title: [A clinical study of drug-related toxicities of CCLG-ALL 08 protocol for childhood acute lymphoblastic leukemia].
abstract: OBJECTIVE
  The Chinese Children's Leukemia Group (CCLG)-acute lymphoblastic leukemia (ALL) 08 protocol for childhood ALL was established in 2008. This study aims to evaluate the drug-related toxicities of CCLG-ALL 08 protocol in the treatment of childhood ALL.
  
  
  METHODS
  A total of 114 children with newly diagnosed ALL were treated with the CCLG-ALL 08 protocol. The protocol was divided into five phases: remission induction (VDLD), early reinforcement (CAM), consolidation therapy, delayed reinforcement (DIa & DIb) and maintenance treatment. Drug-related toxicities in each phase were evaluated according to the Common Terminology Criteria for Adverse Events version 4.0.
  
  
  RESULTS
  Toxicities were more frequent in phase VDLD than other treatment phases, including hepatotoxicity (87.7%), dental ulcer (20.2%), hyperglycemia (20.2%), prolonged activated partial thromboplastin time (21.1%) and decreased fibrinogen (34.2%), with the incidence rates of severe adverse events at 7%, 0, 1.3%, 0.8% and 2.7% respectively. The incidence of allergic reaction to L-ASP was significantly higher in phase DIa than in phase VDLD (28.0% vs 7.9%; P<0.01), and there were no longer any allergic reactions in 15 patients who received continuing treatment with pegaspargase instead. There was no severe arrhythmia, myocardial ischemia, decreased left ventricular function, osteonecrosis, myopathy, organ failure or treatment-related mortality.
  
  
  CONCLUSIONS
  The drug-related toxicities of CCLG-ALL 08 protocol are common in phase VDLD, but they are mild and reversible. There is no treatment-related mortality. The CCLG-ALL 08 protocol for childhood ALL is safe.
authors.affiliation: Department of Hematology/Oncology, Children's Hospital of Chongqing Medical University, Chongqing 400014, China. yujie167@yahoo.com.
authors.forename: Bo
authors.initials: B
authors.lastname: Chen
authors.forename: Ying
authors.initials: Y
authors.lastname: Xian
authors.forename: Yong-Chun
authors.initials: YC
authors.lastname: Su
authors.forename: Xian-Hao
authors.initials: XH
authors.lastname: Wen
authors.forename: Xian-Min
authors.initials: XM
authors.lastname: Guan
authors.forename: Qi-Cheng
authors.initials: QC
authors.lastname: Zheng
authors.forename: Li
authors.initials: L
authors.lastname: Xiao
authors.forename: Lin
authors.initials: L
authors.lastname: Zou
authors.forename: Shi-Yi
authors.initials: SY
authors.lastname: Wang
authors.forename: Xin
authors.initials: X
authors.lastname: Li
authors.forename: Jie
authors.initials: J
authors.lastname: Yu
mesh_terms: D000293:Adolescent; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001215:Asparaginase / Q000009:adverse effects; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D054198:Precursor Cell Lymphoblastic Leukemia-Lymphoma / Q000188:drug therapy*; D012074:Remission Induction
chemical_list: D001215:Asparaginase