Patients with muscle-invasive bladder cancer (MIBC, M0) who cannot receive cisplatin-based chemotherapy — due to reduced kidney function, cardiac status, hearing loss, neuropathy, or performance status — require a distinct treatment pathway. Evidence-based guidance supports a structured perioperative approach for this population ahead of radical surgery.
A patient with muscle-invasive bladder cancer (M0) qualifies for this pathway when at least one of the following is present:
The recommended strategy for this population involves a perioperative combination drug regimen administered before definitive radical surgery with pelvic lymph node dissection. The complete agent list, sequencing, and eligibility details are available in the full protocol.
Offer perioperative enfortumab vedotin plus pembrolizumab to patients with MIBC who are ineligible for cisplatin-based chemotherapy.
At least one of the following criteria must be present: PS > 1; GFR ≤ 60 mL/min.; grade ≥ 2 audiometric hearing loss; grade ≥ 2 peripheral neuropathy or New York Heart Association (NYHA) class III heart failure.
In this, 344 patients with cisplatin-ineligible (or -declining) MIBC were randomised to perioperative EV + P versus RC with pelvic LND followed by observation.
The result of this trial supports a new standard of care with perioperative EV + P for patients with cisplatin-ineligible MIBC.
Pathologic complete response rate was 57.1% versus 8.6%, respectively.
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