Evidence-Based Pharmacy Evaluation of Dasatinib Plus Intensive Chemotherapy in the Therapy of Children with Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Objective To provide evidence-based support for clinicians,a systemic review was conducted to evaluate the safety and efficacy of dasatinib in the treatment of children with Philadelphia chromosomal positive(Ph+)acute lymphoblastic leukemia(ALL).Methods The latest version of dasatinib label was obtained through searching Daily Med,EMC databases and drug packaging,and the differences in the contents of different manufacturers were evaluated.The websites,such as the National Comprehensive Cancer Network(NCCN),the National Cancer Institute(NCI),Yimaitong and UpToDate were searched and the related practice guidelines/norms were retrieved and summrized.PubMed,Embase,Cochrane Library,Clinical Trials.gov,CNKI,CBM,VIP and Wanfang Data from January 1,2000 to March 31,2023 were searched,and all literatures involved dasatinib in treatment of children with Ph+ALL were retrieved,and the meta-analysis was performed.Results A total of 21 drug labels from 4 manufacturers were obtained.Only the original manufacturer's label of dasatinib was the most standardized and comprehensive,and the domestic dasatinib didn't approve the indication for treatment in pediatric population with Ph+ALL.Three guidelines/norms were obtained,and two of which explicitly recommended dasatinib combined with chemotherapy as the first-line treatment for Ph+ALL.A total of 186 studies were retrieved,4 literatures involved 289 children with Ph+ALL were included in the single-arm meta-analysis.Conclusion Dasatinib combined with chemotherapy for treatment in children with Ph+ALL is an off-label drug use in China.Whether the combination therapy could brought clinical benefits,a large-scale real world clinical data and more longer follow-up time would be need.
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