The current state of targeted therapy in melanoma: This time it's personal

Seminars in Oncology

Volumn 39, Issue 2, 2012, Pages 204-214

  Smalley, Keiran S M ^a   McArthur, Grant A ^b,c  

^a H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

^b PETER MACCALLUM CANCER CENTRE   (Australia)

^c UNIVERSITY OF MELBOURNE   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

B RAF KINASE; B RAF KINASE INHIBITOR; DABRAFENIB; DASATINIB; IMATINIB; K RAS PROTEIN; MITOGEN ACTIVATED PROTEIN KINASE KINASE; PHOSPHATIDYLINOSITOL 3 KINASE; PROTEIN FARNESYLTRANSFERASE INHIBITOR; SORAFENIB; SUNITINIB; TRAMETINIB; VEMURAFENIB;

ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER GENETICS; DRUG TARGETING; ENZYME INHIBITION; GENE MUTATION; HUMAN; MELANOMA; NONHUMAN; ONCOGENE C KIT; ONCOGENE H RAS; ONCOGENE N RAS; PRIORITY JOURNAL;

ANIMALS; CLINICAL TRIALS AS TOPIC; HUMANS; INDIVIDUALIZED MEDICINE; MELANOMA; MOLECULAR TARGETED THERAPY; RANDOMIZED CONTROLLED TRIALS AS TOPIC; SKIN NEOPLASMS;

EID: 84859378454     PISSN: 00937754     EISSN: None     Source Type: Journal    
DOI: 10.1053/j.seminoncol.2012.01.008     Document Type: Article

References (115)

1. M.S. Soengas, S.W. Lowe Apoptosis and melanoma chemoresistance Oncogene 22 2003 3138 3151
2. W.M. Lin, A.C. Baker, R. Beroukhim Modeling genomic diversity and tumor dependency in malignant melanoma Cancer Res 68 2008 664 673
3. J.A. Curtin, J. Fridlyand, T. Kageshita Distinct sets of genetic alterations in melanoma N Engl J Med 353 2005 2135 2147
4. H. Davies, G.R. Bignell, C. Cox Mutations of the BRAF gene in human cancer Nature 417 2002 949 954
5. S. Duensing, A. Duensing Targeted therapies of gastrointestinal stromal tumors (GIST)the next frontiers Biochem Pharmacol 80 2010 575 583
6. B.J. Druker, M. Talpaz, D.J. Resta Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia N Engl J Med 344 2001 1031 1037
7. T. Yoshida, G. Zhang, E.B. Haura Targeting epidermal growth factor receptor: central signaling kinase in lung cancer Biochem Pharmacol 80 2010 613 623
8. C. Wellbrock, M. Karasarides, R. Marais The RAF proteins take centre stage Nat Rev Mol Cell Biol 5 2004 875 885
9. M.J. Garnett, R. Marais Guilty as charged: B-RAF is a human oncogene Cancer Cell 6 2004 313 319
10. P.T. Wan, M.J. Garnett, S.M. Roe Mechanism of activation of the RAF-ERK signaling pathway by oncogenic mutations of B-RAF Cell 116 2004 855 867
11. J.C. Rubinstein, M. Sznol, A.C. Pavlick Incidence of the V600K mutation among melanoma patients with BRAF mutations, and potential therapeutic response to the specific BRAF inhibitor PLX4032 J Transl Med 8 2010 67
12. K.V. Bhatt, L.S. Spofford, G. Aram, M. McMullen, K. Pumiglia, A.E. Aplin Adhesion control of cyclin D1 and p27Kip1 levels is deregulated in melanoma cells through BRAF-MEK-ERK signaling Oncogene 24 2005 3459 3471
13. E. Sahai, C.J. Marshall RHO-GTPases and cancer Nat Rev Cancer 2 2002 133 142
14. K.S.M. Smalley A pivotal role for ERK in the oncogenic behaviour of malignant melanoma? Int J Cancer 104 2003 527 532
15. K. Boisvert-Adamo, A.E. Aplin Mutant B-RAF mediates resistance to anoikis via Bad and Bim Oncogene 27 2008 3301 3312
16. C. Wellbrock, L. Ogilvie, D. Hedley V599EB-RAF is an oncogene in melanocytes Cancer Res 64 2004 2338 2342
17. S.R. Hingorani, M.A. Jacobetz, G.P. Robertson, M. Herlyn, D.A. Tuveson Suppression of BRAF(V599E) in human melanoma abrogates transformation Cancer Res 63 2003 5198 5202
18. M. Karasarides, A. Chiloeches, R. Hayward B-RAF is a therapeutic target in melanoma Oncogene 23 37 2004 Aug. 19 6292 6298
19. C. Michaloglou, L.C. Vredeveld, M.S. Soengas, C. Denoyelle, T. Kuilman, C.M. van der Horst BRAFE600-associated senescence-like cell cycle arrest of human naevi Nature 436 2005 720 724
20. D. Dankort, D.P. Curley, R.A. Cartlidge Braf(V600E) cooperates with Pten loss to induce metastatic melanoma Nat Genet 41 2009 544 552
21. M.T. Landi, J. Bauer, R.M. Pfeiffer MC1R germline variants confer risk for BRAF-mutant melanoma Science 313 2006 521 522
22. A. Viros, J. Fridlyand, J. Bauer Improving melanoma classification by integrating genetic and morphologic features PLoS Med 5 2008 e120
23. G.V. Long, A.M. Menzies, A.M. Nagrial Prognostic and clinicopathologic associations of oncogenic BRAF in metastatic melanoma J Clin Oncol 29 2011 1239 1246
24. A.J. King, D.R. Patrick, R.S. Batorsky Demonstration of a genetic therapeutic index for tumors expressing oncogenic BRAF by the kinase inhibitor SB-590885 Cancer Res 66 2006 11100 11105
25. J. Tsai, J.T. Lee, W. Wang Discovery of a selective inhibitor of oncogenic B-Raf kinase with potent antimelanoma activity Proc Natl Acad Sci U S A 105 2008 3041 3046
26. N.K. Haass, K. Sproesser, T.K. Nguyen 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 14 2008 230 239
27. D.B. Solit, L.A. Garraway, C.A. Pratilas BRAF mutation predicts sensitivity to MEK inhibition Nature 439 2006 358 362
28. S.M. Wilhelm, C. Carter, L. Tang BAY 43-9006 exhibits broad spectrum oral antitumor activity and targets the RAF/MEK/ERK pathway and receptor tyrosine kinases involved in tumor progression and angiogenesis Cancer Res 64 2004 7099 7109
29. A. Sharma, N.R. Trivedi, M.A. Zimmerman, D.A. Tuveson, C.D. Smith, G.P. Robertson Mutant V599EB-Raf regulates growth and vascular development of malignant melanoma tumors Cancer Res 65 2005 2412 2421
30. K.S. Smalley, M. Xiao, J. Villanueva CRAF inhibition induces apoptosis in melanoma cells with non-V600E BRAF mutations Oncogene 28 2009 85 94
31. A. Hauschild, S.S. Agarwala, U. Trefzer 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 2009 2823 2830
32. S. Whittaker, R. Kirk, R. Hayward Gatekeeper mutations mediate resistance to BRAF-targeted therapies Sci Transl Med 2 2010 35ra41
33. K.H. Paraiso, I.V. Fedorenko, L.P. Cantini Recovery of phospho-ERK activity allows melanoma cells to escape from BRAF inhibitor therapy Br J Cancer 102 2010 1724 1730
34. P.I. Poulikakos, C. Zhang, G. Bollag, K.M. Shokat, N. Rosen RAF inhibitors transactivate RAF dimers and ERK signalling in cells with wild-type BRAF Nature 464 2010 427 430
35. C. Montagut, S.V. Sharma, T. Shioda Elevated CRAF as a potential mechanism of acquired resistance to BRAF inhibition in melanoma Cancer Res 68 2008 4853 4861
36. J.N. Sondergaard, R. Nazarian, Q. Wang Differential sensitivity of melanoma cell lines with BRAFV600E mutation to the specific Raf inhibitor PLX4032 J Transl Med 8 2010 39
37. W.D. Tap, K.W. Gong, J. Dering Pharmacodynamic characterization of the efficacy signals due to selective BRAF inhibition with PLX4032 in malignant melanoma Neoplasia 12 2010 637 649
38. H. Yang, B. Higgins, K. Kolinsky RG7204 (PLX4032), a selective BRAFV600E inhibitor, displays potent antitumor activity in preclinical melanoma models Cancer Res 70 2010 5518 5527
39. G.K. Schwartz, S. Robertson, A. Shen A phase I study of XL281, a selective oral RAF kinase in patients with advanced solid tumors J Clin Oncol 27 15s 2009 3513
40. G. Bollag, P. Hirth, J. Tsai Clinical efficacy of a RAF inhibitor needs broad target blockade in BRAF-mutant melanoma Nature 467 2010 596 599
41. K.S.M. Smalley, V.K. Sondak Melanomaan unlikely poster child for targeted therapy N Engl J Med 363 2010 876 878
42. K.S. Smalley, K.L. Nathanson, K.T. Flaherty Genetic subgrouping of melanoma reveals new opportunities for targeted therapy Cancer Res 69 2009 3241 3244
43. K.L. Nathanson Using genetics and genomics strategies to personalize therapy for cancer: focus on melanoma Biochem Pharmacol 80 2010 755 761
44. J. Villanueva, A. Cipolla, J. Kong A kinase switch underlies acquired resistance to BRAF inhibitors Pigment Cell Melanoma Res 22 2009 136
45. R. Kefford, H. Arkenau, M.P. Brown Phase I/II study of GSK2118436, a selective inhibitor of oncogenic mutant BRAF kinase, in patients with metastatic melanoma and other solid tumors J Clin Oncol 28 15s 2010 8503
46. J.R. Infante, G.S. Falchook, D.A. Lawrence Phase I/II Study of the oral MEK1/2 inhibitor GSK1120212 dosed in combination with the oral BRAF inhibitor GSK2118436 J Clin Oncol 29 18S 2011 CRA8503
47. L. Jilaveanu, C. Zito, S.J. Lee Expression of sorafenib targets in melanoma patients treated with carboplatin, paclitaxel and sorafenib Clin Cancer Res 15 2009 1076 1085
48. J. Downward Targeting RAS signalling pathways in cancer therapy Nat Rev Cancer 3 2003 11 22
49. C. Milagre, N. Dhomen, F.C. Geyer A mouse model of melanoma driven by oncogenic KRAS Cancer Res 70 2010 5549 5557
50. M.S. Brose, P. Volpe, M. Feldman BRAF and RAS mutations in human lung cancer and melanoma Cancer Res 62 2002 6997 7000
51. S.J. Heidorn, C. Milagre, S. Whittaker Kinase-dead BRAF and oncogenic RAS cooperate to drive tumor progression through CRAF Cell 140 2010 209 221
52. N. Dumaz, R. Hayward, J. Martin In melanoma, RAS mutations are accompanied by switching signaling from BRAF to CRAF and disrupted cyclic AMP signaling Cancer Res 66 2006 9483 9491
53. P.J. Mishra, L. Ha, J. Rieker Dissection of RAS downstream pathways in melanomagenesis: a role for Ral in transformation Oncogene 29 2010 2449 2456
54. L. Chin, J. Pomerantz, D. Polsky Cooperative effects of INK4a and ras in melanoma susceptibility in vivo Genes Dev 11 1997 2822 2834
55. J. Ackermann, M. Frutschi, K. Kaloulis, T. McKee, A. Trumpp, F. Beermann Metastasizing melanoma formation caused by expression of activated N-RasQ61K on an INK4a-deficient background Cancer Res 65 2005 4005 4011
56. P.A. Konstantinopoulos, M.V. Karamouzis, A.G. Papavassiliou Post-translational modifications and regulation of the RAS superfamily of GTPases as anticancer targets Nat Rev Drug Discov 6 2007 541 555
57. K.S.M. Smalley, T.G. Eisen Farnesyl transferase inhibitor SCH66336 is cytostatic, pro-apoptotic and enhances chemosensitivity to cisplatin in melanoma cells Int J Cancer 105 2003 165 175
58. K.P. Hoeflich, C. O'Brien, Z. Boyd In vivo antitumor activity of MEK and phosphatidylinositol 3-kinase inhibitors in basal-like breast cancer models Clin Cancer Res 15 2009 4649 4664
59. J.A. Engelman, L. Chen, X. Tan Effective use of PI3K and MEK inhibitors to treat mutant Kras G12D and PIK3CA H1047R murine lung cancers Nat Med 14 2008 1351 1356
60. B.S. Jaiswal, V. Janakiraman, N.M. Kljavin Combined targeting of BRAF and CRAF or BRAF and PI3K effector pathways is required for efficacy in NRAS mutant tumors PLoS One 4 2009 e5717
61. J.A. Curtin, K. Busam, D. Pinkel, B.C. Bastian Somatic activation of KIT in distinct subtypes of melanoma J Clin Oncol 24 2006 4340 4346
62. M.C. Heinrich, C.D. Blanke, B.J. Druker, C.L. Corless Inhibition of KIT tyrosine kinase activity: a novel molecular approach to the treatment of KIT-positive malignancies J Clin Oncol 20 2002 1692 1703
63. C.A. Torres-Cabala, W.L. Wang, J. Trent Correlation between KIT expression and KIT mutation in melanoma: a study of 173 cases with emphasis on the acral-lentiginous/mucosal type Mod Pathol 22 2009 1446 1456
64. C.R. Antonescu, K.J. Busam, T.D. Francone L576P KIT mutation in anal melanomas correlates with KIT protein expression and is sensitive to specific kinase inhibition Int J Cancer 121 2007 257 264
65. X. Jiang, J. Zhou, N.K. Yuen Imatinib targeting of KIT-mutant oncoprotein in melanoma Clin Cancer Res 14 2008 7726 7732
66. S.E. Woodman, M.A. Davies Targeting KIT in melanoma: a paradigm of molecular medicine and targeted therapeutics Biochem Pharmacol 80 2010 568 574
67. D. Handolias, R. Salemi, W. Murray Mutations in KIT occur at low frequency in melanomas arising from anatomical sites associated with chronic and intermittent sun exposure Pigment Cell Melanoma Res 23 2010 210 215
68. V. Alexeev, K. Yoon Distinctive role of the cKit receptor tyrosine kinase signaling in mammalian melanocytes J Invest Dermatol 126 2006 1102 1110
69. G. Monsel, N. Ortonne, M. Bagot, A. Bensussan, N. Dumaz c-Kit mutants require hypoxia-inducible factor 1alpha to transform melanocytes Oncogene 29 2010 227 236
70. A. Ashida, M. Takata, H. Murata, K. Kido, T. Saida Pathological activation of KIT in metastatic tumors of acral and mucosal melanomas Int J Cancer 124 2009 862 868
71. S.E. Woodman, J.C. Trent, K. Stemke-Hale Activity of dasatinib against L576P KIT mutant melanoma: molecular, cellular, and clinical correlates Mol Cancer Ther 8 2009 2079 2085
72. K.S. Smalley, R. Contractor, T.K. Nguyen Identification of a novel subgroup of melanomas with KIT/cyclin-dependent kinase-4 overexpression Cancer Res 68 2008 5743 5752
73. D. Rimoldi, S. Salvi, D. Lienard Lack of BRAF mutations in uveal melanoma Cancer Res 63 2003 5712 5715
74. M. Pache, K. Glatz, D. Bosch Sequence analysis and high-throughput immunohistochemical profiling of KIT (CD 117) expression in uveal melanoma using tissue microarrays Virchows Arch 443 2003 741 744
75. C. All-Ericsson, L. Girnita, A. Muller-Brunotte c-Kit-dependent growth of uveal melanoma cells: a potential therapeutic target? Invest Ophthalmol Vis Sci 45 2004 2075 2082
76. C.D. Van Raamsdonk, V. Bezrookove, G. Green Frequent somatic mutations of GNAQ in uveal melanoma and blue naevi Nature 457 2009 599 602
77. M.D. Onken, L.A. Worley, M.D. Long Oncogenic mutations in GNAQ occur early in uveal melanoma Invest Ophthalmol Vis Sci 49 2008 5230 5234
78. P.M. Lorusso, A.A. Adjei, M. Varterasian Phase I and pharmacodynamic study of the oral MEK inhibitor CI-1040 in patients with advanced malignancies J Clin Oncol 23 2005 5281 5293
79. J. Rinehart, A.A. Adjei, P.M. Lorusso Multicenter phase II study of the oral MEK inhibitor, CI-1040, in patients with advanced non-small-cell lung, breast, colon, and pancreatic cancer J Clin Oncol 22 2004 4456 4462
80. A.A. Adjei, R.B. Cohen, W. Franklin Phase I pharmacokinetic and pharmacodynamic study of the oral, small-molecule mitogen-activated protein kinase kinase 1/2 inhibitor AZD6244 (ARRY-142886) in patients with advanced cancers J Clin Oncol 26 2008 2139 2146
81. J.R. Infante, L.A. Fecher, S. Nallapareddy Safety and efficacy results from the first-in-human study of the oral MEK 1/2 inhibitor GSL1120212 J Clin Oncol 28 15s 2010 2503
82. A.G. Gilmartin, M.R. Bleam, A. Groy GSK1120212 (JTP-74057) is an inhibitor of MEK activity and activation with favorable pharmacokinetic properties for sustained in vivo pathway inhibition Clin Cancer Res 17 2011 989 1000
83. T. Eisen, T. Ahmad, K.T. Flaherty Sorafenib in advanced melanoma: a Phase II randomised discontinuation trial analysis Br J Cancer 95 2006 581 586
84. D.F. McDermott, J.A. Sosman, R. Gonzalez Double-blind randomized phase II study of the combination of sorafenib and dacarbazine in patients with advanced melanoma: a report from the 11715 Study Group J Clin Oncol 26 2008 2178 2185
85. K.T. Flaherty, I. Puzanov, K.B. Kim Inhibition of mutated, activated BRAF in metastatic melanoma N Engl J Med 363 2010 809 819
86. P.B. Chapman, A. Hauschild, C. Robert Improved survival with vemurafenib in melanoma with BRAF V600E mutation N Engl J Med 364 2011 2507 2516
87. J.P. Arnault, C. Mateus, J. Wechsler Paradoxical cutaneous squamous cell proliferations in patients treated with sorafenib J Clin Oncol 27 15s 2009 9564
88. F.S. Hodi, P. Friedlander, C.L. Corless Major response to imatinib mesylate in KIT-mutated melanoma J Clin Oncol 26 2008 2046 2051
89. A. Quintas-Cardama, A.J. Lazar, S.E. Woodman, K. Kim, M. Ross, P. Hwu Complete response of stage IV anal mucosal melanoma expressing KIT Val560Asp to the multikinase inhibitor sorafenib Nat Clin Pract 5 2008 737 740
90. J. Lutzky, J. Bauer, B.C. Bastian Dose-dependent, complete response to imatinib of a metastatic mucosal melanoma with a K642E KIT mutation Pigment Cell Melanoma Res 21 2008 492 493
91. D. Handolias, A.L. Hamilton, R. Salemi Clinical responses observed with imatinib or sorafenib in melanoma patients expressing mutations in KIT Br J Cancer 102 2010 1219 1223
92. I. Satzger, U. Kuttler, B. Volker, F. Schenck, A. Kapp, R. Gutzmer Anal mucosal melanoma with KIT-activating mutation and response to imatinib therapycase report and review of the literature Dermatology 220 2010 77 81
93. K.S. Smalley, M. Lioni, M.D. Palma Increased cyclin D1 expression can mediate BRAF inhibitor resistance in BRAF V600E-mutated melanomas Mol Cancer Ther 7 2008 2876 2883
94. K.H. Paraiso, Y. Xiang, V.W. Rebecca PTEN loss confers BRAF inhibitor resistance to melanoma cells through the suppression of BIM expression Cancer Res 71 2011 2750 2760
95. F. Xing, Y. Persaud, C.A. Pratilas Concurrent loss of the PTEN and RB1 tumor suppressors attenuates RAF dependence in melanomas harboring (V600E)BRAF Oncogene 2011 Jul 4 10.1038/onc.2011.250
96. S. Bauer, A. Duensing, G.D. Demetri, J.A. Fletcher KIT oncogenic signaling mechanisms in imatinib-resistant gastrointestinal stromal tumor: PI3-kinase/AKT is a crucial survival pathway Oncogene 26 2007 7560 7568
97. C. Sawyers Targeted cancer therapy Nature 432 2004 294 297
98. C.M. Rudin, C.L. Hann, J. Laterra Treatment of medulloblastoma with hedgehog pathway inhibitor GDC-0449 N Engl J Med 361 2009 1173 1178
99. R.L. Yauch, G.J. Dijkgraaf, B. Alicke Smoothened mutation confers resistance to a hedgehog pathway inhibitor in medulloblastoma Science 326 2009 572 574
100. C. Christensen, P. Guldberg Growth factors rescue cutaneous melanoma cells from apoptosis induced by knockdown of mutated (V 600 E) B-RAF Oncogene 24 2005 6292 6302
101. V.C. Gray-Schopfer, M. Karasarides, R. Hayward, R. Marais Tumor necrosis factor-alpha blocks apoptosis in melanoma cells when BRAF signaling is inhibited Cancer Res 67 2007 122 129
102. R. Nazarian, H. Shi, Q. Wang Melanomas acquire resistance to B-RAF(V600E) inhibition by RTK or N-RAS upregulation Nature 468 2010 973 977
103. J. Villanueva, A. Vultur, J.T. Lee 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 18 2010 683 695
104. C.M. Johannessen, J.S. Boehm, S.Y. Kim COT drives resistance to RAF inhibition through MAP kinase pathway reactivation Nature 468 2010 968 972
105. N. Wagle, C. Emery, M.F. Berger Dissecting therapeutic resistance to RAF inhibition in melanoma by tumor genomic profiling J Clin Oncol 29 2011 3085 3096
106. I.V. Fedorenko, K.H. Paraiso, K.S. Smalley Acquired and intrinsic BRAF inhibitor resistance in BRAF V600E mutant melanoma Biochem Pharmacol 82 2011 201 209
107. K.H. Paraiso, I.V. Fedorenko, L.P. Cantini Recovery of phospho-ERK activity allows melanoma cells to escape from BRAF inhibitor therapy Br J Cancer 102 2010 1724 1730
108. C.M. Emery, K.G. Vijayendran, M.C. Zipser MEK1 mutations confer resistance to MEK and B-RAF inhibition Proc Natl Acad Sci U S A 106 2009 20411 20416
109. T. O'Hare, W.C. Shakespeare, X. Zhu AP24534, a pan-BCR-ABL inhibitor for chronic myeloid leukemia, potently inhibits the T315I mutant and overcomes mutation-based resistance Cancer Cell 16 2009 401 412
110. F. Michor, T.P. Hughes, Y. Iwasa Dynamics of chronic myeloid leukaemia Nature 435 2005 1267 1270
111. J. Carnahan, P.J. Beltran, C. Babij Selective and potent Raf inhibitors paradoxically stimulate normal cell proliferation and tumor growth Mol Cancer Ther 9 2010 2399 2410
112. S.J. Heidorn, C. Milagre, S. Whittaker Kinase-dead BRAF and oncogenic RAS cooperate to drive tumor progression through CRAF Cell 140 2010 209 221
113. R. Halaban, W. Zhang, A. Bacchiocchi PLX4032, a selective BRAF(V600E) kinase inhibitor, activates the ERK pathway and enhances cell migration and proliferation of BRAF melanoma cells Pigment Cell Melanoma Res 23 2010 190 200
114. F.M. Kaplan, Y. Shao, M.M. Mayberry, A.E. Aplin Hyperactivation of MEK-ERK1/2 signaling and resistance to apoptosis induced by the ongenic B-RAF inhibitor, PLX4720, in mutant N-Ras melanoma cell lines Oncogene 30 2010 366 371
115. G. Hatzivassiliou, K. Song, I. Yen RAF inhibitors prime wild-type RAF to activate the MAPK pathway and enhance growth Nature 464 2010 431 435