Background
Phase III RCT from Egypt. 120 patients with locally advanced bladder cancer (pT3b, pT4a, or pN+) following radical cystectomy with curative intent. Compared adjuvant chemoradiotherapy vs adjuvant radiotherapy alone for reducing locoregional recurrence after cystectomy.
Interventions and follow up
Arm A: Adjuvant chemoradiotherapy — cisplatin 35 mg/m² weekly × 6 weeks concurrent with radiotherapy 45–50 Gy (n=60)
Arm B: Adjuvant radiotherapy alone 45–50 Gy (n=60)
Primary endpoint: Locoregional recurrence-free survival
mFollow up: 42 month
Arm B: Adjuvant radiotherapy alone 45–50 Gy (n=60)
Primary endpoint: Locoregional recurrence-free survival
mFollow up: 42 month
Results
Locoregional recurrence-free survival at 3 years: 68% (CRT) vs 52% (RT alone), P=.04
Disease-free survival at 3 years: 56% (CRT) vs 41% (RT alone), P=.03
OS at 3 years: 52% (CRT) vs 40% (RT alone), P=.06 (trend)
Disease-free survival at 3 years: 56% (CRT) vs 41% (RT alone), P=.03
OS at 3 years: 52% (CRT) vs 40% (RT alone), P=.06 (trend)
Adverse events
Main adverse events: Grade 3+ acute GI toxicity higher in CRT arm (17% vs 7%). Grade 3+ GU toxicity: 7% (CRT) vs 3% (RT alone). Hematologic grade ≥3: 10% (CRT) vs 0%. No treatment-related deaths.
Conclusions
Adding concurrent weekly cisplatin to adjuvant radiotherapy after radical cystectomy for locally advanced bladder cancer significantly improved locoregional recurrence-free survival and disease-free survival, with a non-significant trend toward improved OS. Adjuvant CRT after cystectomy may benefit selected high-risk patients in resource-limited settings without access to neoadjuvant chemotherapy.
Key Limitations
Key Limitations: Single-institution trial from a lower-income setting; results may not be generalizable to high-income healthcare environments where neoadjuvant chemotherapy is the preferred perioperative approach. Only patients who had not received neoadjuvant chemotherapy were eligible. Sample size is small (n=120). OS benefit did not reach statistical significance.
Clinical Context
This trial provides the only randomized data on adjuvant chemoradiotherapy after cystectomy for locally advanced bladder cancer. It is not widely adopted in Western practice, where neoadjuvant cisplatin-based chemotherapy + cystectomy is standard. Adjuvant pembrolizumab (CheckMate 274/NIAGARA) has since emerged as a newer adjuvant option, further limiting the role of post-cystectomy RT in guidelines.
References