Abstract：
BACKGROUND: Direct oral anticoagulants (DOACs) are the mainstay of treatment for venous thromboembolism (VTE) and non-valvular atrial fibrillation (AF), with or without an underlying cancer. Patients with cancer have a 2-3-fold increase in risk for bleeding complications compared to non-cancer patients taking anticoagulant therapy, however the incidence of bleeding for urogenital and gynecological cancers on DOACs are uncertain.
OBJECTIVE: To assess the bleeding risk associated with the use of DOACs in patients with urogenital and/or gynecological cancers.
METHODS: We conducted a systematic review of randomized controlled trials (RCTs) and prospective cohort studies to address the safety of DOACs for VTE and AF when used in patients with urogenital and/or gynecological malignancy. The primary outcomes assessed were major and clinically relevant non-major (CRNMB) bleeding, with minor bleeding considered as a secondary outcome. MEDLINE, EMBASE and COCHRANE Central Registry of Controlled Trials were searched up to and including Oct 28, 2022. The study protocol was registered in PROSPERO (CRD42022370981). Studies were independently assessed for inclusion and data extracted in duplicate.
RESULTS: Seven studies met our inclusion criteria (Fig. 1): 2 RCTs and 5 prospective cohort studies. A total of 676 patients treated with DOACs were included, 628 (92.8%) had VTE and 48 (7.1%) had AF. In patients with VTE treated with DOACs, the pooled major bleeding rate was 2.1%, 95% confidence intervals (CI) 0.9-3.3% (Fig. 2). Pooled estimates could not be determined for AF patients given small event and patient numbers.
CONCLUSIONS: Major bleeding rates in urogenital and/or gynecological cancer patients treated with DOACs are similar to that of the general cancer population.
OBJECTIVE: To assess the bleeding risk associated with the use of DOACs in patients with urogenital and/or gynecological cancers.
METHODS: We conducted a systematic review of randomized controlled trials (RCTs) and prospective cohort studies to address the safety of DOACs for VTE and AF when used in patients with urogenital and/or gynecological malignancy. The primary outcomes assessed were major and clinically relevant non-major (CRNMB) bleeding, with minor bleeding considered as a secondary outcome. MEDLINE, EMBASE and COCHRANE Central Registry of Controlled Trials were searched up to and including Oct 28, 2022. The study protocol was registered in PROSPERO (CRD42022370981). Studies were independently assessed for inclusion and data extracted in duplicate.
RESULTS: Seven studies met our inclusion criteria (Fig. 1): 2 RCTs and 5 prospective cohort studies. A total of 676 patients treated with DOACs were included, 628 (92.8%) had VTE and 48 (7.1%) had AF. In patients with VTE treated with DOACs, the pooled major bleeding rate was 2.1%, 95% confidence intervals (CI) 0.9-3.3% (Fig. 2). Pooled estimates could not be determined for AF patients given small event and patient numbers.
CONCLUSIONS: Major bleeding rates in urogenital and/or gynecological cancer patients treated with DOACs are similar to that of the general cancer population.
摘要：
背景：直接口服抗凝药（DOAC）是静脉血栓栓塞（VTE）和非瓣膜性心房颤动（AF）的主要治疗方法，有或没有潜在的癌症。与非癌症患者服用抗凝治疗相比，癌症患者出血并发症的风险增加2-3倍，然而,DOAC的泌尿生殖系统和妇科肿瘤的出血发生率尚不确定.
目的：评估泌尿生殖系统和/或妇科癌症患者使用DOAC的出血风险。
方法：我们对随机对照试验（RCT）和前瞻性队列研究进行了系统评价，以探讨DOAC用于泌尿生殖系统和/或妇科恶性肿瘤患者VTE和AF的安全性。评估的主要结果是主要和临床相关的非主要（CRNMB）出血，轻微出血被认为是次要结果。MEDLINE,截至2022年10月28日，对EMBASE和COCHRANE中央对照试验登记处进行了搜索。该研究方案在PROSPERO(CRD42022370981)中注册。独立评估研究的纳入情况，并提取数据，一式两份。
结果：七项研究符合我们的纳入标准（图。1）：2项RCT和5项前瞻性队列研究。共纳入676例接受DOAC治疗的患者，628例（92.8%）发生VTE，48例（7.1%）发生AF。在接受DOAC治疗的VTE患者中，合并大出血率为2.1%,95%置信区间（CI）0.9-3.3%（图。2).对于小事件和患者数量的房颤患者，无法确定汇总的估计值。
结论：接受DOAC治疗的泌尿生殖系统和/或妇科癌症患者的大出血率与普通癌症人群相似。
目的：评估泌尿生殖系统和/或妇科癌症患者使用DOAC的出血风险。
方法：我们对随机对照试验（RCT）和前瞻性队列研究进行了系统评价，以探讨DOAC用于泌尿生殖系统和/或妇科恶性肿瘤患者VTE和AF的安全性。评估的主要结果是主要和临床相关的非主要（CRNMB）出血，轻微出血被认为是次要结果。MEDLINE,截至2022年10月28日，对EMBASE和COCHRANE中央对照试验登记处进行了搜索。该研究方案在PROSPERO(CRD42022370981)中注册。独立评估研究的纳入情况，并提取数据，一式两份。
结果：七项研究符合我们的纳入标准（图。1）：2项RCT和5项前瞻性队列研究。共纳入676例接受DOAC治疗的患者，628例（92.8%）发生VTE，48例（7.1%）发生AF。在接受DOAC治疗的VTE患者中，合并大出血率为2.1%,95%置信区间（CI）0.9-3.3%（图。2).对于小事件和患者数量的房颤患者，无法确定汇总的估计值。
结论：接受DOAC治疗的泌尿生殖系统和/或妇科癌症患者的大出血率与普通癌症人群相似。
