Clinical responses to selumetinib (AZD6244; ARRY-142886)-based combination therapy stratified by gene mutations in patients with metastatic melanoma

Cancer

Volumn 119, Issue 4, 2013, Pages 799-805

  Patel, Sapna P ^a   Lazar, Alexander J ^a   Papadopoulos, Nicholas E ^a   Liu, Ping ^b   Infante, Jeffrey R ^c   Glass, Michelle R ^a   Vaughn, Carol S ^a   Lorusso, Patricia M ^d   Cohen, Roger B ^e,f   Davies, Michael A ^a   Kim, Kevin B ^a  

^a UNIVERSITY OF TEXAS   (United States)

^b Abbott Molecular Inc   (United States)

^c SARAH CANNON RESEARCH INSTITUTE   (United States)

^d KARMANOS CANCER INSTITUTE   (United States)

^e FOX CHASE CANCER CENTER   (United States)

^f UNIVERSITY OF PENNSYLVANIA   (United States)

Author keywords

BRAF; gene mutations; metastatic melanoma; NRAS; selumetinib

Indexed keywords

DACARBAZINE; DOCETAXEL; ERLOTINIB; SELUMETINIB; TEMSIROLIMUS;

ADULT; AGED; ARTICLE; BRAF GENE; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CANCER TISSUE; CLINICAL ARTICLE; CONTROLLED STUDY; DRUG DOSE ESCALATION; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; GENE; HUMAN; HUMAN TISSUE; MALE; MELANOMA METASTASIS; MULTIPLE CYCLE TREATMENT; NONSENSE MUTATION; NRAS GENE; OVERALL SURVIVAL; PRIORITY JOURNAL; RETROSPECTIVE STUDY; TIME; TIME TO PROGRESSION; TREATMENT RESPONSE;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BENZIMIDAZOLES; ENZYME INHIBITORS; FEMALE; HUMANS; MALE; MAP KINASE KINASE KINASES; MELANOMA; MIDDLE AGED; MULTIVARIATE ANALYSIS; PROTO-ONCOGENE PROTEINS B-RAF; PROTO-ONCOGENE PROTEINS P21(RAS); SKIN NEOPLASMS; TREATMENT OUTCOME;

EID: 84873411306     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.27790     Document Type: Article

References (29)

1. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D,. Global cancer statistics. CA Cancer J Clin. 2011; 61: 69-90.
2. Serrone L, Zeuli M, Sega FM, Cognetti F,. Dacarbazine-based chemotherapy for metastatic melanoma: 30-year experience overview. J Exp Clin Cancer Res. 2000; 19: 21-34.
3. Rosenberg SA, Yang JC, Topalian SL, et al. Treatment of 283 consecutive patients with metastatic melanoma or renal cell cancer using high-dose bolus interleukin-2. JAMA. 1994; 271: 907-913.
4. Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med. 2010; 363: 711-723.
5. Flaherty KT, Puzanov I, Kim KB, et al. Inhibition of mutated, activated BRAF in metastatic melanoma. N Engl J Med. 2010; 363: 809-819.
6. 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.
7. Chapman PB, Hauschild A, Robert C, et al. BRIM-,3 Study Group. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med. 2011; 364: 2507-2516.
8. Davies H, Bignell GR, Cox C, et al. Mutations of the BRAF gene in human cancer. Nature. 2002; 417: 949-954.
9. Haluska FG, Tsao H, Wu H, Haluska FS, Lazar A, Goel V,. Genetic alterations in signaling pathways in melanoma. Clin Cancer Res. 2006; 12 (7 pt 2): 2301s-2307s.
10. Goel VK, Lazar AJ, Warneke CL, Redston MS, Haluska FG,. Examination of mutations in BRAF, NRAS, and PTEN in primary cutaneous melanoma. J Invest Dermatol. 2006; 126: 154-160.
11. Yeh TC, Marsh V, Bernat BA, et al. Biological characterization of ARRY-142886 (AZD6244), a potent, highly selective mitogen-activated protein kinase kinase 1/2 inhibitor. Clin Cancer Res. 2007; 13: 1576-1583.
12. Davies BR, Logie A, McKay JS, et al. AZD6244 (ARRY-142886), a potent inhibitor of mitogen-activated protein kinase/extracellular signal-regulated kinase kinase 1/2 kinases: mechanism of action in vivo, pharmacokinetic/ pharmacodynamic relationship, and potential for combination in preclinical models. Mol Cancer Ther. 2007; 6: 2209-2219.
13. Banerji U, Camidge DR, Verheul HM, et al. The first-in-human study of the hydrogen sulfate (Hyd-sulfate) capsule of the MEK1/2 inhibitor AZD6244 (ARRY-142886): a phase I open-label multicenter trial in patients with advanced cancer. Clin Cancer Res. 2010; 16: 1613-1623.
14. Haass NK, Sproesser K, Nguyen TK, et al. The mitogen-activated protein/extracellular signal-regulated kinase kinase inhibitor AZD6244 (ARRY-142886) induces growth arrest in melanoma cells and tumor regression when combined with docetaxel. Clin Cancer Res. 2008; 14: 230-239.
15. Kirkwood JM, Bastholt L, Robert C, et al. Phase II, open-label, randomized trial of the MEK1/2 inhibitor selumetinib as monotherapy versus temozolomide in patients with advanced melanoma. Clini Cancer Res. 2012; 18: 555-567.
16. Ascierto P, Berking C, Agarwala SS, et al. Efficacy and safety of oral MEK162 in patients with locally advanced and unresectable or metastatic cutaneous melanoma harboring BRAFV600 or NRAS mutations [abstract]. J Clin Oncol. 2012; 30 (suppl). Abstract 8511.
17. Flaherty KT, Robert C, Hersey P, et al; METRIC Study Group,. Improved survival with MEK inhibition in BRAF-mutated melanoma. N Engl J Med. 2012; 367: 107-114.
18. Ball DW, Jin N, Rosen DM, et al. Selective growth inhibition in BRAF mutant thyroid cancer by the mitogen-activated protein kinase kinase 1/2 inhibitor AZD6244. J Clin Endocrinol Metab. 2007; 92: 4712-4718.
19. Infante JR, Fecher LA, Nallapareddy S, et al. Safety and efficacy results from the first-in-human study of the oral MEK 1/2 inhibitor GSK1120212 [abstract]. J Clin Oncol. 2010; 28 (suppl). Abstract 2503.
20. 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. 1999; 17: 2745-2751.
21. Bedikian AY, Millward M, Pehamberger H, et al. Bcl-2 antisense (oblimersen sodium) plus dacarbazine in patients with advanced melanoma: the Oblimersen Melanoma Study Group. J Clin Oncol. 2006; 24: 4738-4745.
22. 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 melanoma and other solid tumors [abstract]. J Clin Oncol. 2010; 28 (suppl). Abstract 8503.
23. Montagut C, Sharma SV, Shioda T, et al. Elevated CRAF as a potential mechanism of acquired resistance to BRAF inhibition in melanoma. Cancer Res. 2008; 68: 4853-4861.
24. Johannessen CM, Boehm JS, Kim SY, et al. COT drives resistance to RAF inhibition through MAP kinase pathway reactivation. Nature. 2010; 468: 968-972.
25. V600E melanoma [abstract]. J Clin Oncol. 2012; 30 (suppl). Abstract 8503.
26. Poulikakos PI, Persaud Y, Janakiraman M, et al. RAF inhibitor resistance is mediated by dimerization of aberrantly spliced BRAF(V600E). Nature. 2011; 480: 387-390.
27. Nazarian R, Shi H, Wang Q, et al. Melanomas acquire resistance to B-RAF(V600E) inhibition by RTK or N-RAS upregulation. Nature. 2010; 468: 973-977.
28. Villanueva J, Vultur A, Lee JT, et al. Acquired resistance to BRAF inhibitors mediated by a RAF kinase switch in melanoma can be overcome by cotargeting MEK and IGF-1R/PI3K. Cancer Cell. 2010; 18: 683-695.
29. Shi H, Moriceau G, Kong X, et al. Melanoma whole-exome sequencing identifies (V600E)B-RAF amplification-mediated acquired B-RAF inhibitor resistance [serial online]. Nat Commun. 2012; 3: 724.