutaneous dalteparin for at least 6 months and up to 12 months. Edoxaban was non-inferior to dalteparin with respect to the composite outcome of recurrent VTE and major bleeding. The rate of recurrent VTE was numerically lower, but the rate of major bleeding was significantly higher with edoxaban. The frequency of severe major bleeding was similar with edoxaban and dalteparin. The difference in major bleeding was mainly driven by a higher rate of upper gastrointestinal bleeding with edoxaban, especially in patients with gastrointestinal cancer. The pilot Select-D study randomized 406 patients with cancer and VTE to rivaroxaban or dalteparin for 6 months. Recurrent VTE was reduced, while both major and clinically relevant non major bleeding were significantly increased with rivaroxaban. Bleeding mostly involved the gastrointestinal tract and occurred in patients with gastroesophageal cancer. While waiting for ongoing studies on direct oral anticoagulants, the results of the Hokusai VTE Cancer suggest that edoxaban may represent a valuable alternative to low molecular weight heparin for the treatment of cancer-associated VTE. In patients with gastrointestinal cancer, the use of edoxaban requires careful benefit-risk weighting, taking into consideration patient's preferences.
大多数临床实践指南推荐使用低分子量肝素治疗癌症患者的静脉血栓栓塞症（VTE）。在“日本北陆VTE癌症”研究中，1050例患有癌症和急性VTE的患者被随机分配接受口服艾多沙班或皮下注射达肝素治疗至少6个月，最长12个月。在复发性VTE和大出血的复合结局方面，艾多沙班不劣于达肝素。复发性VTE的发生率在数值上较低，但艾多沙班组的大出血发生率显著更高。艾多沙班和达肝素的严重大出血发生率相似。大出血差异主要是由艾多沙班组较高的上消化道出血率导致的，尤其是在胃肠道癌症患者中。“SELECT-D”先导研究将406例患有癌症和VTE的患者随机分配接受利伐沙班或达肝素治疗6个月。利伐沙班可降低复发性VTE，但大出血和临床相关非大出血均显著增加。出血大多累及胃肠道，发生在胃食管癌患者中。在等待关于直接口服抗凝剂的正在进行的研究结果期间，“日本北陆VTE癌症”研究的结果表明，对于癌症相关VTE的治疗，艾多沙班可能是低分子量肝素的一种有价值的替代药物。对于胃肠道癌症患者，使用艾多沙班需要仔细权衡获益与风险，并考虑患者的偏好。
