Imatinib Increases Complete Response Rate, Decreases HSCT Allocation in Pediatric ALL
Based on findings from previous studies (COG AALL0031 and EsPhALL 2004-2009), researchers are assessing the association of continuous imatinib plus chemotherapy with the reduced need for HSCT.
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Adding continuous imatinib to induction therapy greatly increases the complete response (CR) rate in pediatric patients with Philadelphia chromosome (Ph+) acute lymphocytic leukemia (ALL) and reduces the need for hematopoietic stem cell transplant (HSCT), according to findings presented at the American Society of Hematology (ASH) 59th Annual Meeting & Exposition in Georgia.1
Patients with Ph+ ALL typically exhibit poor prognoses with a long-term event-free-survival (EFS) rate of approximately 30%; most patients in first complete remission (CR1) are allocated to HSCT. Based on findings from previous studies (COG AALL0031 and EsPhALL 2004-2009), researchers are assessing the association between continuous imatinib plus chemotherapy with the reduced need for HSCT.
For the single-arm EsPhALL 2010-2014 study, researchers assigned 155 pediatric patients to receive continuous imatinib 300 mg/m2 starting day 15 of induction therapy. Patients received HSCT based on early response and minimal residual disease (MRD) levels of at least 5 x 10-4. Continuous imatinib was recommended throughout the first year after transplant.
Approximately 97% (151) of patients reached CR1 by the end of induction; 100% of patients reached CR1 by the end of consolidation phase 1B. Thirty-eight percent (59) of patients underwent HSCT in CR1. Only 2 patients discontinued imatinib post-HSCT because of an increase in MRD or gastrointestinal (GI) toxicity.
The median overall follow-up was 57 months. The 5-year EFS was 57.0% (standard error [SE], 4.1) and 5-year overall survival (OS) was 71.8% (SE, 3.8). These findings were comparable to rates previously observed in the EsPhALL 2004-2009 study; the 5-year EFS and 5-year OS rates were 60.3% and 71.6%, respectively.
The 5-year cumulative incidence of relapse was 26.9; 46 events occurred among patients who received chemotherapy only, and 19 among patients who received HSCT in CR1.
Overall, 55% of patients had serious adverse events (SAEs); the most frequently reported SAEs included infection, osteonecrosis, and gastrointestinal disorders.
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- Biondi A, Gandemer V, Campbell M, et al. A treatment protocol with imatinib and intensive chemotherapy for pediatric Philadelphia positive acute lymphoblastic leukemia patients: a single-arm, intergroup study (EsPhALL 2010-2014). Oral presentation at: American Society of Hematology 59th Annual Meeting & Exposition; December 9-12, 2017; Atlanta, GA.