Outcome of children with newly diagnosed acute lymphoblastic leukemia treated with CCLG‐ALL 2008: The first nation‐wide prospective multicenter study in China

Abstract

Acute lymphoblastic leukemia (ALL) is the most common malignancy among children. The trial Chinese Children Leukemia Group (CCLG)-ALL 2008 was a prospective clinical trial designed to improve treatment outcome of childhood ALL through the first nation-wide collaborative study in China. Totally 2231 patients were recruited from ten tertiary hospitals in eight cities. The patients were stratified according to clinical-biological characteristics and early treatment response. Standard risk (SR) and intermediate risk (IR) groups were treated with a modified BFM based protocol, and there was 25%-50% dose reduction during intensification phases in the SR group. Patients in high risk (HR) group received a more intensive maintenance treatment. Minimal residual disease (MRD) monitoring with treatment adjustment was performed in two hospitals (the MRD group). Complete remission (CR) was achieved in 2100 patients (94.1%). At five years, the estimate for overall survival (OS) and event-free survival (EFS) of the whole group was 85.3% and 79.9%, respectively. The cumulative incidence of relapse (CIR) was 15.3% at five years. The OS, EFS and CIR for the SR group were 91.5%, 87.9%, and 9.7%, respectively. The outcome of the MRD group is better than the non-MRD group (5y-EFS: 82.4% vs 78.3%, P = .038; 5y-CIR: 10.7% vs 18.0%, P < .001). Our results demonstrated that the large-scale multicenter trial for pediatric ALL was feasible in China. Dose reduction in the SR group could achieve high EFS. MRD-based risk stratification might improve the treatment outcome for childhood ALL.

Excellent outcome of acute lymphoblastic leukaemia with TCF3‐PBX1 rearrangement in Hong Kong

“…During consolidation phase, patients with B‐ALL of standard risk (SR) and intermediate risk (IR) received a lower dose of methotrexate at 2 g/m 2 compared with 5 g/m 2 for IR T‐ALL. In CCLG 2008, dexamethasone was employed during therapy . The first three clinical trials utilised a BFM‐based approach while the CCCG 2015 is St. Jude Total XV protocol based, which includes a more intensive L‐asparaginase treatment approach.…”

Septicemia after chemotherapy for childhood acute lymphoblastic leukemia in China: A multicenter study CCCG‐ALL‐2015

“…However, the survival outcome is still suboptimal in developing countries . A recent multicenter study from China reported 5‐year EFS of 79.9% . Septicemia is an important cause of treatment‐related mortality.…”

“…In India, septicemia was also reported to be an important cause of death, accounting for 29.7% of deaths . In the multicenter report of ALL from China, non‐relapse mortality during remission was 2.9% and infection was the cause of death in 73.4% . Severe infection during chemotherapy is associated with mortality and also increase in medical cost; from prolonged hospitalization, ICU care, use of expensive antibiotics, and other supportive treatment.…”

“…8,9 A recent multicenter study from China reported 5-year EFS of 79.9%. 10 most important cause of treatment failure. 11 In Turkey, a similar Total XIII protocol was adopted and the 5-year EFS was 77%.…”

“…13 In the multicenter report of ALL from China, non-relapse mortality during remission was 2.9% and infection was the cause of death in 73.4%. 10 Severe infection during chemotherapy is associated with mortality and also increase in medical cost; from prolonged hospitalization, ICU care, use of expensive antibiotics, and other supportive treatment. The high treatment cost is one of the prohibitory factor for completion of chemotherapy treatment in developing countries.…”