Difference between revisions of "Editing test page"

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m (Text replacement - "(NCT[0-9]{8}) Clinical Trial Registry" to "$1 $1")
m (Replaced content with "==Carboplatin & Paclitaxel (CP) & Nivolumab {{#subobject:3a6hg7|Regimen=1}}== CP & Nivolumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Nivolumab <div class="tocc...")
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==Carboplatin & Paclitaxel (CP) & Nivolumab {{#subobject:3a6hg7|Regimen=1}}==
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<div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px">
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CP & Nivolumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Nivolumab
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[[#top|Back to Top]]
 
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</div>
 
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{{#lst:Section editor transclusions|aml}}
 
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<big>'''Note: these are regimens tested in biomarker-specific populations for patients with NPM1-mutated AML, please see the [[Acute myeloid leukemia|main AML page]] for other regimens.'''</big>
 
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{| class="wikitable" style="float:right; margin-right: 5px;"
 
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|-
 
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|<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div>
 
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<div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div>
 
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|}
 
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{{TOC limit|limit=3}}
 
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=Guidelines=
 
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=="How I Treat"==
 
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*'''2021:''' Falini et al. [https://doi.org/10.1182/blood.2020008211 How I diagnose and treat NPM1-mutated AML]
 
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=Upfront induction therapy=
 
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==Cytarabine & Etoposide {{#subobject:e8gacb|Regimen=1}}==
 
 
<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
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===Regimen {{#subobject:15hvdd|Variant=1}}===
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===Regimen variant #1, 5/175/360 {{#subobject:59hhq7|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
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|[https://www.clinicaltrials.gov/study/NCT01237808 Awaiting publication (AMLSG 15-10)]
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844511/ Forde et al. 2022 (CheckMate 816)]
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|2011-NR
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{| class="wikitable" style="margin:auto; color:black; background-color:#d3d3d3"
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| style="background-color:#1a9851" |Phase 3 (C)
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|[[File:HopeAI.png|link=https://hemonc.org|alt=Alt text|Title=text|frameless|150px|center]]
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|[[Stub#ATRA.2C_Cytarabine.2C_Etoposide|ATRA, Cytarabine, Etoposide]]
 
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| style="background-color:#d3d3d3" |Not available
 
 
|-
 
|-
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|}
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|Click to learn more!
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<div class="toccolours" style="background-color:#b3e2cd">
 
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====Chemotherapy====
 
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*[[Cytarabine (Ara-C)]]
 
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*[[Etoposide (Vepesid)]]
 
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</div></div>
 
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===References===
 
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#'''AMLSG 15-10:''' [https://clinicaltrials.gov/study/NCT01237808 NCT01237808]
 
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==ICE & ATRA {{#subobject:e82156|Regimen=1}}==
 
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ICE & ATRA: '''<u>I</u>'''darubicin, '''<u>C</u>'''ytarabine, '''<u>E</u>'''toposide, '''<u>A</u>'''ll-'''<u>T</u>'''rans '''<u>R</u>'''etinoic '''<u>A</u>'''cid
 
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<div class="toccolours" style="background-color:#eeeeee">
 
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===Regimen variant #1, 60 or younger {{#subobject:cf53dd|Variant=1}}===
 
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{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
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!style="width: 20%"|Study
 
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!style="width: 20%"|Dates of enrollment
 
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!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
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!style="width: 20%"|Comparator
 
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
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|-
 
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7030890/ Schlenk et al. 2019 (AMLSG 09-09)]
 
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|2010-2017
 
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| style="background-color:#1a9851" |Phase 3 (C)
 
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|[[#ICE.2C_ATRA.2C_GO_999|ICE, ATRA, GO]]
 
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| style="background-color:#ffffbf" |Did not meet primary endpoint of EFS
 
 
|-
 
|-
 
|}
 
|}
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<div class="toccolours" style="background-color:#b3e2cd">
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|2017-2019
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====Chemotherapy====
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| style="background-color:#1a9851" |Phase 3 (E-RT-esc)
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*[[Idarubicin (Idamycin)]] as follows:
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|1a. [[#Carboplatin_.26_Paclitaxel_.28CP.29|CP]]<br>1b. [[#Cisplatin_.26_Vinorelbine_.28CVb.29|CVb]]<br>1c. [[#Cisplatin_.26_Docetaxel_.28DC.29|DC]]
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**Cycle 1: 12 mg/m<sup>2</sup> IV once per day on days 1, 3, 5
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| style="background-color:#1a9850" |Superior EFS (co-primary endpoint)<br>Median EFS: 31.6 vs 20.8 mo<br>(HR 0.63, 97.38% CI 0.43-0.91)<br><br>Superior pCR rate (co-primary endpoint)<br>pCR rate: 24% vs 2.2%<br>(OR 13.94, 99% CI 3.49-55.75)
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**Cycle 2: 12 mg/m<sup>2</sup> IV once per day on days 1 & 3
 
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*[[Cytarabine (Ara-C)]] 100 mg/m<sup>2</sup>/day IV continuous infusion over 7 days, started on day 1 (total dose per cycle: 700 mg/m<sup>2</sup>)
 
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*[[Etoposide (Vepesid)]] as follows:
 
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**Cycle 1: 100 mg/m<sup>2</sup> IV once per day on days 1 to 3
 
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**Cycle 2: 100 mg/m<sup>2</sup> IV once per day on days 1 & 3
 
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====Targeted therapy====
 
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*[[All-trans retinoic acid (ATRA)]] 45 mg/m<sup>2</sup>/day PO on days 6 to 8, then 15 mg/m<sup>2</sup>/day PO on days 9 to 21
 
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'''2 cycles'''
 
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</div>
 
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<div class="toccolours" style="background-color:#cbd5e7">
 
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====Subsequent treatment====
 
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*[[#HiDAC_.26_ATRA_888|HiDAC & ATRA]] consolidation
 
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</div></div><br>
 
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<div class="toccolours" style="background-color:#eeeeee">
 
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===Regimen variant #2, older than 60 {{#subobject:cfghcd|Variant=1}}===
 
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{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
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!style="width: 20%"|Study
 
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!style="width: 20%"|Dates of enrollment
 
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!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
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!style="width: 20%"|Comparator
 
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
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|-
 
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7030890/ Schlenk et al. 2019 (AMLSG 09-09)]
 
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|2010-2017
 
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| style="background-color:#1a9851" |Phase 3 (C)
 
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|[[#ICE.2C_ATRA.2C_GO_999|ICE, ATRA, GO]]
 
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| style="background-color:#ffffbf" |Did not meet primary endpoint of EFS
 
 
|-
 
|-
 
|}
 
|}
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<div class="toccolours" style="background-color:#b3e2cd">
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''Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.''
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====Chemotherapy====
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<div class="toccolours" style="background-color:#fdcdac">
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*[[Idarubicin (Idamycin)]] 12 mg/m<sup>2</sup> IV once per day on days 1 & 3
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====Biomarker eligibility criteria====
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*[[Cytarabine (Ara-C)]] 100 mg/m<sup>2</sup>/day IV continuous infusion over 7 days, started on day 1 (total dose per cycle: 700 mg/m<sup>2</sup>)
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*CheckMate 816: No sensitizing EGFR or ALK mutations
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*[[Etoposide (Vepesid)]] 100 mg/m<sup>2</sup> IV once per day on days 1 & 3
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</div></div>
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====Targeted therapy====
 
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*[[All-trans retinoic acid (ATRA)]] 45 mg/m<sup>2</sup>/day PO on days 6 to 8, then 15 mg/m<sup>2</sup>/day PO on days 9 to 21
 
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'''2 cycles'''
 
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</div>
 
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<div class="toccolours" style="background-color:#cbd5e7">
 
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====Subsequent treatment====
 
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*[[#HiDAC_.26_ATRA_888|HiDAC & ATRA]] consolidation
 
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</div>
 
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===References===
 
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# '''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/XCT00893399 clinical trial link]
 
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[[Category:Acute myeloid leukemia regimens]]
 
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[[Category:Biomarker-specific pages]]
 
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[[Category:Acute leukemias]]
 

Latest revision as of 12:58, 18 July 2024

Carboplatin & Paclitaxel (CP) & Nivolumab

CP & Nivolumab: Carboplatin, Paclitaxel, Nivolumab

Regimen variant #1, 5/175/360

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Forde et al. 2022 (CheckMate 816)
Alt text
Click to learn more!
2017-2019 Phase 3 (E-RT-esc) 1a. CP
1b. CVb
1c. DC 		Superior EFS (co-primary endpoint)
Median EFS: 31.6 vs 20.8 mo
(HR 0.63, 97.38% CI 0.43-0.91)

Superior pCR rate (co-primary endpoint)
pCR rate: 24% vs 2.2%
(OR 13.94, 99% CI 3.49-55.75)

Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.

Biomarker eligibility criteria

  • CheckMate 816: No sensitizing EGFR or ALK mutations
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