Difference between revisions of "Melanoma, NRAS-mutated"
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{| class="wikitable" style="text-align:center; width:50%;" | {| class="wikitable" style="text-align:center; width:50%;" | ||
| − | !colspan="2" align="center" style="color:white; font-size:125%; background-color:#08519c"|'''Section editor''' | + | ! colspan="2" align="center" style="color:white; font-size:125%; background-color:#08519c" |'''Section editor''' |
|- | |- | ||
| − | |style="background-color:#F0F0F0|[[File:Bethbuchbinder.jpg|frameless|upright=0.3|center]] | + | | style="background-color:#F0F0F0" |[[File:Bethbuchbinder.jpg|frameless|upright=0.3|center]] |
|<big>[[User:Bethbuchbinder|Elizabeth Buchbinder, MD]]<br>Dana-Farber Cancer Institute<br>Boston, MA</big><br>[https://www.linkedin.com/in/beth-buchbinder-2a9b994/ LinkedIn] | |<big>[[User:Bethbuchbinder|Elizabeth Buchbinder, MD]]<br>Dana-Farber Cancer Institute<br>Boston, MA</big><br>[https://www.linkedin.com/in/beth-buchbinder-2a9b994/ LinkedIn] | ||
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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 | + | ! style="width: 25%" |Study |
| − | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]] |
| − | !style="width: 25%"|Comparator | + | ! style="width: 25%" |Comparator |
| − | !style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] |
|- | |- | ||
|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(13)70024-X/fulltext Ascierto et al. 2013] | |[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(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)] | ||
| − | |style="background-color:#1a9851"|Phase III (E-switch-ooc) | + | | style="background-color:#1a9851" |Phase III (E-switch-ooc) |
|[[#Dacarbazine_monotherapy|Dacarbazine]] | |[[#Dacarbazine_monotherapy|Dacarbazine]] | ||
| − | |style="background-color:#1a9850"|Superior PFS | + | | style="background-color:#1a9850" |Superior PFS |
|- | |- | ||
|} | |} | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
| − | |||
| − | + | *[[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 | ||
| + | *Alteration: mutation [Val600 BRAF] | ||
| + | |||
| + | <br /> | ||
===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://www.ncbi.nlm.nih.gov/pubmed/23414587 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://www.ncbi.nlm.nih.gov/pubmed/28284557 PubMed] | + | #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://www.ncbi.nlm.nih.gov/pubmed/23414587 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://www.ncbi.nlm.nih.gov/pubmed/28284557 PubMed] | ||
==Dacarbazine monotherapy {{#subobject:d3599b|Regimen=1}}== | ==Dacarbazine monotherapy {{#subobject:d3599b|Regimen=1}}== | ||
| Line 53: | Line 59: | ||
===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: 25%" |Study |
| − | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] | + | ! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]] |
| − | !style="width: 25%"|Comparator | + | ! style="width: 25%" |Comparator |
| − | !style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | + | ! style="width: 25%" |[[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)] | ||
| − | |style="background-color:#1a9851"|Phase III (C) | + | | style="background-color:#1a9851" |Phase III (C) |
|[[#Binimetinib_monotherapy|Binimetinib]] | |[[#Binimetinib_monotherapy|Binimetinib]] | ||
| − | |style="background-color:#d73027"|Inferior PFS | + | | style="background-color:#d73027" |Inferior PFS |
|- | |- | ||
|} | |} | ||
====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 | ||
| Line 70: | Line 77: | ||
===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://www.ncbi.nlm.nih.gov/pubmed/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://www.ncbi.nlm.nih.gov/pubmed/28284557 PubMed] | ||
[[Category:Melanoma regimens]] | [[Category:Melanoma regimens]] | ||
[[Category:Biomarker-specific pages]] | [[Category:Biomarker-specific pages]] | ||
[[Category:Skin cancers]] | [[Category:Skin cancers]] | ||
Revision as of 23:53, 8 January 2020
| Section editor | |
|---|---|
 |
Elizabeth Buchbinder, MD Dana-Farber Cancer Institute Boston, MA |
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
| back to top |
Regimen
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Ascierto et al. 2013 | Phase II | ||
| Dummer et al. 2017 (NEMO) | Phase III (E-switch-ooc) | Dacarbazine | Superior PFS |
Chemotherapy
- 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
- Alteration: mutation [Val600 BRAF]
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. link to original article contains protocol 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. link to original article contains protocol PubMed
Dacarbazine monotherapy
| back to top |
Regimen
| Study | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|
| Dummer et al. 2017 (NEMO) | Phase III (C) | Binimetinib | Inferior PFS |
Chemotherapy
- Dacarbazine (DTIC) 1000 mg/m2 IV once on day 1
21-day cycles
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. link to original article contains protocol PubMed