Uniform approach to risk classification and treatment assignment for children with acute lymphoblastic leukemia

Purpose: To define more uniform criteria for risk-based treatment assignment for children with acute lymphoblastic leukemia (ALL), the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCl) sponsored a workshop in September 1993. Participants included representatives from the Childrens Cancer Group (CCG), Pediatric Oncology Group (FOG), Dana-Farber Cancer Institute (DFCl), St Jude Children's Research Hospital (SJCRH), and the CTEP. Methods: Workshop participants presented and reviewed data from ALL clinical trials, using weighted averages to combine outcome data from different groups. Results: For patients with B-precursor (ie, non-T, non-B) ALL, the standard-risk category (4-year event-free survival [EFS] rate, similar to 80%) will include patients 1 to 9 years of age with a WBC count at diagnosis less than 50,000/mu L. The remaining patients will be classified as having high-risk ALL (4-year EFS rate, similar to 65%). For patients with T-cell ALL, different treatment strategies have yielded different conclusions concerning the prognostic significance of T-cell immunophenotype. Therefore, some groups/institutions will classify patients with T-cell ALL as high risk, while others will assign risk for patients with T-cell ALL based on the uniform age/WBC count criteria. Workshop participants agreed that the risk category of a patient may be modified by prognostic factors in addition to age and WBC count criteria, and that a common set of prognostic factors should be uniformly obtained, including DNA index (DI), cytogenetics, early response to treat ment (eg, day-14 bone marrow), immunophenotype, and CNS status. Conclusions: The more uniform approach to risk-based treatment assignment and to collection of specific prognostic factors should increase the efficiency of future ALL clinical research.