Difference between revisions of "Melanoma, BRAF-mutated - null regimens"
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| − | The purpose of this page is to provide references to "null therapy" such as placebo and observation. | + | The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the [[Melanoma, BRAF-mutated|main BRAF-mutated melanoma page]] for regimens that include active anticancer treatment. |
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
=Adjuvant therapy= | =Adjuvant therapy= | ||
==Placebo== | ==Placebo== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
| − | !style="width: 20%"| | + | !style="width: 20%"|Dates of enrollment |
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
!style="width: 20%"|Comparator | !style="width: 20%"|Comparator | ||
| Line 24: | Line 24: | ||
|- | |- | ||
|[https://doi.org/10.1056/NEJMoa1708539 Long et al. 2017 (COMBI-AD)] | |[https://doi.org/10.1056/NEJMoa1708539 Long et al. 2017 (COMBI-AD)] | ||
| − | |2013-2014 | + | |2013-01 to 2014-12 |
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
|[[Melanoma,_BRAF-mutated#Dabrafenib_.26_Trametinib|Dabrafenib & Trametinib]] | |[[Melanoma,_BRAF-mutated#Dabrafenib_.26_Trametinib|Dabrafenib & Trametinib]] | ||
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|} | |} | ||
''<sup>1</sup>Reported efficacy for COMBI-AD is based on the 2020 update.''<br> | ''<sup>1</sup>Reported efficacy for COMBI-AD is based on the 2020 update.''<br> | ||
| + | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
*BRIM8: [[Surgery#Melanoma_surgery|Complete resection]], timing not specified | *BRIM8: [[Surgery#Melanoma_surgery|Complete resection]], timing not specified | ||
*COMBI-AD: [[Surgery#Lymphadenectomy|Completion lymphadenectomy]], within 12 weeks | *COMBI-AD: [[Surgery#Lymphadenectomy|Completion lymphadenectomy]], within 12 weeks | ||
| − | + | </div></div> | |
===References=== | ===References=== | ||
| − | #'''COMBI-AD:''' Long GV, Hauschild A, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Schadendorf D, Lesimple T, Plummer R, Ji R, Zhang P, Mookerjee B, Legos J, Kefford R, Dummer R, Kirkwood JM. Adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma. N Engl J Med. 2017 Nov 9;377(19):1813-1823. Epub 2017 Sep 10. [https://doi.org/10.1056/NEJMoa1708539 link to original article] | + | #'''COMBI-AD:''' Long GV, Hauschild A, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Schadendorf D, Lesimple T, Plummer R, Ji R, Zhang P, Mookerjee B, Legos J, Kefford R, Dummer R, Kirkwood JM. Adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma. N Engl J Med. 2017 Nov 9;377(19):1813-1823. Epub 2017 Sep 10. [https://doi.org/10.1056/NEJMoa1708539 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28891408/ PubMed] [https://clinicaltrials.gov/study/NCT01682083 NCT01682083] |
| − | ##'''Update:''' Hauschild A, Dummer R, Schadendorf D, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Lesimple T, Plummer R, Dasgupta K, Haas T, Shilkrut M, Gasal E, Kefford R, Kirkwood JM, Long GV. Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in Patients With Resected BRAF V600-Mutant Stage III Melanoma. J Clin Oncol. 2018 Dec 10;36(35):3441-3449. Epub 2018 Oct 22. [https://doi.org/10.1200/JCO.18.01219 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6286159/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30343620 PubMed] | + | ##'''Update:''' Hauschild A, Dummer R, Schadendorf D, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Lesimple T, Plummer R, Dasgupta K, Haas T, Shilkrut M, Gasal E, Kefford R, Kirkwood JM, Long GV. Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in Patients With Resected BRAF V600-Mutant Stage III Melanoma. J Clin Oncol. 2018 Dec 10;36(35):3441-3449. Epub 2018 Oct 22. [https://doi.org/10.1200/JCO.18.01219 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6286159/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/30343620/ PubMed] |
| − | ## '''Update:''' Dummer R, Hauschild A, Santinami M, Atkinson V, Mandalà M, Kirkwood JM, Chiarion Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Lesimple T, Plummer R, Dasgupta K, Gasal E, Tan M, Long GV, Schadendorf D. Five-Year Analysis of Adjuvant Dabrafenib plus Trametinib in Stage III Melanoma. N Engl J Med. 2020 Sep 17;383(12):1139-1148. Epub 2020 Sep 2. [https://doi.org/10.1056/nejmoa2005493 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32877599 PubMed] | + | ## '''PRO analysis:''' Schadendorf D, Hauschild A, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Lesimple T, Plummer R, Schachter J, Dasgupta K, Manson S, Koruth R, Mookerjee B, Kefford R, Dummer R, Kirkwood JM, Long GV. Patient-reported outcomes in patients with resected, high-risk melanoma with BRAFV600E or BRAFV600K mutations treated with adjuvant dabrafenib plus trametinib (COMBI-AD): a randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 May;20(5):701-710. Epub 2019 Mar 27. [https://doi.org/10.1016/s1470-2045(18)30940-9 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30928620/ PubMed] |
| − | #'''BRIM8:''' Maio M, Lewis K, Demidov L, Mandalà M, Bondarenko I, Ascierto PA, Herbert C, Mackiewicz A, Rutkowski P, Guminski A, Goodman GR, Simmons B, Ye C, Yan Y, Schadendorf D; BRIM8 Investigators. Adjuvant vemurafenib in resected, BRAF(V600) mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):510-520. Epub 2018 Feb 21. Erratum in: Lancet Oncol. 2018 Apr;19(4):e184. [https://doi.org/10.1016/S1470-2045(18)30106-2 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29477665 PubMed] NCT01667419 | + | ## '''Update:''' Dummer R, Hauschild A, Santinami M, Atkinson V, Mandalà M, Kirkwood JM, Chiarion Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Lesimple T, Plummer R, Dasgupta K, Gasal E, Tan M, Long GV, Schadendorf D. Five-Year Analysis of Adjuvant Dabrafenib plus Trametinib in Stage III Melanoma. N Engl J Med. 2020 Sep 17;383(12):1139-1148. Epub 2020 Sep 2. [https://doi.org/10.1056/nejmoa2005493 link to original article] [https://pubmed.ncbi.nlm.nih.gov/32877599/ PubMed] |
| + | #'''BRIM8:''' Maio M, Lewis K, Demidov L, Mandalà M, Bondarenko I, Ascierto PA, Herbert C, Mackiewicz A, Rutkowski P, Guminski A, Goodman GR, Simmons B, Ye C, Yan Y, Schadendorf D; BRIM8 Investigators. Adjuvant vemurafenib in resected, BRAF(V600) mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):510-520. Epub 2018 Feb 21. Erratum in: Lancet Oncol. 2018 Apr;19(4):e184. [https://doi.org/10.1016/S1470-2045(18)30106-2 link to original article] [https://pubmed.ncbi.nlm.nih.gov/29477665/ PubMed] [https://clinicaltrials.gov/study/NCT01667419 NCT01667419] | ||
[[Category:Melanoma regimens]] | [[Category:Melanoma regimens]] | ||
Latest revision as of 14:28, 27 January 2024
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main BRAF-mutated melanoma page for regimens that include active anticancer treatment.
Adjuvant therapy
Placebo
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Maio et al. 2018 (BRIM8) | 2012-2015 | Phase 3 (C) | Vemurafenib | Might have inferior DFS |
| Long et al. 2017 (COMBI-AD) | 2013-01 to 2014-12 | Phase 3 (C) | Dabrafenib & Trametinib | Inferior MFS1 |
1Reported efficacy for COMBI-AD is based on the 2020 update.
Preceding treatment
- BRIM8: Complete resection, timing not specified
- COMBI-AD: Completion lymphadenectomy, within 12 weeks
References
- COMBI-AD: Long GV, Hauschild A, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Schadendorf D, Lesimple T, Plummer R, Ji R, Zhang P, Mookerjee B, Legos J, Kefford R, Dummer R, Kirkwood JM. Adjuvant dabrafenib plus trametinib in stage III BRAF-mutated melanoma. N Engl J Med. 2017 Nov 9;377(19):1813-1823. Epub 2017 Sep 10. link to original article PubMed NCT01682083
- Update: Hauschild A, Dummer R, Schadendorf D, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Lesimple T, Plummer R, Dasgupta K, Haas T, Shilkrut M, Gasal E, Kefford R, Kirkwood JM, Long GV. Longer Follow-Up Confirms Relapse-Free Survival Benefit With Adjuvant Dabrafenib Plus Trametinib in Patients With Resected BRAF V600-Mutant Stage III Melanoma. J Clin Oncol. 2018 Dec 10;36(35):3441-3449. Epub 2018 Oct 22. link to original article link to PMC article PubMed
- PRO analysis: Schadendorf D, Hauschild A, Santinami M, Atkinson V, Mandalà M, Chiarion-Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Lesimple T, Plummer R, Schachter J, Dasgupta K, Manson S, Koruth R, Mookerjee B, Kefford R, Dummer R, Kirkwood JM, Long GV. Patient-reported outcomes in patients with resected, high-risk melanoma with BRAFV600E or BRAFV600K mutations treated with adjuvant dabrafenib plus trametinib (COMBI-AD): a randomised, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 May;20(5):701-710. Epub 2019 Mar 27. link to original article PubMed
- Update: Dummer R, Hauschild A, Santinami M, Atkinson V, Mandalà M, Kirkwood JM, Chiarion Sileni V, Larkin J, Nyakas M, Dutriaux C, Haydon A, Robert C, Mortier L, Schachter J, Lesimple T, Plummer R, Dasgupta K, Gasal E, Tan M, Long GV, Schadendorf D. Five-Year Analysis of Adjuvant Dabrafenib plus Trametinib in Stage III Melanoma. N Engl J Med. 2020 Sep 17;383(12):1139-1148. Epub 2020 Sep 2. link to original article PubMed
- BRIM8: Maio M, Lewis K, Demidov L, Mandalà M, Bondarenko I, Ascierto PA, Herbert C, Mackiewicz A, Rutkowski P, Guminski A, Goodman GR, Simmons B, Ye C, Yan Y, Schadendorf D; BRIM8 Investigators. Adjuvant vemurafenib in resected, BRAF(V600) mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):510-520. Epub 2018 Feb 21. Erratum in: Lancet Oncol. 2018 Apr;19(4):e184. link to original article PubMed NCT01667419