A comprehensive evaluation of clinical efficacy and safety of celecoxib in combination with chemotherapy in metastatic or postoperative recurrent gastric cancer patients: A preliminary, three-center, clinical trial study

Abstract

Aim: To evaluate the efficacy and safety of celecoxib combined with chemotherapy in the treatment of metastatic or postoperative recurrent gastric cancer. Methods: This preliminary, three-center, clinical trial study was conducted between September 2010 and December 2016. In the experimental group (n=100), patients were treated with celecoxib combined with chemotherapy, and chemotherapy alone was used in the control group. Progression-free survival (PFS) was considered as the primary efficacy parameter. Overall survival (OS), remission rate (RR), quality of life (QOL) and drug safety were considered as the secondary efficacy parameters. Results: The PFS of the experimental group was 6 months, which was not significantly longer than that of the control group (5 months, P=.73). The average OS was not significantly different between the experimental group (12 months) and the control group (10 months, P=.59). The average OS of the COX-2 positive patients in the experimental group was 14 months and it was significantly longer than the 10-month OS in the control group (P=.01). The PFS of the COX-2 positive patients in the experimental group was 7.5 months, significantly longer than the 5-month PFS of patients in the control group (P .05 for all mentioned outcomes). Conclusion: Celecoxib combined with chemotherapy offers more clinical benefits for COX-2 positive advanced gastric cancer patients.