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

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===Regimen {{#subobject:e03f2c|Variant=1}}===
 
===Regimen {{#subobject:e03f2c|Variant=1}}===
 
{| class="wikitable" style="width: 50%; text-align:center;"  
 
{| class="wikitable" style="width: 50%; 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]]
 
|-
 
|-
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791845/ Subbiah et al. 2017 (BRF117019)]
 
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5791845/ Subbiah et al. 2017 (BRF117019)]
|style="background-color:#91cf61"|Phase II
+
| style="background-color:#91cf61" |Phase II
 
|-
 
|-
 
|}
 
|}
 
''Note: only partial results have been published to date.''
 
''Note: only partial results have been published to date.''
 
====Chemotherapy====
 
====Chemotherapy====
 +
 
*[[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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===References===
 
===References===
# '''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]
+
 
 +
#'''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]
  
 
==Vemurafenib monotherapy {{#subobject:e0d17a|Regimen=1}}==
 
==Vemurafenib monotherapy {{#subobject:e0d17a|Regimen=1}}==
 
===Regimen {{#subobject:392a4b|Variant=1}}===
 
===Regimen {{#subobject:392a4b|Variant=1}}===
 
{| class="wikitable" style="width: 50%; text-align:center;"  
 
{| class="wikitable" style="width: 50%; 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]]
 
|-
 
|-
 
|[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)]
|style="background-color:#91cf61"|Phase II
+
| style="background-color:#91cf61" |Phase II
 
|-
 
|-
 
|[https://ascopubs.org/doi/full/10.1200/JCO.2017.75.3780 Hainsworth et al. 2018 (MyPathway)]
 
|[https://ascopubs.org/doi/full/10.1200/JCO.2017.75.3780 Hainsworth et al. 2018 (MyPathway)]
|style="background-color:#91cf61"|Phase IIa
+
| style="background-color:#91cf61" |Phase IIa
 
|-
 
|-
 
|}
 
|}
 
====Eligibility criteria====
 
====Eligibility criteria====
 +
 
*VE-BASKET: BRAF p.V600 mutations
 
*VE-BASKET: BRAF p.V600 mutations
 
*MyPathway: BRAF p.V600E mutation without coexisting KRAS mutations, or other BRAF mutations
 
*MyPathway: BRAF p.V600E mutation without coexisting KRAS mutations, or other BRAF mutations
 +
 
====Chemotherapy====
 
====Chemotherapy====
*[[Vemurafenib (Zelboraf)]] 960 mg PO twice per day  
+
 
 +
*[https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202429s012lbl.pdf Vemurafenib (Zelboraf)] 960 mg PO twice per day
  
 
'''Continued indefinitely'''
 
'''Continued indefinitely'''
  
 
===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://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]
+
 
# '''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]
+
#'''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]
 +
#'''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]
  
 
[[Category:BRAF regimens]]
 
[[Category:BRAF regimens]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Biomarker-specific pages]]
 
[[Category:Site-agnostic regimens]]
 
[[Category:Site-agnostic regimens]]

Revision as of 22:49, 8 January 2020

2 regimens on this page
2 variants on this page


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

Dabrafenib & Trametinib

back to top

Regimen

Study Evidence
Subbiah et al. 2017 (BRF117019) Phase II

Note: only partial results have been published to date.

Chemotherapy

Continued indefinitely

References

  1. 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. link to original article contains verified protocol link to PMC article PubMed

Vemurafenib monotherapy

Regimen

Study Evidence
Hyman et al. 2015 (VE-BASKET) Phase II
Hainsworth et al. 2018 (MyPathway) Phase IIa

Eligibility criteria

  • VE-BASKET: BRAF p.V600 mutations
  • MyPathway: BRAF p.V600E mutation without coexisting KRAS mutations, or other BRAF mutations

Chemotherapy

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 protocol link to PMC article PubMed
  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 verified protocol PubMed