Augmented post-induction therapy for children with high-risk acute lymphoblastic leukemia and a slow response to initial therapy

New England Journal of Medicine

Volumn 338, Issue 23, 1998, Pages 1663-1671

  Nachman, James B ^a,c   Sather, Harland N ^b,c   Sensel, Martha G ^c   Trigg, Michael E ^d   Cherlow, Joel M ^e   Lukens, John N ^f   Wolff, Lawrence ^g   Uckun, Fatih M ^h   Gaynon, Paul S ⁱ  

^a UNIVERSITY OF CHICAGO   (United States)

^b UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^c CHILDREN S ONCOLOGY GROUP   (United States)

^d UNIVERSITY OF IOWA HOSPITALS AND CLINICS   (United States)

^e LONG BEACH MEMORIAL MEDICAL CENTER   (United States)

^f VANDERBILT UNIVERSITY   (United States)

^g OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

^h Department of Genetics   (United States)

ⁱ UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT; ASPARAGINASE; CYCLOPHOSPHAMIDE; CYTARABINE; MERCAPTOPURINE; METHOTREXATE; PREDNISONE; TIOGUANINE; VINCRISTINE;

ACUTE LYMPHOBLASTIC LEUKEMIA; ARTICLE; BONE NECROSIS; CANCER CHEMOTHERAPY; CHILD; CHROMOSOME 22; CHROMOSOME TRANSLOCATION 9; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG HYPERSENSITIVITY; FEMALE; HIGH RISK PATIENT; HUMAN; HUMAN CELL; INTRAMUSCULAR DRUG ADMINISTRATION; INTRATHECAL DRUG ADMINISTRATION; INTRAVENOUS DRUG ADMINISTRATION; LEUKEMIA REMISSION; LEUKOCYTE COUNT; LEUKOENCEPHALOPATHY; MAJOR CLINICAL STUDY; MALE; MUCOSA INFLAMMATION; ORAL DRUG ADMINISTRATION; PANCREATITIS; PRACTICE GUIDELINE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEIZURE; SUBCUTANEOUS DRUG ADMINISTRATION; THROMBOSIS; TREATMENT OUTCOME;

ADOLESCENT; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CHILD; CHILD, PRESCHOOL; COMBINED MODALITY THERAPY; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; INFANT; LEUKEMIA, LYMPHOCYTIC, ACUTE, L1; LIFE TABLES; MALE; PROGNOSIS; REMISSION INDUCTION; SURVIVAL ANALYSIS; TIME FACTORS; TREATMENT OUTCOME;

EID: 0032482394     PISSN: 00284793     EISSN: None     Source Type: Journal    
DOI: 10.1056/NEJM199806043382304     Document Type: Article

References (46)

1. Lilleyman JS, Eden OB. United Kingdom Medical Research Council Acute Lymphoblastic Leukaemia (UKALL) Trials I-VIII: clinical features and results of treatment in four groups of children with adverse prognostic features. Med Pediatr Oncol 1986;14:182-6.
2. Hammond D, Sather H, Nesbit M, et al. Analysis of prognostic factors in acute lymphoblastic leukemia. Med Pediatr Oncol 1986;14:124-34.
3. Crist W, Boyett J, Pullen J, van Eys J, Vietti T. Clinical and biologic features predict poor prognosis in acute lymphoid leukemias in children and adolescents: a Pediatric Oncology Group review. Med Pediatr Oncol 1986; 14:135-9.
4. Santana VM, Dodge RK, Crist WM, et al. Presenting features and treatment outcome of adolescents with acute lymphoblastic leukemia. Leukemia 1990;4:87-90.
5. Crist W, Shuster J, Look T, et al. Current results of studies of immunophenotype-, age-and leukocyte-based therapy for children with acute lymphoblastic leukemia: the Pediatric Oncology Group. Leukemia 1992;6: Suppl 2:162-6.
6. Steinherz PG, Siegel SE, Bleyer WA, et al. Lymphomatous presentation of childhood acute lymphoblastic leukemia: a subgroup at high risk of early treatment failure. Cancer 1991;68:751-8.
7. Garand R, Bene MC. Incidence, clinical and laboratory features, and prognostic significance of immunophenotypic subgroups in acute lymphoblastic leukemia: the GEIL experience. Recent Results Cancer Res 1993; 131:283-95.
8. Pullen DJ, Sullivan MP, Falletta JM, et al. Modified LSA2-L2 treatment in 53 children with E-rosette-positive T-cell leukemia: results and prognostic factors (a Pediatric Oncology Group Study). Blood 1982;60:1159-68.
9. Pui CH, Behm FG, Singh B, et al. Heterogeneity of presenting features and their relation to treatment outcome in 120 children with T-cell acute lymphoblastic leukemia. Blood 1990;75:174-9.
10. Pui CH, Frankel LS, Carroll AJ, et al. Clinical characteristics and treatment outcome of childhood acute lymphoblastic leukemia with the t(4;11)(q21;q23): a collaborative study of 40 cases. Blood 1991;77:440-7.
11. Pui CH. Acute leukemias with the t(4;11)(q21;q23). Leuk Lymphoma 1992;7:173-9.
12. Crist WM, Carroll AJ, Shuster JJ, et al. Poor prognosis of children with pre-B acute lymphoblastic leukemia is associated with the t(1;19)(q23;p13): a Pediatric Oncology Group study. Blood 1990;76:117-22.
13. Shikano T, Kaneko Y, Takazawa M, Ueno N, Ohkawa M, Fujimoto T. Balanced and unbalanced 1;19 translocation-associated acute lymphoblastic leukemias. Cancer 1986;58:2239-43.
14. Pui CH, Raimondi SC, Hancock ML, et al. Immunologic, cytogenetic, and clinical characterization of childhood acute lymphoblastic leukemia with the t(1;19)(q23;p13) or its derivative. J Clin Oncol 1994;12:2601-6.
15. Bloomfield CD, Goldman AI, Alimena G, et al. Chromosomal abnormalities identify high-risk and low-risk patients with acute lymphoblastic leukemia. Blood 1986;67:415-20.
16. Raimondi SC. Current status of cytogenetic research in childhood acute lymphoblastic leukemia. Blood 1993;81:2237-51.
17. Reiter A, Schrappe M, Ludwig WD, et al. Chemotherapy in 998 unselected childhood acute lymphoblastic leukemia patients: results and conclusions of the multicenter trial ALL-BFM 86. Blood 1994;84:3122-33.
18. Schrappe M, Reiter A, Sauter S, et al. Konzeption und Zwischenergebnis der Therapiestudie ALL-BFM 90 akuten lymphoblastischen Leukämie bei Kindern und Jugendlichen: Die Bedeutung des initialen therapyieansprechens in Blut und Knochenmark. Klin Padiatr 1994;206: 208-21.
19. Rivera GK, Pinkel D, Simone JV, Hancock ML, Crist WM. Treatment of acute lymphoblastic leukemia: 30 years' experience at St. Jude Children's Research Hospital. N Engl J Med 1993;329:1289-95.
20. Clavell LA, Gelber RD, Cohen HJ, et al. Four-agent induction and intensive asparaginase therapy for treatment of childhood acute lymphoblastic leukemia. N Engl J Med 1986;315:657-63.
21. Gaynon PS, Bleyer WA, Steinherz PG, et al. Modified BFM therapy for children with previously untreated acute lymphoblastic leukemia and unfavorable prognostic features: report of Children's Cancer Study Group Study CCG-193P. Am J Pediatr Hematol Oncol 1988;10:42-50.
22. Steinherz PG, Gaynon P, Miller DR, et al. Improved disease-free survival of children with acute lymphoblastic leukemia at high risk for early relapse with the New York regimen - a new intensive therapy protocol: a report from the Childrens Cancer Study Group. J Clin Oncol 1986;4:744-52.
23. Sallan SE, Camitta BM, Cassady JR, Nathan DG, Frei E III. Intermittent combination chemotherapy with adriamycin for childhood acute lymphoblastic leukemia: clinical results. Blood 1978;51:425-33.
24. Miller DR, Leikin S, Albo V, Sather H, Karon M, Hammond D. Prognostic factors and therapy in acute lymphoblastic leukemia of childhood: CCG-141: a report from Childrens Cancer Study Group. Cancer 1983;51:1041-9.
25. Gajjar A, Ribeiro R, Hancock ML, et al. Persistence of circulating blasts after 1 week of multiagent chemotherapy confers a poor prognosis in childhood acute lymphoblastic leukemia. Blood 1995;86:1292-5.
26. Gaynon PS, Bleyer WA, Steinherz PG, et al. Day 7 marrow response and outcome for children with acute lymphoblastic leukemia and unfavorable presenting features. Med Pediatr Oncol 1990;18:273-9.
27. Steinherz PG, Gaynon PS, Breneman JC, et al. Cytoreduction and prognosis in acute lymphoblastic leukemia - the importance of early marrow response: report from the Childrens Cancer Group. J Clin Oncol 1996;14:389-98.
28. Riehm H, Reiter A, Schrappe M, et al. Die Corticosteroid-abhängige Dezimierung der Leukamiezellzahl im Blut als Prognose faktor bei der akuten lymphoblastischen Leukämie im Kindesalter (Therapiestudie ALL-BMF 83). Klin Padiatr 1987;199:151-60.
29. Schrappe M, Reiter A, Riehm H. Cytoreduction and prognosis in childhood acute lymphoblastic leukemia. J Clin Oncol 1996;14:2403-6.
30. Henze G, Langermann H-J, Brämswig J, et al. Ergebnisse der Studie BFM 76/79 zur Behandlung der akuten lymphoblastischen Leukämie bei Kindern und Jugendlichen. Klin Padiatr 1981;193:145-54.
31. Tubergen D, Gilchrist G, O'Brien RT, et al. Improved outcome with delayed intensification for children with acute lymphoblastic leukemia and intermediate presenting features: a Childrens Cancer Group phase III trial. J Clin Oncol 1993;11:527-37.
32. Pinkerton CR, Mills S, Chessells JM. Modified Capizzi maintenance regimen in children with relapsed acute lymphoblastic leukaemia. Med Pediatr Oncol 1986;14:69-72.
33. Nachman J, Sather HN, Gaynon PS, Lukens JN, Wolff L, Trigg ME. Augmented Berlin-Frankfurt-Munster therapy abrogates the adverse prognostic significance of slow early response to induction chemotherapy for children and adolescents with acute lymphoblastic leukemia and unfavorable presenting features: a report from the Children's Cancer Group. J Clin Oncol 1997;15:2222-30.
34. Uckun F, Reaman G, Steinherz PG, et al. Improved clinical outcome for children with T-lineage acute lymphoblastic leukemia after contemporary chemotherapy: a Children's Cancer Group Study. Leuk Lymphoma 1996;24:57-70.
35. Childhood ALL Collaborative Group. Duration and intensity of maintenance chemotherapy in acute lymphoblastic leukaemia: overview of 42 trials involving 12 000 randomised children. Lancet 1996;347:1783-8.
36. Fleming T, Harrington D, O'Brien P. Designs for group sequential tests. Contemp Clin Trials 1958;53:457-81.
37. Kaplan E, Meier P. Nonparametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
38. Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep 1966;50:163-70.
39. Peto R, Pike MC, Armitage P, et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples. Br J Cancer 1977;35:1-39.
40. Breslow N. Comparison of survival curves. In: Buyse M, Staquet MJ, Sylvester RJ, eds. Cancer clinical trials: methods and practice. Oxford, England: Oxford University Press, 1984:381-406.
41. Idem. Analysis of survival data under the proportional hazards model. Int Stat Rev 1975;43:45-58.
42. Aricò M, Schrappe M, Harbott J, et al. Prednisone good response (PGR) identifies a subset of t(9;22) childhood acute lymphoblastic leukemia (ALL) at lower risk for early leukemia relapse. Blood 1997;90:Suppl 1:560a. abstract.
43. Tubergen DG, Gilchrist GS, O'Brien RT, et al. Prevention of CNS disease in intermediate-risk acute lymphoblastic leukemia: comparison of cranial radiation and intrathecal methotrexate and the importance of systemic therapy: a Childrens Cancer Group report. J Clin Oncol 1993;11: 520-6.
44. Camitta B, Mahoney D, Leventhal B, et al. Intensive intravenous methotrexate and mercaptopurine treatment of higher-risk non-T, non-B acute lymphocytic leukemia: a Pediatric Oncology Group study. J Clin Oncol 1994;12:1383-9.
45. Land VJ, Shuster JJ, Crist WM, et al. Comparison of two schedules of intermediate-dose methotrexate and cytarabine consolidation therapy for childhood B-precursor cell acute lymphoblastic leukemia: a Pediatric Oncology Group study. J Clin Oncol 1994;12:1939-45.
46. Lange B, Sather H, Weetman R, et al. Double delayed intensification improves outcome in moderate risk pediatric acute lymphoblastic leukemia (ALL): a Childrens Cancer Group study, CCG-1891. Blood 1997;90: Suppl 1:559a. abstract.