Treatment intensity and outcome for children with acute lymphocytic leukemia of standard risk. A pediatric oncology group study

Four hundred thirty‐four children, with good‐risk acute lymphocytic leukemia (ALL), were assigned randomly to receive intensive or less intensive maintenance therapy with 6‐mercaptopurine and methotrexate, plus vincristine and prednisone pulses in such a way that patients on treatment 1 had their leukocyte counts maintained between 1500 and 3000/mm3. Patients on treatment 2 had leukocyte counts maintained between 3000 and 4500/mm3. Absolute granulocyte counts were maintained above 500/mm3 on both groups. All children received induction treatment with vincristine, prednisone and L‐asparaginase and had central nervous system (CNS) prophylaxis with cranial irradiation and intrathecal methotrexate. The overall remission rate was 94%. Event‐free survival at 8 years was 44% (SE, 5.6%). There was no significant difference in outcome between treatments 1 and 2 (P = 0.83). The incidence of infection was similar overall and not significantly different between treatment arms.

[1]  D. Pinkel.  General motors cancer research foundation prizes Charles F. Kettering prize curing children of leukemia , 1987 .

[2]  M. Cooper,et al.  Pediatric Oncology Group Utilization of Immunologic Markers in the Designation of Acute Lymphocytic Leukemia Subgroups: Influence on Treatment Response a , 1984, Annals of the New York Academy of Sciences.

[3]  J. Pullen,et al.  Comparison of prednisolone, vincristine, methotrexate and 6‐mercaptopurine vs. 6‐mercaptopurine and prednisone maintenance therapy in childhood acute leukemia: A southwest oncology group study , 1980, Cancer.

[4]  Alan Agresti,et al.  Exact conditional tests for cross-classifications: Approximation of attained significance levels , 1979 .

[5]  M. Pike,et al.  Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. analysis and examples. , 1977, British Journal of Cancer.

[6]  J. Simone.  FACTORS THAT INFLUENCE HAEMATOLOGICAL REMISSION DURATION IN ACUTE LYMPHOCYTIC LEUKAEMIA , 1976, British journal of haematology.

[7]  R. Aur,et al.  Intensity of immunosuppressive therapy and the incidence of pneumocystis carinii pneumonitis , 1975 .

[8]  E. Kaplan,et al.  Nonparametric Estimation from Incomplete Observations , 1958 .

[9]  J. Shuster,et al.  Effect of trimethoprim/sulfamethoxazole prophylaxis on outcome of childhood lymphocytic leukemia a pediatric oncology group study , 1987, Cancer.

[10]  Walker,et al.  Chromosomal abnormalities identify high-risk and low-risk patients with acute lymphoblastic leukemia. , 1986, Blood.

[11]  M H Gail,et al.  Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation. , 1981, Journal of chronic diseases.