OBJECTIVES This study aimed to describe the longitudinal thromboembolism (TE) risk relative to the natural history of disease and clinical course of ROS1 rearranged non-small cell lung cancer (NSCLC). MATERIALS AND METHODS Cases of ROS1-rearranged NSCLC from six Australian hospitals were pooled and evaluated for incidence, timing, predictors and outcomes of venous or arterial TE, as well as objective response rate (ORR) to active therapy and overall survival (OS). RESULTS Of 42 patients recruited, 20 (48%) experienced TE; one (2%) arterial, 13 (31%) a pulmonary emboli (PE), and 12 (29%) a deep vein thrombosis. Among those with TE, six (30%) experienced multiple events, three as concurrent and three as recurrent diagnoses. The cumulative incidence of TE over time, adjusted for death as a competing risk factor, approached 50%. TE occurred prior to, during and post the peri-diagnostic period and occurred irrespective of treatment strategy. A thrombophilia was identified in n = 3/10 (30%) cases screened: in two factor V Leiden and in one anti-thrombin III (ATIII) deficiency. Median OS was 21.3 months in those with TE vs. 28.8 months in those without; hazard ratio 1.16 (95%CI 0.43-3.15). Respective ORR to first-line therapy with TE was 50% vs. 44% without TE in the chemotherapy arm and 67% vs. 50% in the targeted therapy arm. CONCLUSION In the rare cancer subtype, ROS1, these real-world data demonstrate sustained TE risk beyond the diagnostic period irrespective of therapeutic strategy. High incidence of PE, concurrent TE, and recurrent TE warrant validation in larger cohorts. Consideration of primary thromboprophylaxis in ROS1 populations is recommended.

中文翻译：

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在诊断为ROS1重排的非小细胞肺癌患者中血栓栓塞事件的多中心研究。

目的本研究旨在描述相对于ROS1重排非小细胞肺癌（NSCLC）的自然疾病史和临床病程的纵向血栓栓塞（TE）风险。材料与方法汇总了澳大利亚六家医院经ROS1重组的NSCLC病例，并评估了静脉或动脉TE的发生率，时间，预测因素和结局，以及对积极治疗的客观反应率（ORR）和总生存期（OS）。结果在42名患者中，有20名（48％）经历过TE。1例（2％）动脉，13例（31％）肺栓塞（PE）和12例（29％）深静脉血栓形成。在那些患有TE的患者中，有六个（30％）经历了多次事件，其中三个为并发诊断，三个为复发性诊断。将死亡作为竞争性风险因素进行调整后，TE随时间的累积发生率接近50％。TE发生于 在围诊期间和之后，不论治疗策略如何，均会发生。在筛查的n = 3/10（30％）病例中发现了血栓形成倾向：两个因素V Leiden和一个抗凝血酶III（ATIII）缺乏症。TE患者中位OS为21.3个月，而没有TE患者中位值为28.8个月。危险比1.16（95％CI 0.43-3.15）。在化疗组中，使用TE进行一线治疗的ORR分别为50％和44％（不使用TE），在靶向治疗组中分别为67％和50％。结论在罕见的癌症亚型ROS1中，这些实际数据证明了在诊断期内持续存在TE风险，而与治疗策略无关。PE的高发率，同时发生的TE和复发性TE需要在较大的队列中进行验证。建议考虑在ROS1人群中进行一级血栓预防。