Early versus late supplemental parenteral nutrition in gastrointestinal cancer patients undergoing major abdominal surgery: 5-year outcomes from a randomized clinical trial.

BACKGROUND: The long-term effects of supplemental parenteral nutrition (SPN) on survival and recurrence in gastrointestinal (GI) cancer patients undergoing major abdominal surgery remain unclear. This study reports the 5-year overall survival (OS) results from the PNASIT randomized clinical trial (RCT), which compared early SPN [initiated on postoperative day (POD) 3] versus late SPN (initiated on POD 8) in patients with GI undergoing major abdominal surgery. METHODS: This multicenter, open-label, RCT was conducted at 11 centers in China. From 1 April 2017 to 31 December 2018, a total of 217 eligible patients with nutritional risk (Nutritional Risk Screening 2002) score ≥3) who were undergoing elective major abdominal surgery for GI cancer were enrolled. Patients were randomized into two groups: the early SPN group (E-SPN; n = 107) and the late SPN group (L-SPN; n = 110). The primary endpoint was 5-year OS, analyzed using Kaplan-Meier methods and Cox proportional hazards models on an intention-to-treat basis. RESULTS: Among the 217 analyzed patients [mean (SD) age, 60.4 (12.2) years; 60.4% male; all of Asian ethnicity], the 5-year OS rate was 70.1% (75/107) in the E-SPN group and 66.4% (73/110) in the L-SPN group [hazard ratio (HR), 0.857; 95% confidence interval (CI), 0.535-1.374; log-rank P = 0.520]. No significant differences were observed in 5-year disease-free survival rates, recurrence rates, or recurrence patterns between the two groups (all P > 0.05). HRQoL, as measured by the 36-Item Short Form Health Survey scale, was significantly higher in the E-SPN group compared with the L-SPN group during the first 6 postoperative months (P < 0.001). However, no significant differences were observed at 1, 3, or 5 years after surgery. CONCLUSION: In GI cancer patients undergoing major abdominal surgery, early SPN showed no significant difference in 5-year OS compared with late SPN. The findings do not support the use of early SPN to improve long-term survival in this patient population. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03115957.