| Background ＆ Objective: Acute promyelocytic leukemia（APL）has made great progress in diagnosis and treatment after many years of research and development.Nowadays,the clinical efficacy and safety of patients with acute promyelocytic leukemia have been significantly improved due to the extensive use of all-trans retinoic acid（ATRA）and arsenic（ATO）.However,with the better treatment effect of APL today,many scholars have put forward higher requirements for the treatment of acute promyelocytic leukemia.The study and wide application of oral arsenic agent make the treatment of acute promyelocytic leukemia produce a new model.The concept of an all-oral chemotherapy-free regimen was also proposed: the use of oral retinoic acid and oral arsenic to induce,consolidate,and maintain the treatment of acute promyelocytic leukemia without the involvement of other traditional intravenous chemotherapy agents such as anthracyclines or cytarabine.At present,domestic and foreign studies on total oral chemotherapy-free regimen are more focused on the treatment of patients with low and moderate critical promyelocytic leukemia.Better evidence for treatment of high-risk patients is lacking.In this paper,a detailed study was conducted on the treatment of newly treated APL patients with positive PML-RARA fusion gene with chemotherapy regimen and total oral chemotherapy regimen,and the efficacy and safety of chemotherapy regimen and no chemotherapy regimen were compared in the treatment of patients with low,medium and high risk.Methods: A total of 95 patients with newly treated APL in Fuyang People’s Hospital from January 2016 to January 2020 were enrolled and divided into chemotherapy group（n = 48）and non-chemotherapy group（n = 47）,and each group was divided into non-high-risk subgroup and high-risk subgroup.Chemotherapy group was treated with retinoic acid + arsenous acid induction therapy,after complete remission（CR）,chemotherapy consolidation treatment（HA,MA,DA,IA regimen）,and retinoic acid combined with compound Huangdai tablet maintenance treatment after molecular CR was achieved.The non-chemotherapy group received double induction of retinoic acid combined with compound Huangdai tablets,and continued to receive consolidation and maintenance treatment of retinoic acid and compound Huangdai tablets after reaching CR.The two groups were given the corresponding leukocyte lowering and central nervous system leukemia prevention and treatment.The efficacy,early mortality,recurrence rate and other related indicators were analyzed and compared between the two groups.Results: There were no significant differences in early mortality,CR rate,overall survival rate,prothrombin time（PT）,activated partial thrombin time（APTT）,D-dimer and fibrinogen between chemotherapy group and non-chemotherapy group（P>0.05）.The time to first reaching CR in high-risk patients in chemotherapy group was significantly shorter than that in high-risk patients without chemotherapy（P<0.05）.The recurrence rate in the chemotherapy group was significantly higher than that in the nonchemotherapy group,and the incidence of central nervous system leukemia in the chemotherapy group was significantly higher than that in the non-chemotherapy group（P<0.05）.Compared with high-risk patients in chemotherapy group,the negative conversion rate of PML-RARA fusion gene was significantly increased in high-risk patients without chemotherapy at 3 months（P<0.05）.The incidence of adverse reactions in non-chemotherapy group was significantly lower than that in chemotherapy group（P<0.05）.Conclusions: The efficacy of total oral administration without chemotherapy was not lower than that of chemotherapy in newly treated APL patients with POSITIVE PML-RARA fusion gene.In high-risk patients without chemotherapy,the incidence of CNS leukemia and the incidence of adverse reactions were significantly reduced,thus improving the safety and compliance of APL patients. |
PDF Full Text Request