BRIM-1, -2 and -3 trials: Improved survival with vemurafenib in metastatic melanoma patients with a BRAF V600E mutation

Future Oncology

Volumn 8, Issue 5, 2012, Pages 499-507

  Young, Kate ^a   Minchom, Anna ^a   Larkin, James ^a  

^a INSTITUTE OF CANCER RESEARCH   (United Kingdom)

Author keywords

BRAF; BRAF V600E; BRIM 1, 2 and 3; metastatic melanoma; V600E mutation; vemurafenib

Indexed keywords

B RAF KINASE; CYCLIN D1; DACARBAZINE; KI 67 ANTIGEN; LACTATE DEHYDROGENASE; MITOGEN ACTIVATED PROTEIN KINASE; MOLECULAR MARKER; N [3 (5 CHLORO 1H PYRROLO[2,3 B]PYRIDINE 3 CARBONYL) 2,4 DIFLUOROPHENYL]PROPANESULFONAMIDE; VEMURAFENIB;

ARTHRALGIA; BRAF GENE; CANCER GROWTH; CANCER PATIENT; CANCER STAGING; CANCER SURVIVAL; CELLULITIS; DEATH; DELIRIUM; DRUG BLOOD LEVEL; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG EXPOSURE; DRUG HALF LIFE; DRUG MONITORING; DRUG POTENCY; DRUG SAFETY; DRUG SELECTIVITY; DRUG WITHDRAWAL; FATIGUE; GENE MUTATION; HAIR LOSS; HAND FOOT SYNDROME; HUMAN; JAUNDICE; LIVER FUNCTION TEST; METASTATIC MELANOMA; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; NONHUMAN; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PHOTOSENSITIVITY; PRIORITY JOURNAL; PROGNOSIS; PROGRESSION FREE SURVIVAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RASH; RECOMMENDED DRUG DOSE; RETINA VEIN OCCLUSION; REVIEW; RISK REDUCTION; SIDE EFFECT; SKIN CARCINOMA; SKIN PAPILLOMA; SQUAMOUS CELL CARCINOMA; SURVIVAL RATE; TREATMENT OUTCOME; TREATMENT RESPONSE; TUMOR GENE; VOMITING;

ANTINEOPLASTIC AGENTS; CLINICAL TRIALS, PHASE I AS TOPIC; CLINICAL TRIALS, PHASE II AS TOPIC; CLINICAL TRIALS, PHASE III AS TOPIC; FEMALE; HUMANS; INDOLES; MALE; MELANOMA; MULTICENTER STUDIES AS TOPIC; MUTATION; NEOPLASM METASTASIS; PROTO-ONCOGENE PROTEINS B-RAF; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SULFONAMIDES; TREATMENT OUTCOME;

EID: 84861745961     PISSN: 14796694     EISSN: 17448301     Source Type: Journal    
DOI: 10.2217/fon.12.43     Document Type: Review

References (36)

1. Jemal A, Siegel R, Xu J, Ward E. Cancer Statistics, 2010. CA Cancer J. Clin. 60(5), 277-300 (2010).
2. Cummins D, Cummins J, Pantle M et al. Cutaneous malignant melanoma. Mayo Clin. Proc. 81(4), 500-507 (2006).
3. Davies H, Bignell GR, Cox C et al. Mutations of the BRAF gene in human cancer. Nature 417, 949-954 (2002). (Pubitemid 34716871)
4. Tsao H, Goel V, Wu H et al. Genetic Interaction between NRAS and BRAF mutations and PTEN/MMAC1 inactivation in melanoma. J. Invest. Dermatol. 122, 337-341 (2004). (Pubitemid 38281053)
5. Willmore-Payne C, Holden JA, Tripp S, Layfield LJ. Human malignant melanoma: Detection of BRAF and c-KIT activating mutations by high-resolution amplicon melting analysis. Human Pathol. 36, 486-493 (2005). (Pubitemid 40776001)
6. Curtin J, Fridlyand J, Kageshita T et al. Distinct sets of genetic alterations in melanoma. N. Engl. J. Med. 353, 2135-2147 (2005). (Pubitemid 41653105)
7. Zuidervaart W, van Nieupoort F, Stark M et al. Activation of the MAPK pathway is a common event in uveal melanomas although it rarely occurs through mutation of BRAF or RAS. Br. J. Cancer. 92(11), 2032-2038 (2005). (Pubitemid 40897426)
8. van Raamsdonk C, Griewank K, Crosby M et al. Mutations in GNA11 in uveal melanoma. N. Engl. J. Med. 363, 2191-2199, (2010).
9. Gray-Schopfer V, Wellbrock C, Marais R. Melanoma biology and new targeted therapy. Nature 445, 851-857 (2007).
10. Korn EL, Liu PY, Lee SJ et al. Meta-Analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression free and overall survival benchmarks for future Phase II trials. J. Clin. Oncol. 27, 6199-6206 (2009).
11. Long GV, Menzies AM, Nagrial AM et al. Prognostic and clinicopathologic associations of oncogenic BRAF in metastatic melanoma. J. Clin. Oncol. 29(10), 1239-1246 (2011).
12. Serrone L, Zeuli M, Sega FM, Cognetti F. Dacarbazine based chemotherapy for metastatic melanoma: Thirty year experience overview. J. Exp. Clin. Cancer Res. 19(1), 21-34 (2000). (Pubitemid 30305516)
13. Middleton MR, Grob JJ, Aaronson N et al. Randomised Phase III study of temozolamide versus dacarbazine in the treatment of patients with advanced metastatic melanoma. J. Clin. Oncol. 18, 158-166 (2000). (Pubitemid 30036349)
14. Chapman PB, Einhorn LH, Meyers ML et al. Phase III multicenter randomized trial of the Dartmouth regimen versus dacarbazine in patients with metastatic melanoma. J. Clin. Oncol. 22, 1118-1125 (2004).
15. Atkins MB, Lotze MT, Dutcher JP et al. High dose recombinant interleukin 2 therapy for patients with metastatic melanoma: Anlaysis of 270 patients treated between 1985 and 1993. J. Clin. Oncol. 17, 2105-2116 (1999). (Pubitemid 29318842)
16. Ives NJ, Stowe RL, Lorigan P, Wheatley K. Chemotherapy compared with biochemotherapy for the treatment of metastatic melanoma: A meta-Analysis of 18 trials involving 2,621 patients. J. Clin. Oncol. 25, 5426-5434 (2007). (Pubitemid 350232219)
17. Hodi FS, O'Day SJ, McDermott DF et al. Improved survival with ipilimumab in patients with metastatic melanoma. N. Engl. J. Med. 363(8), 711-723 (2010).
18. Wolchok JD, Thomas L, Bondarenko IN et al. Phase III randomized study of ipilimumab (IPI) plus dacarbazine (DTIC) versus DTIC alone as first-line treatment in patients with unresectable stage III or IV melanoma. J. Clin. Oncol. 29(Suppl.) Abstract LBA5 (2011).
19. Hauschild A, Agarwala S, Trefzer U et al. Results of a Phase III randomized placebo-controlled study of sorafenib in combination with carboplatin and paclitaxel as second line treatment in patients with unresectable stage III or stage IV melanoma. J. Clin. Oncol. 27(17), 2823-2830 (2010).
20. Flaherty KT, Lee SJ, Schuchter LM et al. Final results of E2603: A double blind, randomized Phase III trial comparing carboplatin/ paclitaxel with or without sorafenib in metastatic melanoma. J. Clin. Oncol. 28(Suppl. 613), Abstract 8511 (2010).
21. Kefford R, Arkenau H, Brown MP et al. Phase I/II study of GSK2118436, a selective inhibitor of oncogenic mutant BRAF kinase, in patients with metastatic tumours and other solid tumours. J. Clin. Oncol. 28(Suppl. 611), Abstract 8503 (2010).
22. Infante JR, Fecher LA, Nallapareddy S et al. Safety and efficacy results from the first in human study of the oral MED inhibitor GSK1120212. J. Clin. Oncol. 28(Suppl. 204) Abstract 2503 (2010).
23. Curtain J, Busam K, Pinkel D et al. Somatic activation of KIT in distinct subtypes of melanoma. J. Clin. Oncol. 24, 4340-4346 (2006).
24. Guo J, Si L, Kong Y et al. Phase II, open-label, single-Arm trial of imatinib mesylate in patients with metastatic melanoma harbouring c-KIT mutation or amplification. J. Clin. Oncol. 29, 2904-2909, (2011).
25. Carvajal R, Antonescu C, Wolchok J et al. KIT as a therapeutic target in metastatic melanoma. JAMA 305, 2327-2334, (2011).
26. Sondergaard JN, Nazarian R, Wang Q et al. Differential sensitivity of melanoma cell lines with BRAFV600E mutation to the specific Raf inhibitor PLX4032. J. Transl. Med. 8, 39-49 (2010).
27. Tsai J, Lee J, Wang W et al. Discovery of a selective inhibitor of oncogenic B-Raf kinase with potent antimelanoma activity. Proc. Natl Acad. Sci. USA 105(8), 3041-3046 (2008).
28. Lee JT, Ling Li, Brafford P et al. PLX4032, a potent inhibitor of the B-Raf V600E oncogene, selectively inhibits V600E-positive melanomas. Pigment Cell Melanoma Res. 23(6), 820-827 (2010).
29. Flaherty KT, Puzanov I, Kim KB et al. Inhibition of mutated, activated BRAF in metastatic melanoma. N. Engl. J. Med. 363(9), 809-819 (2010).
30. Sosman J, Kim K, Schuchter M et al. Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib. N. Engl. J. Med. 366(8) 707-714 (2012).
31. Chapman PB, Hauschild A, Robert C et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N. Engl. J. Med. 364, 26, 507-516 (2011).
32. Nazarian R, Shi H, Wang Q et al. Melanomas acquire resistance to BRAFV600E inhibition by RTK or N-RAS upregulation. Nature 468, 973-977 (2010).
33. Johannessen CM, Boehm JS, Kim SY et al. COT drives resistance to RAF inhibition through MAP kinase pathway reactivation. Nature 468, 968-972 (2010).
34. Boni A, Cogdill A, Dang P et al. Selective BRAFV600E inhibition enhances T-cell recognition of melanoma without affecting lymphocyte function. Cancer Res. 70, 5213-5219 (2010).
35. Infante JR, Falchook GS, Lawrence DP et al. Phase I/II study to assess safety, pharmacokinetics, and efficacy of the oral MEK 1/2 inhibitor GSK1120212 (GSK212) dosed in combination with the oral BRAF inhibitor GSK2118436 (GSK436). J. Clin. Oncol. 29(Suppl.), Abstract 8503 (2011).
36. Su F, Viros A, Milagre C et al. RAS mutations in cutaneous squamous-cell carcinomas in patients treated with BRAF inhibitors. N. Engl. J. Med. 366(3), 207-215 (2012).