Immune-modulation nutrition did not result in fewer complications in patients undergoing radical cystectomy, results from phase 3 SWOG S1600 trial showed. However, a trend was observed toward fewer patients in the intervention group who progressed or died.
Radical cystectomy is associated with morbidity, and postoperative complications are reported in up to 65% of patients. Poor preoperative nutritional status is associated with a higher complication rate after radical cystectomy, such as infections and rapid muscle wasting. Previous studies showed immune response to surgery and late infection rates differ between patients with radical cystectomy receiving specialized immunonutrition versus oral nutrition supplements in the perioperative period1,2.
Based on these results, the SWOG S1600 trial (NCT03757949), a phase 3, randomized, double-blinded clinical trial, determing the impact of perioperative specialized immunonutrition on postoperative complications after radical cystectomy. Dr. Jill Hamilton-Reeves, PhD, RD, of the University of Kansas Medical Center, KS, presented the first findings3.
The study enrolled 203 patients with bladder carcinoma who were planned to undergo radical cystectomy. Patients were 1:1 randomly assigned to receive a specialized immune-modulation nutrition drink (SIM) or control oral nutrition support drink (ONS). SIM is fortified with L-arginine, omega-3 fatty acids, and dietary nucleotides. Intake of nutrition drinks started on day 5 before surgery and ended on day 5 after surgery.
The primary outcome of the study was the 30-day event rate. Secondary outcomes were day 30 high-grade (Clavien-Dondo III-V) events, day 90 any-grade events, 2-year progression-free survival (PFS) and overall survival (OS).
No difference in any grade surgical complication rates at day 30 were observed between both arms (SIM: 62.2%, ONS: 58.0%). In addition, no differences in high-grade events on day 30, or in any grade events at day 90 were observed. Preliminary evaluation of survival data showed no statistically significant improvement in PFS. 2-Year PFS was 77% versus 68% (P=0.16). A trend toward longer OS was observed: 2-year OS was 87% versus 78% (P=0.07) for SIM and ONS, respectively. The OS data are not yet mature.
More detailed outcomes, e.g. infection rate and muscle mass, as well as data on adherence, are under evaluation.
Dr. Hamilton-Reeves concluded that “immune-modulation nutrition did not result in fewer complications in patients undergoing radical cystectomy. However, fewer patients in the intervention arm progressed or died, although these data are not yet mature.”
Medical writing support was provided by Marten Dooper, PhD.
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