Thromb Haemost 2017; 117(08): 1615-1621
DOI: 10.1160/TH16-11-0895
Stroke, Systemic or Venous Thromboembolism
Schattauer GmbH

Khorana score and histotype predicts incidence of early venous thromboembolism in non-Hodgkin lymphomas[*]

A pooled-data analysis of 12 clinical trials of Fondazione Italiana Linfomi (FIL)
Roberto Mario Santi
1   Division of Hematology, A. O. SS. Antonio e Biagio e Cesare Arrigo of Alessandria, Italy
,
Manuela Ceccarelli
2   Unit of Clinical Epidemiology, A. O. U. Città della Salute e della Scienza di Torino, and CPO Piemonte, Italy
,
Elisa Bernocco
1   Division of Hematology, A. O. SS. Antonio e Biagio e Cesare Arrigo of Alessandria, Italy
,
Chiara Monagheddu
2   Unit of Clinical Epidemiology, A. O. U. Città della Salute e della Scienza di Torino, and CPO Piemonte, Italy
,
Andrea Evangelista
2   Unit of Clinical Epidemiology, A. O. U. Città della Salute e della Scienza di Torino, and CPO Piemonte, Italy
,
Federica Valeri
1   Division of Hematology, A. O. SS. Antonio e Biagio e Cesare Arrigo of Alessandria, Italy
,
Federico Monaco
1   Division of Hematology, A. O. SS. Antonio e Biagio e Cesare Arrigo of Alessandria, Italy
,
Umberto Vitolo
4   Division of Hematology II, A. O. U. Città della Salute e della Scienza of Torino, Italy
,
Sergio Cortelazzo
5   Division of Hematology and Bone Marrow Transplantation, Regional Hospital S.Maurizio of Bolzano, Italy
,
Maria Giuseppina Cabras
6   Division of Hematology, Hospital Businco of Cagliari, Italy
,
Michele Spina
7   Division of Hematology, IRCCS CRO of Aviano, Italy
,
Luca Baldini
8   Division of Hematology, Ospedale Maggiore Policlinico of Milano, University of Milano, Italy
,
Carola Boccomini
4   Division of Hematology II, A. O. U. Città della Salute e della Scienza of Torino, Italy
,
Annalisa Chiappella
4   Division of Hematology II, A. O. U. Città della Salute e della Scienza of Torino, Italy
,
Alessia Bari
9   Division of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Italy
,
Stefano Luminari
9   Division of Diagnostic, Clinical and Public Health Medicine, University of Modena and Reggio Emilia, Italy
,
Carlo Visco
10   Ospedale S. Bortolo, Vicenza, Italy
,
Marco Calabrese
11   Fondazione Italiana Linfomi (FIL), Alessandria, Italy
,
Giulia Limberti
1   Division of Hematology, A. O. SS. Antonio e Biagio e Cesare Arrigo of Alessandria, Italy
,
Alessandro Levis
11   Fondazione Italiana Linfomi (FIL), Alessandria, Italy
,
Laura Contino
1   Division of Hematology, A. O. SS. Antonio e Biagio e Cesare Arrigo of Alessandria, Italy
,
Giovannino Ciccone
2   Unit of Clinical Epidemiology, A. O. U. Città della Salute e della Scienza di Torino, and CPO Piemonte, Italy
,
Marco Ladetto
1   Division of Hematology, A. O. SS. Antonio e Biagio e Cesare Arrigo of Alessandria, Italy
› Author Affiliations
Further Information

Publication History

Received: 30 November 2016

Accepted after major revision: 10 April 2017

Publication Date:
28 November 2017 (online)

Summary

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.

Supplementary Material to this article is available at www.thrombosis-online.com.

* Preliminary results were presented in abstract form at the 2015 ASH meeting (Orlando, FL, USA), at the 2016 EHA meeting (Copenhagen, Denmark, EU),and at the 8th International Conference on Thrombosis and Hemostasis Issues in Cancer, 2016 (Bergamo, Italy, EU).