Comprehensive evaluation of clinical efficacy and safety of celecoxib combined with chemotherapy in management of gastric cancer.

BACKGROUND: To evaluate the clinical efficacy and safety of celecoxib combined with chemotherapy in the treatment of gastric cancer.

METHODS: In total, 240 gastric cancer patients undergoing radical gastrectomy followed by adjuvant chemotherapy were randomly assigned into 2 groups. In the experimental group (n = 120), patients were administered with celecoxib-based chemotherapy, and chemotherapy alone was performed in the control group. Disease-free survival (DFS) and progression-free survival (PFS) were considered as the primary efficacy parameters, and objective response rate (ORR), overall survival (OS), quality of life (QOL), and safety as the secondary efficacy parameters.

RESULTS: The 3-year OS did not significantly differ between the experimental (72%) and control groups (68%, P = .67). The 3-year DFS in the experimental group was 64%, which did not significantly differ from 51% in the control group (P = .41). In patients with positive cyclooxygenase-2 (COX-2) from the experimental group, the 3-year OS was 78%, significantly higher compared with 66% in the control group (P = .02), and the 3-year DFS was 70%, considerably >50% in the control group (P = .01). No statistical significance was identified in the incidence of nausea, neutropenia, anorexia, peripheral neurotoxicity, diarrhea, vomiting, asthenia, and thrombocytopenia, etc. The EORTC quality of life questionnaire (QLQ)-C30 questionnaire revealed that the global QOL in the experimental group was significantly higher than that in the control group (P < .05). No statistical significance was noted in the scores of functioning scale between 2 groups, whereas the scores of the symptom scale, especially pain and fatigue in the experimental group were remarkably higher than that in the control group (P < .05). The global score of EORTC QLQ-STO22 in the experimental group was considerably higher compared with that in 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 groups (all P > .05).

CONCLUSION: Celecoxib combined with chemotherapy yields clinical benefits for gastric cancer patients with positive COX-2, which not only enhances the OS, DFS, PFS, QOL, and short-term clinical efficacy, but also does not increase the risk of adverse events.