Difference between revisions of "Acute myeloid leukemia, IDH-mutated"
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Warner-admin (talk | contribs) m (Text replacement - "{| class="wikitable" style="width: 100%; text-align:center;" !style="width: 33%"|Study !style="width: 33%"|Evidence !style="width: 33%"|Efficacy" to "{| class="wikitable" style="width: 75%; text-align:center;" !style="width: 33%"|Study !style="width: 33%"|Evidence !style="width: 33%"|Efficacy") |
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| + | =IDH1 first-line induction therapy, older or 'unfit' patients= | ||
| + | ==Ivosidenib monotherapy {{#subobject:b11758|Regimen=1}}== | ||
| + | {| class="wikitable" style="float:right; margin-left: 5px;" | ||
| + | |- | ||
| + | |[[#top|back to top]] | ||
| + | |} | ||
| + | ===Regimen {{#subobject:40a68c|Variant=1}}=== | ||
| + | {| class="wikitable" style="color:white; background-color:#404040" | ||
| + | |<small>'''FDA-recommended dose'''</small> | ||
| + | |- | ||
| + | |} | ||
| + | {| class="wikitable" style="width: 50%; text-align:center;" | ||
| + | !style="width: 25%"|Study | ||
| + | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | |- | ||
| + | |[https://www.nejm.org/doi/10.1056/NEJMoa1716984 DiNardo et al. 2018 (AG120-C-001)] | ||
| + | | style="background-color:#91cf61" |Phase I/II | ||
| + | |- | ||
| + | |} | ||
| + | ====Chemotherapy==== | ||
| + | *[[Ivosidenib (Tibsovo)]] 500 mg PO once per day | ||
| + | |||
| + | '''Continued indefinitely''' | ||
| + | ===References=== | ||
| + | # '''AG120-C-001:''' DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, Swords R, Collins RH, Mannis GN, Pollyea DA, Donnellan W, Fathi AT, Pigneux A, Erba HP, Prince GT, Stein AS, Uy GL, Foran JM, Traer E, Stuart RK, Arellano ML, Slack JL, Sekeres MA, Willekens C, Choe S, Wang H, Zhang V, Yen KE, Kapsalis SM, Yang H, Dai D, Fan B, Goldwasser M, Liu H, Agresta S, Wu B, Attar EC, Tallman MS, Stone RM, Kantarjian HM. Durable remissions with ivosidenib in IDH1-mutated relapsed or refractory AML. N Engl J Med. 2018 Jun 21;378(25):2386-2398. Epub 2018 Jun 2. [https://www.nejm.org/doi/10.1056/NEJMoa1716984 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/29860938 PubMed] [https://clinicaltrials.gov/ct2/show/NCT02074839 NCT02074839] | ||
| + | |||
=IDH1 relapsed or refractory, salvage therapy= | =IDH1 relapsed or refractory, salvage therapy= | ||
==Ivosidenib monotherapy {{#subobject:214f83|Regimen=1}}== | ==Ivosidenib monotherapy {{#subobject:214f83|Regimen=1}}== | ||
Revision as of 13:22, 6 June 2019
| Section editor | |
|---|---|
 |
Martin W. Schoen, MD, MPH Saint Louis University St. Louis, MO  mwschoen
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Note: these are biomarker-specific regimens for patients with IDH-mutated AML, please see the main AML page for other regimens.
8 regimens on this page
8 variants on this page
|
IDH1 first-line induction therapy, older or 'unfit' patients
Ivosidenib monotherapy
| back to top |
Regimen
| FDA-recommended dose |
| Study | Evidence |
|---|---|
| DiNardo et al. 2018 (AG120-C-001) | Phase I/II |
Chemotherapy
- Ivosidenib (Tibsovo) 500 mg PO once per day
Continued indefinitely
References
- AG120-C-001: DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, Swords R, Collins RH, Mannis GN, Pollyea DA, Donnellan W, Fathi AT, Pigneux A, Erba HP, Prince GT, Stein AS, Uy GL, Foran JM, Traer E, Stuart RK, Arellano ML, Slack JL, Sekeres MA, Willekens C, Choe S, Wang H, Zhang V, Yen KE, Kapsalis SM, Yang H, Dai D, Fan B, Goldwasser M, Liu H, Agresta S, Wu B, Attar EC, Tallman MS, Stone RM, Kantarjian HM. Durable remissions with ivosidenib in IDH1-mutated relapsed or refractory AML. N Engl J Med. 2018 Jun 21;378(25):2386-2398. Epub 2018 Jun 2. link to original article contains protocol PubMed NCT02074839
IDH1 relapsed or refractory, salvage therapy
Ivosidenib monotherapy
| back to top |
Regimen
| FDA-recommended dose |
| Study | Evidence |
|---|---|
| DiNardo et al. 2018 (AG120-C-001) | Phase I/II |
Chemotherapy
- Ivosidenib (Tibsovo) 500 mg PO once per day
Continued indefinitely
References
- AG120-C-001: DiNardo CD, Stein EM, de Botton S, Roboz GJ, Altman JK, Mims AS, Swords R, Collins RH, Mannis GN, Pollyea DA, Donnellan W, Fathi AT, Pigneux A, Erba HP, Prince GT, Stein AS, Uy GL, Foran JM, Traer E, Stuart RK, Arellano ML, Slack JL, Sekeres MA, Willekens C, Choe S, Wang H, Zhang V, Yen KE, Kapsalis SM, Yang H, Dai D, Fan B, Goldwasser M, Liu H, Agresta S, Wu B, Attar EC, Tallman MS, Stone RM, Kantarjian HM. Durable remissions with ivosidenib in IDH1-mutated relapsed or refractory AML. N Engl J Med. 2018 Jun 21;378(25):2386-2398. Epub 2018 Jun 2. link to original article contains protocol PubMed
IDH2 Relapsed or refractory, salvage therapy
Enasidenib monotherapy
| back to top |
Regimen
| FDA-recommended dose |
| Study | Evidence | Efficacy |
|---|---|---|
| Stein et al. 2017 (AG-221-C-001) | Phase I/II | ORR: 40% |
This is the dose used in the phase II expansion cohort; enrolled patients were required to have IDH2-mutated advanced myeloid malignancies.
Chemotherapy
- Enasidenib (Idhifa) 100 mg PO once per day
28-day cycles
References
- AG-221-C-001: Stein EM, DiNardo CD, Pollyea DA, Fathi AT, Roboz GJ, Altman JK, Stone RM, DeAngelo DJ, Levine RL, Flinn IW, Kantarjian HM, Collins R, Patel MR, Frankel AE, Stein A, Sekeres MA, Swords RT, Medeiros BC, Willekens C, Vyas P, Tosolini A, Xu Q, Knight RD, Yen KE, Agresta S, de Botton S, Tallman MS. Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia. Blood. 2017 Aug 10;130(6):722-731. Epub 2017 Jun 6. link to original article contains verified protocol link to PMC article PubMed