Report of the National Cancer Institute-sponsored workshop on definitions of diagnosis and response in acute myeloid leukemia.

Abstract

The National Cancer Institute (NCI) sponsored a workshop to develop a set of standardized diagnostic and response criteria for acute myeloid leukemia (AML) clinical trials. The French-American-British (FAB) classification was retained for diagnosing AML, with the addition of patients with bone marrow morphologic features of a myelodysplastic syndrome and less than 30% bone marrow blasts, but with greater than or equal to 30% blasts in the peripheral blood. In this report, there are four important subgroups of AML not defined in the FAB classification that are discussed: undifferentiated acute leukemia, MO (AML lacking definitive myeloid differentiation by morphology or conventional cytochemistry but with ultrastructural or immunophenotypic evidence for AML), mixed lineage leukemia, and hypocellular AML. Definitions of response for clinical trials are presented to facilitate comparisons among different studies. Complete remission is considered the only response worth reporting in phase III trials, since lesser responses do not improve survival. Partial remissions may be of interest to identify active new agents in phase I and II studies. Monoclonal antibodies and cytogenetic studies are not part of the routine assessment of remission or reassessment at relapse, and their role in the evaluation of patients with AML is currently being evaluated in clinical trials. Although we recognize that some of the definitions in this report are arbitrary, generalized use of these guidelines will make results of clinical trials more comparable and interpretable.

Results of imatinib mesylate therapy in patients with refractory or recurrent acute myeloid leukemia, high‐risk myelodysplastic syndrome, and myeloproliferative disorders

“…None of these patients had a complete or partial response to therapy by standard criteria. 19,20 There was no significant change (increase or decrease) in the white blood cell count (WBC) throughout the course of therapy except for 2 patients whose WBC doubled and to more than 20 ϫ 10 9 /L. This occurred over a period of more than 90 days in both instances.…”

Intensive chemotherapy with idarubicin, cytosine arabinoside, and granulocyte colony-stimulating factor (G-CSF) in patients with secondary and therapy-related acute myelogenous leukemia

“…31 In addition, all included patients must not have any persistent myelodysplasAll patients received G-CSF at a daily dose of 5 mg/kg of body weight as a 30-min intravenous infusion, starting on day tic features in CR, except mild dyserythropoiesis. Therapeutic failures were classified as resistant disease (including partial 9 following the initiation of chemotherapy in patients receiving SD cytarabine and on day 15 in patients receiving ID cytaremission and failure) or death (including early death and death during treatment-induced bone marrow hypoplasia).…”

How to Establish Acute Myeloid Leukemia Xenograft Models Using Immunodeficient Mice

“…The annual incidence of AML was approximately 1.8 per 100 000 and progressively increased with age to a maximum prevalence of 17.2 per 100 000 adults of 65+ years of age (Ries et al, 2008). Despite modern advances in supportive care and therapeutics (Appelbaum et al, 2001;Trail et al, 2003) and improvement in the diagnosis of AML subtypes (Bennett et al, 1985;Bennett et al, 1989;Cheson et al, 1990;Casasnovas et al, 1998;Lowenberg et al, 1999), the rate of long-term survivors was greatly low.…”