Reduced vs. standard dose native E. coli-asparaginase therapy in childhood acute lymphoblastic leukemia: long-term results of the randomized trial Moscow–Berlin 2002

Autor: Alexander Karelin, Julia Abugova, G.A. Novichkova, Gusel Scharapova, Konstantin Kondratchik, Arend von Stackelberg, Alexander Karachunskiy, Lebedev Vv, Natalia Judina, Oleg Bydanov, N.V. Myakova, T. V. Nasedkina, Natalia Korepanova, Julia Roumiantseva, Almira Chervova, Dmitry Litvinov, Sergei O. Kuznetsov, Natalia Ponomareva, Olga V. Ryskal, O. R. Arakaev, Svetlana Lagoiko, Lyudmila Bajdun, Irina Spichak, Joachim Boos, Alexander Rumjanzew, Günter Henze, Larisa Fechina, Gesche Tallen, Evgeniya Inyushkina, Marina Goroshkova, Alexander Shapochnik, Shamardina Av, Olga V. Aleinikova
Jazyk: angličtina
Rok vydání: 2019
Předmět:
0301 basic medicine
Male
Cancer Research
Original Article – Clinical Oncology
Acute lymphoblastic leukemia
law.invention
chemistry.chemical_compound
0302 clinical medicine
Randomized controlled trial
law
Antineoplastic Combined Chemotherapy Protocols
Medicine
Cumulative incidence
Child
Children
Hematology
Mercaptopurine
Escherichia coli Proteins
Cytarabine
General Medicine
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Oncology
Vincristine
030220 oncology & carcinogenesis
Child
Preschool
Toxicity
Female
Asparaginase
medicine.medical_specialty
Methylprednisolone
Disease-Free Survival
03 medical and health sciences
Multicenter trial
Internal medicine
Escherichia coli
Native Escherichia coli-derived asparaginase
Humans
Childhood Acute Lymphoblastic Leukemia
Dose-Response Relationship
Drug
business.industry
Daunorubicin
Infant
Consolidation Chemotherapy
Regimen
030104 developmental biology
Methotrexate
chemistry
Prednisone
business
Zdroj: Journal of Cancer Research and Clinical Oncology
ISSN: 1432-1335
0171-5216
Popis: 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. Electronic supplementary material The online version of this article (10.1007/s00432-019-02854-x) contains supplementary material, which is available to authorized users.
Databáze: OpenAIRE
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