Efficacy and safety profile of celecoxib for treating advanced cancers: a meta-analysis of 11 randomized clinical trials.

PURPOSE

Evidence on the benefits of combining celecoxib, a cyclooxygenase-2 inhibitor, in treating advanced cancer is still controversial. This study aimed to establish the efficacy and safety profile of celecoxib in treating advanced cancers.

METHODS

The PubMed, Embase, and Cochrane databases and abstracts from the American Society of Clinical Oncology and European Society for Medical Oncology were searched for reports dated up to January 31, 2014, to find relevant randomized clinical trials. The outcomes included overall response rate (ORR), 1-year mortality, progression-free survival, overall survival, and toxicities. Fixed-effects meta-analytical models were used when indicated, and between-study heterogeneity was assessed. Subgroup analysis was conducted according to cancer type, treatment pattern, and treatment line.

FINDINGS

A total of 11 randomized clinical trials consisting of 2570 patients with advanced cancer were included in the final meta-analysis. Addition of celecoxib to the treatment regimen significantly increased the ORR (pooled risk ratio [RR] = 1.20; 95% CI, 1.06-1.36; P = 0.005) but had no effect on 1-year mortality (RR = 1.02; 95% CI, 0.92-1.13; P = 0.68). Subgroup analysis found that the ORR results were significant with non-small cell lung cancer (RR = 1.29; 95% CI, 1.08-1.54; P = 0.005), colorectal cancer (RR = 1.32; 95% CI, 1.02-1.72; P = 0.037), chemotherapy treatment (RR = 1.22; 95% CI, 1.07-1.39; P = 0.003), and first-line treatment (RR = 1.22; 95% CI, 1.07-1.38; P = 0.003). However, celecoxib increased the risk of cardiovascular events (RR = 1.78; 95% CI, 1.30-2.43; P < 0.001) and anemia (RR = 1.88; 95% CI, 0.95-3.74; P = 0.071).

IMPLICATIONS

Celecoxib is beneficial in the treatment of advanced cancers but with increased risk of cardiovascular events. Benefit versus harm needs to be carefully considered when celecoxib is recommended in patients with advanced cancers.