Difference between revisions of "Non-small cell lung cancer, BRAF-mutated"
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!style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
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| − | |[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30679-4 | + | |[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30679-4 Planchard et al. 2017 (BRF113928 untreated)] |
|2014-2015 | |2014-2015 | ||
|style="background-color:#91cf61"|Phase 2 (RT) | |style="background-color:#91cf61"|Phase 2 (RT) | ||
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===References=== | ===References=== | ||
| − | # '''BRF113928 untreated:''' Planchard D, Smit EF, Groen HJM, Mazieres J, Besse B, Helland Å, Giannone V, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously untreated BRAF(V600E)-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1307-1316. Epub 2017 Sep 11. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30679-4 | + | # '''BRF113928 untreated:''' Planchard D, Smit EF, Groen HJM, Mazieres J, Besse B, Helland Å, Giannone V, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously untreated BRAF(V600E)-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1307-1316. Epub 2017 Sep 11. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(17)30679-4 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28919011 PubMed] NCT01336634 |
##'''Update:''' Planchard D, Besse B, Groen HJM, Hashemi SMS, Mazieres J, Kim TM, Quoix E, Souquet PJ, Barlesi F, Baik C, Villaruz LC, Kelly RJ, Zhang S, Tan M, Gasal E, Santarpia L, Johnson BE. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. J Thorac Oncol. 2022 Jan;17(1):103-115. Epub 2021 Aug 26. [https://doi.org/10.1016/j.jtho.2021.08.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34455067/ PubMed] | ##'''Update:''' Planchard D, Besse B, Groen HJM, Hashemi SMS, Mazieres J, Kim TM, Quoix E, Souquet PJ, Barlesi F, Baik C, Villaruz LC, Kelly RJ, Zhang S, Tan M, Gasal E, Santarpia L, Johnson BE. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. J Thorac Oncol. 2022 Jan;17(1):103-115. Epub 2021 Aug 26. [https://doi.org/10.1016/j.jtho.2021.08.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34455067/ PubMed] | ||
| Line 71: | Line 71: | ||
===References=== | ===References=== | ||
| − | # '''BRF113928 previously treated:''' Planchard D, Besse B, Groen HJ, Souquet PJ, Quoix E, Baik CS, Barlesi F, Kim TM, Mazieres J, Novello S, Rigas JR, Upalawanna A, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial. Lancet Oncol. 2016 Jul;17(7):984-93. Epub 2016 Jun 6. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30146-2 | + | # '''BRF113928 previously treated:''' Planchard D, Besse B, Groen HJ, Souquet PJ, Quoix E, Baik CS, Barlesi F, Kim TM, Mazieres J, Novello S, Rigas JR, Upalawanna A, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial. Lancet Oncol. 2016 Jul;17(7):984-93. Epub 2016 Jun 6. [https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(16)30146-2 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4993103/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/27283860 PubMed] NCT01336634 |
##'''Update:''' Planchard D, Besse B, Groen HJM, Hashemi SMS, Mazieres J, Kim TM, Quoix E, Souquet PJ, Barlesi F, Baik C, Villaruz LC, Kelly RJ, Zhang S, Tan M, Gasal E, Santarpia L, Johnson BE. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. J Thorac Oncol. 2022 Jan;17(1):103-115. Epub 2021 Aug 26. [https://doi.org/10.1016/j.jtho.2021.08.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34455067/ PubMed] | ##'''Update:''' Planchard D, Besse B, Groen HJM, Hashemi SMS, Mazieres J, Kim TM, Quoix E, Souquet PJ, Barlesi F, Baik C, Villaruz LC, Kelly RJ, Zhang S, Tan M, Gasal E, Santarpia L, Johnson BE. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. J Thorac Oncol. 2022 Jan;17(1):103-115. Epub 2021 Aug 26. [https://doi.org/10.1016/j.jtho.2021.08.011 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34455067/ PubMed] | ||
Revision as of 12:06, 16 September 2022
Section editor transclusions Note: these are regimens tested in biomarker-specific populations, please see the main NSCLC page for other regimens.
3 regimens on this page
3 variants on this page
|
Advanced or metastatic disease, first-line
Dabrafenib & Trametinib
Regimen
| FDA-recommended dose |
| Study | Years of enrollment | Evidence |
|---|---|---|
| Planchard et al. 2017 (BRF113928 untreated) | 2014-2015 | Phase 2 (RT) |
Biomarker eligibility criteria
- Biomarker: BRAF V600E
Targeted therapy
- Dabrafenib (Tafinlar) 150 mg PO twice per day
- Trametinib (Mekinist) 2 mg PO once per day
Continued indefinitely
References
- BRF113928 untreated: Planchard D, Smit EF, Groen HJM, Mazieres J, Besse B, Helland Å, Giannone V, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously untreated BRAF(V600E)-mutant metastatic non-small-cell lung cancer: an open-label, phase 2 trial. Lancet Oncol. 2017 Oct;18(10):1307-1316. Epub 2017 Sep 11. link to original article PubMed NCT01336634
- Update: Planchard D, Besse B, Groen HJM, Hashemi SMS, Mazieres J, Kim TM, Quoix E, Souquet PJ, Barlesi F, Baik C, Villaruz LC, Kelly RJ, Zhang S, Tan M, Gasal E, Santarpia L, Johnson BE. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. J Thorac Oncol. 2022 Jan;17(1):103-115. Epub 2021 Aug 26. link to original article PubMed
Advanced or metastatic disease, previously treated, BRAF inhibitor-naive
Dabrafenib & Trametinib
Regimen
| FDA-recommended dose |
| Study | Years of enrollment | Evidence |
|---|---|---|
| Planchard et al. 2016 (BRF113928 previously treated) | 2013-2015 | Phase 2 (RT) |
All patients enrolled in this cohort had progressed on 1 to 3 prior regimens.
Biomarker eligibility criteria
- Biomarker: BRAF V600E
Targeted therapy
- Dabrafenib (Tafinlar) 150 mg PO twice per day
- Trametinib (Mekinist) 2 mg PO once per day
Continued indefinitely
References
- BRF113928 previously treated: Planchard D, Besse B, Groen HJ, Souquet PJ, Quoix E, Baik CS, Barlesi F, Kim TM, Mazieres J, Novello S, Rigas JR, Upalawanna A, D'Amelio AM Jr, Zhang P, Mookerjee B, Johnson BE. Dabrafenib plus trametinib in patients with previously treated BRAF(V600E)-mutant metastatic non-small cell lung cancer: an open-label, multicentre phase 2 trial. Lancet Oncol. 2016 Jul;17(7):984-93. Epub 2016 Jun 6. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01336634
- Update: Planchard D, Besse B, Groen HJM, Hashemi SMS, Mazieres J, Kim TM, Quoix E, Souquet PJ, Barlesi F, Baik C, Villaruz LC, Kelly RJ, Zhang S, Tan M, Gasal E, Santarpia L, Johnson BE. Phase 2 Study of Dabrafenib Plus Trametinib in Patients With BRAF V600E-Mutant Metastatic NSCLC: Updated 5-Year Survival Rates and Genomic Analysis. J Thorac Oncol. 2022 Jan;17(1):103-115. Epub 2021 Aug 26. link to original article PubMed