title: [Homoharringtonine in newly diagnosed acute promyelocytic leukemia treatment: a prospective, randomized controlled trial].
abstract: OBJECTIVE
  To compare the efficacy and toxicities of combining homoharringtonine (HHT)±daunorubicin (DNR) with all-trans-retinoic acid (ATRA) based therapy and DNR plus ATRA based therapy in newly diagnosed low/intermediate risk acute promyelocytic leukemia (APL).
  
  
  METHODS
  A total of 96 newly diagnosed patients with APL were randomized to HHT group, DNR group and HHT+ DNR group prospectively. The complete remission (CR) rate, the overall survival (OS) and event-free survival (EFS) of three groups were analyzed.
  
  
  RESULTS
  There were 31 patients in HHT group, 33 patients in DNR group and 32 patients in HHT+ DNR group. The baseline characteristics of three groups were similar. No patient died during induction therapy. The morphologic CR rate was 100.0%. The median time to peak WBC counts in HHT+DNR group (4 days, range: 1-23 days) was significantly shorter than that in HHT group (9 days, range: 1-27 days) (P=0.008) and DNR group (7 days, range: 1-27 days) (P=0.240). There was no difference among three groups about the incidence of differentiation syndrome, the median interval to achieve CR, peak WBC counts and transfusions (P >0.05). All patients achieved complete molecular remission (CMR) during consolidation therapy. The interval to achieve CMR was no significantly difference among three groups (P >0.05). The 3-year OS rates for HHT group, DNR group and HHT+DNR group were 95.0%, 100.0% and 91.0%, respectively (P=0.595). The 3-year EFS rates for three groups were 93.0%, 90.0% and 85.0% (P=0.382). No difference was found in the incidence of adverse events among three groups (P >0.05).
  
  
  CONCLUSIONS
  Similar to DNR plus ATRA based therapy, HHT plus ATRA based induction and consolidation therapy should be one of highly-efficient treatment options for newly diagnosed APL. Clinical trial registration Chinese Clinical Trial Registry, ChiCTR-TRC-12002628.
authors.affiliation: Leukemia Center, Institute of Hematology & Blood Disease Hospital, CAMS & PUMC, Tianjin 300020, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Wang
authors.forename: B C
authors.initials: BC
authors.lastname: Liu
authors.forename: H
authors.initials: H
authors.lastname: Wei
authors.forename: D
authors.initials: D
authors.lastname: Lin
authors.forename: C L
authors.initials: CL
authors.lastname: Zhou
authors.forename: K Q
authors.initials: KQ
authors.lastname: Liu
authors.forename: W
authors.initials: W
authors.lastname: Li
authors.forename: S N
authors.initials: SN
authors.lastname: Wei
authors.forename: J Y
authors.initials: JY
authors.lastname: Wang
authors.forename: B F
authors.initials: BF
authors.lastname: Gong
authors.forename: G J
authors.initials: GJ
authors.lastname: Zhang
authors.forename: X L
authors.initials: XL
authors.lastname: Zhao
authors.forename: Y T
authors.initials: YT
authors.lastname: Liu
authors.forename: X Y
authors.initials: XY
authors.lastname: Gong
authors.forename: Y
authors.initials: Y
authors.lastname: Li
authors.forename: R X
authors.initials: RX
authors.lastname: Gu
authors.forename: Y C
authors.initials: YC
authors.lastname: Mi
authors.forename: J X
authors.initials: JX
authors.lastname: Wang
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols; D001803:Blood Transfusion; D003630:Daunorubicin / Q000627:therapeutic use; D018572:Disease-Free Survival; D006248:Harringtonines / Q000627:therapeutic use*; D000077863:Homoharringtonine; D006801:Humans; D015994:Incidence; D015473:Leukemia, Promyelocytic, Acute / Q000188:drug therapy*; D007958:Leukocyte Count; D020360:Neoadjuvant Therapy; D017713:Platelet Transfusion; D011446:Prospective Studies; D012074:Remission Induction; D015996:Survival Rate; D016896:Treatment Outcome; D014212:Tretinoin / Q000627:therapeutic use
chemical_list: D006248:Harringtonines; D014212:Tretinoin; D000077863:Homoharringtonine; D003630:Daunorubicin