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

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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-α 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.

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Acknowledgment

The authors take full responsibility for the content of the paper but thank Ms. Anna Rita Succa for her assistance in editing the article.

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The authors have no financial or personal relationships with other people or organizations that could inappropriately influence their work.

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Authors and Affiliations

  1. Department of Medical Oncology, University of Cagliari, Cagliari, Italy

    Giovanni Mantovani, Antonio Macciò, Clelia Madeddu, Roberto Serpe, Giorgia Antoni, Elena Massa, Mariele Dessì & Filomena Panzone

  2. Cattedra di Oncologia Medica, Università di Cagliari, Azienda Ospedaliero-Universitaria di Cagliari, S.S. 554, Km 4,500, Monserrato, Cagliari, 09042, Italy

    Giovanni Mantovani

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  1. Giovanni Mantovani
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  2. Antonio Macciò
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Correspondence to Giovanni Mantovani.

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Mantovani, G., Macciò, A., Madeddu, C. et al. Phase II nonrandomized study of the efficacy and safety of COX-2 inhibitor celecoxib on patients with cancer cachexia. J Mol Med 88, 85–92 (2010). https://doi.org/10.1007/s00109-009-0547-z

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  • DOI: https://doi.org/10.1007/s00109-009-0547-z

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