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

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<div class="toccolours" style="background-color:#eeeeee">
 
<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:e03f2c|Variant=1}}===
 
===Regimen {{#subobject:e03f2c|Variant=1}}===
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{| class="wikitable" style="width: 40%; 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/PMC7676884/ Salama et al. 2020 (EAY131-H)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7676884/ Salama et al. 2020 (EAY131-H)]
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|2015-08 to 2018-02
 
| style="background-color:#91cf61" |Non-randomized
 
| style="background-color:#91cf61" |Non-randomized
 
|-
 
|-
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<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
−
*[[Dabrafenib (Tafinlar)]] 150 mg PO twice per day
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*[[Dabrafenib (Tafinlar)]] 150 mg PO twice per day on days 1 to 28
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*[[Trametinib (Mekinist)]] 2 mg PO once per day
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*[[Trametinib (Mekinist)]] 2 mg PO once per day on days 1 to 28
 
'''28-day cycles'''
 
'''28-day cycles'''
 
</div></div>
 
</div></div>
 +
 
===References===
 
===References===
−
#'''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] NCT02465060
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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] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/32758030/ PubMed] [https://clinicaltrials.gov/study/NCT02465060 NCT02465060]
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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">
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{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
{| class="wikitable sortable" style="width: 60%; text-align:center;"  
 
!style="width: 33%"|Study
 
!style="width: 33%"|Study
−
!style="width: 33%"|Years of enrollment
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!style="width: 33%"|Dates of enrollment
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
|-
 
|-
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<div class="toccolours" style="background-color:#fdcdac">
 
<div class="toccolours" style="background-color:#fdcdac">
 
====Biomarker eligibility criteria====
 
====Biomarker eligibility criteria====
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*''VE-BASKET''
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*VE-BASKET:
 
**Gene: BRAF V600  
 
**Gene: BRAF V600  
 
**Alteration: [[Biomarkers#Substitution|substitution]]
 
**Alteration: [[Biomarkers#Substitution|substitution]]
 
**Acceptable methods of measurement: mutational analysis assays
 
**Acceptable methods of measurement: mutational analysis assays
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*''MyPathway''
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*MyPathway:
 
**Gene: BRAF V600E  
 
**Gene: BRAF V600E  
 
**Alteration: [[Biomarkers#Substitution|substitution]]
 
**Alteration: [[Biomarkers#Substitution|substitution]]
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</div></div>
 
</div></div>
 
===References===
 
===References===
−
#'''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] NCT01524978
+
#'''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] '''dosing details in abstract have been reviewed by our editors''' [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]
−
#'''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] NCT02091141
+
#'''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] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/29320312/ PubMed] [https://clinicaltrials.gov/study/NCT02091141 NCT02091141]
−
[[Category:BRAF regimens]]
+
[[Category:Malignant solid neoplasm, BRAF-mutated regimens]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Malignant solid neoplasm]]
 
[[Category:Malignant solid neoplasm]]
−
[[Category:Site-agnostic regimens]]
 

Latest revision as of 23:36, 15 July 2024

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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 Dates of enrollment Evidence
Salama et al. 2020 (EAY131-H) 2015-08 to 2018-02 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 dosing details in manuscript have been reviewed by our editors 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 dosing details in abstract have been reviewed by our editors 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 dosing details in manuscript have been reviewed by our editors PubMed NCT02091141
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