Trial reportWorld journal of urology2026
Surgical outcomes after neoadjuvant avelumab with or without chemotherapy for Muscle-Invasive bladder cancer: a Post-Hoc analysis of the aura trial (Oncodistinct-004).
Trial report in World journal of urology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03674424 (Avelumab as Neoadjuvant Therapy in Subjects With Urothelial Muscle Invasive Bladder Cancers), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Avelumab as Neoadjuvant Therapy in Subjects With Urothelial Muscle Invasive Bladder Cancers
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeNeoadjuvant chemo-immunotherapy is emerging as promising strategy in muscle-invasive bladder cancer (MIBC), yet its perioperative safety remains understudied. This post-hoc analysis of the AURA phase-II trial assesses surgical outcomes following neoadjuvant avelumab with or without chemotherapy.
methodsWe analyzed 88 patients with localized MIBC from the phase 2 multicenter AURA trial (NCT03674424) who underwent radical cystectomy after receiving either avelumab monotherapy (n = 22) or chemo-immunotherapy (n = 66). Surgical complications were classified using Clavien-Dindo criteria. A LASSO regression was used to identify predictors of overall complications, followed by multivariable and mixed-effects models.
resultsNo increased intra-operative surgical complexity was noted. The overall complication rate was 52%. Major complications occurred significantly more often in the chemo-immunotherapy group compared to monotherapy (21.2% vs. 15.4%, p = 0.03), despite more favorable patient profiles. Neobladder diversion and open surgery were both associated with higher complication rates (81% vs. ileal conduit 40%, p = 0.001; 61% vs. robotic surgery 53%, p = 0.04, respectively). Uretero-enteric stricture occurred in 7.6% of patients, with no significant difference between groups. The predictive model demonstrated high accuracy (AUC 0.851) and identified key risk factors for major complications: neobladder reconstruction (OR 10.9[2.4-48.4], p = 0.002), older age, longer operative time, and low preoperative hemoglobin. Limitations include the non-randomized treatment allocation and small sample size in the monotherapy group, which may limit generalizability.
conclusionRadical cystectomy after neoadjuvant immunotherapy+/-chemotherapy is feasible, safe, and is not associated with increased intra-operative surgical complexity. Neoadjuvant chemo-immunotherapy prior to cystectomy was associated with increased risk of major surgical complications compared to immunotherapy alone.
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