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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] [https://clinicaltrials.gov/study/NCT01286753 NCT01286753] | # '''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] [https://clinicaltrials.gov/study/NCT01286753 NCT01286753] | ||
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[[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 16:03, 6 October 2023
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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
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Guidelines
NCCN
- NCCN does not have guidelines at this granular level; please see NCCN Guidelines - Thyroid Carcinoma.
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
- Dabrafenib (Tafinlar) 150 mg PO twice per day
- Trametinib (Mekinist) 2 mg PO once per day
Continued indefinitely
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. link to original article contains dosing details in manuscript link to PMC article PubMed NCT02034110
- 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
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. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01286753