Venous thromboembolism incidence associated with pegylated asparaginase (ASP) compared to the native L-ASP: A retrospective analysis with an ASP-based protocol in adult patients with acute lymphoblastic leukaemia.
DFCI 91-01 protocol
acute lymphoblastic leukemia
asparaginase
therapy-related thrombosis
Journal
British journal of haematology
ISSN: 1365-2141
Titre abrégé: Br J Haematol
Pays: England
ID NLM: 0372544
Informations de publication
Date de publication:
05 2023
05 2023
Historique:
revised:
17
01
2023
received:
14
11
2022
accepted:
24
01
2023
medline:
4
5
2023
pubmed:
17
2
2023
entrez:
16
2
2023
Statut:
ppublish
Résumé
Venous thromboembolism (VTE) is a well-known complication in patients with acute lymphoblastic leukaemia (ALL) receiving asparaginase (ASP)-based chemotherapy, including the ASP-intensive Dana-Farber Cancer Institute (DFCI) 91-01 protocol for adults. Since 2019, native L-ASP is no longer available in Canada and was replaced by pegylated (PEG)-ASP. To determine whether the incidence of VTE has changed since switching from L-ASP to PEG-ASP, we conducted a single-centred retrospective cohort study. We included 245 adult patients with Philadelphia chromosome negative ALL between 2011 and 2021, with 175 from the L-ASP group (2011-2019) and 70 from the PEG-ASP group (2018-2021). During Induction, 10.29% (18/175) of patients who received L-ASP developed VTE, whereas 28.57% (20/70) of patients who received PEG-ASP developed VTE (p = 0.0035; odds ratio [OR] 3.35, 95% confidence interval [CI] 1.51-7.39), after adjusting for line type, gender, history of VTE, platelets at diagnosis. Similarly, during Intensification, 13.64% (18/132) of patients had VTE on L-ASP while 34.37% (11/32) of patients on PEG-ASP developed VTE (p = 0.0096; OR 3.96, 95% CI 1.57-9.96 with multivariable analysis). We found that PEG-ASP is associated with a higher incidence of VTE compared to L-ASP, both during Induction and Intensification, despite the administration of prophylactic anticoagulation. Further VTE mitigation strategies are needed in particular for adult patients with ALL receiving PEG-ASP.
Substances chimiques
pegaspargase
7D96IR0PPM
Asparaginase
EC 3.5.1.1
Polyethylene Glycols
3WJQ0SDW1A
Antineoplastic Agents
0
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
645-652Informations de copyright
© 2023 The Authors. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.
Références
Poch Martell M, Atenafu EG, Minden MD, Schuh AC, Yee KWL, Schimmer AD, et al. Treatment of elderly patients with acute lymphoblastic leukaemia using a paediatric-based protocol. Br J Haematol. 2013;163(4):458-64.
Storring JM, Minden MD, Kao S, Gupta V, Schuh AC, Schimmer AD, et al. Treatment of adults with BCR-ABL negative acute lymphoblastic leukaemia with a modified paediatric regimen. Br J Haematol. 2009;146(1):76-85.
DeAngelo DJ, Stevenson KE, Dahlberg SE, Silverman LB, Couban S, Supko JG, et al. Long-term outcome of a pediatric-inspired regimen used for adults aged 18-50 years with newly diagnosed acute lymphoblastic leukemia. Leukemia. 2015;29(3):526-34.
Truelove E, Fielding AK, Hunt BJ. The coagulopathy and thrombotic risk associated with L-asparaginase treatment in adults with acute lymphoblastic leukaemia. Leukemia. 2013;27(3):553-9. https://doi.org/10.1038/leu.2012.290
Staddon JH, Smock KJ, Schiffman JD, Fluchel MN, Engel ME, Weyrich AS, et al. Pegasparaginase treatment alters thrombin generation by modulating the protein C and S system in acute lymphoblastic leukaemia/lymphoma. Blood Coagul Fibrinolysis. 2015;26(7):840-3.
Caruso V, Iacoviello L, Di Castelnuovo A, Storti S, Mariani G, De Gaetano G, et al. Thrombotic complications in childhood acute lymphoblastic leukemia: a meta-analysis of 17 prospective studies comprising 1752 pediatric patients. Blood. 2006;108(7):2216-22.
Mitchell LG, Andrew M, Abshire T, Halton J, Anderson R, Cherrick I, et al. A prospective cohort study determining the prevalence of thrombotic events in children with acute lymphoblastic leukemia and a central venous line who are treated with L-asparaginase: results of the prophylactic antithrombin replacement in kids with acute. Cancer. 2003;97(2):508-16.
Grace RF, Dahlberg SE, Neuberg D, Sallan SE, Connors JM, Neufeld EJ, et al. The frequency and management of asparaginase-related thrombosis in paediatric and adult patients with acute lymphoblastic leukaemia treated on Dana-Farber Cancer Institute consortium protocols. Br J Haematol. 2011;152(4):452-9.
Sibai H, Seki JT, Wang TQ, Sakurai N, Atenafu EG, Yee KWL, et al. Venous thromboembolism prevention during asparaginase-based therapy for acute lymphoblastic leukemia. Current Oncology. 2016;23(4). Available from: http://www.current-oncology.com/index.php/oncology/article/view/3077:355-61.
Grace RF, DeAngelo DJ, Stevenson KE, Neuberg D, Sallan SE, Mourad YRA, et al. The use of prophylactic anticoagulation during induction and consolidation chemotherapy in adults with acute lymphoblastic leukemia. J Thromb Thrombolysis. 2018;45(2):306-14. https://doi.org/10.1007/s11239-017-1597-7
Zwicker JI, Wang TF, DeAngelo DJ, Lauw MN, Connors JM, Falanga A, et al. The prevention and management of asparaginase-related venous thromboembolism in adults: guidance from the SSC on hemostasis and malignancy of the ISTH. J Thromb Haemost. 2020;18(2):278-84.
Sibai H, Chen R, Liu X, Falcone U, Schimmer A, Schuh A, et al. Anticoagulation prophylaxis reduces venous thromboembolism rate in adult acute lymphoblastic leukaemia treated with asparaginase-based therapy. Br J Haematol. 2020;2:1-7.
Douer D, Aldoss I, Lunning MA, Burke PW, Ramezani L, Mark L, et al. Pharmacokinetics-based integration of multiple doses of intravenous pegaspargase in a pediatric regimen for adults with newly diagnosed acute lymphoblastic leukemia. J Clin Oncol. 2014;32(9):905-11.
Place AE, Stevenson KE, Vrooman LM, Harris MH, Hunt SK, O'Brien JE, et al. Intravenous pegylated asparaginase versus intramuscular native Escherichia coli L-asparaginase in newly diagnosed childhood acute lymphoblastic leukaemia (DFCI 05-001): a randomised, open-label phase 3 trial. Lancet Oncol. 2015;16(16):1677-90.
Derman BA, Streck M, Wynne J, Christ TN, Curran E, Stock W, et al. Efficacy and toxicity of reduced vs. standard dose pegylated asparaginase in adults with Philadelphia chromosome-negative acute lymphoblastic leukemia. Leuk Lymphoma. 2020;61(3):614-22.
Underwood B, Zhao Q, Walker AR, Mims AS, Vasu S, Long M, et al. Incidence of venous thrombosis after peg-asparaginase in adolescent and young adults with acute lymphoblastic leukemia. Int J Hematol Oncol. 2020;9(3):IJH28.
Ribera JM, Morgades M, Montesinos P, Martino R, Barba P, Soria B, et al. Efficacy and safety of native versus pegylated Escherichia coli asparaginase for treatment of adults with high-risk, Philadelphia chromosome-negative acute lymphoblastic leukemia. Leuk Lymphoma. 2018;59(7):1634-43. https://doi.org/10.1080/10428194.2017.1397661
Kashanian SM, Holtzman NG, Patzke CL, Cornu J, Duffy A, Koka M, et al. Venous thromboembolism incidence and risk factors in adults with acute lymphoblastic leukemia treated with and without pegylated E. coli asparaginase-containing regimens. Cancer Chemother Pharmacol. 2021;87(6):817-26. https://doi.org/10.1007/s00280-021-04252-y
Albertsen BK, Grell K, Abrahamsson J, Lund B, Vettenranta K, Jónsson ÓG, et al. Intermittent versus continuous PEG-asparaginase to reduce asparaginase-associated toxicities: a NOPHO ALL2008 randomized study. J Clin Oncol. 2019;37(19):1638-46.
Sui J, Zhang Y, Yang L, Wang H, Xu J, Wei R, et al. Successful treatment with rivaroxaban of cerebral venous thrombosis and bone marrow necrosis induced by pegaspargase: a case report and literature review. Medicine (United States). 2017;96(46):e8715.
Koganesawa M, Matsuno R, Sugishita Y, Kaneko R, Kawabata N, Fujita S, et al. Anticoagulation treatment and prophylactic edoxaban for cerebral sinus venous thrombosis in an adolescent with acute lymphoblastic leukemia. SAGE Open Med Case Rep. 2021;9:2050313X211013225.
Talamo L, Douvas M, Macik BG, Ornan D. Successful treatment with apixaban of sinus venous thrombosis due to pegylated asparaginase in a young adult with T cell acute lymphoblastic leukemia: case report and review of management. Ann Hematol. 2017;96(4):691-3.
Plander M, Szendrei T, Bodó I, Iványi JL. Successful treatment with rivaroxaban of an extended superficial vein thrombosis in a patient with acquired antithrombin deficiency due to peg-asparaginase treatment. Ann Hematol. 2015;94(7):1257-8.