Difference between revisions of "Thyroid cancer, BRAF-mutated"

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<big>'''Note: these are regimens tested in biomarker-specific populations, please see the [[Thyroid cancer|main thyroid cancer page]] for other regimens.'''</big>
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'''Note: these are regimens tested in biomarker-specific populations, please see the [[Thyroid cancer|main thyroid cancer page]] for other regimens.'''
 
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=Guidelines=
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=Differentiated thyroid cancer, all lines of therapy=
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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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==Vemurafenib monotherapy {{#subobject:3f8f49|Regimen=1}}==
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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=1470 NCCN Guidelines - Thyroid Carcinoma].''
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=Locally advanced or metastatic, all lines of therapy=
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===Regimen {{#subobject:7fb6ac|Variant=1}}===
 
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!style="width: 25%"|Study
 
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!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5532535/ Brose et al. 2016 (NO25530)]
 
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| style="background-color:#91cf61" |Phase II
 
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''Note: this study was in patients with papillary thyroid cancer, only.''
 
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====Targeted therapy====
 
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*[[Vemurafenib (Zelboraf)]] 960 mg PO twice per day
 
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'''Continued indefinitely'''
 
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===References===
 
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# '''NO25530:''' Brose MS, Cabanillas ME, Cohen EE, Wirth LJ, Riehl T, Yue H, Sherman SI, Sherman EJ. Vemurafenib in patients with BRAF(V600E)-positive metastatic or unresectable papillary thyroid cancer refractory to radioactive iodine: a non-randomised, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016 Sep;17(9):1272-82. Epub 2016 Jul 23. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30166-8/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5532535/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/27460442 PubMed]
 
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=Anaplastic thyroid cancer, all lines of therapy=
 
 
==Dabrafenib & Trametinib {{#subobject:b078c2|Regimen=1}}==
 
==Dabrafenib & Trametinib {{#subobject:b078c2|Regimen=1}}==
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===Regimen {{#subobject:e03f2c|Variant=1}}===
 
===Regimen {{#subobject:e03f2c|Variant=1}}===
 
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!style="width: 25%"|Study
 
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!style="width: 25%"|Years of enrollment
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!style="width: 25%"|Dates of enrollment
 
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]]
 
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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/PMC5791845/ Subbiah et al. 2017 (ROAR)]
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|2014-2016
 
|2014-2016
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| style="background-color:#ffffbe" |Phase II, <20 pts in subgroup (RT)
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| style="background-color:#ffffbe" |Phase 2, fewer than 20 pts in subgroup (RT)
 
| style="background-color:#bfd3e6" |ORR: 63% (95% CI, 35-85)
 
| style="background-color:#bfd3e6" |ORR: 63% (95% CI, 35-85)
 
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''Patients in this subgroup had previously treated anaplastic thyroid cancer with BRAF p.V600E mutation.''
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<div class="toccolours" style="background-color:#fdcdac">
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====Eligibility criteria====
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*Biomarker: BRAF p.V600E
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*Histology: Anaplastic thyroid cancer
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</div>
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<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
 
*[[Dabrafenib (Tafinlar)]] 150 mg PO twice per day
 
*[[Dabrafenib (Tafinlar)]] 150 mg PO twice per day
 
*[[Trametinib (Mekinist)]] 2 mg PO once per day
 
*[[Trametinib (Mekinist)]] 2 mg PO once per day
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'''Continued indefinitely'''
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</div></div>
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===References===
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# '''ROAR:''' 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://doi.org/10.1200/JCO.2017.73.6785 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791845/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29072975/ PubMed] [https://clinicaltrials.gov/study/NCT02034110 NCT02034110]
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##'''Update:''' Subbiah V, Kreitman RJ, Wainberg ZA, Cho JY, Schellens JHM, Soria JC, Wen PY, Zielinski CC, Cabanillas ME, Boran A, Ilankumaran P, Burgess P, Romero Salas T, Keam B. Dabrafenib plus trametinib in patients with BRAF V600E-mutant anaplastic thyroid cancer: updated analysis from the phase II ROAR basket study. Ann Oncol. 2022 Apr;33(4):406-415. Epub 2022 Jan 10. [https://doi.org/10.1016/j.annonc.2021.12.014 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc9338780/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/35026411/ PubMed]
  
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==Vemurafenib monotherapy {{#subobject:3f8f49|Regimen=1}}==
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<div class="toccolours" style="background-color:#eeeeee">
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===Regimen {{#subobject:7fb6ac|Variant=1}}===
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{| class="wikitable sortable" style="width: 60%; text-align:center;"
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!style="width: 33%"|Study
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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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|-
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|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5532535/ Brose et al. 2016 (NO25530)]
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|2011-2013
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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">
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====Eligibility criteria====
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*Biomarker: BRAF p.V600E
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*Histology: Papillary thyroid cancer
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*Prior treatment: Radioactive iodine
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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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# '''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://doi.org/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] NCT02034110
+
# '''NO25530:''' Brose MS, Cabanillas ME, Cohen EE, Wirth LJ, Riehl T, Yue H, Sherman SI, Sherman EJ. Vemurafenib in patients with BRAF(V600E)-positive metastatic or unresectable papillary thyroid cancer refractory to radioactive iodine: a non-randomised, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016 Sep;17(9):1272-82. Epub 2016 Jul 23. [https://doi.org/10.1016/S1470-2045(16)30166-8 link to original article] '''dosing details in manuscript have been reviewed by our editors''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5532535/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27460442/ PubMed] [https://clinicaltrials.gov/study/NCT01286753 NCT01286753]
  
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]

Latest revision as of 12:25, 15 July 2024

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Section editor
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If you are interested in this role, please contact us at [email protected].

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

2 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

Locally advanced or metastatic, all lines of therapy

Dabrafenib & Trametinib

Regimen

FDA-recommended dose
Study Dates of enrollment Evidence Efficacy
Subbiah et al. 2017 (ROAR) 2014-2016 Phase 2, fewer than 20 pts in subgroup (RT) ORR: 63% (95% CI, 35-85)

Eligibility criteria

  • Biomarker: BRAF p.V600E
  • Histology: Anaplastic thyroid cancer

Targeted therapy

Continued indefinitely

References

  1. ROAR: 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. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT02034110
    1. Update: Subbiah V, Kreitman RJ, Wainberg ZA, Cho JY, Schellens JHM, Soria JC, Wen PY, Zielinski CC, Cabanillas ME, Boran A, Ilankumaran P, Burgess P, Romero Salas T, Keam B. Dabrafenib plus trametinib in patients with BRAF V600E-mutant anaplastic thyroid cancer: updated analysis from the phase II ROAR basket study. Ann Oncol. 2022 Apr;33(4):406-415. Epub 2022 Jan 10. link to original article link to PMC article PubMed

Vemurafenib monotherapy

Regimen

Study Dates of enrollment Evidence
Brose et al. 2016 (NO25530) 2011-2013 Phase 2

Eligibility criteria

  • Biomarker: BRAF p.V600E
  • Histology: Papillary thyroid cancer
  • Prior treatment: Radioactive iodine

Targeted therapy

Continued indefinitely

References

  1. NO25530: Brose MS, Cabanillas ME, Cohen EE, Wirth LJ, Riehl T, Yue H, Sherman SI, Sherman EJ. Vemurafenib in patients with BRAF(V600E)-positive metastatic or unresectable papillary thyroid cancer refractory to radioactive iodine: a non-randomised, multicentre, open-label, phase 2 trial. Lancet Oncol. 2016 Sep;17(9):1272-82. Epub 2016 Jul 23. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT01286753
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