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CNS melanoma

Section editors
SeemaNagpal.jpg
Seema Nagpal, MD
Stanford University
Palo Alto, CA
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Elizabeth Buchbinder, MD
Dana-Farber Cancer Institute
Boston, MA

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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.


Contents

Guidelines

All lines of therapy

Dabrafenib monotherapy

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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

Continued indefinitely

References

  1. 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

Continued indefinitely

References

  1. 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

  1. 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

21-day cycle for 4 cycles, followed by:

Immunotherapy, part 2

14-day cycles

References

  1. 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

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Regimen

Study Years of enrollment Evidence
McArthur et al. 2017 2011-2013 Phase II (RT)

Biomarker eligiblity criteria

Chemotherapy

References

  1. 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