New therapeutic options for advanced non-resectable malignant melanoma

Advances in Medical Sciences

Volumn 60, Issue 1, 2015, Pages 83-88

  Stadler, Simone ^a,b   Weina, Kasia ^a,b   Gebhardt, Christoffer ^a,b   Utikal, Jochen ^a,b  

^a GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

^b UNIVERSITY OF HEIDELBERG   (Germany)

Author keywords

Immunotherapy; Melanoma; Metastasis; Targeted therapy; Treatment

Indexed keywords

B RAF KINASE INHIBITOR; CYTOTOXIC T LYMPHOCYTE ANTIGEN 4 ANTIBODY; MITOGEN ACTIVATED PROTEIN KINASE INHIBITOR; ANTINEOPLASTIC AGENT;

CANCER IMMUNOTHERAPY; HUMAN; MELANOMA; OVERALL SURVIVAL; PROGRESSION FREE SURVIVAL; REVIEW; SIGNAL TRANSDUCTION; DISEASE COURSE; IMMUNOTHERAPY; MORTALITY;

ANTINEOPLASTIC AGENTS; DISEASE PROGRESSION; HUMANS; IMMUNOTHERAPY; MELANOMA;

EID: 84927746895     PISSN: 18961126     EISSN: 18984002     Source Type: Journal    
DOI: 10.1016/j.advms.2014.12.002     Document Type: Review

References (53)

1. Pflugfelder A, Kochs C, Blum A, Capellaro M, Czeschik C, Dettenborn T, et al. Malignant melanoma S3-guideline "diagnosis, therapy and follow-up of mel-anoma". J Dtsch Dermatol Ges 2013;11(Suppl. 6):1-116.
2. Chapman PB, Hauschild A, Robert C, Haanen JB, Ascierto P, Larkin J, et al., BRIM-3 Study Group. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 2011;364:2507-16.
3. Ascierto PA, Minor D, Ribas A, Lebbe C, O'Hagan A, Arya N, et al. Phase II trial (BREAK-2) of the braf inhibitor dabrafenib (GSK2118436) in patients with metastatic melanoma. J Clin Oncol 2013;31:3205-11.
4. Hallmeyer S, Hamid O, Sorof TA, Mun Y, Liu S, Abhyankar S, et al. Phase II study of vemurafenib in patients with locally advanced, unresectable stage IIIc or metastatic melanoma and activating exon 15 BRAF mutations other than V600E. J Clin Oncol 2014;32(5s). suppl; abstract 9075.
5. Manousaridis I, Mavridou S, Goerdt S, Leverkus M, Utikal J. Cutaneous side effects of inhibitors of the RAS/RAF/MEK/ERK signalling pathway and their management. J Eur Acad Dermatol Venereol 2013;27:11-8.
6. Ascierto PA, Minor DR, Ribas A, Lebbe C, O'Hagan A, Swann RS, et al. Long-term safety and overall survival update for BREAK-2, a phase 2, single-arm, open-label study of dabrafenib in previously treated metastatic melanoma (NCT01153763). J Clin Oncol 2014;32(5s). suppl; abstract 9034.
7. McArthur GA, Chapman PB, Robert C, Larkin J, Haanen JB, Dummer R, et al. Safety and efficacy of vemurafenib in BRAF(V600E) and BRAF(V600K) muta-tion-positive melanoma (BRIM-3): extended follow-up of a phase 3, random-ised, open-label study. Lancet Oncol 2014;15:323-32.
8. Schilling B, Sondermann W, Zhao F, Griewank KG, Livingstone E, Sucker A, et al. Differential influence of vemurafenib and dabrafenib on patients' lymphocytes despite similar clinical efficacy in melanoma. Ann Oncol 2014;25:747-53.
9. Orouji E, Ziegler B, Umansky V, Gebhardt C, Utikal J. Leukocyte count restora-tion under dabrafenib treatment in a melanoma patient with vemurafenib-induced leukopenia: case report. Medicine (Baltimore) 2014;93(28):e161.
10. Oberholzer PA, Kee D, Dziunycz P, Sucker A, Kamsukom N, Jones R, et al. RAS mutations are associated with the development of cutaneous squamous cell tumors in patients treated with RAF inhibitors. J Clin Oncol 2012;30:316-21.
11. Zimmer L, Hillen U, Livingstone E, Lacouture ME, Busam K, Carvajal RD, et al. Atypical melanocytic proliferations and new primary melanomas in patients with advanced melanoma undergoing selective BRAF inhibition. J Clin Oncol 2012;30:2375-83.
12. Flaherty KT, Robert C, Hersey P, Nathan P, Garbe C, Milhem M, et al., METRIC Study Group. Improved survival with MEK inhibition in BRAF-mutated mela-noma. N Engl J Med 2012;367:107-14.
13. Coupe N, Corrie P, Hategan M, Larkin J, Gore ME, Gupta A, et al. A phase 1, does escalation study of paclitaxel with GSK1120212 (Trametinib) for the treat-ment of advanced melanoma. Ann Oncol 2014;25(S4). abstract 1094PD.
14. Robert C, Dummer R, Gutzmer R, Lorigan P, Kim KB, Nyakas M, et al. Selumetinib plus dacarbazine versus placebo plus dacarbazine as first-line treatment for BRAF-mutant metastatic melanoma: a phase 2 double-blind randomised study. Lancet Oncol 2013;14:733-40.
15. Bernhardt M, Orouji E, Larribere L, Gebhardt C, Utikal J. Efficacy of vemurafenib in a trametinib-resistant stage IV melanoma patient-letter. Clin Cancer Res 2014;20:2498-9.
16. Goldinger SM, Zimmer L, Schulz C, Ugurel S, Hoeller C, Kaehler KC, et al. Dermatology Cooperative Oncology Group (DeCOG). Upstream mitogen-acti-vated protein kinase (MAPK) pathway inhibition: MEK inhibitor followed by a BRAF inhibitor in advanced melanoma patients. Eur J Cancer 2014;50:406-10.
17. Hodis E, Watson IR, Kryukov GV, Arold ST, Imielinski M, Theurillat JP, et al. A landscape of driver mutations in melanoma. Cell 2012;150:251-63.
18. Ascierto PA, Schadendorf D, Berking C, Agarwala SS, van Herpen CM, Queirolo P, et al. MEK162 for patients with advanced melanoma harbouring NRAS or Val600 BRAF mutations: a non-randomised, open-label phase 2 study. Lancet Oncol 2013;14:249-56.
19. Kwong LN, Costello JC, Liu H, Jiang S, Helms TL, Langsdorf AE, et al. Oncogenic NRAS signaling differentially regulates survival and proliferation in melano-ma. Nat Med 2012;18:1503-10.
20. Sosman JA, Kittaneh M, Lolkema MPJK, Postow MA, Schwartz G, Franklin C, et al. A phase 1b/2 study of LEE011 in combination with binimetinib (MEK162) in patients with NRAS-mutant melanoma: Early encouraging clinical activity. J Clin Oncol 2014;32(5s). suppl; abstract 9009.
21. Trunzer K, Pavlick AC, Schuchter L, Gonzalez R, McArthur GA, Hutson TE, et al. Pharmacodynamic effects and mechanisms of resistance to vemurafenib in patients with metastatic melanoma. J Clin Oncol 2013;31:1767-74.
22. Das Thakur M, Salangsang F, Landman AS, Sellers WR, Pryer NK, Levesque MP, et al. Modelling vemurafenib resistance in melanoma reveals a strategy to forestall drug resistance. Nature 2013;494:251-5.
23. Sun C, Wang L, Huang S, Heynen GJ, Prahallad A, Robert C, et al. Reversible and adaptive resistance to BRAF(V600E) inhibition in melanoma. Nature 2014;508:118-22.
24. Flaherty KT, Infante JR, Daud A, Gonzalez R, Kefford RF, Sosman J, et al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. N Engl J Med 2012;367:1694-703.
25. Kefford R, Miller WH, Shao-Weng Tan D, Sullivan RJ, Long G, Dienstmann R, et al. Preliminary results from a phase Ib/II, open-label, dose-escalation study of the oral BRAF inhibitor LGX818 in combination with the oral MEK1/2 inhibitor MEK162 in BRAFV600-dependent advanced solid tumors. J Clin Oncol 2013;31. suppl; abstract 9029.
26. Flaherty K, Daud A, Weber JS, Sosman JA, Kim K, Gonzalez R, et al. Updated overall survival (OS) for BRF113220, a phase 1-2 study of dabrafenib (D) alone versus combined dabrafenib and trametinib (D + T) in pts with BRAF V600 mutation-positive (+) metastatic melanoma (MM). J Clin Oncol 2014;32(5s). suppl; abstract 9010.
27. Ribas A, Gonzalez R, Pavlick A, Hamid O, Gajewski TF, Daud A, et al. Combina-tion of vemurafenib and cobimetinib in patients with advanced BRAF(V600)-mutated melanoma: a phase 1b study. Lancet Oncol 2014;15:954-65.
28. Long GV, Stroyakovskiy D, Gogas H, Levchenko E, de Braud F, Larkin J, et al. Combined BRAF and MEK inhibition versus BRAF inhibition alone in melano-ma. N Engl J Med 2014;371:1877-88.
29. Larkin J, Ascierto PA, Dréno B, Atkinson V, Liszkay G, Maio M, et al. Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med 2014;371:1867-76.
30. Robert C1, Karaszewska B, Schachter J, Rutkowski P, Mackiewicz A, Stroia-kovski D, et al. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med 2014 [Epub ahead of print].
31. Carvajal RD, Antonescu CR, Wolchok JD, Chapman PB, Roman RA, Teitcher J, et al. KIT as a therapeutic target in metastatic melanoma. JAMA 2011;305: 2327-34.
32. Guo J, Si L, Kong Y, Flaherty KT, Xu X, Zhu Y, et al. Phase II, open-label, single-arm trial of imatinib mesylate in patients with metastatic melanoma harbor-ing c-Kit mutation or amplification. J Clin Oncol 2011;29:2904-9.
33. Hodi FS, Corless CL, Giobbie-Hurder A, Fletcher JA, Zhu M, Marino-Enriquez A, et al. Imatinib for melanomas harboring mutationally activated or amplified KIT arising on mucosal, acral, and chronically sun-damaged skin. J Clin Oncol 2013;31:3182-90.
34. Woodman SE, Trent JC, Stemke-Hale K, Lazar AJ, Pricl S, Pavan GM, et al. Activity of dasatinib against L576P KIT mutant melanoma: molecular, cellular, and clinical correlates. Mol Cancer Ther 2009;8:2079-85.
35. Kluger HM, Dudek AZ, McCann C, Ritacco J, Southard N, Jilaveanu LB, et al. A phase 2 trial of dasatinib in advanced melanoma. Cancer 2011;117:2202-8.
36. Lebbe C, Chevret S, Jouary T, Dalac S, Dalle S, Guillot B, et al. Phase II multi-centric uncontrolled national trial assessing the efficacy of nilotinib in the treatment of advanced melanomas with c-KIT mutation or amplification. J Clin Oncol 2014;32(5s). suppl; abstract 9032.
37. Hodi FS, O'Day SJ, McDermott DF, Weber RW, Sosman JA, Haanen JB, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010;363:711-23.
38. Zimmer L, Eigentler TK, Vaubel JM, Mohr P, Jradi Z, Kiecker F, et al. Open-label, multicenter, single-arm phase II study (DeCOG-Trial) to further evaluate the efficacy and safety of ipilimumab in patients with cutaneous melanoma and rare subgroups. J Clin Oncol 2014;32(5s). suppl; abstract 9031.
39. Luke JJ, Callahan MK, Postow MA, Romano E, Ramaiya N, Bluth M, et al. Clinical activity of ipilimumab for metastatic uveal melanoma: a retrospective review of the Dana-Farber Cancer Institute, Massachusetts General Hospital, Memorial Sloan-Kettering Cancer Center, and University Hospital of Lausanne experience. Cancer 2013;119:3687-95.
40. Piulats Rodriguez JM, Ochoa de Olza M, Codes M, Lopez-Martin JA, Berrocal A, García M, et al. Phase II study evaluating ipilimumab as a single agent in the first-line treatment of adult patients (Pts) with metastatic uveal melanoma (MUM): the GEM-1 trial. J Clin Oncol 2014;32(5s). suppl; abstract 9033.
41. Postow MA, Luke JJ, Bluth MJ, Ramaiya N, Panageas KS, Lawrence DP, et al. Ipilimumab for patients with advanced mucosal melanoma. Oncologist 2013;18:726-32.
42. Lee-Ying RM, Feng X, Smylie M, Monzon JG, Cheng T. Efficacy of two ipilimu-mab (IPI) doses (10 vs. 3 mg/kg) in Alberta, Canada, tertiary cancer centers. J Clin Oncol 2014;32(5s). suppl; abstract 9090.
43. Eggermont AM, Chiarion-Sileni V, Grob JJ, Dummer R, Wolchok JD, Schmidt H, et al. Ipilimumab versus placebo after complete resection of stage III melano-ma: initial efficacy and safety results from the EORTC 18071 phase III trial. J Clin Oncol 2014;32(5s). suppl; abstract LBA9008.
44. Brahmer JR, Tykodi SS, Chow LQ, Hwu WJ, Topalian SL, Hwu P, et al. Safety and activity of anti-PD-L1 antibody in patients with advanced cancer. N Engl J Med 2012;366:2455-65.
45. Topalian SL, Hodi FS, Brahmer JR, Gettinger SN, Smith DC, McDermott DF, et al. Safety, activity, and immune correlates of anti-PD-1 antibody in cancer. N Engl J Med 2012;366:2443-54.
46. Hamid O, Robert C, Daud A, Hodi FS, Hwu WJ, Kefford R, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med 2013;369:134-44.
47. Wolchok JD, Kluger H, Callahan MK, Postow MA, Rizvi NA, Lesokhin AM, et al. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med 2013;369:122-33.
48. Ribas A, Hodi FS, Kefford R, Hamid O, Daud A, Wolchok JD, et al. Efficacy and safety of the anti-PD-1 monoclonal antibody MK-3475 in 411 patients (pts) with melanoma (MEL). J Clin Oncol 2014;32(5s). suppl; abstract LBA9000.
49. Hodi FS, Sznol M, Kluger HM, McDermott DF, Carvajal RD, Lawrence DP, et al. Long-term survival of ipilimumab-naive patients (pts) with advanced mela-noma (MEL) treated with nivolumab (anti-PD-1, BMS-936558, ONO-4538) in a phase I trial. J Clin Oncol 2014;32(5s). suppl; abstract 9002.
50. Weber JS, Minor DR, D'Angelo SP, Hodie FS, Gutzmer R, Neyns B, et al. A phase 3 randomized, open-label study of nivolumab (anti-PD-1, BMS-936558, ONO-4538) versus investigator's choice chemotherapy (ICC) in patients with advanced melanoma and prior anti-CTLA-4 therapy. Ann Oncol 2014;25(S4). abstract LBA3.
51. Sznol M, Kluger HM, Callahan MK, Postow MA, Gordon RA, Segal NH, et al. Survival, response duration, and activity by BRAF mutation (MT) status of nivolumab (NIVO, anti-PD-1, BMS-936558, ONO-4538) and ipilimumab (IPI) concurrent therapy in advanced melanoma (MEL). J Clin Oncol 2014;32(5s). suppl; abstract LBA9003.
52. Ribas A, Hodi FS, Callahan M, Konto C, Wolchok J. Hepatotoxicity with combination of vemurafenib and ipilimumab. N Engl J Med 2013;368: 1365-6.
53. Kudchadkar RR, Gibney GT, Dorman D, Merek S, Ramadan H, Chen A, et al. A phase IB study of ipilimumab with peginterferon alfa-2b for patients with unresectable stages IIIB/C/IV melanoma. J Clin Oncol 2014;32(5s). suppl; abstract 9098.