Santi Roberto Mario, Ceccarelli Manuela, Bernocco Elisa, Monagheddu Chiara, Evangelista Andrea, Valeri Federica, Monaco Federico, Vitolo Umberto, Cortelazzo Sergio, Cabras Maria Giuseppina, Spina Michele, Baldini Luca, Boccomini Carola, Chiappella Annalisa, Bari Alessia, Luminari Stefano, Visco Carlo, Calabrese Marco, Limberti Giulia, Levis Alessandro, Contino Laura, Ciccone Giovannino, Ladetto Marco
Giulia Limberti, AO SS Antonio e Biagio e C. Arrigo - SC Ematolgoia, Via Venezia 16, 15121 Alessandria, Italy, Tel.: +39 0131206930, Fax: +39 0131261029, E-mail:
Thromb Haemost. 2017 Apr 27. doi: 10.1160/TH16-11-0895.
Current data suggests that the risk of venous thromboembolism (VTE) in patients with non-Hodgkin lymphoma (NHL) is comparable to that observed in patients with solid tumours, although more robust confirmatory analyses are required. With that in mind, we investigated the occurrence of VTE in a pooled analysis of 12 "Fondazione Italiana Linfomi" (FIL) prospective clinical studies. Specifically, we wished to assess the cumulative incidence of VTE in NHL patients, evaluate the predictive value of the Khorana Score (KS), and identify other potential risk factors for VTEs. Data for VTE occurrence were retrieved from study databases and pharmacovigilance reports. Our analysis includes 1717 patients from 12 prospective phase II and III trials, including newly diagnosed NHL. We observed 53 VTEs (any grade) in 46 patients, with 20 severe VTEs in 17 patients. The cumulative incidences for "all-grade" or grade ≥3 VTEs were 2.9 % (95 % CI: 2.1-3.8) and 1.1 % (95 % CI: 0.6-1.6), respectively. KS categories were positively associated with the risk of VTE of any grade, and with severe events (i. e. grade ≥3; Gray's test p-values = 0.048 and 0.012, respectively). Among NHL patients, those with diffuse large B-cell lymphoma (DLBCL) showed a greater risk of (any grade) VTE (HR: 3.42, 95 % CI: 1.32-8.84, p-value = 0.011). Our study indicates that 1) VTE is a relevant complication for NHL patients, 2) KS is predictive of VTE events and 3) DLBCL histotype is an independent risk factor for VTE incidence, for which preventative interventions could be considered.
目前的数据表明，非霍奇金淋巴瘤（NHL）患者发生静脉血栓栓塞（VTE）的风险与实体瘤患者相当，不过仍需要更有力的验证性分析。考虑到这一点，我们在一项对12项“意大利淋巴瘤基金会”（FIL）前瞻性临床研究的汇总分析中调查了VTE的发生情况。具体而言，我们希望评估NHL患者VTE的累积发病率，评估科拉纳评分（KS）的预测价值，并确定VTE的其他潜在风险因素。VTE发生的数据从研究数据库和药物警戒报告中获取。我们的分析纳入了来自12项前瞻性II期和III期试验的1717例患者，包括新诊断的NHL患者。我们在46例患者中观察到53例VTE（任何级别），其中17例患者发生20例严重VTE。“所有级别”或≥3级VTE的累积发病率分别为2.9%（95%CI：2.1 - 3.8）和1.1%（95%CI：0.6 - 1.6）。KS类别与任何级别的VTE风险以及严重事件（即≥3级；格雷检验p值分别为0.048和0.012）呈正相关。在NHL患者中，弥漫性大B细胞淋巴瘤（DLBCL）患者发生（任何级别）VTE的风险更高（HR：3.42，95%CI：1.32 - 8.84，p值 = 0.011）。我们的研究表明：1）VTE是NHL患者的一种相关并发症；2）KS可预测VTE事件；3）DLBCL组织学类型是VTE发生率的独立风险因素，对此可考虑采取预防性干预措施。
