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

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=Differentiated thyroid cancer, all lines of therapy=
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=Locally advanced or metastatic, all lines of therapy=
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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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''Note: this study was in patients with papillary thyroid cancer, only.''
 
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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
 
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'''Continued indefinitely'''
 
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</div></div>
 
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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://doi.org/10.1016/S1470-2045(16)30166-8 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5532535/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27460442/ PubMed] NCT01286753
 
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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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''Note: 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>
 
<div class="toccolours" style="background-color:#b3e2cd">
 
<div class="toccolours" style="background-color:#b3e2cd">
 
====Targeted therapy====
 
====Targeted therapy====
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===References===
 
===References===
 
# '''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] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791845/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29072975 PubMed] NCT02034110
 
# '''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] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791845/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/29072975 PubMed] 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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##'''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]  
 +
==Vemurafenib monotherapy {{#subobject:3f8f49|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:7fb6ac|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 60%; text-align:center;"
 +
!style="width: 33%"|Study
 +
!style="width: 33%"|Dates of enrollment
 +
!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]]
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5532535/ Brose et al. 2016 (NO25530)]
 +
|2011-2013
 +
| style="background-color:#91cf61" |Phase 2
 +
|-
 +
|}
 +
<div class="toccolours" style="background-color:#fdcdac">
 +
====Eligibility criteria====
 +
*Biomarker: BRAF p.V600E
 +
*Histology: Papillary thyroid cancer
 +
*Prior treatment: Radioactive iodine
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Targeted therapy====
 +
*[[Vemurafenib (Zelboraf)]] 960 mg PO twice per day
 +
'''Continued indefinitely'''
 +
</div></div>
 +
===References===
 +
# '''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] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5532535/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27460442/ PubMed] NCT01286753
 +
 
 +
[https://pubmed.ncbi.nlm.nih.gov/35026411/ PubMed]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Thyroid cancer regimens]]
 
[[Category:Thyroid cancer regimens]]
 
[[Category:Endocrine cancers]]
 
[[Category:Endocrine cancers]]
 
[[Category:Head and neck cancers]]
 
[[Category:Head and neck cancers]]

Revision as of 23:04, 26 April 2023

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Section editor transclusions 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


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)
ESMO-MCBS (3)
2014-2016 Phase 2, <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 contains dosing details in manuscript 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

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 contains dosing details in manuscript link to PMC article PubMed NCT01286753

PubMed

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