Long-Term Effects of Oral Nutritional Supplements After Gastrectomy for Gastric Cancer: A Survival Analysis from a Multicenter, Open-Label, Randomized Controlled Trial.

Abstract

Weight loss (WL) after gastrectomy for gastric cancer is associated with both decreased compliance with adjuvant chemotherapy and impaired survival. This study examined the effects of administering oral nutritional supplements (ONS) for 3months after gastrectomy in terms of compliance with adjuvant chemotherapy and survival outcomes. This large-scale, multicenter, open-label, randomized controlled trial enrolled 1,003 gastric cancer patients undergoing curative gastrectomy. Patients were assigned to the control group (n = 503) or ONS group (n = 500). In the ONS group, 400kcal/day of ONS was recommended in addition to a regular diet for 3months after gastrectomy. Compliance with adjuvant chemotherapy and survival outcomes were compared between the two groups. Compared with the control group, the ONS group showed significantly decreased WL at 3months after gastrectomy (8.6 ± 6.1 vs. 7.2 ± 5.7%, respectively, P = 0.0004). The control and ONS groups did not differ regarding the induction rate of adjuvant chemotherapy (84.9 vs. 82.8%, respectively, P = 0.614) or the continuation rate at 3months postoperatively (75.3 vs. 76.6%, respectively, P = 0.809). Oral nutritional supplements for 3months showed no survival benefit; the 3- and 5-year overall survival (OS) rates were 91.3% and 87.6% in the control group and 89.6% and 86.4% in the ONS group, respectively, indicating no significant difference (P = 0.548). Subgroup analysis could not detect a population in which ONS administration increased OS. Administration of ONS for 3months after gastrectomy was not associated with increased compliance with adjuvant chemotherapy or with improved prognosis.