Neoadjuvant chemotherapy for patients with muscle-invasive urothelial bladder cancer candidates for curative surgery: A prospective clinical trial based on cisplatin feasibility

Background: Neoadjuvant chemotherapy demonstrated a survival benefit versus cystectomy alone in muscle-invasive urothelial bladder cancer. Despite this advantage, preoperative chemotherapy is not widely employed. When patients are unfit for cisplatin-based regimen, they are often candidates for immediate surgery. In our study, patients with muscle-invasive bladder cancer were treated with neoadjuvant chemotherapy. The principal objective was the rate of complete pathological response (PCR). Secondary end-points were disease-free survival (DFS), overall survival (OS) and toxicity. Patients and Methods: Patients (n=72) with Eastern Cooperative Oncology Group (ECOG) performance status 0-1, clinical stage cT3-4, and/or N+ muscle-invasive bladder cancer were enrolled. The chemotherapy regimen was established according to the cisplatin feasibility. Thirty patients were treated with cisplatin/gemcitabine (Gem) and 42 with carboplatin/Gem. Results: The rate of PCR was 29.2%, 36% with cisplatin-based treatment and 23.8% with carboplatin (p=0.3574). DFS and OS were longer in PCR patients, while no difference was reported between cisplatin/Gem and Carboplatin/Gem groups. Conclusion: Our results confirm the prognostic value of PCR in neoadjuvant chemotherapy for muscle-invasive bladder cancer. When the patients are not fit for cisplatin, a carboplatin/Gem regimen represents a valid option because of comparable long-term outcome. When cisplatin is not feasible, the exclusion of a preoperative treatment is not justified.