Difference between revisions of "Melanoma, NRAS-mutated"

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=Advanced or metastatic disease, TKI-naive=
 
=Advanced or metastatic disease, TKI-naive=
 
==Binimetinib monotherapy {{#subobject:aa3a2b|Regimen=1}}==
 
==Binimetinib monotherapy {{#subobject:aa3a2b|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:8d6382|Variant=1}}===
 
===Regimen {{#subobject:8d6382|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
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|}
 
|}
 
''Note: dosing is different for BRAF mutations (45 to 60 mg twice per day)''
 
''Note: dosing is different for BRAF mutations (45 to 60 mg twice per day)''
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<div class="toccolours" style="background-color:#fdcdac">
 
====Biomarker eligibility criteria====
 
====Biomarker eligibility criteria====
−
 
 
*Gene: NRAS or BRAF
 
*Gene: NRAS or BRAF
 
*Alteration: mutation [Val600 BRAF]
 
*Alteration: mutation [Val600 BRAF]
−
 
+
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
−
 
 
*[[Binimetinib (Mektovi)]] 45 mg PO twice per day
 
*[[Binimetinib (Mektovi)]] 45 mg PO twice per day
 +
</div></div>
 
===References===
 
===References===
−
 
 
#'''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://doi.org/10.1016/S1470-2045(13)70024-X link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/23414587 PubMed] NCT01320085
 
#'''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://doi.org/10.1016/S1470-2045(13)70024-X link to original article] '''contains dosing details in abstract''' [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://doi.org/10.1016/S1470-2045(17)30180-8 link to original article] '''contains dosing details in abstract'''  [https://pubmed.ncbi.nlm.nih.gov/28284557 PubMed] NCT01763164
 
#'''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://doi.org/10.1016/S1470-2045(17)30180-8 link to original article] '''contains dosing details in abstract'''  [https://pubmed.ncbi.nlm.nih.gov/28284557 PubMed] NCT01763164
−
 
 
==Dacarbazine monotherapy {{#subobject:d3599b|Regimen=1}}==
 
==Dacarbazine monotherapy {{#subobject:d3599b|Regimen=1}}==
−
 
+
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:bede4c|Variant=1}}===
 
===Regimen {{#subobject:bede4c|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
−
 
 
*[[Dacarbazine (DTIC)]] 1000 mg/m<sup>2</sup> IV once on day 1
 
*[[Dacarbazine (DTIC)]] 1000 mg/m<sup>2</sup> IV once on day 1
−
 
 
'''21-day cycles'''
 
'''21-day cycles'''
−
 
+
</div></div>
 
===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://doi.org/10.1016/S1470-2045(17)30180-8 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/28284557 PubMed] NCT01763164
 
#'''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://doi.org/10.1016/S1470-2045(17)30180-8 link to original article] '''contains dosing details in abstract''' [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 12:18, 12 January 2023

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Section editor transclusions 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

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Ascierto et al. 2013 (CMEK162X2201) 2011-2012 Phase 2
Dummer et al. 2017 (NEMO) 2013-2015 Phase 3 (E-switch-ooc) Dacarbazine Superior PFS
Median PFS: 2.8 vs 1.5 mo
(HR 0.62, 95% CI 0.47-0.80)

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 dosing details in abstract 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 dosing details in abstract PubMed NCT01763164

Dacarbazine monotherapy

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Dummer et al. 2017 (NEMO) 2013-2015 Phase 3 (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 dosing details in abstract PubMed NCT01763164
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