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.

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 < .001). No statistical significance was identified in the incidence of nausea, neutropenia, anorexia, peripheral neurotoxicity, diarrhea, vomiting, asthenia and thrombocytopenia. The EORTC QLQ-C30 questionnaire revealed that the overall QOL of the experimental group was significantly higher than that of the control group (P < .05). No statistical significance was found in the scores of functioning scale between the 2 groups. However, the scores of the symptom scale, especially for pain and fatigue in the experimental group was remarkably higher than that in the control group (P < .05). The overall score of EORTC QLQ-STO22 for the experimental group was considerably higher compared to that for the control group (P < .05). No statistical significance was identified in term of the domains of restrictions on feeding, dysphagia, anxiety, reflux, sense of taste, dry mouth, hair loss and body shape between the 2 groups (P > .05 for all mentioned outcomes).

CONCLUSION

Celecoxib combined with chemotherapy offers more clinical benefits for COX-2 positive advanced gastric cancer patients.