Effects of perioperative eicosapentaenoic acid-enriched oral nutritional supplement on the long-term oncological outcomes after total gastrectomy for gastric cancer

Abstract

Basic and clinical reports have suggested that eicosapentaenoic acid (EPA) exhibits anti-tumor activity. The present study evaluated whether perioperative EPA could improve the survival of patients with localized gastric cancer as a key secondary endpoint of a randomized clinical study. The present study was designed as multicenter, open-label, superiority, randomized trial to confirm the preventive effect of EPA on body weight loss after total gastrectomy for gastric cancer. Eligible patients were randomized to either the standard-diet group (EPA-off group) or EPA-on group by a centralized dynamic method. An EPA-enriched supplement (ProSure^®) was given to the EPA-on group in addition to their standard diet. This supplement included 600 kcal with 2.2 g/day of EPA. Among the 126 patients who were randomized, 123 patients (EPA-off group, n=60; EPA-on group, n=63) were examined in the survival analyses. All background factors were well balanced between the two groups. The 3-year and 5-year overall survival rates were 74.6 and 67.8%, respectively, in the EPA-off group, and 77.8 and 76.2% in the EPA-on group. There was no significant difference between the EPA-off and EPA-on groups (hazard ratio, 0.77; P=0.424). In the subgroup analysis, the hazard ratio was 0.39 in patients who received neoadjuvant chemotherapy and 0.57 in patients with nodal metastasis. In conclusion, a clear survival benefit of perioperative EPA was not observed in localized gastric cancer. The value of EPA should be further tested in a future study in patients with unfavorable advanced gastric cancer. Clinical trial number: UMIN000006380; date of registration, September 21, 2011.

Keywords: eicosapentaenoic acid; gastrectomy; gastric cancer; survival.

Figure 1.

Flow diagram of the 127 patients. EPA, eicosapentaenoic acid.

Figure 2.

Comparison of overall survival in the patients in the EPA-on and EPA-off groups. EPA, eicosapentaenoic acid.

Figure 3.

Overall survival in the subgroups. NAC, neoadjuvant chemotherapy.

Figure 4.

Comparison of overall survival in the patients who received neoadjuvant chemotherapy in the EPA-on and EPA-off groups. EPA, eicosapentaenoic acid.

Figure 5.

Comparison of overall survival in the patients who did not receive neoadjuvant chemotherapy in the EPA-on and EPA-off groups. EPA, eicosapentaenoic acid.