DIET & NUTRITION 
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EXERCISE/TRAINING 
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GUIDELINES/RECOMMENDATIONS ✅ Clinical Decision Support / Validated Tool
Perioperative treatment strategies continue to evolve in muscle-invasive bladder cancer (MIBC), where cisplatin-based neoadjuvant chemotherapy followed by radical cystectomy has remained the standard approach for decades. The phase 3 KEYNOTE-B15 trial evaluated whether perioperative enfortumab vedotin plus pembrolizumab could improve outcomes compared with neoadjuvant gemcitabine-cisplatin in cisplatin-eligible patients undergoing radical cystectomy.
Clinical Considerations
- Patients with clinically localized MIBC eligible for cisplatin and radical cystectomy were randomized to perioperative enfortumab vedotin plus pembrolizumab or standard neoadjuvant gemcitabine-cisplatin.
- Both treatment groups received four cycles of preoperative therapy followed by radical cystectomy and pelvic lymph-node dissection.
- Patients in the investigational arm subsequently received adjuvant enfortumab vedotin plus pembrolizumab, while the control group underwent observation.
- The primary endpoint was event-free survival, with overall survival and pathologic complete response among key secondary endpoints.
- Investigators reported a 47% reduction in the risk of recurrence, progression, or death with the perioperative enfortumab vedotin and pembrolizumab regimen.
Practice Applications
- The results suggest a potential new perioperative treatment paradigm for cisplatin-eligible patients with muscle-invasive bladder cancer.
- Positive event-free survival and overall survival findings strengthen interest in moving active regimens that demonstrated efficacy in metastatic urothelial cancer into earlier disease settings.
- The study may influence future guideline discussions if the reported benefits are incorporated into broader evidence reviews and regulatory decision-making.
- Clinicians should interpret the findings within the context of a perioperative strategy that includes both neoadjuvant and adjuvant treatment components.
