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Prolonged versus standard native E-coli asparaginase therapy in childhood acute lymphoblastic leukemia and non-Hodgkin lymphoma : final results of the EORTC-CLG randomized phase III trial 58951

(2017) HAEMATOLOGICA. 102(10). p.1727-1738
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Abstract
Asparaginase is an essential component of combination chemotherapy for childhood acute lymphoblastic leukemia and non-Hodgkin lymphoma. The value of asparaginase was further addressed in a group of non-very high-risk patients by comparing prolonged (long-asparaginase) versus standard (short-asparaginase) native E. coli asparaginase treatment in a randomized part of the phase III 58951 trial of the European Organization for Research and Treatment of Cancer Children's Leukemia Group. The main endpoint was disease-free survival. Overall, 1,552 patients were randomly assigned to long-asparaginase (775 patients) or short-asparaginase (777 patients). Patients with grade >= 2 allergy to native E. coli asparaginase were switched to equivalent doses of Erwinia or pegylated E. coli asparaginase. The 8-year disease-free survival rate (+/- standard error) was 87.0 +/- 1.3% in the long-asparaginase group and 84.4 +/- 1.4% in the short-asparaginase group (hazard ratio: 0.87; P=0.33) and the 8-year overall survival rate was 92.6 +/- 1.0% and 91.3 +/- 1.2% respectively (hazard ratio: 0.89; P=0.53). An exploratory analysis suggested that the impact of long-asparaginase was beneficial in the National Cancer Institute standard-risk group with regards to disease-free survival (hazard ratio: 0.70; P=0.057), but far less so with regards to overall survival (hazard ratio: 0.89). The incidences of grade 3-4 infection during consolidation (25.2% versus 14.4%) and late intensification (22.6% versus 15.9%) and the incidence of grade 2-4 allergy were higher in the long-asparaginase arm (30% versus 21%). Prolonged native E. coli asparaginase therapy in consolidation and late intensification for our non-very high-risk patients did not improve overall outcome but led to an increase in infections and allergy.
Keywords
MINIMAL RESIDUAL DISEASE, ERWINIA-ASPARAGINASE, INDUCTION THERAPY, ONCOLOGY-GROUP, CHILDREN, DEXAMETHASONE, RISK, REDUCTION, EXPOSURE, CANCER

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Citation

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MLA
Mondelaers, Veerle, Stefan Suciu, Barbara De Moerloose, et al. “Prolonged Versus Standard Native E-coli Asparaginase Therapy in Childhood Acute Lymphoblastic Leukemia and non-Hodgkin Lymphoma : Final Results of the EORTC-CLG Randomized Phase III Trial 58951.” HAEMATOLOGICA 102.10 (2017): 1727–1738. Print.
APA
Mondelaers, V., Suciu, S., De Moerloose, B., Ferster, A., Mazingue, F., Plat, G., Yakouben, K., et al. (2017). Prolonged versus standard native E-coli asparaginase therapy in childhood acute lymphoblastic leukemia and non-Hodgkin lymphoma : final results of the EORTC-CLG randomized phase III trial 58951. HAEMATOLOGICA, 102(10), 1727–1738.
Chicago author-date
Mondelaers, Veerle, Stefan Suciu, Barbara De Moerloose, Alina Ferster, Francoise Mazingue, Geneviève Plat, Karima Yakouben, et al. 2017. “Prolonged Versus Standard Native E-coli Asparaginase Therapy in Childhood Acute Lymphoblastic Leukemia and non-Hodgkin Lymphoma : Final Results of the EORTC-CLG Randomized Phase III Trial 58951.” Haematologica 102 (10): 1727–1738.
Chicago author-date (all authors)
Mondelaers, Veerle, Stefan Suciu, Barbara De Moerloose, Alina Ferster, Francoise Mazingue, Geneviève Plat, Karima Yakouben, Anne Uyttebroeck, Patrick Lutz, Vitor Costa, Nicolas Sirvent, Emmanuel Plouvier, Martine Munzer, Maryline Poirée, Odile Minckes, Frédéric Millot, Dominique Plantaz, Philip Maes, Claire Hoyoux, Hélène Cavé, Pierre Rohrlich, Yves Bertrand, and Yves Benoit. 2017. “Prolonged Versus Standard Native E-coli Asparaginase Therapy in Childhood Acute Lymphoblastic Leukemia and non-Hodgkin Lymphoma : Final Results of the EORTC-CLG Randomized Phase III Trial 58951.” Haematologica 102 (10): 1727–1738.
Vancouver
1.
Mondelaers V, Suciu S, De Moerloose B, Ferster A, Mazingue F, Plat G, et al. Prolonged versus standard native E-coli asparaginase therapy in childhood acute lymphoblastic leukemia and non-Hodgkin lymphoma : final results of the EORTC-CLG randomized phase III trial 58951. HAEMATOLOGICA. 2017;102(10):1727–38.
IEEE
[1]
V. Mondelaers et al., “Prolonged versus standard native E-coli asparaginase therapy in childhood acute lymphoblastic leukemia and non-Hodgkin lymphoma : final results of the EORTC-CLG randomized phase III trial 58951,” HAEMATOLOGICA, vol. 102, no. 10, pp. 1727–1738, 2017.
@article{8549773,
  abstract     = {Asparaginase is an essential component of combination chemotherapy for childhood acute lymphoblastic leukemia and non-Hodgkin lymphoma. The value of asparaginase was further addressed in a group of non-very high-risk patients by comparing prolonged (long-asparaginase) versus standard (short-asparaginase) native E. coli asparaginase treatment in a randomized part of the phase III 58951 trial of the European Organization for Research and Treatment of Cancer Children's Leukemia Group. The main endpoint was disease-free survival. Overall, 1,552 patients were randomly assigned to long-asparaginase (775 patients) or short-asparaginase (777 patients). Patients with grade >= 2 allergy to native E. coli asparaginase were switched to equivalent doses of Erwinia or pegylated E. coli asparaginase. The 8-year disease-free survival rate (+/- standard error) was 87.0 +/- 1.3% in the long-asparaginase group and 84.4 +/- 1.4% in the short-asparaginase group (hazard ratio: 0.87; P=0.33) and the 8-year overall survival rate was 92.6 +/- 1.0% and 91.3 +/- 1.2% respectively (hazard ratio: 0.89; P=0.53). An exploratory analysis suggested that the impact of long-asparaginase was beneficial in the National Cancer Institute standard-risk group with regards to disease-free survival (hazard ratio: 0.70; P=0.057), but far less so with regards to overall survival (hazard ratio: 0.89). The incidences of grade 3-4 infection during consolidation (25.2% versus 14.4%) and late intensification (22.6% versus 15.9%) and the incidence of grade 2-4 allergy were higher in the long-asparaginase arm (30% versus 21%). Prolonged native E. coli asparaginase therapy in consolidation and late intensification for our non-very high-risk patients did not improve overall outcome but led to an increase in infections and allergy.},
  author       = {Mondelaers, Veerle and Suciu, Stefan and De Moerloose, Barbara and Ferster, Alina and Mazingue, Francoise and Plat, Geneviève and Yakouben, Karima and Uyttebroeck, Anne and Lutz, Patrick and Costa, Vitor and Sirvent, Nicolas and Plouvier, Emmanuel and Munzer, Martine and Poirée, Maryline and Minckes, Odile and Millot, Frédéric and Plantaz, Dominique and Maes, Philip and Hoyoux, Claire and Cavé, Hélène and Rohrlich, Pierre and Bertrand, Yves and Benoit, Yves},
  issn         = {0390-6078},
  journal      = {HAEMATOLOGICA},
  keywords     = {MINIMAL RESIDUAL DISEASE,ERWINIA-ASPARAGINASE,INDUCTION THERAPY,ONCOLOGY-GROUP,CHILDREN,DEXAMETHASONE,RISK,REDUCTION,EXPOSURE,CANCER},
  language     = {eng},
  number       = {10},
  pages        = {1727--1738},
  title        = {Prolonged versus standard native E-coli asparaginase therapy in childhood acute lymphoblastic leukemia and non-Hodgkin lymphoma : final results of the EORTC-CLG randomized phase III trial 58951},
  url          = {http://dx.doi.org/10.3324/haematol.2017.165845},
  volume       = {102},
  year         = {2017},
}

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