Cachexia Not Improved With Celecoxib Plus Megestrol vs Megestrol Alone
Double-blind phase 3 study evaluated the effect of megestrol combined with celecoxib vs monotherapy on cachexia in patients with gastrointestinal cancer.
Celecoxib plus megestrol acetate (MA) does not improve cachexia in patients with gastrointestinal cancer compared with MA alone, according to a study published in Supportive Care in Cancer.
MA is a commonly used treatment for cachexia, a condition characterized by weakening and wasting away commonly observed among patients with cancer. Studies have shown that cachexia may be mediated by inflammatory processes, making anti-inflammatory products such as COX-2 inhibitors a potential therapeutic option.
For this double-blinded phase 3 study, researchers randomly assigned 90 patients with gastrointestinal cancers to receive MA 320 mg daily plus placebo or celecoxib 200 mg/day. Patients had various clinical features such as body mass index (BMI), EORCT-QLQ C30 global quality of life, appetite score, grip strength (Kg), and ECOG-performance score measured at baseline, and 1 and 2 months after intervention initiation.
Patient characteristics were comparable at baseline, and 60 and 33 patients were evaluable after the first and second months, respectively.
After 2 months, patients who received only MA had a 4.0±3.4 kg compared with 2.2±3.6 kg weight gain compared with patients who received MA plus celecoxib (P =.0163) — an insignificant difference — but changes relative to baseline were significantly improved in both arms (P =.001).
Similarly, other measures of the study — such as quality of life and appetite score — did not significantly differ between the 2 study arms, but the within-group changes were significant for both treatment groups.
The authors concluded that “results of the present study failed to show that adding celecoxib (200 mg/day) to megestrol (320 mg/day) could enhance anticachexic effects of megestrol. However, patients used MA plus placebo and those who used the combinational regimen both experienced improvements relative to baseline.”
Kouchaki B, Janbabai G, Alipour A, Ala S, Borhani S, Salehifar E. Randomized double-blind clinical trial of combined treatment with megestrol acetate plus celecoxib versus megestrol acetate alone in cachexia-anorexia syndrome induced by GI cancers [published online February 13, 2018]. Support Care Cancer. doi: 10.1007/s00520-018-4047-y