Use of prognostic factors in improving the design and efficiency of clinical trials in childhood leukemia: Children's Cancer Study Group Report.
Prognostic factors are exerting an increasingly apparent and important influence on the results of comparative treatment regimens in childhood leukemia. Since February 1975, 883 previously untreated children with acute lymphocytic leukemia were entered in a protocol designed to evaluate prognostic factors that influence induction rate, remission duration, and survival and to identify subsets of patients with a high risk of early failure. Stratification was based upon the initial wbc count, and standard and more intensive induction and maintenance therapy programs were compared. The combination of older age (> 10 years), high initial wbc counts (greater than or equal to 20 x 10(9)/liter), and low serum IgG is associated with a significantly lower rate of induction of complete remission. The following factors were associated with an unfavorable prognosis with regard to bone marrow relapse and death: wbc count of greater than or equal to 20 x 10(9)/liter; age > 7 years old; CNS disease at diagnosis; L2 lymphoblasts; hemoglobin level greater than or equal to 11 g/dl; decreased concentration of serum immunoglobulin; and M3 marrow on Day 14 of induction. None of the 41 patients in the low-risk prognostic group (3-7 years old with an initial wbc count of < 10 x 10(9)/liter) with L1 blast cells, normal Ig, and M1 marrow on Day 14 has sustained an adverse event. Identification of prognostic factors should permit more efficient and effective design of future protocols by refining the classification of acute lymphocytic leukemia, decreasing the toxic risk to patients with a better prognosis, and improving the relatively poor remission duration and survival for patients with a poor prognosis.
D000367:Age Factors; D002648:Child; D002986:Clinical Trials as Topic / Q000379:methods*; D003201:Computers; D006801:Humans; D007074:Immunoglobulin G; D007938:Leukemia / Q000276:immunology / Q000628:therapy*; D007945:Leukemia, Lymphoid / Q000276:immunology / Q000628:therapy; D007970:Leukopenia; D008214:Lymphocytes; D011379:Prognosis; D012107:Research Design; D012306:Risk; D013997:Time Factors
D007074:Immunoglobulin G