Difference between revisions of "Acute myeloid leukemia, NPM1-mutated"
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Warner-admin (talk | contribs) m (Text replacement - "=Guidelines=" to "=Guidelines= '''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any article published 5+ years ago to be for historical purposes, only.'''") |
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| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
|[[Stub#ICE.2C_ATRA.2C_GO|ICE, ATRA, GO]] | |[[Stub#ICE.2C_ATRA.2C_GO|ICE, ATRA, GO]] | ||
| − | | style="background-color:# | + | | style="background-color:#fee08b" |Might have inferior EFS6<sup>1</sup> (co-primary endpoint) |
|- | |- | ||
|} | |} | ||
| + | ''<sup>1</sup>Reported efficacy is based on the 2023 update.'' | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
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| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
|[[Stub#ICE.2C_ATRA.2C_GO|ICE, ATRA, GO]] | |[[Stub#ICE.2C_ATRA.2C_GO|ICE, ATRA, GO]] | ||
| − | | style="background-color:# | + | | style="background-color:#fee08b" |Might have inferior EFS6<sup>1</sup> (co-primary endpoint) |
|- | |- | ||
|} | |} | ||
| + | ''<sup>1</sup>Reported efficacy is based on the 2023 update.'' | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
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===References=== | ===References=== | ||
# '''AMLSG 09-09:''' Schlenk RF, Paschka P, Krzykalla J, Weber D, Kapp-Schwoerer S, Gaidzik VI, Leis C, Fiedler W, Kindler T, Schroeder T, Mayer K, Lübbert M, Wattad M, Götze K, Horst HA, Koller E, Wulf G, Schleicher J, Bentz M, Greil R, Hertenstein B, Krauter J, Martens U, Nachbaur D, Abu Samra M, Girschikofsky M, Basara N, Benner A, Thol F, Heuser M, Ganser A, Döhner K, Döhner H. Gemtuzumab Ozogamicin in NPM1-Mutated Acute Myeloid Leukemia: Early Results From the Prospective Randomized AMLSG 09-09 Phase III Study. J Clin Oncol. 2020 Feb 20;38(6):623-632. Epub 2019 Dec 18. [https://doi.org/10.1200/JCO.19.01406 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7030890/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31851556/ PubMed] [https://clinicaltrials.gov/study/NCT00893399 NCT00893399] | # '''AMLSG 09-09:''' Schlenk RF, Paschka P, Krzykalla J, Weber D, Kapp-Schwoerer S, Gaidzik VI, Leis C, Fiedler W, Kindler T, Schroeder T, Mayer K, Lübbert M, Wattad M, Götze K, Horst HA, Koller E, Wulf G, Schleicher J, Bentz M, Greil R, Hertenstein B, Krauter J, Martens U, Nachbaur D, Abu Samra M, Girschikofsky M, Basara N, Benner A, Thol F, Heuser M, Ganser A, Döhner K, Döhner H. Gemtuzumab Ozogamicin in NPM1-Mutated Acute Myeloid Leukemia: Early Results From the Prospective Randomized AMLSG 09-09 Phase III Study. J Clin Oncol. 2020 Feb 20;38(6):623-632. Epub 2019 Dec 18. [https://doi.org/10.1200/JCO.19.01406 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7030890/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/31851556/ PubMed] [https://clinicaltrials.gov/study/NCT00893399 NCT00893399] | ||
| + | ##'''Update:''' Döhner H, Weber D, Krzykalla J, Fiedler W, Kühn MWM, Schroeder T, Mayer K, Lübbert M, Wattad M, Götze K, Fransecky L, Koller E, Wulf G, Schleicher J, Ringhoffer M, Greil R, Hertenstein B, Krauter J, Martens UM, Nachbaur D, Samra MA, Machherndl-Spandl S, Basara N, Leis C, Schrade A, Kapp-Schwoerer S, Cocciardi S, Bullinger L, Thol F, Heuser M, Paschka P, Gaidzik VI, Saadati M, Benner A, Schlenk RF, Döhner K, Ganser A; German–Austrian AML Study Group. Intensive chemotherapy with or without gemtuzumab ozogamicin in patients with NPM1-mutated acute myeloid leukaemia (AMLSG 09-09): a randomised, open-label, multicentre, phase 3 trial. Lancet Haematol. 2023 Jul;10(7):e495-e509. Epub 2023 May 12. [https://doi.org/10.1016/s2352-3026(23)00089-3 link to original article] [https://pubmed.ncbi.nlm.nih.gov/37187198/ PubMed] | ||
| + | |||
[[Category:Acute myeloid leukemia regimens]] | [[Category:Acute myeloid leukemia regimens]] | ||
[[Category:Biomarker-specific pages]] | [[Category:Biomarker-specific pages]] | ||
[[Category:Acute leukemias]] | [[Category:Acute leukemias]] | ||
Revision as of 00:46, 31 October 2023
| Section editor | |
|---|---|
 |
Ashwin Kishtagari, MD Vanderbilt University Nashville, TN, USA |
Note: these are regimens tested in biomarker-specific populations for patients with NPM1-mutated AML, please see the main AML page for other regimens.
3 regimens on this page
4 variants on this page
|
Guidelines
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any article published 5+ years ago to be for historical purposes, only.
NCCN
- NCCN does not have guidelines at this granular level; please see NCCN Guidelines - Acute Myeloid Leukemia.
Upfront induction therapy
Cytarabine & Etoposide
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Awaiting publication (AMLSG 15-10) | 2011-NR | Phase 3 (C) | ATRA, Cytarabine, Etoposide | Not available |
Chemotherapy
References
- AMLSG 15-10: NCT01237808
ICE & ATRA
ICE & ATRA: Idarubicin, Cytarabine, Etoposide, All-Trans Retinoic Acid
Regimen variant #1, 60 or younger
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Schlenk et al. 2019 (AMLSG 09-09) | 2010-2017 | Phase 3 (C) | ICE, ATRA, GO | Might have inferior EFS61 (co-primary endpoint) |
1Reported efficacy is based on the 2023 update.
Chemotherapy
- Idarubicin (Idamycin) as follows:
- Cycle 1: 12 mg/m2 IV once per day on days 1, 3, 5
- Cycle 2: 12 mg/m2 IV once per day on days 1 & 3
- Cytarabine (Ara-C) 100 mg/m2/day IV continuous infusion over 7 days, started on day 1 (total dose per cycle: 700 mg/m2)
- Etoposide (Vepesid) as follows:
- Cycle 1: 100 mg/m2 IV once per day on days 1 to 3
- Cycle 2: 100 mg/m2 IV once per day on days 1 & 3
Targeted therapy
- All-trans retinoic acid (ATRA) 45 mg/m2/day PO on days 6 to 8, then 15 mg/m2/day PO on days 9 to 21
2 cycles
Subsequent treatment
- HiDAC & ATRA consolidation
Regimen variant #2, older than 60
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Schlenk et al. 2019 (AMLSG 09-09) | 2010-2017 | Phase 3 (C) | ICE, ATRA, GO | Might have inferior EFS61 (co-primary endpoint) |
1Reported efficacy is based on the 2023 update.
Chemotherapy
- Idarubicin (Idamycin) 12 mg/m2 IV once per day on days 1 & 3
- Cytarabine (Ara-C) 100 mg/m2/day IV continuous infusion over 7 days, started on day 1 (total dose per cycle: 700 mg/m2)
- Etoposide (Vepesid) 100 mg/m2 IV once per day on days 1 & 3
Targeted therapy
- All-trans retinoic acid (ATRA) 45 mg/m2/day PO on days 6 to 8, then 15 mg/m2/day PO on days 9 to 21
2 cycles
Subsequent treatment
- HiDAC & ATRA consolidation
References
- AMLSG 09-09: Schlenk RF, Paschka P, Krzykalla J, Weber D, Kapp-Schwoerer S, Gaidzik VI, Leis C, Fiedler W, Kindler T, Schroeder T, Mayer K, Lübbert M, Wattad M, Götze K, Horst HA, Koller E, Wulf G, Schleicher J, Bentz M, Greil R, Hertenstein B, Krauter J, Martens U, Nachbaur D, Abu Samra M, Girschikofsky M, Basara N, Benner A, Thol F, Heuser M, Ganser A, Döhner K, Döhner H. Gemtuzumab Ozogamicin in NPM1-Mutated Acute Myeloid Leukemia: Early Results From the Prospective Randomized AMLSG 09-09 Phase III Study. J Clin Oncol. 2020 Feb 20;38(6):623-632. Epub 2019 Dec 18. link to original article link to PMC article contains dosing details in manuscript PubMed NCT00893399
- Update: Döhner H, Weber D, Krzykalla J, Fiedler W, Kühn MWM, Schroeder T, Mayer K, Lübbert M, Wattad M, Götze K, Fransecky L, Koller E, Wulf G, Schleicher J, Ringhoffer M, Greil R, Hertenstein B, Krauter J, Martens UM, Nachbaur D, Samra MA, Machherndl-Spandl S, Basara N, Leis C, Schrade A, Kapp-Schwoerer S, Cocciardi S, Bullinger L, Thol F, Heuser M, Paschka P, Gaidzik VI, Saadati M, Benner A, Schlenk RF, Döhner K, Ganser A; German–Austrian AML Study Group. Intensive chemotherapy with or without gemtuzumab ozogamicin in patients with NPM1-mutated acute myeloid leukaemia (AMLSG 09-09): a randomised, open-label, multicentre, phase 3 trial. Lancet Haematol. 2023 Jul;10(7):e495-e509. Epub 2023 May 12. link to original article PubMed