Design and conduct of a double-blind, placebo-controlled trial of daunorubicin and cytarabine with or without granulocyte colony-stimulating factor in elderly patients with acute myeloid leukemia: a Southwest Oncology Group study.

From the public health standpoint, acute myeloid leukemia (AML) is an important problem for both young and older adults. AML is the leading cause of cancer death in men aged 15-34 years and the second leading cause of cancer death in women in this age group. This clearly has an impact on loss of life in the productive years. But in terms of the population most affected and of the biology of the disease, the impact is even greater for the elderly patient. Age has been established in many AML treatment trials as a poor prognosis factor. Although ther is no consensus as to what age defines an elderly AML patient, those older than 45 years have a lower complete remission (CR) rate than those who are younger. In patients younger than 50 years, the average CR rate is 60%-75%; in contrast, in patients older than 70 years, the CR rate is 35%-40%. Long-term disease-free survival ranges from 25% to 50% in adult AML, depending on the post-remission therapy used and the age of the patient. In November 1991, the Southwest Oncology Group began a study to address the problems of treating AML in the elderly. Many previous treatment trials of AML have included elderly patients as a subgroup of the study analysis, with a larger proportion of young patients. This trial was designed to test the hypothesis that a myeloid growth factor used as supportive care could improve the outcomes in elderly patients with AML.(ABSTRACT TRUNCATED AT 250 WORDS)