Immune-enhancing nutrition does not affect complication rate of radical cystectomy

Immune-modulation nutrition did not result in fewer complications in patients undergoing radical cystectomy in the phase 3 SWOG S1600 trial. However, a trend was observed towards fewer patients who experienced progression or died in the intervention group.

Radical cystectomy is associated with morbidity, and post-operative complications are reported in up to 65% of patients. Poor pre-operative nutritional status is associated with a higher complication rate (e.g. infection or rapid muscle wasting) after radical cystectomy. In previous studies, it was shown that immune response to surgery and late infection rates differed between radical cystectomy patients receiving specialised ‘immunonutrition’ versus oral nutrition supplements in the peri-operative period [1,2].

The randomised, double-blinded, phase 3 SWOG S1600 trial (NCT03757949) aimed to determine the impact of peri-operative specialised immunonutrition on post-operative complications after radical cystectomy. The study enrolled 203 participants with bladder carcinoma who were planned to undergo radical cystectomy. They were 1:1 randomised to receive a specialised immunonutrition drink (SIM arm) or a control oral nutrition support drink (ONS arm). SIM is fortified with L-arginine, omega-3 fatty acids, and dietary nucleotides. The intake of either drink started on day 5 before surgery and ended on day 5 after surgery.

The primary outcome of the study was 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). The first findings were presented by Prof. Jill Hamilton-Reeves (University of Kansas Medical Center, KS, USA) [3].

There was no difference in rates of surgical complication of any grade on day 30 between both arms (SIM 62.2%, ONS 58.0%). In addition, no differences were observed in high-grade events on day 30 or in any-grade events on day 90. Preliminary evaluation of survival data showed no statistically significant improvement in PFS (2-year PFS 77% vs 68%; P=0.16); a trend towards longer OS was observed (2-year OS 87% vs 78%; P=0.07) for SIM and ONS, respectively. Nevertheless, these OS data are not yet mature.

Dr Hamilton-Reeves concluded that “immunonutrition did not result in fewer complications in patients undergoing radical cystectomy. However, fewer patients in the intervention arm experienced progression or died, although these data are not yet mature.” More detailed outcomes are currently being evaluated, including infection rate, muscle mass, and data on adherence.

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 of immune-enhancing nutrition on radical cystectomy outcomes: primary results from the randomized phase III double-blind clinical trial (SWOG S1600). Abstract 4501, ASCO Annual Meeting 2024, 31 May–4 June, Chicago, IL, USA.

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Posted on 18 July 202418 July 2024