According to a study published in Blood, using a pediatric regimen for patients up to 40 years of age with acute lymphoblastic leukemia (ALL) may improve survival rates compared with historical controls.
The prospective study (CALGB 10403; ClinicalTrials.gov Identifier: NCT00558519) took place from 2007 to 2012 and used the same treatment doses and schedule as one arm of a previous Children’s Oncology Group study (AALL0232; ClinicalTrials.gov Identifier: NCT00075725). The primary endpoints were induction response rate, event-free survival (EFS), disease-free survival (DFS), and overall survival (OS). The historical control data came from patients with ALL (16-29 years of age) who were enrolled in previous CALGB trials.
The new study evaluated 295 patients with newly diagnosed B- or T-precursor ALL; median age was 24 years (range, 17-39). After induction (237 patients) or extended induction therapy (26 patients), 89% (263/295) of patients achieved a complete bone marrow response. At the time of publication, the median EFS was more than double that of the historical control (78.1 months, 95% CI: 41.8-not reached vs 30 months, 95% CI: 22-38). The 3-year EFS was 59% (95% CI: 54-65%). After a median follow-up of 64 months, 64% (190/295) of patients were still alive. The median OS had not been reached. The estimated 3-year OS was 73% (95% CI: 68-78).
Nine (3%) deaths occurred during induction; 6 were treatment related. Two postremission deaths occurred. A variety of nonhematologic grade 3 and 4 toxicities occurred, such as hypofibrinogenemia (42%), elevated transaminases (28%), elevated bilirubin (18%), hyperglycemia (30%), febrile neutropenia (22%), and infection (18%).
“Taken together, these results support the use of an intensive pediatric approach as a standard of care for young adults with ALL and as the platform for future therapeutic development,” the authors concluded.
- Stock W, Luger SM, Advani AS, et al. A pediatric regimen for older adolescents and young adults with acute lymphoblastic leukemia: results of CALGB 10403 [published online January 18, 2019]. Blood. doi: 10.1182/blood-2018-10-881961