High-dose compared with intermediate-dose methotrexate in children with a first relapse of acute lymphoblastic leukemia

Blood

Volumn 111, Issue 5, 2008, Pages 2573-2580

  Von Stackelberg, Arend ^a   Hartmann, Reinhard ^a   Bührer, Christoph ^b   Fengler, Rüdiger ^a   Janka Schaub, Gritta ^c   Reiter, Alfred ^d   Mann, Georg ^e   Schmiegelow, Kjeld ^f   Ratei, Richard ^g   Klingebiel, Thomas ^h   Ritter, Jörg ⁱ   Henze, Günter ^a  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b UNIVERSITY CHILDREN S HOSPITAL   (Switzerland)

^c UNIVERSITY OF HAMBURG   (Germany)

^d JUSTUS LIEBIG UNIVERSITY   (Germany)

^e ST ANNA CHILDREN S HOSPITAL   (Austria)

^f Rigshospitalet   (Denmark)

^g Section of Pathology   (Germany)

^h GOETHE UNIVERSITY   (Germany)

ⁱ UNIVERSITY OF MÜNSTER   (Germany)

Author keywords

[No Author keywords available]

Indexed keywords

ASPARAGINASE; CYTARABINE; DEXAMETHASONE; FOLINIC ACID; IFOSFAMIDE; MERCAPTOPURINE; METHOTREXATE; PREDNISONE; TIOGUANINE; VINCRISTINE; VINDESINE; ANTINEOPLASTIC AGENT;

ACUTE LYMPHOBLASTIC LEUKEMIA; ADOLESCENT; ARTICLE; BRAIN RADIATION; CANCER RADIOTHERAPY; CANCER RELAPSE; CHILD; CLINICAL TRIAL; CONTINUOUS INFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG DOSAGE FORM COMPARISON; FEMALE; HUMAN; KAPLAN MEIER METHOD; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; COMPARATIVE STUDY; DOSE RESPONSE; INFANT; LYMPHATIC LEUKEMIA; PRESCHOOL CHILD; RECURRENT DISEASE;

ADOLESCENT; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHILD; CHILD, PRESCHOOL; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; INFANT; KAPLAN-MEIERS ESTIMATE; MALE; METHOTREXATE; PRECURSOR CELL LYMPHOBLASTIC LEUKEMIA-LYMPHOMA; RECURRENCE;

EID: 41949122481     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2007-07-102525     Document Type: Article

References (67)

1. Henze G, Fengler R, Hartmann R, et al. Six-year experience with a comprehensive approach to the treatment of recurrent childhood acute lymphoblastic leukemia (ALL-REZ BFM 85): a relapse study of the BFM Group. Blood. 1991;78:1166-1172.
2. Sadowitz PD, Smith SD, Shuster J, et al. Treatment of late bone marrow relapse in children with acute lymphoblastic leukemia: A Pediatric Oncology Group study. Blood. 1993;81:602-609.
3. Bührer C, Hartmann R, Fengler R, et al. Importance of effective central nervous system therapy in isolated bone marrow relapse of childhood acute lymphoblastic leukemia. Blood. 1994;83: 3468-3472.
4. Buhrer C, Hartmann R, Fengler R, et al. Peripheral blast counts at diagnosis of late isolated bone marrow relapse of childhood acute lymphoblastic leukemia predict response to salvage chemotherapy and outcome. J Clin Oncol. 1996;14:2812-2817.
5. Einsiedel HG, von Stackelberg A, Hartmann R, et al. Long-term outcome in children with relapsed ALL by risk-stratified salvage therapy: results of trial acute lymphoblastic leukemia-relapse study of the Berlin-Frankfurt-Munster Group 87. J Clin Oncol. 2005;23:7942-7950.
6. Buchanan GR, Rivera GK, Pollock BH, et al. Alternating drug pairs with or without periodic rein- duction in children with acute lymphoblastic leukemia in second bone marrow remission: A Pediatric Oncology Group study. Cancer. 2000; 88:1166-1174.
7. Rivera GK, Hudson MM, Liu Q, et al. Effectiveness of intensified rotational combination chemotherapy for late hematologic relapse of childhood acute lympho- blastic leukemia. Blood. 1996;88:831-837.
8. Henze G, Fengler R, Hartmann R. Chemotherapy for relapsed childhood acute lymphoblastic leukemia: results of the BFM Study Group. Haematol Blood Transfus. 1994;36:374-379.
9. Giona F, Testi AM, Rondelli R, et al. ALL R-87 protocol in the treatment of children with acute lymphoblastic leukaemia in early bone marrow relapse. Br J Haematol. 1997;99:671-677.
10. Buhrer C, Henze G, Hofmann J, et al. Central nervous system relapse prevention in 1165 standard-risk children with acute lymphoblastic leukemia in five BFM trials. Haematol Blood Transfus. 1990;33:500-503.
11. Ritchey AK, Pollock BH, Lauer SJ, et al. Improved survival of children with isolated CNS relapse of acute lymphoblastic leukemia: a pediatric oncology group study. J Clin Oncol. 1999;17:3745-3752.
12. Lawson SE, Harrison G, Richards S, et al. The UK experience in treating relapsed childhood acute lymphoblastic leukaemia: a report on the Medical Research Council UKALLR1 study. Br J Haematol. 2000;108:531-543.
13. Wofford MM, Smith SD, Shuster JJ, et al. Treatment of occult or late overt testicular relapse in children with acute lymphoblastic leukemia: APe- diatric Oncology Group study. J Clin Oncol. 1992; 10:624-630.
14. Wolfrom C, Hartmann R, Bruhmuller S, et al. Similar outcome on boys with isolated and combined testicular acute lymphoblastic leukemia relapse after stratified BFM salvage therapy. Haematol Blood Transfus. 1997;38:647-651.
15. Grundy RG, Leiper AD, Stanhope R, et al. Survival and endocrine outcome after testicular relapse in acute lymphoblastic leukaemia. Arch Dis Child. 1997;76:190-196.
16. Gaynon PS, Qu RP, Chappell RJ, et al. Survival after relapse in childhood acute lymphoblastic leukemia: impact of site and time to first relapse: the Children's Cancer Group Experience. Cancer. 1998;82:1387-1395.
17. Barrett AJ, Horowitz MM, Pollock BH, et al. Bone marrow transplants from HLA-identical siblings as compared with chemotherapy for children with acute lymphoblastic leukemia in a second remission. N Engl J Med. 1994;331:1253-1258.
18. Dopfer R, Henze G, Bender-Gotze C, et al. Allogeneic bone marrow transplantation for childhood acute lymphoblastic leukemia in second remission after intensive primary and relapse therapy according to the BFM- and CoALL-protocols: results of the German Cooperative Study. Blood. 1991;78:2780-2784.
19. Borgmann A, von Stackelberg A, Hartmann R, et al. Unrelated donor stem cell transplantation compared with chemotherapy for children with acute lymphoblastic leukemia in a second remission: a matched- pair analysis. Blood. 2003;101:3835-3839.
20. Wheeler K, Richards S, Bailey C, et al. Comparison of bone marrow transplant and chemotherapy for relapsed childhood acute lymphoblastic leukaemia: The MRCUKALLX experience: Medical Research Council Working Partyon Childhood Leukaemia. Br J Haematol. 1998;101:94-103.
21. Masson E, Relling MV, Synold TW, et al. Accumulation of methotrexate polyglutamates in lymphoblasts is a determinant of antileukemic effects in vivo: a rationale for high-dose methotrexate. J Clin Invest. 1996;97:73-80.
22. Clarke M, Gaynon P, Hann I, et al. CNS-directed therapy for childhood acute lymphoblastic leukemia: Childhood ALL Collaborative Group overview of 43 randomized trials. J Clin Oncol. 2003;21:1798-1809.
23. Brecher ML, Weinberg V, Boyett JM, et al. Intermediate dose methotrexate in childhood acute lymphoblastic leukemia resulting in decreased incidence of testicular relapse. Cancer. 1986;58: 1024-1028.
24. Niemeyer CM, Gelber RD, Tarbell NJ, et al. Low- dose versus high-dose methotrexate during remission induction in childhood acute lymphoblastic leukemia (Protocol 81-01 update). Blood. 1991;78:2514-2519.
25. Chessells JM, Bailey C, Richards SM. Intensification of treatment and survival in all children with lymphoblastic leukaemia: results of UK Medical Research Council trial UKALLX: Medical Research Council Working Partyon Childhood Leukaemia. Lancet. 1995;345:143-148.
26. Veerman AJ, Hahlen K, Kamps WA, 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 Childhood Leukemia Study Group. J Clin Oncol. 1996;14:911-918.
27. Pui CH, Simone JV, Hancock ML, et al. Impact of three methods of treatment intensification on acute lymphoblastic leukemia in children: long- term results of St Jude total therapy study X. Leukemia. 1992;6:150-157.
28. Lange BJ, Blatt J, Sather HN, Meadows AT. Randomized comparison of moderate-dose methotrexate infusions to oral methotrexate in children with intermediate risk acute lymphoblastic leukemia: a Childrens Cancer Group study. Med Pediatr Oncol. 1996;27:15-20.
29. Wolfrom C, Hartmann R, Fengler R, et al. Randomized comparison of 36-hour intermediate- dose versus 4-hour high-dose methotrexate infusions for remission induction in relapsed childhood acute lymphoblastic leukemia. J Clin Oncol. 1993;11:827-833.
30. Ochs J, Mulhern R, Fairclough D, et al. Comparison of neuropsychologic functioning and clinical indicators of neurotoxicity in long-term survivors of childhood leukemia given cranial radiation or parenteral methotrexate: a prospective study. J Clin Oncol. 1991;9:145-151.
31. Waber DP, Tarbell NJ, Kahn CM, et al. The relationship of sex and treatment modality to neuropsychologic outcome in childhood acute lymphoblastic leukemia. J Clin Oncol. 1992;10:810-817.
32. Waber DP, Tarbell NJ, Fairclough D, et al. Cognitive sequelae of treatment in childhood acute lymphoblastic leukemia: cranial radiation requires an accomplice. J Clin Oncol. 1995;13:2490-2496.
33. Bene MC, Castoldi G, Knapp W, et al. Proposals for the immunological classification of acute leukemias: European Group for the Immunological Characterization of Leukemias (EGIL). Leukemia. 1995;9:1783-1786.
34. Beyermann B, Agthe AG, Adams HP, et al. Clinical features and outcome of children with first marrow relapse of acute lymphoblastic leukemia expressing BCR-ABL fusion transcripts: BFM Relapse Study Group. Blood. 1996;87:1532-1538.
35. Schrappe M, Reiter A, Zimmermann M, 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- Munster. Leukemia. 2000;14:2205-2222.
36. Harms DO, Janka-Schaub GE. Co-operative study group for childhood acute lymphoblastic leukemia (COALL): long-term follow-up of trials 82, 85, 89 and 92. Leukemia. 2000;14:2234-2239.
37. Allegra CJ, Drake JC, Jolivet J, et al. Inhibition of phosphoribosylaminoimidazolecarboxamide transformylase by methotrexate and dihydrofolic acid polyglutamates. Proc Natl Acad Sci USA. 1985;82:4881-4885.
38. Allegra CJ, Chabner BA, Drake JC, et al. Enhanced inhibition of thymidylate synthase by methotrexate polyglutamates. J Biol Chem. 1985;260:9720-9726.
39. Spinella MJ, Brigle KE, Sierra EE, et al. Distinguishing between folate receptor-alpha-mediated transport and reduced folate carrier-mediated transport in L1210 leukemia cells. J Biol Chem. 1995;270:7842-7849.
40. Whitehead VM, Vuchich MJ, Lauer SJ, et al. Accumulation of high levels of methotrexate polyglutamates in lymphoblasts from children with hyper- diploid (greater than 50 chromosomes) B-lineage acute lymphoblastic leukemia: a Pediatric Oncology Group study. Blood. 1992;80:1316-1323.
41. Barrueco JR, O'Leary DF, Sirotnak FM. Metabolic turnover of methotrexate polyglutamates in lysosomes derived from S180 cells: definition of a two-step process limited by mediated lysosomal permeation of polyglutamates and activating reduced sulfhydryl compounds. J Biol Chem. 1992; 267:15356-15361.
42. Gorlick R, Goker E, Trippett T, et al. Defective transport is a common mechanism of acquired methotrexate resistance in acute lymphocytic leukemia and is associated with decreased reduced folate carrier expression. Blood. 1997;89:1013-1018.
43. Goker E, Waltham M, Kheradpour A, et al. Amplification of the dihydrofolate reductase gene is a mechanism of acquired resistance to methotrexate in patients with acute lymphoblastic leukemia and is correlated with p53 gene mutations. Blood. 1995;86:677-684.
44. Matherly LH, Taub JW, Wong SC, et al. Increased frequency of expression of elevated dihydrofolate reductase in T-cell versus B-precursor acute lymphoblastic leukemia in children. Blood. 1997;90: 578-589.
45. Pizzorno G, Mini E, Coronnello M, et al. Impaired polyglutamylation of methotrexate as a cause of resistance in CCRF-CEM cells after short-term, high-dose treatment with this drug. Cancer Res. 1988;48:2149-2155.
46. Rots MG, Pieters R, Peters GJ, et al. Role of folylpolyglutamate synthetase and folylpolyglutamate hydrolase in methotrexate accumulation and polyglutamylation in childhood leukemia. Blood. 1999;93:1677-1683.
47. Rots MG, Pieters R, Peters GJ, et al. Methotrex- ate resistance in relapsed childhood acute lym- phoblastic leukaemia. Br J Haematol. 2000;109: 629-634.
48. Klumper E, Pieters R, Veerman AJ, et al. In vitro cellular drug resistance in children with relapsed/ refractory acute lymphoblastic leukemia. Blood. 1995;86:3861-3868.
49. Weigand M, Frei E, Graf N, et al. Mechanisms of resistance to methotrexate in childhood acute lymphoblastic leukemia: circumvention of thymidylate synthase inhibition. J Cancer Res Clin Oncol. 1999;125:513-519.
50. Skarby TV, Anderson H, Heldrup J, et al. High leucovorin doses during high-dose methotrexate treatment may reduce the cure rate in childhood acute lymphoblastic leukemia. Leukemia. 2006; 20:1955-1962.
51. Goldie JH, Price LA, Harrap KR. Methotrexate toxicity: correlation with duration of administration, plasma levels, dose and excretion pattern. Eur J Cancer. 1972;8:409-414.
52. Nathan PC, Whitcomb T, Wolters PL, et al. Very high-dose methotrexate (33.6 g/m(2)) as central nervous system preventive therapy for childhood acute lymphoblastic leukemia: results of National Cancer Institute/Children's Cancer Group trials CCG-191P, CCG-134P and CCG-144P. Leuk Lymphoma. 2006;47:2488-504.
53. Brenner T, Evans W. Rationale for high-dose methotrexate in childhood acute lymphoblastic leukemia. In: Pui CH, ed. Treatment of Acute Leu- kemias New Directions for Clinical Research. Totowa, NJ: Humana Press; 2002:339-356.
54. Shapiro WR, Young DF, Mehta BM. Methotrexate: distribution in cerebrospinal fluid after intravenous, ventricular and lumbar injections. N Engl J Med. 1975;293:161-166.
55. Evans WE, Crom WR, Abromowitch M, et al. Clinical pharmacodynamics of high-dose metho- trexate in acute lymphocytic leukemia: identification of a relation between concentration and effect. N Engl J Med. 1986;314:471-477.
56. Rots MG, Pieters R, Peters GJ, et al. Circumvention of methotrexate resistance in childhood leukemia subtypes by rationally designed antifolates. Blood. 1999;94:3121-3128.
57. Pui CH, Relling MV, Sandlund JT, et al. Rationale and design of Total Therapy Study XV for newly diagnosed childhood acute lymphoblastic leukemia. Ann Hematol. 2004;83(suppl 1):S124-S126.
58. Relling MV, Fairclough D, Ayers D, et al. Patient characteristics associated with high-risk metho- trexate concentrations and toxicity. J Clin Oncol. 1994;12:1667-1672.
59. Widemann BC, Balis FM, Murphy RF, et al. Carboxypeptidase-G2, thymidine, and leucovorin rescue in cancer patients with methotrexate- induced renal dysfunction. J Clin Oncol. 1997;15:2125-2134.
60. Buchen S, Ngampolo D, Melton RG, et al. Carboxypeptidase G2 rescue in patients with methotrexate intoxication and renal failure. Br J Cancer. 2005;92:480-487.
61. Rubnitz JE, Relling MV, Harrison PL, et al. Transient encephalopathy following high-dose methotrexate treatment in childhood acute lymphoblastic leukemia. Leukemia. 1998;12:1176-1181.
62. Spiegler BJ, Kennedy K, Maze R, et al. Comparison of long-term neurocognitive outcomes in young children with acute lymphoblastic leukemia treated with cranial radiation or high-dose or very high-dose intravenous methotrexate. J Clin Oncol. 2006;24:3858-3864.
63. ReddickWE, Glass JO, Helton KJ,et al. Prevalence of leukoencephalopathy in children treated for acute lymphoblastic leukemia with high-dose methotrexate. Am J Neuroradiol. 2005;26:1263-1269.
64. Schroeder H, Garwicz S, Kristinsson J, et al. Outcome after first relapse in children with acute lymphoblastic leukemia: a population-based study of 315 patients from the Nordic Society of Pediatric Hematology and Oncology (NOPHO). Med Pediatr Oncol. 1995;25:372-378.
65. Eckert C, Biondi A, Seeger K, et al. Prognostic value of minimal residual disease in relapsed childhood acute lymphoblastic leukaemia. Lancet. 2001;358:1239-1241.
66. Henze G, von Stackelberg A. Treatment of relapsed acute lymphoblastic leukemia. In: Pui CH, ed. Treatment of Acute Leukemias New Directions for Clinical Research. Totowa, NJ: Humana Press; 2002:199-219.
67. Nachman JB, Sather HN, Sensel MG, et al. Augmented post-induction therapy for children with high-risk acute lymphoblastic leukemia and a slow response to initial therapy. N Engl J Med. 1998;338:1663-1671.