Difference between revisions of "CNS melanoma"
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− | {| class="wikitable" style="width: | + | {| class="wikitable" style="width: 100%; text-align:center;" |
− | ! style="width: | + | !style="width: 25%"|Study |
− | ! style="width: | + | !style="width: 25%"|Years of enrollment |
− | ! style="width: | + | !style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]] |
+ | !style="width: 25%"|[[Levels_of_Evidence#Efficacy|Efficacy]] | ||
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|[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(12)70431-X/fulltext Long et al. 2012 (BREAK-MB)] | |[https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(12)70431-X/fulltext Long et al. 2012 (BREAK-MB)] | ||
+ | |2011 | ||
| style="background-color:#91cf61" |Phase II (RT) | | style="background-color:#91cf61" |Phase II (RT) | ||
| style="background-color:#8c6bb1" |ORR: 31-39% | | style="background-color:#8c6bb1" |ORR: 31-39% | ||
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− | + | ====Biomarker eligiblity criteria==== | |
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* [[Biomarkers#Genes#BRAF|BRAF]] V600 mutant | * [[Biomarkers#Genes#BRAF|BRAF]] V600 mutant | ||
* Study Inclusion criteria: Val600Glu or Val600Lys | * Study Inclusion criteria: Val600Glu or Val600Lys | ||
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− | + | ====Biomarker eligiblity criteria==== | |
− | ====== | ||
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* ''[[Biomarkers#Genes#BRAF|BRAF]]'' V600 mutant | * ''[[Biomarkers#Genes#BRAF|BRAF]]'' V600 mutant | ||
* Clinical Trial Inclusion: BRAF V600 E/K/D/R | * Clinical Trial Inclusion: BRAF V600 E/K/D/R | ||
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===Regimen {{#subobject:6cfyyz|Variant=1}}=== | ===Regimen {{#subobject:6cfyyz|Variant=1}}=== | ||
− | {| class="wikitable" style="width: | + | {| class="wikitable" style="width: 75%; text-align:center;" |
− | ! style="width: | + | !style="width: 33%"|Study |
− | ! style="width: | + | !style="width: 33%"|Years of enrollment |
+ | !style="width: 33%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
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|[https://academic.oup.com/annonc/article/28/3/634/2716532 McArthur et al. 2017] | |[https://academic.oup.com/annonc/article/28/3/634/2716532 McArthur et al. 2017] | ||
+ | |2011-2013 | ||
| style="background-color:#91cf61" |Phase II (RT) | | style="background-color:#91cf61" |Phase II (RT) | ||
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− | + | ====Biomarker eligiblity criteria==== | |
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* [[Biomarkers#Genes#BRAF|BRAFV600]] mutant | * [[Biomarkers#Genes#BRAF|BRAFV600]] mutant |
Revision as of 13:50, 12 February 2020
Section editors | |||
---|---|---|---|
Seema Nagpal, MD Stanford University Palo Alto, CA |
Elizabeth Buchbinder, MD Dana-Farber Cancer Institute Boston, MA |
5 regimens on this page
5 variants on this page
|
Note: these are CNS-specific regimens, please see the main melanoma page for other regimens.
Guidelines
EANO/ESMO
- 2017: Le Rhun et al. EANO–ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up of patients with leptomeningeal metastasis from solid tumours
NCCN
All lines of therapy
Dabrafenib monotherapy
back to top |
Regimen
FDA-recommended dose |
Study | Years of enrollment | Evidence | Efficacy |
---|---|---|---|
Long et al. 2012 (BREAK-MB) | 2011 | Phase II (RT) | ORR: 31-39% |
Biomarker eligiblity criteria
- BRAF V600 mutant
- Study Inclusion criteria: Val600Glu or Val600Lys
Chemotherapy
- Dabrafenib (Tafinlar) 150 mg PO twice per day
Continued indefinitely
References
- BREAK-MB: Long GV, Trefzer U, Davies MA, Kefford RF, Ascierto PA, Chapman PB, Puzanov I, Hauschild A, Robert C, Algazi A, Mortier L, Tawbi H, Wilhelm T, Zimmer L, Switzky J, Swann S, Martin AM, Guckert M, Goodman V, Streit M, Kirkwood JM, Schadendorf D. Dabrafenib in patients with Val600Glu or Val600Lys BRAF-mutant melanoma metastatic to the brain (BREAK-MB): a multicentre, open-label, phase 2 trial. Lancet Oncol. 2012 Nov;13(11):1087-95. Epub 2012 Oct 8. link to original article contains verified protocol PubMed
Dabrafenib & Trametinib
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Regimen
FDA-recommended dose |
Study | Evidence | Efficacy |
---|---|---|
Davies et al. 2017 (COMBI-MB) | Phase II | ORR: 44-59% |
Biomarker eligiblity criteria
- BRAF V600 mutant
- Clinical Trial Inclusion: BRAF V600 E/K/D/R
Chemotherapy
- Dabrafenib (Tafinlar) 150 mg PO twice per day
- Trametinib (Mekinist) 2 mg PO once per day
Continued indefinitely
References
- COMBI-MB: Davies MA, Saiag P, Robert C, Grob JJ, Flaherty KT, Arance A, Chiarion-Sileni V, Thomas L, Lesimple T, Mortier L, Moschos SJ, Hogg D, Márquez-Rodas I, Del Vecchio M, Lebbé C, Meyer N, Zhang Y, Huang Y, Mookerjee B, Long GV. Dabrafenib plus trametinib in patients with BRAF(V600)-mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial. Lancet Oncol. 2017 Jul;18(7):863-873. Epub 2017 Jun 4. link to original article contains protocol PubMed
Fotemustine monotherapy
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Regimen
Study | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|
Mornex et al. 2003 | Phase III (C) | Fotemustine & WBRT | Did not meet endpoint of OS |
Chemotherapy
Regimen
- Mornex F, Thomas L, Mohr P, Hauschild A, Delaunay MM, Lesimple T, Tilgen W, Bui BN, Guillot B, Ulrich J, Bourdin S, Mousseau M, Cupissol D, Bonneterre ME, De Gislain C, Bensadoun RJ, Clavel M. A prospective randomized multicentre phase III trial of fotemustine plus whole brain irradiation versus fotemustine alone in cerebral metastases of malignant melanoma. Melanoma Res. 2003 Feb;13(1):97-103. link to original article PubMed
Ipilimumab & Nivolumab
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Regimen
Study | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|
Long et al. 2018 (ANZMTG 01.14) | Randomized Phase II (E-esc) | Nivolumab | Did not meet primary endpoint of intracranial response from week 12 |
Immunotherapy, part 1
- Ipilimumab (Yervoy) 3 mg/kg IV once on day 1
- Nivolumab (Opdivo) 1 mg/kg IV once on day 1
21-day cycle for 4 cycles, followed by:
Immunotherapy, part 2
- Nivolumab (Opdivo) 3 mg/kg IV over 60 minutes once on day 1
14-day cycles
References
- ANZMTG 01.14: Long GV, Atkinson V, Lo S, Sandhu S, Guminski AD, Brown MP, Wilmott JS, Edwards J, Gonzalez M, Scolyer RA, Menzies AM, McArthur GA. Combination nivolumab and ipilimumab or nivolumab alone in melanoma brain metastases: a multicentre randomised phase 2 study. Lancet Oncol. 2018 Mar 27. link to original article contains verified protocol PubMed
Vemurafenib monotherapy
back to top |
Regimen
Study | Years of enrollment | Evidence |
---|---|---|
McArthur et al. 2017 | 2011-2013 | Phase II (RT) |
Biomarker eligiblity criteria
- BRAFV600 mutant
Chemotherapy
References
- McArthur GA, Maio M, Arance A, Nathan P, Blank C, Avril MF, Garbe C, Hauschild A, Schadendorf D, Hamid O, Fluck M, Thebeau M, Schachter J, Kefford R, Chamberlain M, Makrutzki M, Robson S, Gonzalez R, Margolin K. Vemurafenib in metastatic melanoma patients with brain metastases: an open-label, single-arm, phase 2, multicentre study. Ann Oncol. 2017 Mar 1;28(3):634-641. link to original article PubMed