Difference between revisions of "Melanoma, NRAS-mutated"

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===Regimen {{#subobject:8d6382|Variant=1}}===
 
===Regimen {{#subobject:8d6382|Variant=1}}===
 
{| class="wikitable" style="width: 100%; text-align:center;"  
 
{| class="wikitable" style="width: 100%; text-align:center;"  
−
! style="width: 25%" |Study
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!style="width: 20%"|Study
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! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 20%"|Years of enrollment
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! style="width: 25%" |Comparator
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!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
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!style="width: 20%"|Comparator
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!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
−
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70024-X/fulltext Ascierto et al. 2013]
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|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70024-X/fulltext Ascierto et al. 2013 (CMEK162X2201)]
 +
|2011-2012
 
| style="background-color:#91cf61" |Phase II
 
| style="background-color:#91cf61" |Phase II
 
| style="background-color:#d3d3d3" |
 
| style="background-color:#d3d3d3" |
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|-
 
|-
 
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30180-8/fulltext Dummer et al. 2017 (NEMO)]
 
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30180-8/fulltext Dummer et al. 2017 (NEMO)]
 +
|2013-2015
 
| style="background-color:#1a9851" |Phase III (E-switch-ooc)
 
| style="background-color:#1a9851" |Phase III (E-switch-ooc)
 
|[[#Dacarbazine_monotherapy|Dacarbazine]]
 
|[[#Dacarbazine_monotherapy|Dacarbazine]]
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|-
 
|-
 
|}
 
|}
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====Chemotherapy====
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''Note: dosing is different for BRAF mutations (45 to 60 mg twice per day)''
−
 
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====Biomarker eligibility criteria====
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*[[Binimetinib (Mektovi)]] 45 mg PO twice per day for NRAS mutation; 45-60 mg twice a day for BRAF mutations
 
−
 
 
−
'''Biomarker eligibility criteria'''
 
  
 
*Gene: NRAS or BRAF
 
*Gene: NRAS or BRAF
 
*Alteration: mutation [Val600 BRAF]
 
*Alteration: mutation [Val600 BRAF]
  
−
<br />
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====Targeted therapy====
 +
 
 +
*[[Binimetinib (Mektovi)]] 45 mg PO twice per day
 
===References===
 
===References===
  
−
#Ascierto PA, Schadendorf D, Berking C, Agarwala SS, van Herpen CM, Queirolo P, Blank CU, Hauschild A, Beck JT, St-Pierre A, Niazi F, Wandel S, Peters M, Zubel A, Dummer R. MEK162 for patients with advanced melanoma harbouring NRAS or Val600 BRAF mutations: a non-randomised, open-label phase 2 study. Lancet Oncol. 2013 Mar;14(3):249-56. Epub 2013 Feb 13. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70024-X/fulltext link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/23414587 PubMed]
+
#'''CMEK162X2201:''' Ascierto PA, Schadendorf D, Berking C, Agarwala SS, van Herpen CM, Queirolo P, Blank CU, Hauschild A, Beck JT, St-Pierre A, Niazi F, Wandel S, Peters M, Zubel A, Dummer R. MEK162 for patients with advanced melanoma harbouring NRAS or Val600 BRAF mutations: a non-randomised, open-label phase 2 study. Lancet Oncol. 2013 Mar;14(3):249-56. Epub 2013 Feb 13. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70024-X/fulltext link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/23414587 PubMed] NCT01320085
−
#'''NEMO:''' Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, Rutkowski P, Del Vecchio M, Gutzmer R, Mandala M, Thomas L, Demidov L, Garbe C, Hogg D, Liszkay G, Queirolo P, Wasserman E, Ford J, Weill M, Sirulnik LA, Jehl V, Bozón V, Long GV, Flaherty K. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):435-445. Epub 2017 Mar 8. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30180-8/fulltext link to original article] '''contains protocol'''  [https://pubmed.ncbi.nlm.nih.gov/28284557 PubMed]
+
#'''NEMO:''' Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, Rutkowski P, Del Vecchio M, Gutzmer R, Mandala M, Thomas L, Demidov L, Garbe C, Hogg D, Liszkay G, Queirolo P, Wasserman E, Ford J, Weill M, Sirulnik LA, Jehl V, Bozón V, Long GV, Flaherty K. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):435-445. Epub 2017 Mar 8. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30180-8/fulltext link to original article] '''contains protocol'''  [https://pubmed.ncbi.nlm.nih.gov/28284557 PubMed] NCT01763164
  
 
==Dacarbazine monotherapy {{#subobject:d3599b|Regimen=1}}==
 
==Dacarbazine monotherapy {{#subobject:d3599b|Regimen=1}}==
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===Regimen {{#subobject:bede4c|Variant=1}}===
 
===Regimen {{#subobject:bede4c|Variant=1}}===
 
{| class="wikitable" style="width: 100%; text-align:center;"  
 
{| class="wikitable" style="width: 100%; text-align:center;"  
−
! style="width: 25%" |Study
+
!style="width: 20%"|Study
−
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 20%"|Years of enrollment
−
! style="width: 25%" |Comparator
+
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
−
! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
+
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
 
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30180-8/fulltext Dummer et al. 2017 (NEMO)]
 
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30180-8/fulltext Dummer et al. 2017 (NEMO)]
 +
|2013-2015
 
| style="background-color:#1a9851" |Phase III (C)
 
| style="background-color:#1a9851" |Phase III (C)
 
|[[#Binimetinib_monotherapy|Binimetinib]]
 
|[[#Binimetinib_monotherapy|Binimetinib]]
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===References===
 
===References===
  
−
#'''NEMO:''' Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, Rutkowski P, Del Vecchio M, Gutzmer R, Mandala M, Thomas L, Demidov L, Garbe C, Hogg D, Liszkay G, Queirolo P, Wasserman E, Ford J, Weill M, Sirulnik LA, Jehl V, Bozón V, Long GV, Flaherty K. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):435-445. Epub 2017 Mar 8. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30180-8/fulltext link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/28284557 PubMed]
+
#'''NEMO:''' Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, Rutkowski P, Del Vecchio M, Gutzmer R, Mandala M, Thomas L, Demidov L, Garbe C, Hogg D, Liszkay G, Queirolo P, Wasserman E, Ford J, Weill M, Sirulnik LA, Jehl V, Bozón V, Long GV, Flaherty K. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):435-445. Epub 2017 Mar 8. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30180-8/fulltext link to original article] '''contains protocol''' [https://pubmed.ncbi.nlm.nih.gov/28284557 PubMed] NCT01763164
  
 
[[Category:Melanoma regimens]]
 
[[Category:Melanoma regimens]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Skin cancers]]
 
[[Category:Skin cancers]]

Revision as of 19:17, 29 July 2020

Section editor
Bethbuchbinder.jpg
 Elizabeth Buchbinder, MD
Dana-Farber Cancer Institute
Boston, MA
LinkedIn

Note: these are regimens tested in biomarker-specific populations, please see the main melanoma page for other regimens.

2 regimens on this page
2 variants on this page


Advanced or metastatic disease, TKI-naive

Binimetinib monotherapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Ascierto et al. 2013 (CMEK162X2201) 2011-2012 Phase II
Dummer et al. 2017 (NEMO) 2013-2015 Phase III (E-switch-ooc) Dacarbazine Superior PFS

Note: dosing is different for BRAF mutations (45 to 60 mg twice per day)

Biomarker eligibility criteria

  • Gene: NRAS or BRAF
  • Alteration: mutation [Val600 BRAF]

Targeted therapy

References

  1. CMEK162X2201: Ascierto PA, Schadendorf D, Berking C, Agarwala SS, van Herpen CM, Queirolo P, Blank CU, Hauschild A, Beck JT, St-Pierre A, Niazi F, Wandel S, Peters M, Zubel A, Dummer R. MEK162 for patients with advanced melanoma harbouring NRAS or Val600 BRAF mutations: a non-randomised, open-label phase 2 study. Lancet Oncol. 2013 Mar;14(3):249-56. Epub 2013 Feb 13. link to original article contains protocol PubMed NCT01320085
  2. NEMO: Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, Rutkowski P, Del Vecchio M, Gutzmer R, Mandala M, Thomas L, Demidov L, Garbe C, Hogg D, Liszkay G, Queirolo P, Wasserman E, Ford J, Weill M, Sirulnik LA, Jehl V, Bozón V, Long GV, Flaherty K. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):435-445. Epub 2017 Mar 8. link to original article contains protocol PubMed NCT01763164

Dacarbazine monotherapy

back to top

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Dummer et al. 2017 (NEMO) 2013-2015 Phase III (C) Binimetinib Inferior PFS

Chemotherapy

21-day cycles

References

  1. NEMO: Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, Rutkowski P, Del Vecchio M, Gutzmer R, Mandala M, Thomas L, Demidov L, Garbe C, Hogg D, Liszkay G, Queirolo P, Wasserman E, Ford J, Weill M, Sirulnik LA, Jehl V, Bozón V, Long GV, Flaherty K. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):435-445. Epub 2017 Mar 8. link to original article contains protocol PubMed NCT01763164
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