Difference between revisions of "Malignant solid neoplasm, BRAF-mutated"

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'''Note: most other regimen pages are tissue-specific. We will collect published information from basket trials on these pages, as well as regimens that are FDA approved.'''
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'''Note: this is a new type of page for HemOnc.org, as most other regimen pages are tissue-specific. We will collect published information from basket trials on these pages, as well as regimens that are FDA approved.'''
 
 
=All lines of therapy=
 
=All lines of therapy=
 
==Dabrafenib & Trametinib {{#subobject:b078c2|Regimen=1}}==
 
==Dabrafenib & Trametinib {{#subobject:b078c2|Regimen=1}}==
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|[[#top|back to top]]
 
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===Regimen {{#subobject:e03f2c|Variant=1}}===
 
===Regimen {{#subobject:e03f2c|Variant=1}}===
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{| class="wikitable" style="width: 50%; text-align:center;"  
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{| class="wikitable" style="width: 40%; 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]]
 
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791845/ Subbiah et al. 2017 (BRF117019)]
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7676884/ Salama et al. 2020 (EAY131-H)]
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| style="background-color:#91cf61" |Phase II
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| style="background-color:#91cf61" |Non-randomized
 
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''Note: only partial results have been published to date.''
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<div class="toccolours" style="background-color:#fdcdac">
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====Biomarker eligibility criteria====
 
====Biomarker eligibility criteria====
 
*Gene: BRAF V600E
 
*Gene: BRAF V600E
 
*Alteration: [[Biomarkers#Substitution|substitution]]
 
*Alteration: [[Biomarkers#Substitution|substitution]]
 
*Acceptable methods of measurement: archival or fresh tumor tissue
 
*Acceptable methods of measurement: archival or fresh tumor tissue
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====Prior treatment criteria====
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====Preceding treatment====
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*No prior treatment with [[:Category:BRAF inhibitors|BRAF]] and/or [[:Category:MEK inhibitors|MEK]] inhibitor(s)
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*No prior treatment with [[Category:BRAF inhibitors|BRAF]] and/or [[Category:MEK inhibitors|MEK]] inhibitor(s)
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</div>
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<div class="toccolours" style="background-color:#b3e2cd">
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====Chemotherapy====
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====Targeted therapy====
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*[[Dabrafenib (Tafinlar)]] 150 mg PO twice per day on days 1 to 28
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*[[Dabrafenib (Tafinlar)]] 150 mg PO twice per day
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*[[Trametinib (Mekinist)]] 2 mg PO once per day on days 1 to 28
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*[[Trametinib (Mekinist)]] 2 mg PO once per day
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'''28-day cycles'''
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</div></div>
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'''Eligibility criteria'''
 
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Gene: BRAF
 
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Alteration: mutation
 
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===References===
 
===References===
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#'''EAY131-H:''' Salama AKS, Li S, Macrae ER, Park JI, Mitchell EP, Zwiebel JA, Chen HX, Gray RJ, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Armstrong DK, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Dabrafenib and Trametinib in Patients With Tumors With BRAFV600E Mutations: Results of the NCI-MATCH Trial Subprotocol H. J Clin Oncol. 2020 Nov 20;38(33):3895-3904. Epub 2020 Aug 6. [https://doi.org/10.1200/jco.20.00762 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7676884/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32758030/ PubMed] [https://clinicaltrials.gov/study/NCT02465060 NCT02465060]
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#'''BRF117019:''' Subbiah V, Kreitman RJ, Wainberg ZA, Cho JY, Schellens JHM, Soria JC, Wen PY, Zielinski C, Cabanillas ME, Urbanowitz G, Mookerjee B, Wang D, Rangwala F, Keam B. Dabrafenib and trametinib treatment in patients with locally advanced or metastatic BRAF V600-mutant anaplastic thyroid cancer. J Clin Oncol. 2018 Jan 1;36(1):7-13. Epub 2017 Oct 26. [https://ascopubs.org/doi/full/10.1200/JCO.2017.73.6785 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791845/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/29072975 PubMed]
 
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==Vemurafenib monotherapy {{#subobject:e0d17a|Regimen=1}}==
 
==Vemurafenib monotherapy {{#subobject:e0d17a|Regimen=1}}==
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<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:392a4b|Variant=1}}===
 
===Regimen {{#subobject:392a4b|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/PMC4971773/ Hyman et al. 2015 (VE-BASKET)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4971773/ Hyman et al. 2015 (VE-BASKET)]
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| style="background-color:#91cf61" |Phase II
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|2012-2014
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| style="background-color:#91cf61" |Phase 2
 
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|-
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|[https://ascopubs.org/doi/full/10.1200/JCO.2017.75.3780 Hainsworth et al. 2018 (MyPathway)]
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|[https://doi.org/10.1200/JCO.2017.75.3780 Hainsworth et al. 2018 (MyPathway)]
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| style="background-color:#91cf61" |Phase IIa
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|2014-2016
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| style="background-color:#91cf61" |Phase 2a
 
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|-
 
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|}
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====Eligibility criteria====
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<div class="toccolours" style="background-color:#fdcdac">
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====Biomarker eligibility criteria====
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*VE-BASKET: BRAF p.V600 mutations
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*VE-BASKET:
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*MyPathway: BRAF p.V600E mutation without coexisting KRAS mutations, or other BRAF mutations
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**Gene: BRAF V600  
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**Alteration: [[Biomarkers#Substitution|substitution]]
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====Chemotherapy====
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**Acceptable methods of measurement: mutational analysis assays
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*MyPathway:
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*[https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s012lbl.pdf Vemurafenib (Zelboraf)] 960 mg PO twice per day
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**Gene: BRAF V600E  
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**Alteration: [[Biomarkers#Substitution|substitution]]
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**Acceptable methods of measurement: molecular profiling performed on tissue obtained at the most recent tumor biopsy
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**Biomarker exclusions: no coexisting KRAS mutations, or other BRAF mutations
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====Prior treatment criteria====
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*VE-BASKET: no prior treatment with [[:Category:BRAF inhibitors|BRAF]] and/or [[:Category:MEK inhibitors|MEK]] inhibitor(s)
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</div>
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<div class="toccolours" style="background-color:#b3e2cd">
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====Targeted therapy====
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*[[Vemurafenib (Zelboraf)]] 960 mg PO twice per day
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
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</div></div>
 
===References===
 
===References===
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#'''VE-BASKET:''' Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in multiple nonmelanoma cancers with BRAF V600 mutations. N Engl J Med. 2015 Aug 20;373(8):726-736. [https://doi.org/10.1056/NEJMoa1502309 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4971773/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26287849/ PubMed] [https://clinicaltrials.gov/study/NCT01524978 NCT01524978]
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#'''VE-BASKET:''' Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in multiple nonmelanoma cancers with BRAF V600 mutations. N Engl J Med. 2015 Aug 20;373(8):726-736. [https://www.nejm.org/doi/full/10.1056/NEJMoa1502309 link to original article] '''contains protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4971773/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/26287849 PubMed]
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#'''MyPathway:''' Hainsworth JD, Meric-Bernstam F, Swanton C, Hurwitz H, Spigel DR, Sweeney C, Burris H, Bose R, Yoo B, Stein A, Beattie M, Kurzrock R. Targeted therapy for advanced solid tumors on the basis of molecular profiles: results from MyPathway, an open-label, phase IIa multiple basket study. J Clin Oncol. 2018 Feb 20;36(6):536-542. Epub 2018 Jan 10. [https://doi.org/10.1200/JCO.2017.75.3780 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29320312/ PubMed] [https://clinicaltrials.gov/study/NCT02091141 NCT02091141]
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#'''MyPathway:''' Hainsworth JD, Meric-Bernstam F, Swanton C, Hurwitz H, Spigel DR, Sweeney C, Burris H, Bose R, Yoo B, Stein A, Beattie M, Kurzrock R. Targeted therapy for advanced solid tumors on the basis of molecular profiles: results from MyPathway, an open-label, phase IIa multiple basket study. J Clin Oncol. 2018 Feb 20;36(6):536-542. Epub 2018 Jan 10. [https://ascopubs.org/doi/full/10.1200/JCO.2017.75.3780 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/29320312 PubMed]
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[[Category:Malignant solid neoplasm, BRAF-mutated regimens]]
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[[Category:BRAF regimens]]
 
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]
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[[Category:Site-agnostic regimens]]
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[[Category:Malignant solid neoplasm]]

Latest revision as of 22:25, 16 January 2024

Back to Top

2 regimens on this page
2 variants on this page


Note: most other regimen pages are tissue-specific. We will collect published information from basket trials on these pages, as well as regimens that are FDA approved.

All lines of therapy

Dabrafenib & Trametinib

Regimen

Study Evidence
Salama et al. 2020 (EAY131-H) Non-randomized

Biomarker eligibility criteria

  • Gene: BRAF V600E
  • Alteration: substitution
  • Acceptable methods of measurement: archival or fresh tumor tissue

Prior treatment criteria

  • No prior treatment with BRAF and/or MEK inhibitor(s)

Targeted therapy

28-day cycles

References

  1. EAY131-H: Salama AKS, Li S, Macrae ER, Park JI, Mitchell EP, Zwiebel JA, Chen HX, Gray RJ, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Armstrong DK, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Dabrafenib and Trametinib in Patients With Tumors With BRAFV600E Mutations: Results of the NCI-MATCH Trial Subprotocol H. J Clin Oncol. 2020 Nov 20;38(33):3895-3904. Epub 2020 Aug 6. link to original article link to PMC article contains dosing details in manuscript PubMed NCT02465060

Vemurafenib monotherapy

Regimen

Study Dates of enrollment Evidence
Hyman et al. 2015 (VE-BASKET) 2012-2014 Phase 2
Hainsworth et al. 2018 (MyPathway) 2014-2016 Phase 2a

Biomarker eligibility criteria

  • VE-BASKET:
    • Gene: BRAF V600
    • Alteration: substitution
    • Acceptable methods of measurement: mutational analysis assays
  • MyPathway:
    • Gene: BRAF V600E
    • Alteration: substitution
    • Acceptable methods of measurement: molecular profiling performed on tissue obtained at the most recent tumor biopsy
    • Biomarker exclusions: no coexisting KRAS mutations, or other BRAF mutations

Prior treatment criteria

  • VE-BASKET: no prior treatment with BRAF and/or MEK inhibitor(s)

Targeted therapy

Continued indefinitely

References

  1. VE-BASKET: Hyman DM, Puzanov I, Subbiah V, Faris JE, Chau I, Blay JY, Wolf J, Raje NS, Diamond EL, Hollebecque A, Gervais R, Elez-Fernandez ME, Italiano A, Hofheinz RD, Hidalgo M, Chan E, Schuler M, Lasserre SF, Makrutzki M, Sirzen F, Veronese ML, Tabernero J, Baselga J. Vemurafenib in multiple nonmelanoma cancers with BRAF V600 mutations. N Engl J Med. 2015 Aug 20;373(8):726-736. link to original article contains dosing details in abstract link to PMC article PubMed NCT01524978
  2. MyPathway: Hainsworth JD, Meric-Bernstam F, Swanton C, Hurwitz H, Spigel DR, Sweeney C, Burris H, Bose R, Yoo B, Stein A, Beattie M, Kurzrock R. Targeted therapy for advanced solid tumors on the basis of molecular profiles: results from MyPathway, an open-label, phase IIa multiple basket study. J Clin Oncol. 2018 Feb 20;36(6):536-542. Epub 2018 Jan 10. link to original article contains dosing details in manuscript PubMed NCT02091141
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