Reduced vs. standard dose native E. coli-asparaginase therapy in childhood acute lymphoblastic leukemia: long-term results of the randomized trial Moscow–Berlin ... View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-04

AUTHORS

Alexander Karachunskiy, Gesche Tallen, Julia Roumiantseva, Svetlana Lagoiko, Almira Chervova, Arend von Stackelberg, Olga Aleinikova, Oleg Bydanov, Lyudmila Bajdun, Tatiana Nasedkina, Natalia Korepanova, Sergei Kuznetsov, Galina Novichkova, Marina Goroshkova, Dmitry Litvinov, Natalia Myakova, Natalia Ponomareva, Evgeniya Inyushkina, Konstantin Kondratchik, Julia Abugova, Larisa Fechina, Oleg Arakaev, Alexander Karelin, Vladimir Lebedev, Natalia Judina, Gusel Scharapova, Irina Spichak, Anastasia Shamardina, Olga Ryskal, Alexander Shapochnik, Alexander Rumjanzew, Joachim Boos, Günter Henze, for the ALL-MB study group

ABSTRACT

PURPOSE: Favorable outcomes were achieved for children with acute lymphoblastic leukemia (ALL) with the first Russian multicenter trial Moscow-Berlin (ALL-MB) 91. One major component of this regimen included a total of 18 doses of weekly intramuscular (IM) native Escherichia coli-derived asparaginase (E. coli-ASP) at 10000 U/m2 during three consolidation courses. ASP was initially available from Latvia, but had to be purchased from abroad at substantial costs after the collapse of Soviet Union. Therefore, the subsequent trial ALL-MB 2002 aimed at limiting costs to a reasonable extent and also at reducing toxicity by lowering the dose for standard risk (SR-) patients to 5000 U/m2 without jeopardizing efficacy. METHODS: Between April 2002 and November 2006, 774 SR patients were registered in 34 centers across Russia and Belarus, 688 of whom were randomized. In arm ASP-5000 (n = 334), patients received 5000 U/m2 and in arm ASP-10000 (n = 354) 10 000 U/m2 IM. RESULTS: Probabilities of disease-free survival, overall survival and cumulative incidence of relapse at 10 years were comparable: 79 ± 2%, 86 ± 2% and 17.4 ± 2.1% (ASP-5000) vs. 75 ± 2% and 82 ± 2%, and 17.9 ± 2.0% (ASP-10000), while death in complete remission was significantly lower in arm ASP-5000 (2.7% vs. 6.5%; p = 0.029). CONCLUSION: Our findings suggest that weekly 5000 U/m2E. coli-ASP IM during consolidation therapy are equally effective, more cost-efficient and less toxic than 10000 U/m2 for SR patients with childhood ALL. More... »

PAGES

1001-1012

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00432-019-02854-x

DOI

http://dx.doi.org/10.1007/s00432-019-02854-x

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1112584717

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30840197


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