Optimization of native E. coli-asparaginase therapy in standard risk-group children with acute lymphoblastic leukemia treated by the ALL-MB 2002 protocol
- Authors: Goroshkova M.Y.1, Rumyantseva Y.V.2, Aleinikova O.V.3, Dudkin S.A.1, Fechina L.G.4, Shamardina A.V.5, Streneva O.V.4, Kondratchik K.L.6, Minkina L.M.7, Lapotentova E.S.3, Inyushkina E.V.8, Kozlova O.B.9, Zhukovskaya E.V.10, Khlebnikova O.P.4, Basharova E.V.10, Timofeeva V.N.10, Pavlova G.P.11, Zlobina V.D.9, Utrobina O.A.9, Banshchikova E.S.12, Aslanyan K.S.10, Kondakova E.V.10, Tselousova E.V.13, Myakova N.V.14,15, Turobova T.V.10, Ryskal O.V.10, Fuks O.Y.2,6, Lebedev V.V.10, Chipsanova N.F.16, Varfolomeeva S.R.2, Karachunsky A.I.2
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Affiliations:
- Clinical Children Hospital №4
- Federal Research Centre of Pediatric Hematology, Oncology and Immunology
- Republic Centre for Paediatric Oncology and Haematology
- Regional Centre for Paediatric Oncology and Haematology
- Regional Clinical Children Hospital
- Morozov Children Clinical Hospital
- Clinical Children Hospital
- Moscow District Oncology Dispanser
- Regional Clinical Hospital
- Regional Children Clinical Hospital
- Republic Children Clinical Hospital
- Republic Hospital №1 — National Medicine Centre
- Kirov Research Centre of Hematology and Transfusiology
- Federal Research Centre of Pediatric Hematology
- Russian Children Clinical Hospital
- Regional cardiological dispanser
- Issue: No 3 (2008)
- Pages: 25-33
- Section: HEMATOLOGIC MALIGNANCIES: TREATMENT
- Published: 24.08.2008
- URL: https://oncohematology.abvpress.ru/ongm/article/view/722
- DOI: https://doi.org/10.17650/1818-8346-2008-0-3-25-33
- ID: 722
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Abstract
The paper presents the results of a multicenter randomized study of two-dose COLI-ASP regimens in therapy of consolidation of standard risk-group (SRG) children and adolescents with acute lymphoblastic leukemia (ALL) treated by the ALL-MB-2002 protocol. The principal aim of the study was to elucidate whether the dose of COLI-ASP might be reduced without losing the efficiency of therapy. The analysis covered primary ALL patients notified at 36 clinics of Russia and Belarus, enrolled for the study in the period of May 1, 2002, to October 10, 2006. Out of 819 patients to be examined, 414 received COLI-ASP in a dose of 10,000 U/m2 (a control group), and 405 children took it in a dose of 5,000 U/m2 (a study group). No statistically significant differences were found between the patients in gender, age, baseline leukocytosis, and spleen size. The study showed no statistically and clinically significant differences in event-free, overall, and relapse-free survival (EFS, OS, and RFS, respectively) and relapse rates with the use of two-dose COLI-ASP regimens. However, in the control group, the death rate in remission was twice greater than that in the study group (p = 0.02). Detailed analysis of the outcomes of therapy in some subgroups revealed no differences between the control and study groups. The Cox multiple regression analysis has indicated that the factors influencing EFS and RFS are the baseline sizes of the spleen, baseline leukocytosis, age, and a response to treatment in the period of induction, rather than the dose of E. coli asparaginase. The authors have also found that among the SRG patients, there is a subgroup of patients without risk factors, in whom the reduction in the COLI-ASP dose may substantially increase survival rates, by lowering toxicity and mortality in remission.
Keywords
About the authors
M. Yu. Goroshkova
Clinical Children Hospital №4
Author for correspondence.
Novokuznetsk
Russian FederationYu. V. Rumyantseva
Federal Research Centre of Pediatric Hematology, Oncology and Immunology
Moscow
Russian FederationO. V. Aleinikova
Republic Centre for Paediatric Oncology and Haematology
Minsk
BelarusS. A. Dudkin
Clinical Children Hospital №4
Novokuznetsk
Russian FederationL. G. Fechina
Regional Centre for Paediatric Oncology and Haematology
Yekaterinburg
Russian FederationA. V. Shamardina
Regional Clinical Children Hospital
N. Novgorod
Russian FederationO. V. Streneva
Regional Centre for Paediatric Oncology and Haematology
Yekaterinburg
Russian FederationK. L. Kondratchik
Morozov Children Clinical Hospital
Moscow
Russian FederationL. M. Minkina
Clinical Children Hospital
Vladivostok
Russian FederationE. S. Lapotentova
Republic Centre for Paediatric Oncology and Haematology
Minsk
BelarusE. V. Inyushkina
Moscow District Oncology Dispanser
Balaschicha
Russian FederationO. B. Kozlova
Regional Clinical Hospital
Ivanovo
Russian FederationE. V. Zhukovskaya
Regional Children Clinical Hospital
Chelyabinsk
Russian FederationO. P. Khlebnikova
Regional Centre for Paediatric Oncology and Haematology
Yekaterinburg
Russian FederationE. V. Basharova
Regional Children Clinical Hospital
Chelyabinsk
Russian FederationV. N. Timofeeva
Regional Children Clinical Hospital
Ulyanovsk
Russian FederationG. P. Pavlova
Republic Children Clinical Hospital
Cheboksary
Russian FederationV. D. Zlobina
Regional Clinical Hospital
Novosibirsk
Russian FederationO. A. Utrobina
Regional Clinical Hospital
Novosibirsk
Russian FederationE. S. Banshchikova
Republic Hospital №1 — National Medicine Centre
Yakutsk
Russian FederationK. S. Aslanyan
Regional Children Clinical Hospital
Rostov-on-Don
Russian FederationE. V. Kondakova
Regional Children Clinical Hospital
Surgut
Russian FederationE. V. Tselousova
Kirov Research Centre of Hematology and Transfusiology
Kirov
Russian FederationN. V. Myakova
Federal Research Centre of Pediatric Hematology; Russian Children Clinical Hospital
Moscow
Russian FederationT. V. Turobova
Regional Children Clinical Hospital
Archangelsk
Russian FederationO. V. Ryskal
Regional Children Clinical Hospital
Perm
Russian FederationO. Yu. Fuks
Federal Research Centre of Pediatric Hematology, Oncology and Immunology; Morozov Children Clinical Hospital
Moscow
Russian FederationV. V. Lebedev
Regional Children Clinical Hospital
Krasnodar
Russian FederationN. F. Chipsanova
Regional cardiological dispanser
Syktyvkar
Russian FederationS. R. Varfolomeeva
Federal Research Centre of Pediatric Hematology, Oncology and Immunology
Moscow
Russian FederationA. I. Karachunsky
Federal Research Centre of Pediatric Hematology, Oncology and Immunology
Moscow
Russian FederationReferences
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