R Tuckuviene1, S Ranta2, B K Albertsen3, N G Andersson4, M D Bendtsen5, T Frisk2, M W Gunnes6, J Helgestad1, M M Heyman2, O G Jonsson7, A Mäkipernaa8, K Pruunsild9, U Tedgård4, S S Trakymiene10, E Ruud11. 1. Department of Pediatrics, Aalborg University Hospital, Aalborg, Denmark. 2. Childhood Cancer Research Unit, Department of Women's and Children's Health, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden. 3. Department of Pediatrics, Aarhus University Hospital, Aarhus, Denmark. 4. Departments of Pediatrics and Coagulation Disorders, University of Lund, University Hospital, Malmö, Sweden. 5. Department of Clinical Medicine, Aalborg University, Aalborg, Denmark. 6. Department of Pediatrics, Haukeland University Hospital, Bergen, Norway. 7. Children's Hospital, Landspitali University Hospital, Reykjavík, Iceland. 8. Children's Hospital and Department of Hematology, Cancer Center, Helsinki University Central Hospital, Helsinki, Finland. 9. Department of Oncohematology, Tallinn Children's Hospital, Tallinn, Estonia. 10. Center for Pediatric Oncology and Hematology, Children's Hospital, Affiliate of Vilnius University Hospital Santariskiu Klinikos, Vilnius, Lithuania. 11. Department of Pediatric Medicine, Oslo University Hospital, Rikshospitalet, Oslo, Norway.
Abstract
UNLABELLED: 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. 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.
RCT Entities:
UNLABELLED: 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. 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.
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Authors: Marion K Mateos; Morten Tulstrup; Michael Cj Quinn; Ruta Tuckuviene; Glenn M Marshall; Ramneek Gupta; Chelsea Mayoh; Benjamin O Wolthers; Pasquale M Barbaro; Ellen Ruud; Rosemary Sutton; Pasi Huttunen; Tamas Revesz; Sonata S Trakymiene; Draga Barbaric; Ulf Tedgård; Jodie E Giles; Frank Alvaro; Olafur G Jonsson; Françoise Mechinaud; Kadri Saks; Daniel Catchpoole; Rishi S Kotecha; Luciano Dalla-Pozza; Georgia Chenevix-Trench; Toby N Trahair; Stuart MacGregor; Kjeld Schmiegelow Journal: Cancers (Basel) Date: 2020-05-19 Impact factor: 6.639