Results of the first randomized multicentre trial on childhood acute lymphoblastic leukaemia in Russia

Leukemia

Volumn 22, Issue 6, 2008, Pages 1144-1153

  Karachunskiy, A ^a   Herold, R ^b   von Stackelberg, A ^b   Miakova, N ^a   Timakow, A ^c   Mahortih, T ^c   Bajdun, L ^a   Maschan, A ^a   Fechina, L ^d   Shamardina, A ^e   Dudkin, S ^f   Lebedev, V ^g   Varfolomeeva, S ^h   Timofeeva, V ⁱ   Roumiantseva, J ^a   Chipsanova, N ^j   Rumjanzew, A ^a   Henze, G ^b  

^a Federal Clinical Research Center for Paediatric Haematology Oncology and Immunology   (Russian Federation)

^b CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^c Morozov Children's Hospital   (Russian Federation)

^d Regional Children's Hospital   (Russian Federation)

^e Regional Children's Hospital   (Russian Federation)

^f Regional Children's Hospital   (Russian Federation)

^g Regional Children's Hospital   (Russian Federation)

^h Regional Oncological Hospital   (Russian Federation)

ⁱ Regional Children's Hospital   (Russian Federation)

^j Department of Paediatric Oncology/Haematology   (Russian Federation)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTHRACYCLINE; ASPARAGINASE; CYCLOPHOSPHAMIDE; CYTARABINE; DAUNORUBICIN; DEXAMETHASONE; DOXORUBICIN; FOLINIC ACID; MERCAPTOPURINE; METHOTREXATE; PREDNISONE; TIOGUANINE; VINCRISTINE;

ACUTE HEMORRHAGIC PANCREATITIS; ACUTE LYMPHOBLASTIC LEUKEMIA; ADOLESCENT; ADRENAL INSUFFICIENCY; ADULT; AGRANULOCYTOSIS; ANEMIA; ARTICLE; BLEEDING; BONE MARROW APLASIA; BRAIN DISEASE; CANCER COMBINATION CHEMOTHERAPY; CANCER RADIOTHERAPY; CANCER REGISTRY; CANCER SURVIVAL; CATHETER COMPLICATION; CENTRAL NERVOUS SYSTEM DISEASE; CHICKENPOX; CHILD; CHILDHOOD LEUKEMIA; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSE REDUCTION; DRUG MEGADOSE; DRUG RESPONSE; FEASIBILITY STUDY; FEMALE; FOLLOW UP; HIGH RISK PATIENT; HUMAN; LENGTH OF STAY; LEUKOCYTOSIS; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NECROTIZING ENTEROCOLITIS; OVERALL SURVIVAL; PNEUMONIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RUSSIAN FEDERATION; SEPSIS; SURVIVAL RATE; THROMBOCYTOPENIA; TREATMENT INDICATION;

EID: 45149090106     PISSN: 08876924     EISSN: 14765551     Source Type: Journal    
DOI: 10.1038/leu.2008.63     Document Type: Article

References (41)

1. Alekseev N, Vorontsov I. Leukaemias in children. Leningrad 1988.
2. Kisliak NS, Makhonova LA, Koshel' IV, Kurmashov VI, Maiakova SA, Rumiantsev AG et al. Late (after 5-year remission) recurrences of acute leukemia in children (a cooperative study). Gematol Transfuziol 1989; 34: 8-12.
3. Rumiantsev AG, Samochatova EV, Khamdan T. Treatment of acute lymphoblastic leukemia in children according to the Berlin-Frankfurt-Münster Program. Pediatriia 1991; 11: 58-63.
4. Rumiantsev AG, Samochatova EV, Maschan AA, Kryzhanovskii OI. Supportive care in the treatment of childhood acute lymphoblastic leukemia according to BFM programme. Pediatriia 1992; 2: 68-73.
5. Henze G, Langermann HJ, Brämswig J, Breu H, Gadner H, Schellong G et al. Ergebnisse der Studie BFM 76/79 zur Behandlung der akuten lymphoblastischen Leukämie bei Kindern und Jugendlichen. Klin Pädiatrie 1981; 193: 145-154.
6. Riehm H, Gadner H, Henze G, Kornhuber B, Lampert F, Niethammer D et al. Results and significance of six randomized trials in four consecutive ALL-BFM studies. Haematol Blood Transfus 1990; 33 439-458.
7. Reiter A, Schrappe M, Ludwig WD, Lampert F, Harbott J, Henze G et al Favorable outcome of B-cell acute lymphoblastic leukemia in childhood: A report of three consecutive studies of the BFM group. Blood 1992; 80: 2471-2478.
8. Reiter A, Schrappe M. Ludwig WD, Hiddemann W, Sauter S, Henze G et al Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients. Results and conclusions of the multicenter triat ALL-BFM 86. Blood 1994; 84: 3122-3133.
9. Veerman AJ, Hahlen K, Kamps WA, van Leeuwen EF, de Vaan GA, Vanwering ER et al. Dutch childhood leukemia study group: Early results of study ALL VI (1984-1988). Haematol Blood Transfus 1990; 33: 473-477.
10. Veermann A, Hählen K, Kamps W, van Leeuwen E, de Vaan G, Solbu G et al. High cure rate with a moderately intensive treatment regimen in non-high-risk childhood acute lymphoblastic leukemia: Results of protocol ALL-VI from the Dutch Leukemia Study Group. J Clin Oncol 1996; 14: 911-918.
11. Clavell LA, Gelber RD, Cohen HJ, Hitchcock-Bryan S, Cassady JR, Tarbell NJ et al. Four-agent induction and intensive asparaginase therapy for childhood acute lymphoblastic leukemia. N Engl J Med 1986; 315: 657-663.
12. Barr RD, DeVeber LL, Pai KM, Andrew M, Halton J, Cairney AE et al. Management of children with acute lymphoblastic leukemia by the Dana-Farber cancer institute protocols. Am J Pediatr Hem Onc 1992; 14: 136-139.
13. Schorin MA, Blattner S, Gelber RD, Tarbell NJ, Donnelly M, Dalton V et al. Treatment of childhood acute lymphoblastic leukemia: Results of Dana-Farber institute/children's hospital acute lymphoblastic leukemia consortium protocol 85-01. J Clin Oncol 1994; 12: 740-747.
14. Karachunskiy A, Stackelberg A, Miakova N. Comparative treatment results of childhood acute lymphoblastic leukemia according to protocols ALL-BFM 90 and ALL-MB 91. Pediatriia 1995; 2: 10-16.
15. von Stackelberg A, Karatchunsky A, Kudrjashova J, Miakova N, Belikova L, Rumiantzev A et al. Toxicity, supportive care and costs of two chemotherapy protocols for treatment of childhood all in Russia: BFM 90m and MB 91. Eur J Cancer 1999; 35: 1349-1355.
16. Bene MC, Castoldi G, Knapp W, Ludwig WD, Matutes E, Orfao A et al. Proposals for the immunological classification of acute leukemias. European Group for the Immunological Characterization of Leukemias (EGIL). Leukemia 1995; 9: 1783-1786.
17. Uckun FM, Sensel MG, Sun L, Steinherz PG, Trigg ME, Heerema NA et al Biology and treatment of childhood T-lineage acute lymphoblastic leukemia. Blood 1998; 91: 735-746.
18. Langermann HJ, Henze G, Wulf M, Riehm H. Estimation of tumor cell mass in childhood acute lymphoblastic leukemia: Prognostic significance and practical application. Klin Pädiatr 1992; 194: 209-213.
19. Bostrom BC, Sensel MR, Sather HN, Gaynon PS, La MK, Johnston K, et al., Children's Cancer Group. Dexamethasone versus prednisone and daily oral versus weekly intravenous mercaptopurine for patients with standard-risk acute lymphoblastic leukemia: A report from the Children's Cancer Group. Blood 2003; 101: 3809-3817.
20. Schrappe M, Reiter A, Ludwig WD, Harbott J, Zimmermann M, Hiddemann W et al. Improved outcome in childhood acute lymphoblastic leukemia despite reduced use of anthracyclines and cranial radiotherapy. Blood 2000; 95: 3310-3322.
21. Machin D, Gardner MJ. Calculating confidence intervals for survival time analyses. Br Med J 1988; 296: 1369-1371.
22. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJW. Reporting of noninferiority and equivalence randomized trials: An extension of the CONSORT statement. JAMA 2006; 295: 1152-1160.
23. Kaplan EL, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958; 53: 457-481.
24. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 1966; 50: 163-170.
25. Kalbfleisch J, Prentice R. The Statistical Analysis of Failure Time Data. Wiley: New York (NY), 1980.
26. Gray B. cmprsk: Subdistribution analysis of competing risks (resource on the Internet). R package version 2.1-7 [cited 2007 Oct 12]. Available from: http://www.r-project.org http://biowww.dfci.harvard.edu/~gray.
27. Gray RJ. A class of k-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1988; 16: 1141-1154.
28. Harrell Jr FE and with contributions from many other users [resource on the Internet] Hmisc: Harrell miscellaneous (cited 2007 Oct 12). Available from: http://biostat.mc.vanderbilt.edu/s/Hmisc.
29. Smith M, Arthur D, Camitta B, Carroll AJ, Crist W, Gaynon P et al. Uniform approach to risk classification and treatment assignment for children with acute lymphoblastic leukaemia. J Clin Oncol 1996; 14: 18-24.
30. Jones B, Freeman AI, Shuster JJ, Jacquillat C, Weil M, Pochedly C et al. Lower incidence of meningeal leukemia when prednisolone is replaced by dexamethasone in the treatment of acute lymphoblastic leukemia. Med Pediatr Oncol 1991; 19: 269-275.
31. Balis FM, Lester CM, Chrousos GP, Heideman RL, Poplack DG. Differences in cerebrospinal fluid penetration of corticosteroids: Possible relationship to the prevention of meningeal leukemia. J Clin Oncol 1987; 5: 202-207.
32. Balis FM, Poplack D. Central nervous system pharmacology of antileukemic drugs. Am J Pediatr Hemtol Oncol 1989; 11: 74-86.
33. Nesbit M, Chard R, Evans A, Karon M, Hammond GD. Evaluation of intramuscular versus intravenous administration of L-asparaginase in childhood leukemia. Am J Pediatr Haematol Oncol 1979; 1: 9-13.
34. Kamps WA, Bökkerink JP, Hahlen K, Hermans J, Riehm H, Gadner H et al. Intensive treatment of children with acute lymphoblastic leukemia according to ALL-BFM 86 without cranial radiotherapy: Results of DCLSG protocol ALL-7 (1988-1991). Blood 1999; 94: 1226-1236.
35. Bleyer WA, Coccia PF, Sather HN, Level C, Lukens J, Niebrugge DJ et al. Reduction of central nervous system leukemia with a pharmacokinetically derived intrathecal methotrexate dosage regimen. J Clin Oncol 1983; 1: 317-325.
36. Clarke M, Gaynon P, Hann I, Harrison G, Masera G, Peto R, et al., Childhood ALL Collaborative Group. CNS-directed therapy for childhood acute lymphoblastic leukemia: Childhood ALL collaborative group overview of 43 randomized trials. J Clin Oncol 2003; 21: 1798-1809.
37. Chessells JM, Hall E, Prentice HG, Durrant J, Bailey CC, Richards SM. The impact of age on outcome in lymphoblastic leukaemia; MIRC UKALL X and XA compared: A report from the MRC Paediatric and Adult Working Parties. Leukemia 1998; 12: 463-473.
38. Rumiantsev AG, Samachatova EV, Karachunsky AI. Intensive chemotherapy of acute leukaemias (AL) in childhood with BFM protocols and Moscow experiences 1990-1992. First successes and failures. In: Büchner et al. (eds). Acute Leukemias IV. Prognostic Factors. Springer: Berlin, 1993, pp 344-346.
39. Samochatova EV, Aslanyan KS, Belikova L. The retrospective analysis of the treatment results of childhood acute lymphoblastic leukemia according to modified BFM protocol in the 9 Russian clinics (1991-1996). Pediatriia 1997; 4: 34-37.
40. Miakova NV, Aleinikova OV, Hartmann R, Rudneva AE, Trubina NM, Fechina LG et al. Treatment of acute lymphoblastic leukemia in children according to the ALL-BFM 90m protocol in the Russian Federation and the Republic of Belarus. Vopr Onkol 2002; 48: 347-351.
41. Schrappe M, Reiter A, Zimmermann M, Harbott J, Ludwig WD, Henze G et al. Long-term results of four consecutive trials in childhood ALL performed by the ALL-BFM study group from 1981 to 1995. Berlin-Frankfurt-Münster. Leukemia 2000; 14: 2205-2222.