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

Abstract

Chronic inflammation is one of the main features of cancer cachexia. Experimental and clinical studies showed that cyclooxygenase-2 inhibitors, such as celecoxib, may be beneficial in counteracting major symptoms of this devastating syndrome. We carried out a prospective phase II clinical trial to test the safety and effectiveness of an intervention with the COX-2 inhibitor celecoxib (300 mg/day for 4 months) on key variables of cachexia (lean body mass, resting energy expenditure, serum levels of proinflammatory cytokines, and fatigue) in patients with advanced cancer at different sites. A sample of 24 patients was enrolled from January to December 2008 and all were deemed assessable. A significant increase of lean body mass and a significant decrease of TNF-alpha were observed. Moreover, an improvement of grip strength, quality of life, performance status, and Glasgow prognostic score was shown. There were no grade 3/4 toxicities. Patient compliance was very good; no patient had to reduce the celecoxib dosage nor interrupt treatment. Our results showed that the COX-2 selective inhibitor celecoxib is an effective single agent for the treatment of cancer cachexia. Although the treatment of cancer cachexia, a multifactorial syndrome, is more likely to yield success with a multitargeted approach; in the present study, we were able to show that a treatment, such as celecoxib, addressing a single target, albeit very important as chronic inflammation, could have positive effects. Therefore, phase III clinical trials are warranted to test the efficacy and safety of celecoxib.

• Authors: Giovanni Mantovani, Antonio Macciò, Clelia Madeddu, Roberto Serpe, Giorgia Antoni, Elena Massa, Mariele Dessì, Filomena Panzone
• Journal: Journal of molecular medicine (Berlin, Germany) (J Mol Med (Berl)) Vol. 88 Issue 1 Pg. 85-92 (Jan 2010) ISSN: 1432-1440 [Electronic] Germany
• PMID: 19802504 (Publication Type: Clinical Trial, Phase II, Journal Article)

Chemical References

• Cyclooxygenase 2 Inhibitors
• Pyrazoles
• Sulfonamides
• Celecoxib

Topics

• Aged
• Cachexia (drug therapy, etiology)
• Celecoxib
• Cyclooxygenase 2 Inhibitors (adverse effects, therapeutic use)
• Female
• Humans
• Middle Aged
• Neoplasms (complications)
• Pyrazoles (adverse effects, therapeutic use)
• Sulfonamides (adverse effects, therapeutic use)