| Purpose:To test the efficacy and adverse reactions of single-agent Realgar-Indigo Naturalis Formula(RIF)induced remission and sequential chemotherapy on long-term survival in children with newly diagnosed acute promyelocytic leukemia(APL).Patients and Methods:Eighteen children with newly diagnosed APL who were hospitalized in the No.967 Hospital of PLA Joint Logistics Support Force from October 1997 to September 2010 were enrolled.All patients with complete date were?15 years old,tested positive for chromosome t(15;17)or fusion gene PML-RARa,clinically diagnosed APL and did not receive any treatment.RIF was administered orally at an initial dose of 5 tablets each time,three times a day after meals followed by 10 tablets each time,three times a day after a week for patients with a weight greater than 50 kg and the half dosage for patients with a weight less than 50 kg,low-dose homoharringtonine(H)and/or cytarabine(A)were added to 7 patients,and RIF was administered orally again when the digestive tract symptoms disappeared.Commonly,the procedure continued 1-2 weeks.The total daily dose was given until achievement of HCR.Patients who achieved HCR received 5-year postrermission therapy that consisted of the sequential use of oral RIF combined with chemotherapy.Combination chemotherapy regimens used for postremission treatment included homoharringtonine 2 mg/m2 at days 1 to 2,and days 8 to 9,cytarabine 100mg/m2 at days 1 through 3,and 8 through 10,alternatively combine with etoposide 100mg/m2 at days 1 through 3 and days 8 through 10(HAE,regimen),or with daunorubicin 40 mg/m2 at days 3 and 10(HAD),or with mitoxantrone 6mg/m2 at days 3 and 10(HAM),or with cyclophosphamide 800?1200mg/m2 at days 3 and 10(HAC).One cycle of consolidation treatment comprised of one chemothearpy regimen,4-week RIF,and 4-week interval for rest,and 10 cycles of above treatment were given to patients during the first 2 and half years.Afterwards,4-week interval for rest prolonged to 16-week interval,then,5 cycles of consolidation treatment were given to patients for the next 2.5 years.Results:1.17 of 18 patients received HCR,the HCR rate was 94.4%,and the median time to HCR was 54(48?73)days.2?18 children,17 of 18 patients with MCR,MCR rate was 94.44%,of which 5 patients with HCR and PML/RARa fusion gene negative,the remaining 12 patients with MCR median time was 5.27(2.1?7.4)month.3?1 case ED on the 15th day of RIF treatment,the cause of death was intracranial hemorrhage.The patient was high risk.WBC increased sharply during the treatment,and reached the highest on the 12th day of treatment.The WBC count was 72.4×109/L,and the diagnosis of DIC was on the 14th day of treatment.4?17 patients with HCR were followed up until May 31,2017.One patient(5.9%)had hematologic relapse on 23 months after HCR,and received HCR again after RIF induced remission.The median follow-up time of the 17 patients was 131(78?218)months,and the 5-year OS and DFS were 94.4%and 88.9%,respectively.6?An increase in leukocute counts occurred in 15 patients(83.3%)during RIF induction.The median WBC count was 97(18.3?164.4)× 109/L,and the highest WBC count was 21(11?26)days.5 patients(27.8%)developed DIC,1 patient with ED,and the remaining 4 patients received heparin,fresh frozen plasma(15ml/kg/d)and cryoprecipitate treatment at 6th,7th,13 th and 21th corrected,respectively.A small number of patients had the following adverse reactions of the digestive tract,including 3 cases of nausea,2 cases of vomiting,2 cases of abdominal pain,1 case of diarrhea,2 cases of grade 1-2 liver damage.Other adverse reactions:1 case of facial edema.Conclusion:Single-agent RIF induces remission,and the treatment of children with newly diagnosed APL after remission of sequential chemotherapy is effective.It has a high HCR rate and long-term survival rate,and has fewer side effects.It can also be tolerated in children.It can be used as an early acute treatment for children.Selection of treatment options for myelocyte leukemia. |
PDF Full Text Request