Background
Spanish prospective comparison of two bladder-sparing trimodality therapy (TMT) regimens for muscle-invasive bladder cancer (T2–T4a). 74 patients treated at a single institution with either TURBT alone followed by radiotherapy (RT) or TURBT with neoadjuvant cisplatin chemotherapy followed by concurrent cisplatin CRT. Compared response rates, bladder preservation rates, and toxicity.
Interventions and follow up
Arm A: TURBT + neoadjuvant cisplatin + concurrent cisplatin + radiotherapy 64 Gy (n=40)
Arm B: TURBT + radiotherapy 64 Gy alone (n=34)
Primary endpoint: Complete response rate, bladder preservation rate, and late toxicity
mFollow up: Not specified
Arm B: TURBT + radiotherapy 64 Gy alone (n=34)
Primary endpoint: Complete response rate, bladder preservation rate, and late toxicity
mFollow up: Not specified
Results
Complete response: 72.5% (CRT arm) vs 61.8% (RT alone arm)
5-yr bladder preservation: 54% (CRT) vs 41% (RT alone)
5-yr OS: Comparable between arms (small sample; not powered for superiority)
5-yr bladder preservation: 54% (CRT) vs 41% (RT alone)
5-yr OS: Comparable between arms (small sample; not powered for superiority)
Adverse events
Main adverse events: Grade ≥3 acute GU toxicity higher in CRT arm. Late grade ≥3 toxicity low in both groups. No significant difference in quality of preserved bladder function between arms.
Conclusions
Adding concurrent cisplatin to radiotherapy improved complete response rates and bladder preservation compared with RT alone in this small Spanish series, consistent with findings from BC-2001 and RTOG pooled analyses. Toxicity was acceptable in both arms.
Key Limitations
Key Limitations: Small sample size (n=74), retrospective/prospective single-center design with limited power. Not a randomized controlled trial — treatment allocation is not described as randomized. Results consistent with but do not add to evidence from BC-2001 (randomized) and RTOG pooled analyses.
Clinical Context
Corroborates concurrent chemotherapy benefit in bladder preservation, consistent with the definitive BC-2001 trial. This paper is primarily of historical and regional interest; BC-2001 and RTOG series are the primary references for concurrent CRT benefit in modern guidelines.
References
References: Zapatero A et al, Urology 2012