Home > Oncology > ASCO 2024 > Immune-enhancing nutrition has no effect on complication rates after radical cystectomy

Immune-enhancing nutrition has no effect on complication rates after radical cystectomy

Presented by
Dr Jill Hamilton-Reeves, University of Kansas Medical Center, KS, USA
Conference
ASCO 2024
Trial
Phase 3, SWOG S1600
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 radical cystectomy patients receiving specialized immunonutrition versus oral nutrition supplements in the perioperative period [1,2].

Based on these results, the SWOG S1600 trial (NCT03757949), a phase 3, randomised, double-blinded clinical trial, aimed to determine the impact of perioperative specialized immunonutrition on postoperative complications after radical cystectomy. Dr Jill Hamilton-Reeves (University of Kansas Medical Center, KS, USA) presented the first findings [3].

The study enrolled 203 patients with bladder carcinoma who were planned to undergo radical cystectomy. Patients were 1:1 randomised 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, and 2-year progression-free survival (PFS) and overall survival (OS).

No difference in any grade surgical complication rates at day 30 was observed between both arms (SIM: 62.2%, ONS: 58.0%). In addition, no differences in high-grade events at day 30, nor in any grade events a 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. These 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 ‚Äúimmune-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.‚ÄĚ

  1. Hamilton-Reeves JM, et al. Eur Urol. 2016; 69: 389-392.
  2. Hamilton-Reeves JM, et al. J Urol. 2018; 200: 292-301.
  3. Hamilton-Reeves JM, et al. Effects in immune-enhancing nutrition on radical cystectomy outcomes: primary results from the randomised phase III double-blind clinical trial (SWOG S1600). Abstract 4501. ASCO Annual Meeting 2024, May 31-June 4, Chicago, IL, USA.

Medical writing support was provided by Marten Dooper, PhD.

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