Table 3.
Commonly employed current treatment regimens in APL, stratified by risk category
| Protocol | Induction | Consolidation | Maintenance |
|---|---|---|---|
| Low-intermediate risk | |||
| APL040639 | ATRA 45 mg/m2/d PO + ATO 0.15 mg/kg/d IV until CR (max 60 days) | ATRA 45 mg/m2/d PO for 14 days then rest for 14 days ×7 cycles + ATO 0.15 mg/kg/d IV for 5 days per week for 4 weeks then rest for 4 weeks ×4 cycles | Nil |
| LPA200537 | ATRA 45 mg/m2/d POc + ATO 0.15 mg/kg/d IV until CR (max 60 days) | 1. ATRA 45 mg/m2/d PO d1–15 + Idarubicin 5low/7int mg/m2/d d1–4 2. ATRA 45 mg/m2/d PO d1–15 + MTZ 10 mg/m2/d d1–3 3. ATRA 45 mg/m2/d PO d1–15 + Idarubicin 12 mg/m2/d d1low or d1–2int |
ATRA 45 mg/m2/day PO d1–15 every 90 days MTX 15 mg/m2/wk IM d15–90 6-MP 50 mg/m2/wk PO d15–90 for 2 years |
| High risk | |||
| APML438 | ATRA 45 mg/m2/day PO d1–36 ATO 0.15 mg/kg/day IV d9–36 Idarubicin 6–12 mg/m2 d2, 4, 6, 8a,b |
1. ATRA 45 mg/m2/d PO days 1–28 + ATO 0.15 mg/kg/d IV d1–28 2. ATRA 45 mg/m2/d PO d1–7, 15–21 and 29–35 + ATO 0.15 mg/kg/d IV for 5 days per week for 5 weeks |
ATRA 45 mg/m2/day PO d1–14 every 90 days MTX 5–15 mg/m2/wk PO d15–90 6-MP 50–90 mg/m2/wk PO d15–90 ×8 cycles |
| Study C971036 | ATRA 45 mg/m2/d PO until CR (max 90 days) + Cytarabine 200 mg/m2 d3–9 + DNR 50 mg/m2 d3–6 | 1. ATO 0.15 mg/kg/d IV for 5 days per week for 5 weeks ×2 cycles 2. ATRA mg/m2/d PO days 1–7 + DNR 50 mg/m2 d1–3 ×2 cycles |
ATRA mg/m2/d PO days 1–7 repeated on alternate weeks MTX 20 mg/m2/wk PO 6-MP 60 mg/m2/d PO for 1 year |
| APL200096 | ATRA 45 mg/m2/d PO until CR + Cytarabine 200 mg/m2 d1–7 + DNR 60 mg/m2 d1–3 |
1. DNR 60 mg/m2/d d1–3 + Cytarabine 200 mg/m2/d d1–7 2. DNR 45 mg/m2/d d1–3 + Cytarabine 2 g/m2/12 h d1–5 (50 years) or Cytarabine 1.5 g/m2/12 h d1–5 (50–60 years) + 5 doses of MTX 15 mg/Cytarabine 50 mg given IT |
ATRA 45 mg/m2/day POd1–15 every 90 days MTX 15 mg/m2/wk PO d15–90 6-MP 50 mg/m2/wk PO d15–90 for 2 years |
| LPA200537 | ATRA 45 mg/m2/d POc until CR + Idarubicin 12 mg/m2/d d2, 4, 6, 8d | 1. ATRA 45 mg/m2/d PO d1–15 + Idarubicin 5 mg/m2/d d1–4 + Cytarabine 1 g/m2/d d1–4e 2. ATRA 45 mg/m2/d PO + MTZ 10 mg/m2/d d1–5 3. ATRA 45 mg/m2/d PO + Idarubicin 12 mg/m2/d d1 + Cytarabine 150 mg/m2/8h d1–4 |
ATRA 45 mg/m2/day PO d1–15 every 90 days MTX 15 mg/m2/wk IM d15–90 6-MP 50 mg/m2/wk PO d15–90 for 2 years |
Notes:
a
Age adjusted; 1–60 years, 12 mg/m2; 61–70 years, 9 mg/m2; >70 years, 6 mg/m2.
b
Prednisolone 1 mg/kg/day PO on d1–10 or until WCC <1×109/L.
c
ATRA 25 mg/m2/d if ≤20 years.
d
If >70 years Idarubicin 12 mg/m2 d8 omitted.
e
If >60 years no Cytarabine given in consolidation and Idarubicin dose as per intermediate risk patients described in LPA2005 low-int risk protocol.
Abbreviations: Low, low risk patients; Int, intermediate risk patients; MTX, Methotrexate; 6-MP, Mercaptopurine; DNR, Daunorubicin; MTZ, Mitoxantrone; IT, intrathecal; IM, intramuscular; IV, intravenous; PO, per os (orally).