There are errors in Table 1 on pages 600 to 602. Many entries that should be in a single table cell are divided among multiple cells. Throughout the table, the unit “ms” should read “m2”. In the information for reference Iland 201513 (page 601), in the “Induction” column, in “ATO 0.15 mg/kg/days 9-36 + ATRA 45 mg/ms/days 1-36 + IDA 6-12 mg/ms/days 2, 4, 6, 8,” “6-12” should read “6, 9, or 12”; in the “Consolidation” column, in “ATRA 45 mg/ms/d days 1-7,15-21 and 29-35 + ATO 0.15 mg/kg/d 5 d per week for 5 wk for 2rd cycle,” “2rd” should read “2nd”; and in the “Maintenance” column, “6-MP 50-90 mg/m2/wk days 15-90” should appear once rather than twice. In the information for reference Yang 201848 (page 602), the reference number should be 47 instead of 48, and in the “Induction” column, “ATO 0.16 mg/kg/d + ATRA 25 mg/ms/d +” should read “ATO 0.16 mg/kg/d + ATRA 25 mg/m2/d + mitoxantrone.” In the footnote, the abbreviation PO should be defined as “by mouth,” not “postoperatively.” The corrected table follows.
The recent trials including RIF or ATO plus ATRA as frontline treatment of APL patients
Reference . | Type of study setting . | Arsenic type . | No. of patients . | % high risk . | Induction . | HCR % . | ED % . | DS % . | Hepatic toxicity % . | Consolidation . | Maintenance . | MCR % . | CIR % . | DFS % . | EFS % . | OS % . |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lo-Coco 201310 | Randomized phase 3 | ATO | 77 | 0 | ATO 0.15 mg/kg/d + ATRA 45 mg/m2/d | 100 | 0 | 19 | 63 (grade 3-4) | ATRA 45 mg/m2/d 2 wk on/2 wk off for 7 mo ATO 0.15 mg/kg/d 4 wk on/4 wk off for 7 mo | No | 100 | 1 (2 y) | 97 (2 y) | 97 (2 y) | 99 (2 y) |
Zhu 201321 | Randomized phase 3 | RIF | 111 | 19 | RIF 60 mg/kg/d + ATRA 25 mg/m2/d | 99.1 | 0.9 | 19 | 64.9 | Chemotherapy 3 cycles | ATRA 25 mg/m2/d for 2 wk/mo (in mo 1) + RIF 60 mg/kg/d for 2 wk/mo (in mo 2 and mo 3) for 2 y 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) | |
ATO | 114 | 21 | ATO 0.16 mg/kg/d + ATRA 25 mg/m2/d | 97.4 | 2.6 | 24.8 | 74.5 | Chemotherapy 3 cycles | ATRA 25 mg/m2/d for 2 wk/mo (in mo1) + ATO 0.16 mg/kg/d for 2 wk/mo (in mo 2 and mo 3) for 2 y | 100 | n = 1 | 95.5 (2 y) | 96.6 (3 y) | |||
Zhu 201430 | Nonrandomized | RIF | 20 | 0 | RIF 60 mg/kg/d + ATRA 25 mg/m2/d | 100 | 0 | 10 | 55 | ATRA 25 mg/m2/d 2 wk on/2 wk off for 7 mo RIF 60 mg/kg/d 4 wk on/4 wk off for 7 mo | No | 100 | n = 0 | 100 (14 mo and 4 y) | 100 (14 mo and 4 y) | |
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 ATRA 45 mg/m2/d + GO in high-risk | 94 | 4 | 19 | 71 | ATRA 45 mg/m2/d 2 wk on/2 wk off for 7 mo ATO 0.25 mg/kg twice weekly 4 wk on/4 wk off for 7 mo | No | NA | 1 (4 y) | 97 (4 y) | 91 (4 y) | 93 (4 y) |
Iland 201513 | Nonrandomized | ATO | 124 | 18 | ATO 0.15 mg/kg/days 9-36 + ATRA 45 mg/m2/days 1-36 + IDA 6, 9, or 12 mg/m2/days 2, 4, 6, 8 | 95 | 3 | 14 | 44 | ATRA 45 mg/m2/d + ATO 0.15 mg/kg/d for 28 days for 1st cycle ATRA 45 mg/m2/d days 1-7, 15-21, and 29-35 + ATO 0.15 mg/kg/d 5 d per week for 5 wk for 2nd cycle | ATRA 45 mg/m2/days 1-14 every 90 d 6-MP 50-90 mg/m2/wk days 15-90 MTX 5-15 mg/m2/wk PO days 15-90 × 8 cycles | 100 | 97 (5 y) | 95 (5 y) | 94 (5 y) | |
Abaza 201715 | Nonrandomized | ATO | 187 | 28.9 | ATO 0.15 mg/kg/d + ATRA 45 mg/m2/d + GO in high-risk | 96 | 4 | 11 | 14 (grade 3-4) | ATRA 45 mg/m2/d 2 wk on/2 wk off for 7 mo ATO 0.15 mg/kg/d 4 wk on/4 wk off for 7 mo | No | 98 | 4 (5 y) | 96 (5 y) | 85 (5 y) | 88 (5 y) |
Zhu 201838 | Nonrandomized | RIF | 20 | 100 | RIF 60 mg/kg/d + ATRA 25 mg/m2/d + GO in low-dose chemo | 100 | 0 | 35 | 45 | ATRA 25 mg/m2/d 2 wk on/2 wk off for 7 mo RIF 60 mg/kg/d 4 wk on/4 wk off for 7 mo | No | 100 | 10 | 89.4 (3 y) | 100 (3 y) | |
Zhu 201823 | Randomized phase 3 | RIF | 69 | 0 | RIF 60 mg/kg/d + ATRA 25 mg/m2/d | 100 | 0 | 26 | 58 | ATRA 25 mg/m2/d 2 wk on/2 wk off for 7 mo RIF 60 mg/kg/d 4 wk on/4 wk off for 7 mo | No | 100 | 3 (2 y) | 97 (2 y) | 100 (2 y) | |
ATO | 36 | 0 | ATO 0.16 mg/kg/d + ATRA 25 mg/m2/d | 94 | 6 | 28 | 78 | ATRA 25 mg/m2/d 2 wk on/2 wk off for 7 mo ATO 0.16 mg/kg/d 4 wk on/4 wk off for 7 mo | No | 100 | 0 (2 y) | 94 (2 y) | 94 (2 y) | |||
Yang 201847 | Randomized phase 3 (children) | RIF | 40 | 20 | RIF 135 mg/kg/d + ATRA 25 mg/m2/d + mitoxantrone | 100 | 0 | 2.5 | 5 (grade 3-4) | Chemotherapy-based 3 cycles | ATRA+RIF/MTX-6MP/ATRA/MTX-6MP in mo 1-3 for 8 cycles (2 y) | 100 | 0 (5 y) | 100 (5 y) | 100 (5 y) | |
ATO | 42 | 33.3 | ATO 0.16 mg/kg/d + ATRA 25 mg/m2/d + mitoxantrone | 100 | 0 | 9.5 | 2.4 (grade 3-4) | Chemotherapy-based 3 cycles | ATRA+ATO/MTX-6MP/ATRA/MTX-6MP in mo 1-3 for 8 cycles (2 y) | 100 | 0 (5 y) | 100 (5 y) | 100 (5 y) |
Reference . | Type of study setting . | Arsenic type . | No. of patients . | % high risk . | Induction . | HCR % . | ED % . | DS % . | Hepatic toxicity % . | Consolidation . | Maintenance . | MCR % . | CIR % . | DFS % . | EFS % . | OS % . |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Lo-Coco 201310 | Randomized phase 3 | ATO | 77 | 0 | ATO 0.15 mg/kg/d + ATRA 45 mg/m2/d | 100 | 0 | 19 | 63 (grade 3-4) | ATRA 45 mg/m2/d 2 wk on/2 wk off for 7 mo ATO 0.15 mg/kg/d 4 wk on/4 wk off for 7 mo | No | 100 | 1 (2 y) | 97 (2 y) | 97 (2 y) | 99 (2 y) |
Zhu 201321 | Randomized phase 3 | RIF | 111 | 19 | RIF 60 mg/kg/d + ATRA 25 mg/m2/d | 99.1 | 0.9 | 19 | 64.9 | Chemotherapy 3 cycles | ATRA 25 mg/m2/d for 2 wk/mo (in mo 1) + RIF 60 mg/kg/d for 2 wk/mo (in mo 2 and mo 3) for 2 y 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) | |
ATO | 114 | 21 | ATO 0.16 mg/kg/d + ATRA 25 mg/m2/d | 97.4 | 2.6 | 24.8 | 74.5 | Chemotherapy 3 cycles | ATRA 25 mg/m2/d for 2 wk/mo (in mo1) + ATO 0.16 mg/kg/d for 2 wk/mo (in mo 2 and mo 3) for 2 y | 100 | n = 1 | 95.5 (2 y) | 96.6 (3 y) | |||
Zhu 201430 | Nonrandomized | RIF | 20 | 0 | RIF 60 mg/kg/d + ATRA 25 mg/m2/d | 100 | 0 | 10 | 55 | ATRA 25 mg/m2/d 2 wk on/2 wk off for 7 mo RIF 60 mg/kg/d 4 wk on/4 wk off for 7 mo | No | 100 | n = 0 | 100 (14 mo and 4 y) | 100 (14 mo and 4 y) | |
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 ATRA 45 mg/m2/d + GO in high-risk | 94 | 4 | 19 | 71 | ATRA 45 mg/m2/d 2 wk on/2 wk off for 7 mo ATO 0.25 mg/kg twice weekly 4 wk on/4 wk off for 7 mo | No | NA | 1 (4 y) | 97 (4 y) | 91 (4 y) | 93 (4 y) |
Iland 201513 | Nonrandomized | ATO | 124 | 18 | ATO 0.15 mg/kg/days 9-36 + ATRA 45 mg/m2/days 1-36 + IDA 6, 9, or 12 mg/m2/days 2, 4, 6, 8 | 95 | 3 | 14 | 44 | ATRA 45 mg/m2/d + ATO 0.15 mg/kg/d for 28 days for 1st cycle ATRA 45 mg/m2/d days 1-7, 15-21, and 29-35 + ATO 0.15 mg/kg/d 5 d per week for 5 wk for 2nd cycle | ATRA 45 mg/m2/days 1-14 every 90 d 6-MP 50-90 mg/m2/wk days 15-90 MTX 5-15 mg/m2/wk PO days 15-90 × 8 cycles | 100 | 97 (5 y) | 95 (5 y) | 94 (5 y) | |
Abaza 201715 | Nonrandomized | ATO | 187 | 28.9 | ATO 0.15 mg/kg/d + ATRA 45 mg/m2/d + GO in high-risk | 96 | 4 | 11 | 14 (grade 3-4) | ATRA 45 mg/m2/d 2 wk on/2 wk off for 7 mo ATO 0.15 mg/kg/d 4 wk on/4 wk off for 7 mo | No | 98 | 4 (5 y) | 96 (5 y) | 85 (5 y) | 88 (5 y) |
Zhu 201838 | Nonrandomized | RIF | 20 | 100 | RIF 60 mg/kg/d + ATRA 25 mg/m2/d + GO in low-dose chemo | 100 | 0 | 35 | 45 | ATRA 25 mg/m2/d 2 wk on/2 wk off for 7 mo RIF 60 mg/kg/d 4 wk on/4 wk off for 7 mo | No | 100 | 10 | 89.4 (3 y) | 100 (3 y) | |
Zhu 201823 | Randomized phase 3 | RIF | 69 | 0 | RIF 60 mg/kg/d + ATRA 25 mg/m2/d | 100 | 0 | 26 | 58 | ATRA 25 mg/m2/d 2 wk on/2 wk off for 7 mo RIF 60 mg/kg/d 4 wk on/4 wk off for 7 mo | No | 100 | 3 (2 y) | 97 (2 y) | 100 (2 y) | |
ATO | 36 | 0 | ATO 0.16 mg/kg/d + ATRA 25 mg/m2/d | 94 | 6 | 28 | 78 | ATRA 25 mg/m2/d 2 wk on/2 wk off for 7 mo ATO 0.16 mg/kg/d 4 wk on/4 wk off for 7 mo | No | 100 | 0 (2 y) | 94 (2 y) | 94 (2 y) | |||
Yang 201847 | Randomized phase 3 (children) | RIF | 40 | 20 | RIF 135 mg/kg/d + ATRA 25 mg/m2/d + mitoxantrone | 100 | 0 | 2.5 | 5 (grade 3-4) | Chemotherapy-based 3 cycles | ATRA+RIF/MTX-6MP/ATRA/MTX-6MP in mo 1-3 for 8 cycles (2 y) | 100 | 0 (5 y) | 100 (5 y) | 100 (5 y) | |
ATO | 42 | 33.3 | ATO 0.16 mg/kg/d + ATRA 25 mg/m2/d + mitoxantrone | 100 | 0 | 9.5 | 2.4 (grade 3-4) | Chemotherapy-based 3 cycles | ATRA+ATO/MTX-6MP/ATRA/MTX-6MP in mo 1-3 for 8 cycles (2 y) | 100 | 0 (5 y) | 100 (5 y) | 100 (5 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, by mouth.
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