Phase II nonrandomized study of the efficacy and safety of COX-2 inhibitor celecoxib on patients with cancer cachexia

Journal of Molecular Medicine

Volumn 88, Issue 1, 2010, Pages 85-92

  Mantovani, Giovanni ^a,b   MacCiò, Antonio ^a   Madeddu, Clelia ^a   Serpe, Roberto ^a   Antoni, Giorgia ^a   Massa, Elena ^a   Dessì, Mariele ^a   Panzone, Filomena ^a  

^a UNIVERSITY OF CAGLIARI   (Italy)

^b DEPARTMENT OF RADIOLOGY   (Italy)

Author keywords

Cancer cachexia; Celecoxib; Chronic inflammation; COX 2 inhibitors; Fatigue; Lean body mass, resting energy expenditure; Proinflammatory cytokines

Indexed keywords

CELECOXIB; INTERLEUKIN 6; TUMOR NECROSIS FACTOR ALPHA;

ADULT; ANEMIA; ARTICLE; CACHEXIA; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; ENERGY EXPENDITURE; EPIGASTRIC PAIN; FATIGUE; FEMALE; GASTROINTESTINAL HEMORRHAGE; GRIP STRENGTH; HEART DEATH; HEART INFARCTION; HUMAN; LEAN BODY WEIGHT; MALE; NAUSEA AND VOMITING; NEUTROPENIA; PATIENT COMPLIANCE; PHASE 2 CLINICAL TRIAL; PROSPECTIVE STUDY; QUALITY OF LIFE; STROKE; TRANSIENT ISCHEMIC ATTACK; TREATMENT DURATION; UNSTABLE ANGINA PECTORIS;

AGED; CACHEXIA; CYCLOOXYGENASE 2 INHIBITORS; FEMALE; HUMANS; MIDDLE AGED; NEOPLASMS; PYRAZOLES; SULFONAMIDES;

EID: 75749118481     PISSN: 09462716     EISSN: None     Source Type: Journal    
DOI: 10.1007/s00109-009-0547-z     Document Type: Article

References (41)

1. MG Thompson RM Palmer 1998 Signalling pathways regulating protein turnover in skeletal muscle Cell Signal 10 1 11 10.1016/S0898-6568(97)00076-4 1:CAS:528:DyaK1cXitleqtw%3D%3D 9502112 (Pubitemid 28021330)
2. MF Brennan 1977 Uncomplicated starvation versus cancer cachexia Cancer Res 37 2359 2364 1:CAS:528:DyaE2sXkvVaiu7c%3D 861953
3. E Bruera 1992 Clinical management of anorexia and cachexia in patients with advanced cancer Oncology 49 Suppl 2 35 42 10.1159/000227126 1461626
4. D Heber LO Byerley J Chi M Grosvenor RN Bergman M Coleman RT Chlebowski 1986 Pathophysiology of malnutrition in the adult cancer patient Cancer 58 1867 1873 10.1002/1097-0142(19861015)58:8+<1867::AID-CNCR2820581413>3.0.CO;2-A 1:STN:280:DyaL2s%2FgtF2mtg%3D%3D 3093049
5. K Nelson D Walsh 1991 Management of the anorexia/cachexia syndrome Cancer Bull 43 403 406
6. E Bruera 1997 ABC of palliative care. Anorexia, cachexia, and nutrition Bmj 315 1219 1222 1:STN:280:DyaK1c%2FlsV2nsg%3D%3D 9393230
7. MJ Tisdale 2004 Cancer cachexia Langenbecks Arch Surg 389 299 305 10.1007/s00423-004-0486-7 15168125
8. LL Moldawer J Gelin T Schersten KG Lundholm 1987 Circulating interleukin 1 and tumor necrosis factor during inflammation Am J Physiol 253 R922 R928 1:CAS:528:DyaL1cXntlCqtw%3D%3D 3501249
9. G Strassmann M Fong JS Kenney CO Jacob 1992 Evidence for the involvement of interleukin 6 in experimental cancer cachexia J Clin Invest 89 1681 1684 10.1172/JCI115767 1:CAS:528:DyaK38XisFehs7Y%3D 1569207
10. J Busbridge MJ Dascombe S Hoopkins 1989 Acute central effects of interleukin-6 on body temperature, thermogenesis and food intake in the rat Proc Nutr Soc 38 48A
11. J Gelin LL Moldawer C Lonnroth B Sherry R Chizzonite K Lundholm 1991 Role of endogenous tumor necrosis factor alpha and interleukin 1 for experimental tumor growth and the development of cancer cachexia Cancer Res 51 415 421 1:CAS:528:DyaK3MXpvFKqtg%3D%3D 1703040
12. CL McLaughlin GJ Rogan J Tou CA Baile WD Joy 1992 Food intake and body temperature responses of rats to recombinant human interleukin-1 beta and a tripeptide interleukin-1 beta antagonist Physiol Behav 52 1155 1160 10.1016/0031-9384(92)90475-H 1:CAS:528:DyaK3sXhsVGlsb4%3D 1484875
13. S Perboni A Inui 2006 Anorexia in cancer: role of feeding-regulatory peptides Philos Trans R Soc Lond B Biol Sci 361 1281 1289 10.1098/rstb.2006.1863 1:CAS:528:DC%2BD28XhtVygtL%2FP 16815804
14. G Mantovani A Maccio E Massa C Madeddu 2001 Managing cancer-related anorexia/cachexia Drugs 61 499 514 10.2165/00003495-200161040-00004 1:CAS:528:DC%2BD3MXjsFSgsbs%3D 11324680
15. G Mantovani C Madeddu 2008 Cyclooxygenase-2 inhibitors and antioxidants in the treatment of cachexia Curr Opin Support Palliat Care 2 275 281 10.1097/SPC.0b013e32830f47e4 19069312
16. AP Dicker 2003 COX-2 inhibitors and cancer therapeutics: potential roles for inhibitors of COX-2 in combination with cytotoxic therapy: reports from a symposium held in conjunction with the Radiation Therapy Oncology Group June 2001 meeting Am J Clin Oncol 26 S46 S47 12902855
17. WH Wang M Andersson C Lonnroth E Svanberg K Lundholm 2005 Prostaglandin E and prostacyclin receptor expression in tumor and host tissues from MCG 101-bearing mice: a model with prostanoid-related cachexia Int J Cancer 115 582 590 10.1002/ijc.20539 1:CAS:528:DC%2BD2MXksFKitrY%3D 15704139 (Pubitemid 40656716)
18. TW Davis BS Zweifel JM O'Neal DM Heuvelman AL Abegg TO Hendrich JL Masferrer 2004 Inhibition of cyclooxygenase-2 by celecoxib reverses tumor-induced wasting J Pharmacol Exp Ther 308 929 934 10.1124/jpet.103.063099 1:CAS:528:DC%2BD2cXhvVWntLg%3D 14711936 (Pubitemid 38263967)
19. HW Seyberth GV Segre JL Morgan BJ Sweetman JT Potts Jr JA Oates 1975 Prostaglandins as mediators of hypercalcemia associated with certain types of cancer N Engl J Med 293 1278 1283 1:STN:280:DyaE28%2FltFagsQ%3D%3D 1186822
20. KL Smith MJ Tisdale 1993 Mechanism of muscle protein degradation in cancer cachexia Br J Cancer 68 314 318 1:CAS:528:DyaK2cXhtVemurk%3D 8347486
21. HJ Hussey MJ Tisdale 2000 Effect of the specific cyclooxygenase-2 inhibitor meloxicam on tumour growth and cachexia in a murine model Int J Cancer 87 95 100 10.1002/1097-0215(20000701)87:1<95::AID-IJC14>3.0.CO;2-D 1:CAS:528:DC%2BD3cXktlGksLo%3D 10861458 (Pubitemid 30368421)
22. H Saito Y Inagaki T Tsunenari M Ura H Mizuno K Fujimoto-Ouchi E Onuma K Sato E Ogata H Yamada-Okabe 2007 Involvement of cyclooxygenase-2 in the tumor site-dependent production of parathyroid hormone-related protein in colon 26 carcinoma Cancer Sci 98 1563 1569 10.1111/j.1349-7006.2007.00568.x 1:CAS:528:DC%2BD2sXhtF2qtb%2FO 17645771 (Pubitemid 47308451)
23. MJ Diament GD Peluffo I Stillitani LC Cerchietti A Navigante SM Ranuncolo SM Klein 2006 Inhibition of tumor progression and paraneoplastic syndrome development in a murine lung adenocarcinoma by medroxyprogesterone acetate and indomethacin Cancer Invest 24 126 131 10.1080/07357900500524322 1:CAS:528:DC%2BD28XisVartrg%3D 16537180
24. MM Oken RH Creech DC Tormey J Horton TE Davis ET McFadden PP Carbone 1982 Toxicity and response criteria of the eastern cooperative oncology group Am J Clin Oncol 5 649 655 10.1097/00000421-198212000-00014 1:STN:280: DyaL3s7kvFOgsw%3D%3D 7165009
25. G Mantovani A Maccio C Madeddu G Gramignano MR Lusso R Serpe E Massa G Astara L Deiana 2006 A phase II study with antioxidants, both in the diet and supplemented, pharmaconutritional support, progestagen, and anti-cyclooxygenase- 2 showing efficacy and safety in patients with cancer-related anorexia/cachexia and oxidative stress Cancer Epidemiol Biomarkers Prev 15 1030 1034 10.1158/1055-9965.EPI-05-0538 1:CAS:528:DC%2BD28XksFeitbo%3D 16702388 (Pubitemid 43823535)
26. LC Cerchietti AH Navigante GD Peluffo MJ Diament I Stillitani SA Klein ME Cabalar 2004 Effects of celecoxib, medroxyprogesterone, and dietary intervention on systemic syndromes in patients with advanced lung adenocarcinoma: a pilot study J Pain Symptom Manage 27 85 95 10.1016/j.jpainsymman.2003.05.010 1:CAS:528:DC%2BD2cXhsVGnsL0%3D 14711473 (Pubitemid 38050252)
27. V Lai J George L Richey HJ Kim T Cannon C Shores M Couch 2008 Results of a pilot study of the effects of celecoxib on cancer cachexia in patients with cancer of the head, neck, and gastrointestinal tract Head Neck 30 67 74 10.1002/hed.20662 17615567 (Pubitemid 351158323)
28. KD Stein SC Martin DM Hann PB Jacobsen 1998 A multidimensional measure of fatigue for use with cancer patients Cancer Pract 6 143 152 10.1046/j.1523-5394.1998.006003143.x 1:STN:280:DyaK1czhs1Slsw%3D%3D 9652245 (Pubitemid 28225636)
29. G Prue J Rankin F Cramp J Allen J Gracey 2006 Fatigue in gynaecological cancer patients: a pilot study Support Care Cancer 14 78 83 10.1007/s00520-005- 0830-7 1:STN:280:DC%2BD28%2FjtFejsA%3D%3D 15883794 (Pubitemid 43119601)
30. G Mantovani C Madeddu A Maccio G Gramignano MR Lusso E Massa G Astara R Serpe 2004 Cancer-related anorexia/cachexia syndrome and oxidative stress: an innovative approach beyond current treatment Cancer Epidemiol Biomarkers Prev 13 1651 1659 1:CAS:528:DC%2BD2cXotFWnsro%3D 15466983
31. AB Crumley DC McMillan M McKernan AC McDonald RC Stuart 2006 Evaluation of an inflammation-based prognostic score in patients with inoperable gastro-oesophageal cancer Br J Cancer 94 637 641 1:CAS:528:DC%2BD28XitVyjtrc%3D 16479253
32. NIH guide. Cachexia: research into biobehaviorial management and quality of life. June 11, 2001.
33. P Therasse SG Arbuck EA Eisenhauer J Wanders RS Kaplan L Rubinstein J Verweij M Van Glabbeke AT van Oosterom MC Christian, et al. 2000 New guidelines to evaluate the response to treatment in solid tumors. European organization for research and treatment of cancer, national cancer institute of the United States, national cancer institute of Canada J Natl Cancer Inst 92 205 216 10.1093/jnci/92.3.205 1:STN:280:DC%2BD3c7it1Gitg%3D%3D 10655437
34. National Cancer Institute-Cancer Therapy Evaluation Program: common terminology criteria for adverse events v3.0 (CTCAE), August 9, 2006
35. M Funakoshi-Tago T Shimizu K Tago M Nakamura H Itoh Y Sonoda T Kasahara 2008 Celecoxib potently inhibits TNFalpha-induced nuclear translocation and activation of NF-kappaB Biochem Pharmacol 76 662 671 10.1016/j.bcp.2008.06.015 1:CAS:528:DC%2BD1cXhtVSitbfF 18644347
36. AJ Baumgarten HH Fiebig AM Burger 2007 Molecular analysis of xenograft models of human cancer cachexia-possibilities for therapeutic intervention Cancer Genomics Proteomics 4 223 231 1:CAS:528:DC%2BD2sXls1Grtbs%3D 17878525
37. K Lundholm P Daneryd U Korner A Hyltander I Bosaeus 2004 Evidence that long-term COX-treatment improves energy homeostasis and body composition in cancer patients with progressive cachexia Int J Oncol 24 505 512 1:CAS:528:DC%2BD2cXitFant7w%3D 14767534
38. DC McMillan SJ Wigmore KC Fearon P O'Gorman CE Wright CS McArdle 1999 A prospective randomized study of megestrol acetate and ibuprofen in gastrointestinal cancer patients with weight loss Br J Cancer 79 495 500 10.1038/sj.bjc.6690077 1:CAS:528:DyaK1MXhtlejtrs%3D 10027319 (Pubitemid 29046225)
39. LC Cerchietti AH Navigante MA Castro 2007 Effects of eicosapentaenoic and docosahexaenoic n-3 fatty acids from fish oil and preferential Cox-2 inhibition on systemic syndromes in patients with advanced lung cancer Nutr Cancer 59 14 20 1:CAS:528:DC%2BD2sXht1CltrfK 17927497
40. SP Motsko KL Rascati AJ Busti JP Wilson JC Barner KA Lawson J Worchel 2006 Temporal relationship between use of NSAIDs, including selective COX-2 inhibitors, and cardiovascular risk Drug Saf 29 621 632 10.2165/00002018- 200629070-00007 1:CAS:528:DC%2BD28Xot1amsbw%3D 16808554 (Pubitemid 44175032)
41. G Mantovani A Maccio C Madeddu G Gramignano R Serpe E Massa M Dessi FM Tanca E Sanna L Deiana, et al. 2008 Randomized phase III clinical trial of five different arms of treatment for patients with cancer cachexia: interim results Nutrition 24 305 313 1:CAS:528:DC%2BD1cXjtVSqurs%3D 18262758