Hemostatic imbalances are frequent in patients with cancer. Although cancer-associated thrombotic complications have been well characterized, data on bleeding events in patients with cancer are sparse. Therefore, we aimed to investigate the incidence, risk factors, and impact on prognosis of bleeding events in patients with cancer initiating systemic anticancer therapies in a prospective cohort study, the Vienna Cancer, Thrombosis, and Bleeding Study. The primary study outcome was defined as clinically relevant bleeding (CRB), comprising major bleeding (MB) and clinically relevant nonmajor bleeding. In total, 791 patients (48% female), with median age of 63 years (interquartile range [IQR], 54-70), with various cancer types, 65.5% stage IV, were included. Over a median follow-up of 19 months (IQR, 8.7-24.0), we observed 194 CRB events in 139 (17.6%) patients, of which 42 (30.0%) were tumor related, 64 (46.0%) gastrointestinal, and 7 (5.0%) intracerebral. The 12-month cumulative incidence of first CRB and MB was 16.6% (95% confidence interval [CI], 13.7-19.6) and 9.1% (95% CI, 6.8-11.3), respectively, in the whole cohort, and 14.4% (95% CI, 11.2-17.5) and 7.0% (95% CI, 4.7-9.2), respectively, in those without anticoagulation. Patients with head and neck cancer had the highest risk of CRB. Lower baseline hemoglobin and albumin were associated with bleeding in patients without anticoagulation. Seven (5.0%) bleeding events were fatal, of which 6 occurred in patients without anticoagulation. Patients with CRB were at an increased risk of all-cause mortality (multivariable transition hazard ratio, 5.80; 95% CI, 4.53-7.43). In patients with cancer, bleeding events represent a frequent complication and are associated with increased mortality.

中文翻译：

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癌症患者出血事件：前瞻性队列研究中的发病率、危险因素和对预后的影响


止血失衡在癌症患者中很常见。尽管癌症相关的血栓并发症已经被很好地表征，但关于癌症患者出血事件的数据很少。因此，我们旨在调查在一项前瞻性队列研究 Vienna Cancer， Thrombosis， and Bleeding Study 中开始全身抗癌治疗的癌症患者出血事件的发生率、危险因素和对预后的影响。主要研究结局定义为临床相关出血 （CRB），包括大出血 （MB） 和临床相关的非大出血。总共纳入了 791 名患者 （48% 为女性），中位年龄为 63 岁 （四分位距 [IQR]，54-70），患有各种癌症类型，65.5% 为 IV 期。在中位随访 19 个月 （IQR，8.7-24.0） 中，我们在 139 例 （17.6%） 患者中观察到 194 例 CRB 事件，其中 42 例 （30.0%） 与肿瘤相关，64 例 （46.0%） 胃肠道相关，7 例 （5.0%） 脑内。在整个队列中，首次 CRB 和 MB 的 12 个月累积发生率分别为 16.6% （95% 置信区间 [CI]，13.7-19.6） 和 9.1% （95% CI，6.8-11.3），在未接受抗凝治疗的患者中分别为 14.4% （95% CI，11.2-17.5） 和 7.0% （95% CI，4.7-9.2）。头颈癌患者发生 CRB 的风险最高。在未接受抗凝治疗的患者，较低的基线血红蛋白和白蛋白与出血相关。7 例 （5.0%） 出血事件是致命的，其中 6 例发生在未接受抗凝治疗的患者中。CRB 患者的全因死亡风险增加 （多变量转换风险比，5.80;95% CI，4.53-7.43）。在癌症患者中，出血事件是一种常见的并发症，并且与死亡率增加有关。