Difference between revisions of "Melanoma, KIT-mutated"

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! colspan="2" align="center" style="color:white; font-size:125%; background-color:#08519c" |'''Section editor'''
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| style="background-color:#F0F0F0" |[[File:Bethbuchbinder.jpg|frameless|upright=0.3|center]]
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|<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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<big>'''Note: these are regimens tested in biomarker-specific populations, please see the [[Melanoma|main melanoma page]] for other regimens.'''</big>
 
<big>'''Note: these are regimens tested in biomarker-specific populations, please see the [[Melanoma|main melanoma page]] for other regimens.'''</big>
 
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{{TOC limit|limit=3}}
 
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=Guidelines=
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'''Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.'''
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==NCCN==
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*''NCCN does not currently have guidelines at this granular level; please see [https://www.nccn.org/guidelines/guidelines-detail?category=1&id=1492 NCCN Guidelines - Melanoma: Cutaneous].''
 
=Advanced or metastatic disease, TKI-naive=
 
=Advanced or metastatic disease, TKI-naive=
 
==Imatinib monotherapy {{#subobject:8686d5|Regimen=1}}==
 
==Imatinib monotherapy {{#subobject:8686d5|Regimen=1}}==
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<div class="toccolours" style="background-color:#eeeeee">
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|[[#top|back to top]]
 
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===Regimen variant #1, pre-planned escalation {{#subobject:662612|Variant=1}}===
 
===Regimen variant #1, pre-planned escalation {{#subobject:662612|Variant=1}}===
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{| class="wikitable" style="width: 50%; text-align:center;"  
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{| class="wikitable sortable" style="width: 60%; text-align:center;"  
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! style="width: 25%" |Study
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!style="width: 33%"|Study
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! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 33%"|Dates of enrollment
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!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4878082/ Hodi et al. 2013 (BUS255)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4878082/ Hodi et al. 2013 (BUS255)]
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| style="background-color:#91cf61" |Phase II
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|2006-2011
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| style="background-color:#91cf61" |Phase 2
 
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|-
 
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|}
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'''Biomarker eligibility criteria'''
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''Note: upon progression, the dose of imatinib was escalated; see below.''
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<div class="toccolours" style="background-color:#fdcdac">
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====Biomarker eligibility criteria====
 
*Gene: KIT
 
*Gene: KIT
 
*Alteration: amplification and mutation
 
*Alteration: amplification and mutation
 
*Acceptable methods of measurement: PCR or HPLC
 
*Acceptable methods of measurement: PCR or HPLC
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</div>
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====Chemotherapy====
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<div class="toccolours" style="background-color:#b3e2cd">
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====Targeted therapy====
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*[[Imatinib (Gleevec)]] as follows:
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*[[Imatinib (Gleevec)]] 400 mg PO once per day
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**Starting dose: 400 mg PO once per day
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'''Continued indefinitely (see note)'''
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**Upon progression: 400 mg PO twice per day
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</div></div><br>
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<div class="toccolours" style="background-color:#eeeeee">
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'''Continued indefinitely'''
 
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===Regimen variant #2 {{#subobject:d1f61b|Variant=1}}===
 
===Regimen variant #2 {{#subobject:d1f61b|Variant=1}}===
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{| class="wikitable" style="width: 50%; text-align:center;"  
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{| class="wikitable sortable" style="width: 60%; text-align:center;"  
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! style="width: 25%" |Study
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!style="width: 33%"|Study
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! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
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!style="width: 33%"|Dates of enrollment
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!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3986039/ Carvajal et al. 2011]
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3986039/ Carvajal et al. 2011 (MSKCC 07-014)]
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| style="background-color:#91cf61" |Phase II
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|2007-2010
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| style="background-color:#91cf61" |Phase 2
 
|-
 
|-
 
|}
 
|}
 
''Patients had melanomas arising from mucosal, acral, and chronically sun-damaged skin with KIT mutations or amplifications.''
 
''Patients had melanomas arising from mucosal, acral, and chronically sun-damaged skin with KIT mutations or amplifications.''
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====Chemotherapy====
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<div class="toccolours" style="background-color:#fdcdac">
−
 
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====Biomarker eligibility criteria====
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*Gene: KIT
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*Alteration: amplification or mutation
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</div>
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<div class="toccolours" style="background-color:#b3e2cd">
 +
====Targeted therapy====
 
*[[Imatinib (Gleevec)]] 400 mg PO once or twice per day
 
*[[Imatinib (Gleevec)]] 400 mg PO once or twice per day
 +
'''Continued indefinitely'''
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</div></div>
 +
===References===
 +
#'''MSKCC 07-014:''' Carvajal RD, Antonescu CR, Wolchok JD, Chapman PB, Roman RA, Teitcher J, Panageas KS, Busam KJ, Chmielowski B, Lutzky J, Pavlick AC, Fusco A, Cane L, Takebe N, Vemula S, Bouvier N, Bastian BC, Schwartz GK. KIT as a therapeutic target in metastatic melanoma. JAMA. 2011 Jun 8;305(22):2327-34. [https://doi.org/10.1001/jama.2011.746 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3986039/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/21642685/ PubMed] [https://clinicaltrials.gov/study/NCT00470470 NCT00470470]
  
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=Advanced or metastatic disease, TKI-exposed=
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==Imatinib monotherapy {{#subobject:8686d5|Regimen=1}}==
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<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #1, pre-planned escalation {{#subobject:662612|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 60%; text-align:center;"
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!style="width: 33%"|Study
 +
!style="width: 33%"|Dates of enrollment
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!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
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|-
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4878082/ Hodi et al. 2013 (BUS255)]
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|2006-2011
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| style="background-color:#91cf61" |Phase 2
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|-
 +
|}
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<div class="toccolours" style="background-color:#fdcdac">
 +
====Biomarker eligibility criteria====
 +
*Gene: KIT
 +
*Alteration: amplification and mutation
 +
*Acceptable methods of measurement: PCR or HPLC
 +
====Prior treatment criteria====
 +
*[[#Imatinib_monotherapy|Imatinib]] 400 mg/day, with progression
 +
</div>
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<div class="toccolours" style="background-color:#b3e2cd">
 +
====Targeted therapy====
 +
*[[Imatinib (Gleevec)]] 400 mg PO twice per day
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
−
 
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</div></div>
 
===References===
 
===References===
−
 
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#'''BUS255:''' Hodi FS, Corless CL, Giobbie-Hurder A, Fletcher JA, Zhu M, Marino-Enriquez A, Friedlander P, Gonzalez R, Weber JS, Gajewski TF, O'Day SJ, Kim KB, Lawrence D, Flaherty KT, Luke JJ, Collichio FA, Ernstoff MS, Heinrich MC, Beadling C, Zukotynski KA, Yap JT, Van den Abbeele AD, Demetri GD, Fisher DE. Imatinib for Melanomas Harboring Mutationally Activated or Amplified KIT Arising on Mucosal, Acral, and Chronically Sun-Damaged Skin. J Clin Oncol. 2013 Sep 10;31(26):3182-90. Epub 2013 Jun 17. [https://doi.org/10.1200/jco.2012.47.7836 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4878082/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23775962/ PubMed] [https://clinicaltrials.gov/study/NCT00424515 NCT00424515]
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#Carvajal RD, Antonescu CR, Wolchok JD, Chapman PB, Roman RA, Teitcher J, Panageas KS, Busam KJ, Chmielowski B, Lutzky J, Pavlick AC, Fusco A, Cane L, Takebe N, Vemula S, Bouvier N, Bastian BC, Schwartz GK. KIT as a therapeutic target in metastatic melanoma. JAMA. 2011 Jun 8;305(22):2327-34. '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3986039/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/21642685 PubMed]
 
−
#'''BUS255:''' Hodi FS, Corless CL, Giobbie-Hurder A, Fletcher JA, Zhu M, Marino-Enriquez A, Friedlander P, Gonzalez R, Weber JS, Gajewski TF, O'Day SJ, Kim KB, Lawrence D, Flaherty KT, Luke JJ, Collichio FA, Ernstoff MS, Heinrich MC, Beadling C, Zukotynski KA, Yap JT, Van den Abbeele AD, Demetri GD, Fisher DE. Imatinib for Melanomas Harboring Mutationally Activated or Amplified KIT Arising on Mucosal, Acral, and Chronically Sun-Damaged Skin. J Clin Oncol. 2013 Sep 10;31(26):3182-90. Epub 2013 Jun 17. [http://jco.ascopubs.org/content/31/26/3182.long link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4878082/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/23775962 PubMed]
 
  
 
[[Category:Melanoma regimens]]
 
[[Category:Melanoma regimens]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Skin cancers]]
 
[[Category:Skin cancers]]

Latest revision as of 11:22, 13 May 2024

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Page editor Section editor
RyanNguyen.jpg
 Ryan Nguyen, DO
University of Illinois at Chicago
Chicago, IL, USA
LinkedIn
Bethbuchbinder.jpg
 Elizabeth Buchbinder, MD
Dana-Farber Cancer Institute
Boston, MA, USA
LinkedIn

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

1 regimens on this page
2 variants on this page


Guidelines

Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.

NCCN

Advanced or metastatic disease, TKI-naive

Imatinib monotherapy

Regimen variant #1, pre-planned escalation

Study Dates of enrollment Evidence
Hodi et al. 2013 (BUS255) 2006-2011 Phase 2

Note: upon progression, the dose of imatinib was escalated; see below.

Biomarker eligibility criteria

  • Gene: KIT
  • Alteration: amplification and mutation
  • Acceptable methods of measurement: PCR or HPLC

Targeted therapy

Continued indefinitely (see note)


Regimen variant #2

Study Dates of enrollment Evidence
Carvajal et al. 2011 (MSKCC 07-014) 2007-2010 Phase 2

Patients had melanomas arising from mucosal, acral, and chronically sun-damaged skin with KIT mutations or amplifications.

Biomarker eligibility criteria

  • Gene: KIT
  • Alteration: amplification or mutation

Targeted therapy

Continued indefinitely

References

  1. MSKCC 07-014: Carvajal RD, Antonescu CR, Wolchok JD, Chapman PB, Roman RA, Teitcher J, Panageas KS, Busam KJ, Chmielowski B, Lutzky J, Pavlick AC, Fusco A, Cane L, Takebe N, Vemula S, Bouvier N, Bastian BC, Schwartz GK. KIT as a therapeutic target in metastatic melanoma. JAMA. 2011 Jun 8;305(22):2327-34. link to original article contains dosing details in abstract link to PMC article PubMed NCT00470470

Advanced or metastatic disease, TKI-exposed

Imatinib monotherapy

Regimen variant #1, pre-planned escalation

Study Dates of enrollment Evidence
Hodi et al. 2013 (BUS255) 2006-2011 Phase 2

Biomarker eligibility criteria

  • Gene: KIT
  • Alteration: amplification and mutation
  • Acceptable methods of measurement: PCR or HPLC

Prior treatment criteria

Targeted therapy

Continued indefinitely

References

  1. BUS255: Hodi FS, Corless CL, Giobbie-Hurder A, Fletcher JA, Zhu M, Marino-Enriquez A, Friedlander P, Gonzalez R, Weber JS, Gajewski TF, O'Day SJ, Kim KB, Lawrence D, Flaherty KT, Luke JJ, Collichio FA, Ernstoff MS, Heinrich MC, Beadling C, Zukotynski KA, Yap JT, Van den Abbeele AD, Demetri GD, Fisher DE. Imatinib for Melanomas Harboring Mutationally Activated or Amplified KIT Arising on Mucosal, Acral, and Chronically Sun-Damaged Skin. J Clin Oncol. 2013 Sep 10;31(26):3182-90. Epub 2013 Jun 17. link to original article contains dosing details in manuscript link to PMC article PubMed NCT00424515
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