1422O - Efficacy and safety of a two drug-combination regimen for cancer-related cachexia in the clinical practice

Date 01 October 2012
Event ESMO Congress 2012
Session Supportive and palliative care
Topics Supportive Care
Presenter Clelia Madeddu
Authors C. Madeddu1, M. Dessi'1, F. Panzone1, R. Serpe1, G. Antoni2
  • 1Department Of Medical Oncology, University of Cagliari, 09042 - Cagliari/IT
  • 2Department Of Cardiovascular Diseases, University of Cagliari, 09042 - Cagliari/IT

Abstract

Background and aims

To test the safety and efficacy of a two-drug combination (including nutraceuticals, i.e. antioxidants) with carnitine + celecoxib for the treatment of cancer-related anorexia/cachexia syndrome (CACS) in the clinical practice. Primary endpoints: safety, increase of lean body mass (LBM) and improvement of quality of life. Secondary endpoints: increase of physical performance (tested by grip strength and 6-min walk test, 6MWT) and decrease of inflammation (assessed by serum levels of IL-6 and Glasgow prognostic score, GPS).

Patients and methods

Outpatients with advanced cancer at different sites with CACS (i.e. loss of body weight >5% of the pre-illness or ideal weight in the last 3 months) were eligible to receive: L-carnitine 4 g/day + Celecoxib 300 mg/day. All patients received as basic treatment polyphenols 300 mg/day, lipoic acid 300 mg/day, carbocysteine 2.7 g/day, Vitamin E, A, C, all orally. Treatment duration was 4 months.

Results

From June 2011 to April 2012, 50 patients with advanced cancer (all stage IV) at different sites were enrolled: 40 completed the treatment and were evaluable (mean age 63.8 ± 9.6, range 32-81 years). Results showed a significant increase of LBM (by dual-energy X-ray absorptiometry and by L3 computed tomography) from baseline as well as physical performance assessed by 6MWT. Quality of life (assessed by EORTC-QLQ-C30 and EQ-5D) also improved significantly. ECOG PS and GPS decreased significantly. The treatment was safe, no grade 3–4 toxicities occurred and no patient had to discontinue the treatment due to severe adverse events.

Conclusions

The results of the present study confirm the efficacy and safety of the two-drug combination regimen previously shown in a randomized clinical trial (Madeddu et al, Clinical Nutrition 31:176-182, 2012). Therefore, this simple, feasible, effective, safe, with favorable cost-benefit profile, two-drug approach could be suggested in the clinical practice as a treatment for CACS.

Disclosure

All authors have declared no conflicts of interest.