Novel investigational biologics for the treatment of cancer cachexia

Expert Opinion on Biological Therapy

Volumn 14, Issue 8, 2014, Pages 1113-1120

  Ma, Joseph D ^a   Heavey, Sean F ^b   Revta, Carolyn ^b   Roeland, Eric J ^b  

^a UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^b UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Cachexia; Cancer; Myostatin; Skeletal muscle loss

Indexed keywords

AVR 118; BIMAGRUMAB; BIOLOGICAL PRODUCT; CLAZAKIZUMAB; IP 1510; MONOCLONAL ANTIBODY P1; REGN 1033; UNCLASSIFIED DRUG; XILONIX; ALD518 MONOCLONAL ANTIBODY; INTERLEUKIN 1 RECEPTOR; MONOCLONAL ANTIBODY; MSTN PROTEIN, HUMAN; MYOSTATIN;

ABDOMINAL PAIN; ADVANCED CANCER; CACHEXIA; CANCER PATIENT; COUGHING; DIARRHEA; DRUG EFFICACY; DRUG MECHANISM; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; FATIGUE; HEMOPTYSIS; HEMORRHOID; HUMAN; HYPERCALCEMIA; HYPOKALEMIA; INFECTION; NAUSEA; NONHUMAN; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PROTEINURIA; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECTUM HEMORRHAGE; REVIEW; SEPSIS; SIDE EFFECT; SOLID TUMOR; THORAX PAIN; TREATMENT RESPONSE; UNSPECIFIED SIDE EFFECT; VOMITING; ANIMAL; ANTAGONISTS AND INHIBITORS; COMPLICATION; DRUG EFFECTS; EXPERIMENTAL THERAPY; METABOLISM; MOLECULARLY TARGETED THERAPY; NEOPLASMS; PROCEDURES; SIGNAL TRANSDUCTION; SKELETAL MUSCLE; TRENDS;

ANIMALS; ANTIBODIES, MONOCLONAL, HUMANIZED; BIOLOGICAL PRODUCTS; CACHEXIA; HUMANS; MOLECULAR TARGETED THERAPY; MUSCLE, SKELETAL; MYOSTATIN; NEOPLASMS; RECEPTORS, INTERLEUKIN-1; SIGNAL TRANSDUCTION; THERAPIES, INVESTIGATIONAL;

EID: 84903935131     PISSN: 14712598     EISSN: 17447682     Source Type: Journal    
DOI: 10.1517/14712598.2014.907788     Document Type: Review

References (56)

1. Tisdale MJ. Cachexia in cancer patients. Nat Rev Cancer 2002;2(11):862-71 (Pubitemid 37328904)
2. Fearon KC. Cancer cachexia: Developing multimodal therapy for a multidimensional problem. Eur J Cancer 2008;44(8):1124-32
3. von Haehling S, Anker SD. Cachexia as a major underestimated and unmet medical need: Facts and numbers. J Cachexia Sarcopenia Muscle 2010;1(1):1-5
4. Utech AE, Tadros EM, Hayes TG, Garcia JM. Predicting survival in cancer patients: The role of cachexia and hormonal, nutritional and inflammatory markers. J Cachexia Sarcopenia Muscle 2012;3(4):245-51
5. Farkas J, von Haehling S, Kalantar-Zadeh K, et al. Cachexia as a major public health problem: Frequent, costly, and deadly. J Cachexia Sarcopenia Muscle 2013;4(3):173-8
6. Laine A, Iyengar P, Pandita TK. The role of inflammatory pathways in cancer-Associated cachexia and radiation resistance. Mol Cancer Res 2013;11(9):967-72
7. Evans WJ, Morley JE, Argiles J, et al. Cachexia: A new definition. Clin Nutr 2008;27(6):793-9
8. Fearon KC, Voss AC, Hustead DS. Definition of cancer cachexia: Effect of weight loss, reduced food intake, and systemic inflammation on functional status and prognosis. Am J Clin Nutr 2006;83(6):1345-50 (Pubitemid 44713065)
9. Muscaritoli M, Anker SD, Argiles J, et al Consensus definition of sarcopenia, cachexia and pre-cachexia: Joint document elaborated by Special Interest Groups (SIG) "cachexia-Anorexia in chronic wasting diseases" and "nutrition in geriatrics". Clin Nutr 2010;29(2):154-9
10. Fearon K, Strasser F, Anker SD, et al. Definition and classification of cancer cachexia: An international consensus. Lancet Oncol 2011;12(5):489-95
11. Wallengren O, Lundholm K, Bosaeus I. Diagnostic criteria of cancer cachexia: Relation to quality of life, exercise capacity and survival in unselected palliative care patients. Support Care Cancer 2013;21(6):1569-77
12. Dewys WD, Begg C, Lavin PT, et al. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med 1980;69(4):491-7 (Pubitemid 10018703)
13. Tuca A, Jimenez-Fonseca P, Gascon P. Clinical evaluation and optimal management of cancer cachexia. Crit Rev Oncol Hematol 2013;88(3):625-36
14. Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcopenia) in older persons is associated with functional impairment and physical disability. J Am Geriatr Soc 2002;50(5):889-96 (Pubitemid 34496687)
15. Prado CM, Baracos VE, McCargar LJ, et al. Sarcopenia as a determinant of chemotherapy toxicity and time to tumor progression in metastatic breast cancer patients receiving capecitabine treatment. Clin Cancer Res 2009;15(8):2920-6
16. Bachmann J, Heiligensetzer M, Krakowski-Roosen H, et al. Cachexia worsens prognosis in patients with resectable pancreatic cancer. J Gastrointest Surg 2008;12(7):1193-201
17. Mariani L, Lo Vullo S, Bozzetti F. Weight loss in cancer patients: A plea for a better awareness of the issue. Support Care Cancer 2011;20(2):301-9
18. Martignoni ME, Kunze P, Friess H. Cancer cachexia. Mol Cancer 2003;2:36
19. Suzuki H, Asakawa A, Amitani H, et al. Cancer cachexia-pathophysiology and management. J Gastroenterol 2013;48(5):574-94
20. Blum D, Omlin A, Baracos VE, et al. Cancer cachexia: A systematic literature review of items and domains associated with involuntary weight loss in cancer. Crit Rev Oncol Hematol 2011;80(1):114-44
21. Dodson S, Baracos VE, Jatoi A, et al. Muscle wasting in cancer cachexia: Clinical implications, diagnosis, and emerging treatment strategies. Annu Rev Med 2011;62:265-79
22. Nicolini A, Ferrari P, Masoni MC, et al. Malnutrition, anorexia and cachexia in cancer patients: A mini-review on pathogenesis and treatment. Biomed Pharmacother 2013;67(8):807-17
23. Argiles JM, Busquets S, Lopez-Soriano FJ. Anti-inflammatory therapies in cancer cachexia. Eur J Pharmacol 2011;668(Suppl 1):S81-6
24. Seelaender M, Batista M Jr, Lira F, et al. Inflammation in cancer cachexia: To resolve or not to resolve (is that the question?). Clin Nutr 2012;31(4):562-6
25. Haslett PA. Anticytokine approaches to the treatment of anorexia and cachexia. Semin Oncol 1998;25(2 Suppl 6):53-7 (Pubitemid 28268505)
26. Mantovani G, Maccio A, Lai P, et al. Cytokine activity in cancer-related anorexia/cachexia: Role of megestrol acetate and medroxyprogesterone acetate. Semin Oncol 1998;25(2 Suppl 6):45-52 (Pubitemid 28268504)
27. Songur N, Kuru B, Kalkan F, et al. Serum interleukin-6 levels correlate with malnutrition and survival in patients with advanced non-small cell lung cancer. Tumori 2004;90(2):196-200 (Pubitemid 38745608)
28. Staal-van den Brekel AJ, Dentener MA, Schols AM, et al. Increased resting energy expenditure and weight loss are related to a systemic inflammatory response in lung cancer patients. J Clin Oncol 1995;13(10):2600-5
29. Bayliss TJ, Smith JT, Schuster M, et al. A humanized anti-IL-6 antibody (ALD518) in non-small cell lung cancer. Expert Opin Biol Ther 2011;11(12):1663-8
30. Clarke SJ, Gebbie C, Sweeney C, et al. A phase I, pharmacokinetic (PK), and preliminary efficacy assessment of ALD518, a humanized anti-IL-6 antibody, in patients with advanced cancer. J Cachexia Sarcopenia Muscle 2010;1:98
31. Clarke SJ, Smith JT, Gebbie C, et al. A phase I, pharmacokinetic (PK), and preliminary efficacy assessment of ALD518, a humanized anti-IL-6 antibody, in patients with advanced cancer. J Clin Oncol (2009 ASCO Annual Meeting Proceedings) 2009;27(15S):3025
32. Rigas JR, Schuster M, Orlov SV, et al. Effect of ALD518, a humanized anti-IL-6 antibody, on lean body mass loss and symptoms in patients with advanced non-small cell lung cancer (NSCLC): Results of a phase II randomized, double-blind safety and efficacy trial. J Clin Oncol (2010 ASCO Annual Meeting Abstracts) 2010;28(15):7622
33. Schuster M, Rigas JR, Orlov SV, et al. ALD518, a humanized anti-IL-6 antibody, treats anemia in patients with advanced non-small cell lung cancer (NSCLC): Results of a phase II, randomized, double-blind, placebocontrolled trial. J Clin Oncol (2010 ASCO Annual Meeting Abstracts) 2010;28(15):7631
34. Clinical trial activities. Available from: Http://www.xbiotech.com/ clinical/clinicaltrial-Activity.html [Last accessed 11 December 2013]
35. A study using MABp1 to increase overall survival in patients with colorectal cancer and weight loss. Available from: Http:// clinicaltrials.gov/ ct2/show/ NCT01767857?term=MABp1&rank=1 [Last accessed 11 December 2013]
36. Baracos VE. Clinical trials of cancer cachexia therapy, now and hereafter. J Clin Oncol 2013;31(10):1257-8
37. Bruera E, Strasser F, Palmer JL, et al. Effect of fish oil on appetite and other symptoms in patients with advanced cancer and anorexia/cachexia: A doubleblind, placebo-controlled study. J Clin Oncol 2003;21(1):129-34
38. Del Fabbro E, Dev R, Hui D, et al. Effects of melatonin on appetite and other symptoms in patients with advanced cancer and cachexia: A doubleblind placebo-controlled trial. J Clin Oncol 2013;31(10):1271-6
39. Paspaliaris V, Langan B, DeAndrea R, et al. Phase I/II study of IP-1510 a novel interleukin-1 receptor antagonist in the management of cancer-related cachexia. J Cachexia Sarcopenia Muscle 2011;2:261
40. Chasen MR, Bhargava R, Hirschman SZ, Taraporewala I. Phase II study of OHR/ AVR118 in anorexia-cachexia. J Cachexia Sarcopenia Muscle 2013;4:335
41. Chasen MR, Hirschman SZ, Bhargava R. Phase II study of the novel peptidenucleic acid AVR118 in the management of cancer-related anorexia/cachexia. J Cachexia Sarcopenia Muscle 2010;2010(1):98
42. D'Olimpio JT, Chasen MR, Sharma R, et al. Phase II study of AVR118 in the management of cancer related anorexia/ cachexia. J Clin Oncol (2009 ASCO Annual Meeting Proceedings) 2009;27(15S):e20631
43. McPherron AC, Lawler AM, Lee SJ. Regulation of skeletal muscle mass in mice by a new TGF-beta superfamily member. Nature 1997;387(6628):83-90 (Pubitemid 27202654)
44. Roth SM, Walsh S. Myostatin: A therapeutic target for skeletal muscle wasting. Curr Opin Clin Nutr Metab Care 2004;7(3):259-63 (Pubitemid 40340662)
45. Thomas M, Langley B, Berry C, et al. Myostatin, a negative regulator of muscle growth, functions by inhibiting myoblast proliferation. J Biol Chem 2000;275(51):40235-43 (Pubitemid 32064654)
46. Elkina Y, von Haehling S, Anker SD, Springer J. The role of myostatin in muscle wasting: An overview. J Cachexia Sarcopenia Muscle 2011;2(3):143-51
47. Lee SJ, McPherron AC. Regulation of myostatin activity and muscle growth. Proc Natl Acad Sci USA 2001;98(16):9306-11 (Pubitemid 32743912)
48. Aversa Z, Bonetto A, Penna F, et al. Changes in myostatin signaling in non-weight-losing cancer patients. Ann Surg Oncol 2012;19(4):1350-6
49. Bonetto A, Penna F, Aversa Z, et al. Early changes of muscle insulin-like growth factor-1 and myostatin gene expression in gastric cancer patients. Muscle Nerve 2013;48(3):387-92
50. Lokireddy S, Wijesoma IW, Bonala S, et al. Myostatin is a novel tumoral factor that induces cancer cachexia. Biochem J 2012;446(1):23-36
51. Lach-Trifilieff E, Minetti GC, Sheppard K, et al. An antibody blocking activin type II receptors induces strong skeletal muscle hypertrophy and protects from atrophy. Mol Cell Biol 2013, doi:10.1128/MCB.01307-13
52. Clinical study of BYM338 for the treatment of unintentional weight loss in patients with cancer of the lung or the pancreas. Available from: Http:// clinicaltrials.gov/ct2/show/ NCT01433263?term=BYm338&rank=6 [Last accessed 11 December 2013]
53. Bauerlein R, Pangilinan J, Salzler R, et al. Efficacy of REGN1033, a fully human anti-myostatin antagonist antibody, in rodent muscle function. J Cachexia Sarcopenia Muscle 2013;4:331
54. A study to access the safety and tolerability of single ascending doses of REGN1033(SAR391786). Available from: Http://clinicaltrials.gov/ct2/results? term=regn1033&Search=Search [Last accessed 11 December 2013]
55. Lieffers JR, Mourtzakis M, Hall KD, et al. A viscerally driven cachexia syndrome in patients with advanced colorectal cancer: Contributions of organ and tumor mass to whole-body energy demands. Am J Clin Nutr 2009;89(4):1173-9
56. Mourtzakis M, Prado CM, Lieffers JR, et al. A practical and precise approach to quantification of body composition in cancer patients using computed tomography images acquired during routine care. Appl Physiol Nutr Metab 2008;33(5):997-1006.