Dabrafenib in patients with Val600Glu or Val600Lys BRAF-mutant melanoma metastatic to the brain (BREAK-MB): A multicentre, open-label, phase 2 trial

The Lancet Oncology

Volumn 13, Issue 11, 2012, Pages 1087-1095

  Long, Georgina V ^a   Trefzer, Uwe ^b   Davies, Michael A ^c   Kefford, Richard F ^a   Ascierto, Paolo A ^d   Chapman, Paul B ^e   Puzanov, Igor ^f   Hauschild, Axel ^g   Robert, Caroline ^h   Algazi, Alain ⁱ   Mortier, Laurent ^j   Tawbi, Hussein ^k,l   Wilhelm, Tabea ^b   Zimmer, Lisa ^m   Switzky, Julie ⁿ   Swann, Suzanne ⁿ   Martin, Anne Marie ⁿ   Guckert, Mary ⁿ   Goodman, Vicki ⁿ   Streit, Michael ⁿ   Kirkwood, John M ^k,l   Schadendorf, Dirk ^m   more..

^a UNIVERSITY OF SYDNEY   (Australia)

^b CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d NATIONAL CANCER INSTITUTE   (Italy)

^e MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^f VANDERBILT INGRAM CANCER CENTER   (United States)

^g UNIVERSITY HOSPITAL SCHLESWIG HOLSTEIN   (Germany)

^h INSTITUT GUSTAVE ROUSSY   (France)

ⁱ UNIVERSITY OF CALIFORNIA   (United States)

^j LILLE UNIVERSITY HOSPITAL   (France)

^k UNIVERSITY OF PITTSBURGH CANCER INSTITUTE   (United States)

^l Department of Translational Science ^*  (United States)

^m UNIVERSITY OF DUISBURG ESSEN   (Germany)

ⁿ GLAXOSMITHKLINE   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

AMYLASE; B RAF KINASE; DABRAFENIB; GLUTAMIC ACID; LYSINE; MUTANT PROTEIN; TRIACYLGLYCEROL LIPASE; VALINE;

ACTINIC KERATOSIS; ADULT; AGRANULOCYTOSIS; AMINO ACID SUBSTITUTION; AMYLASE BLOOD LEVEL; ARTICLE; BASAL CELL CARCINOMA; BRAIN HEMORRHAGE; BRAIN METASTASIS; COHORT ANALYSIS; CONVULSION; DEATH; DISEASE COURSE; DRUG ACTIVITY; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; FEVER; HUMAN; KERATOACANTHOMA; MAJOR CLINICAL STUDY; MALE; METASTATIC MELANOMA; MULTICENTER STUDY; NAMED INVENTORIES, QUESTIONNAIRES AND RATING SCALES; NEUTROPENIA; OPEN STUDY; OVERALL SURVIVAL; PATIENT CODING; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RESPONSE EVALUATION CRITERIA IN SOLID TUMORS; SIDE EFFECT; SKIN CARCINOMA; SQUAMOUS CELL CARCINOMA;

ADULT; BRAIN NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; IMIDAZOLES; MALE; MELANOMA; MIDDLE AGED; MUTATION; NEOPLASM STAGING; OXIMES; PROTO-ONCOGENE PROTEINS B-RAF;

EID: 84868120907     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(12)70431-X     Document Type: Article

References (34)

1. Carlino MS, Atkins MB, Warneke CL, et al. Differences between Australia (OZ) and the United States (US) in the patterns, prognosis, and treatment of melanoma CNS metastases: analysis from the PHAMOUS (prognostic heterogeneity in patients with advanced melanoma between OZ and the US) study. 7th International Melanoma Congress; Sydney, Australia; Nov 4-7, 2010. 8516.
2. Jakob JA, Bassett RL, Ng CS, et al. NRAS mutation status is an independent prognostic factor in metastatic melanoma. Cancer 2011, 118:4014-4023.
3. Davies MA, Liu P, McIntyre S, et al. Prognostic factors for survival in melanoma patients with brain metastases. Cancer 2011, 117:1687-1696.
4. Fife KM, Colman MH, Stevens GN, et al. Determinants of outcome in melanoma patients with cerebral metastases. J Clin Oncol 2004, 22:1293-1300.
5. Eigentler TK, Figl A, Krex D, et al. Number of metastases, serum lactate dehydrogenase level, and type of treatment are prognostic factors in patients with brain metastases of malignant melanoma. Cancer 2011, 117:1697-1703.
6. Carlino MS, Fogarty GB, Long GV Treatment of melanoma brain metastases: a new paradigm. Cancer J 2012, 18:208-212.
7. Agarwala SS, Kirkwood JM, Gore M, et al. Temozolomide for the treatment of brain metastases associated with metastatic melanoma: a phase II study. J Clin Oncol 2004, 22:2101-2107.
8. Margolin K, Ernstoff MS, Hamid O, et al. Ipilimumab in patients with melanoma and brain metastases: an open-label, phase 2 trial. Lancet Oncol 2012, 13:459-465.
9. Mornex F, Thomas L, Mohr P, et al. 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, 13:97-103.
10. Long GV, Menzies AM, Nagrial AM, et al. Prognostic and clinicopathologic associations of oncogenic BRAF in metastatic melanoma. J Clin Oncol 2011, 29:1239-1246.
11. Menzies AM, Haydu LE, Visintin L, et al. Distinguishing clinicopathologic features of patients with V600E and V600K BRAF-mutant metastatic melanoma. Clin Cancer Res 2012, 18:3242-3249.
12. Cheng S, Chu P, Hinshaw M, et al. Frequency of mutations associated with targeted therapy in malignant melanoma patients. Proc Am Soc Clin Oncol 2011, 29(suppl). abstr 8597.
13. Thomas NE, Edmiston SN, Alexander A, et al. Number of nevi and early-life ambient UV exposure are associated with BRAF-mutant melanoma. Cancer Epidemiol Biomarkers Prev 2007, 16:991-997.
14. Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 2011, 364:2507-2516.
15. Falchook GS, Long GV, Kurzrock R, et al. Dabrafenib in patients with melanoma, untreated brain metastases, and other solid tumours: a phase 1 dose-escalation trial. Lancet 2012, 379:1893-1901.
16. Flaherty KT, Puzanov I, Kim KB, et al. Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med 2010, 363:809-819.
17. Hauschild A, Grob JJ, Demidov LV, et al. Dabrafenib in BRAF-mutated metastatic melanoma: a multicentre, open-label, phase 3 randomised controlled trial. Lancet 2012, 380:358-365.
18. Sosman JA, Kim KB, Schuchter L, et al. Survival in BRAF V600-mutant advanced melanoma treated with vemurafenib. N Engl J Med 2012, 366:707-714.
19. V600E mutation. Mol Cancer Ther 2009, 8. abstr B88.
20. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer 2009, 45:228-247.
21. Balch CM, Gershenwald JE, Soong SJ, et al. Final version of 2009 AJCC melanoma staging and classification. J Clin Oncol 2009, 27:6199-6206.
22. Dummer R, Rinderknecht J, Goldinger SM, et al. An open-label pilot study of vemurafenib in previously treated metastatic melanoma patients with brain metastases. Proc Am Soc Clin Oncol 2011, 29(suppl 15). abstr 8548.
23. Schuchter L, Flaherty LE, Hamid O, et al. A single-arm, open-label, US expanded access study of vemurafenib in patients with metastatic melanoma. Proc Am Soc Clin Oncol 2012, 30(suppl 15). abstr 8567.
24. Di Giacomo AM, Ascierto PA, Pilla L, et al. Ipilimumab and fotemustine in patients with advanced melanoma (NIBIT-M1): an open-label, single-arm phase 2 trial. Lancet Oncol 2012, 13:879-886.
25. Gounder MM, Spriggs DR Inclusion of patients with brain metastases in phase I trials: an unmet need. Clin Cancer Res 2011, 17:3855-3857.
26. Trefzer U, Minor D, Ribas A, et al. BREAK-2: a Phase IIA trial of the selective BRAF kinase inhibitor GSK2118436 in patients with BRAF (V600E/K) mutation-positive metastatic melanoma. Pigment Cell Melanoma Res 2011, 24:1020. (abstr LBA1-1).
27. Alvarado G, Noor R, Bassett RL, et al. Risk of intracranial hemorrhage with anticoagulation therapy in melanoma patients with brain metastases. Melanoma Res 2012, 22:310-315.
28. Raizer JJ, Hwu WJ, Panageas KS, et al. Brain and leptomeningeal metastases from cutaneous melanoma: survival outcomes based on clinical features. Neuro Oncol 2008, 10:199-207.
29. Hatzivassilou G, Song K, Yen I, et al. RAF inhibitors prime wild-type RAF to activate the MAPK pathway and enhance growth. Nature 2010, 464:431-435.
30. Heidorn SJ, Milagre C, Whittaker S, et al. Kinase-dead BRAF and oncogenic RAS cooperate to drive tumor progression through CRAF. Cell 2010, 140:209-221.
31. Poulikakos PI, Zhang C, Bollag G, Shokat KM, Rosen N RAF inhibitors transactivate RAF dimers and ERK signalling in cells with wild-type BRAF. Nature 2010, 464:427-430.
32. Amit O, Mannino F, Stone AM, et al. Blinded independent central review of progression in cancer clinical trials: results from a meta-analysis. Eur J Cancer 2011, 47:1772-1778.
33. Kanaly CW, Ding D, Mehta AI, et al. A novel method for volumetric MRI response assessment of enhancing brain tumors. PLoS One 2011, 26:e16031.
34. Eichler AF, Chung E, Kodack DP, et al. The biology of brain metastases-translation to new therapies. Nat Rev Clin Oncol 2011, 8:344-356.