Cancer-associated thrombosis: How many patients seen in clinical practice would be eligible for a direct oral anticoagulant randomized controlled trial?

IF 2.2 4区 医学 Q3 RESPIRATORY SYSTEM Respiratory Medicine and Research Pub Date : 2023-11-30 DOI:10.1016/j.resmer.2023.101069
Bastien Petit , Simon Soudet , Géraldine Poenou , Emma Zarrat , Sandrine Accassat , Ludovic Plaisance , Hélène Helfer , Valentine Mismetti , Claire Le Hello , Marie-Antoinette Sevestre , Isabelle Mahé , Laurent Bertoletti
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Abstract

Based on the results of randomized clinical trials (RCT) assessing direct oral anticoagulants (DOACs) for the treatment of patients with cancer-associated thrombosis (CAT), DOACs have been proposed as alternative to low molecular weight heparin by several international guidelines. However, the proportion of CAT patients who would have not been eligible for such trials is currently unknown.

Our primary aim was to assess the proportion of patients seen in clinical practice for acute CAT who would not have been eligible for CARAVAGGIO or HOKUSAI-VTE RCT. Secondary aim was to describe patients outcomes according to eligibility.

In a multicenter, observational study, all patients consecutively admitted from January 2017 to December 2019 for an acute CAT event were retrospectively analyzed. Patients were classified according to the presence or absence of non-inclusion criteria for CARAVAGGIO or HOKUSAI-VTE RCT. Event free survival during a 6-month follow-up were analyzed as secondary endpoints.

Among the 302 patients (women: 53 %, mean age: 67.9 ± 13.2) analyzed, 138 (46 %) for HOKUSAI-VTE cancer and 161 (53 %) for CARAVAGGIO met one or more non-inclusion criteria. Main criteria were upper limb and unsual site thrombosis (n = 63, 18.5 %), anemia/thrombopenia (n = 43, 14.2 %), brain tumors (n = 33, 10.9 %), ECOG PS >2 (n = 28, 9.3 %), severe renal failure (n = 16, 5.3 %).

At 6 months, the event-free survival rate was not statistically different between the two groups.

Almost half of CAT patients would have not been able to participate to a modern DOAC RCT. Evaluation of DOACs safety and efficacy in this subset of patients deserves further research.

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癌症相关血栓:临床实践中有多少患者符合直接口服抗凝剂随机对照试验的条件?
根据评估直接口服抗凝剂(DOAC)治疗癌症相关血栓(CAT)患者的随机临床试验(RCT)结果,一些国际指南建议将直接口服抗凝剂作为低分子量肝素的替代药物。然而,目前尚不清楚不符合此类试验条件的 CAT 患者的比例。我们的主要目的是评估在临床实践中,不符合 CARAVAGGIO 或 HOKUSAI-VTE RCT 条件的急性 CAT 患者的比例。次要目的是根据资格描述患者的治疗效果。在一项多中心观察性研究中,对2017年1月至2019年12月期间因急性CAT事件连续入院的所有患者进行了回顾性分析。根据是否符合 CARAVAGGIO 或 HOKUSAI-VTE RCT 的非纳入标准对患者进行分类。随访 6 个月期间的无事件存活率作为次要终点进行分析。在分析的 302 名患者(女性:53%,平均年龄:67.9 ± 13.2)中,HOKUSAI-VTE 癌症患者 138 人(46%)和 CARAVAGGIO 癌症患者 161 人(53%)符合一项或多项非纳入标准。主要标准为上肢和非特殊部位血栓形成(63 人,18.5%)、贫血/血栓减少症(43 人,14.2%)、脑肿瘤(33 人,10.9%)、ECOG PS >2 (28 人,9.3%)、严重肾功能衰竭(16 人,5.3%)。6 个月后,两组患者的无事件生存率无统计学差异。几乎一半的 CAT 患者无法参加现代 DOAC RCT。对这部分患者的 DOAC 安全性和疗效评估值得进一步研究。
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来源期刊
Respiratory Medicine and Research
Respiratory Medicine and Research RESPIRATORY SYSTEM-
CiteScore
2.70
自引率
0.00%
发文量
82
审稿时长
50 days
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