Premium
Prospective study of thromboembolism in 1038 children with acute lymphoblastic leukemia: a Nordic Society of Pediatric Hematology and Oncology (NOPHO) study
Author(s) -
Tuckuviene R.,
Ranta S.,
Albertsen B. K.,
Andersson N. G.,
Bendtsen M. D.,
Frisk T.,
Gunnes M. W.,
Helgestad J.,
Heyman M. M.,
Jonsson O. G.,
Mäkipernaa A.,
Pruunsild K.,
Tedgård U.,
Trakymiene S. S.,
Ruud E.
Publication year - 2016
Publication title -
journal of thrombosis and haemostasis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.947
H-Index - 178
eISSN - 1538-7836
pISSN - 1538-7933
DOI - 10.1111/jth.13236
Subject(s) - medicine , cumulative incidence , incidence (geometry) , prospective cohort study , hazard ratio , hematology , case fatality rate , acute lymphocytic leukemia , proportional hazards model , pediatrics , lymphoblastic leukemia , cohort , confidence interval , leukemia , epidemiology , physics , optics
Essentials Children with acute lymphoblastic leukemia (ALL) are at risk of thromboembolism (TE). This is a prospective evaluation of the incidence, risk factors and outcomes of TE in 1038 children with ALL. TE occurred in 6.1% of children, with the highest incidence (20.5%) among those aged 15–17 years. A TE‐associated case fatality of 6.4% indicates that TE is a severe complication of ALL treatment.Summary Background Thromboembolism (TE) is a major toxicity in children with acute lymphoblastic leukemia (ALL) and may have a negative impact on ALL treatment. Objectives To examine the cumulative incidence, outcomes and risk factors associated with TE in children with leukemia. Patients/Methods We prospectively evaluated TE in 1038 Nordic children and adolescents (≥ 1 and < 18 years) diagnosed with ALL during 2008–2013 and treated according to the NOPHO (Nordic Society of Pediatric Hematology and Oncology)‐ALL 2008 protocol. The cohort was followed until December 2014. Cox proportional regression was used to compute hazard ratios (HRs). Results TE events ( n = 63) occurred most frequently in conjunction with asparaginase (ASP) administration (52/63). The cumulative incidence of TE was 6.1% (95% confidence interval [CI], 4.8–7.7). Being aged 15–17 years was associated with an increased risk of TE (adjusted HR of 4.0; 95% CI, 2.1–7.7). We found a TE‐associated 30‐day case fatality of 6.4% (95% CI, 1.8–15.5) and TE‐related truncation of ASP therapy in 36.2% (21/58). Major hemorrhage occurred in 3.5% (2/58) of anticoagulated patients. Minor hemorrhage was reported in two out of 58 patients. No major bleeds occurred in children who received low‐molecular‐weight heparin. Conclusions Methods to identify children and adolescents who will benefit from thromboprophylaxis during ALL treatment are called for. The truncation of ASP should be avoided. The long‐term survival outcomes for ALL patients with TE require close monitoring in the future.