Table 1.

The recent trials including RIF or ATO plus ATRA as frontline treatment of APL patients

ReferenceType of study settingArsenic typeNo. of patients% high riskInductionHCR %ED %DS %Hepatic toxicity %ConsolidationMaintenanceMCR %CIR %DFS %EFS %OS %
Lo-Coco 201310  Randomized phase 3 ATO 77 0 ATO 0.15 mg/kg/d + 100 0 19 63 ATRA 45mg/ms/d No 100 1 (2 y) 97 (2 y) 97 (2 y) 99 (2 y) 
     ATRA 45 mg/ms/d    (grade 3-4) 2 wk on/2 wk off for 7 mo       
          ATO 0.15mg/kg/d       
          4 wk on/4 wk off for 7 mo       
Zhu 201321  Randomized phase 3 RIF 111 19 RIF 60 mg/kg/d + 99.1 0.9 19 64.9 Chemotherapy ATRA 25 mg/ms/d for 2 wk/mo(in mo1)+RIF 60 mg/kg/d for 2 wk/mo(in mo 2 and mo 3) for 2 y 100 n = 1 98.1 (2 y)  99.1 (3 y) 
     ATRA 25 mg/ms/d     3 cycles RIF 60 mg/kg/d for 2 wk/mo      
           (in mo 2 and mo 3) for 2 y      
  ATO 114 21 ATO 0.16 mg/kg/d + 97.4 2.6 24.8 74.5 Chemotherapy ATRA 25 mg/ms/d for 2 wk/mo(in mo1)+ 100 n = 1 95.5 (2 y)  96.6 (3 y) 
     ATRA 25 mg/ms/d     3 cycles ATO 0.16 mg/kg/d for 2 wk/mo      
           (in mo 2 and mo 3) for 2 y      
Zhu 201430  Nonrandomized RIF 20 0 RIF 60 mg/kg/d + 100 0 10 55 ATRA 25mg/ms/d No 100 n = 0 100  100 
     ATRA 25 mg/ms/d     2 wk on/2 wk off for 7 mo    (14 mo and 4y)  (14 mo and 4 y) 
          RIF 60 mg/kg/d       
          4 wk on/4 wk off for 7 mo       
Burnett 201512  Randomized phase 3 ATO 116 26 ATO 0.3 mg/kg/days 1-5 → 0.25 mg/kg,2/wk, wk 2-8 94 4 19 71 ATRA 45mg/ms/d No NA 1 (4 y) 97 (4 y) 91 (4 y) 93 (4 y) 
     ATRA 45 mg/ms/d +     2 wk on/2 wk off for 7 mo       
     GO in high-risk     ATO 0.25mg/kg twice weekly       
          4 wk on/4 wk off for 7 mo       
Iland 201513  Nonrandomized ATO 124 18 ATO 0.15 mg/kg/days 9-36 + 95 3 14 44 ATRA 45mg/ms/d + ATO 0.15mg/kg/d ATRA 45 mg/m2/days 1-14 every 90 d6-MP 50-90 mg/m2/wk days 15-90 100  97 (5 y) 95 (5 y) 94 (5 y) 
     ATRA 45 mg/ms/days 1-36 +     for 28days for 1st cycle 6-MP 50-90 mg/m2/wk days 15-90      
     IDA 6-12 mg/ms/days 2,4,6,8     ATRA 45mg/ms/d days 1-7,15-21 and 29-35 + ATO 0.15 mg/kg/d 5 d MTX 5-15 mg/m2/wk PO days 15-90      
          per week for 5 wk for 2rd cycle ×8 cycles      
Abaza 201715  Nonrandomized ATO 187 28.9 ATO 0.15 mg/kg/d + 96 4 11 14 ATRA 45 mg/ms/d No 98 4 (5 y) 96 (5 y) 85 (5 y) 88 (5 y) 
     ATRA 45 mg/ms/d +    (grade 3-4) 2 wk on/2 wk off for 7 mo       
     GO in high-risk     ATO 0.15 mg/kg/d       
          4 wk on/4 wk off for 7 mo       
Zhu 201838  Nonrandomized RIF 20 100 RIF 60 mg/kg/d + 100 0 35 45 ATRA 25 mg/ms/d No 100 10  89.4 (3 y) 100 (3 y) 
     ATRA 25 mg/ms/d+     2 wk on/2 wk off for 7 mo       
     GO in low-dose chemo     RIF 60 mg/kg/d       
          4 wk on/4 wk off for 7 mo       
Zhu 201823  Randomized phase 3 RIF 69 0 RIF 60 mg/kg/d + 100 0 26 58 ATRA 25 mg/ms/d No 100 3 (2 y)  97 (2 y) 100 (2 y) 
     ATRA 25 mg/ms/d     2 wk on/2 wk off for 7 mo       
          RIF 60 mg/kg/d       
          4 wk on/4 wk off for 7 mo       
  ATO 36 0 ATO 0.16 mg/kg/d + 94 6 28 78 ATRA 25 mg/ms/d No 100 0 (2 y)  94 (2 y) 94 (2 y) 
     ATRA 25 mg/ms/d     2 wk on/2 wk off for 7 mo       
          ATO 0.16mg/kg/d       
          4 wk on/4 wk off for 7 mo       
Yang 201848  Randomized phase 3 (children) RIF 40 20 RIF 135 mg/kg/d + 100 0 2.5 5 Chemotherapy-based ATRA+RIF/MTX-6MP/ATRA/MTX-6MP 100 0 (5 y)  100 (5 y) 100 (5 y) 
     ATRA 25 mg/ms/d +    (grade 3-4) 3 cycles in mo 1-3 for 8 cycles (2y)      
     mitoxantrone            
  ATO 42 33.3 ATO 0.16 mg/kg/d + 100 0 9.5 2.4 Chemotherapy-based ATRA+ATO/MTX-6MP/ATRA/MTX-6MP 100 0 (5 y)  100 (5 y) 100 (5 y) 
     ATRA 25 mg/ms/d +    (grade 3-4) 3 cycles in mo 1-3 for 8 cycles (2 y)      
ReferenceType of study settingArsenic typeNo. of patients% high riskInductionHCR %ED %DS %Hepatic toxicity %ConsolidationMaintenanceMCR %CIR %DFS %EFS %OS %
Lo-Coco 201310  Randomized phase 3 ATO 77 0 ATO 0.15 mg/kg/d + 100 0 19 63 ATRA 45mg/ms/d No 100 1 (2 y) 97 (2 y) 97 (2 y) 99 (2 y) 
     ATRA 45 mg/ms/d    (grade 3-4) 2 wk on/2 wk off for 7 mo       
          ATO 0.15mg/kg/d       
          4 wk on/4 wk off for 7 mo       
Zhu 201321  Randomized phase 3 RIF 111 19 RIF 60 mg/kg/d + 99.1 0.9 19 64.9 Chemotherapy ATRA 25 mg/ms/d for 2 wk/mo(in mo1)+RIF 60 mg/kg/d for 2 wk/mo(in mo 2 and mo 3) for 2 y 100 n = 1 98.1 (2 y)  99.1 (3 y) 
     ATRA 25 mg/ms/d     3 cycles RIF 60 mg/kg/d for 2 wk/mo      
           (in mo 2 and mo 3) for 2 y      
  ATO 114 21 ATO 0.16 mg/kg/d + 97.4 2.6 24.8 74.5 Chemotherapy ATRA 25 mg/ms/d for 2 wk/mo(in mo1)+ 100 n = 1 95.5 (2 y)  96.6 (3 y) 
     ATRA 25 mg/ms/d     3 cycles ATO 0.16 mg/kg/d for 2 wk/mo      
           (in mo 2 and mo 3) for 2 y      
Zhu 201430  Nonrandomized RIF 20 0 RIF 60 mg/kg/d + 100 0 10 55 ATRA 25mg/ms/d No 100 n = 0 100  100 
     ATRA 25 mg/ms/d     2 wk on/2 wk off for 7 mo    (14 mo and 4y)  (14 mo and 4 y) 
          RIF 60 mg/kg/d       
          4 wk on/4 wk off for 7 mo       
Burnett 201512  Randomized phase 3 ATO 116 26 ATO 0.3 mg/kg/days 1-5 → 0.25 mg/kg,2/wk, wk 2-8 94 4 19 71 ATRA 45mg/ms/d No NA 1 (4 y) 97 (4 y) 91 (4 y) 93 (4 y) 
     ATRA 45 mg/ms/d +     2 wk on/2 wk off for 7 mo       
     GO in high-risk     ATO 0.25mg/kg twice weekly       
          4 wk on/4 wk off for 7 mo       
Iland 201513  Nonrandomized ATO 124 18 ATO 0.15 mg/kg/days 9-36 + 95 3 14 44 ATRA 45mg/ms/d + ATO 0.15mg/kg/d ATRA 45 mg/m2/days 1-14 every 90 d6-MP 50-90 mg/m2/wk days 15-90 100  97 (5 y) 95 (5 y) 94 (5 y) 
     ATRA 45 mg/ms/days 1-36 +     for 28days for 1st cycle 6-MP 50-90 mg/m2/wk days 15-90      
     IDA 6-12 mg/ms/days 2,4,6,8     ATRA 45mg/ms/d days 1-7,15-21 and 29-35 + ATO 0.15 mg/kg/d 5 d MTX 5-15 mg/m2/wk PO days 15-90      
          per week for 5 wk for 2rd cycle ×8 cycles      
Abaza 201715  Nonrandomized ATO 187 28.9 ATO 0.15 mg/kg/d + 96 4 11 14 ATRA 45 mg/ms/d No 98 4 (5 y) 96 (5 y) 85 (5 y) 88 (5 y) 
     ATRA 45 mg/ms/d +    (grade 3-4) 2 wk on/2 wk off for 7 mo       
     GO in high-risk     ATO 0.15 mg/kg/d       
          4 wk on/4 wk off for 7 mo       
Zhu 201838  Nonrandomized RIF 20 100 RIF 60 mg/kg/d + 100 0 35 45 ATRA 25 mg/ms/d No 100 10  89.4 (3 y) 100 (3 y) 
     ATRA 25 mg/ms/d+     2 wk on/2 wk off for 7 mo       
     GO in low-dose chemo     RIF 60 mg/kg/d       
          4 wk on/4 wk off for 7 mo       
Zhu 201823  Randomized phase 3 RIF 69 0 RIF 60 mg/kg/d + 100 0 26 58 ATRA 25 mg/ms/d No 100 3 (2 y)  97 (2 y) 100 (2 y) 
     ATRA 25 mg/ms/d     2 wk on/2 wk off for 7 mo       
          RIF 60 mg/kg/d       
          4 wk on/4 wk off for 7 mo       
  ATO 36 0 ATO 0.16 mg/kg/d + 94 6 28 78 ATRA 25 mg/ms/d No 100 0 (2 y)  94 (2 y) 94 (2 y) 
     ATRA 25 mg/ms/d     2 wk on/2 wk off for 7 mo       
          ATO 0.16mg/kg/d       
          4 wk on/4 wk off for 7 mo       
Yang 201848  Randomized phase 3 (children) RIF 40 20 RIF 135 mg/kg/d + 100 0 2.5 5 Chemotherapy-based ATRA+RIF/MTX-6MP/ATRA/MTX-6MP 100 0 (5 y)  100 (5 y) 100 (5 y) 
     ATRA 25 mg/ms/d +    (grade 3-4) 3 cycles in mo 1-3 for 8 cycles (2y)      
     mitoxantrone            
  ATO 42 33.3 ATO 0.16 mg/kg/d + 100 0 9.5 2.4 Chemotherapy-based ATRA+ATO/MTX-6MP/ATRA/MTX-6MP 100 0 (5 y)  100 (5 y) 100 (5 y) 
     ATRA 25 mg/ms/d +    (grade 3-4) 3 cycles in mo 1-3 for 8 cycles (2 y)      

6-MP, 6-mercaptopurine; DS, differentiation syndrome; ED, early death; GO: gemtuzumab ozogamicin; HCR, hematological complete remission; IDA, idarubicin; MCR, molecular remission; MTX, methotrexate; NA, not applicable; PO, postoperatively.

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