IV Vitamin C with Chemotherapy for Cisplatin-Ineligible Bladder Cancer Patients: A Forgotten Group

Purpose: Neoadjuvant cisplatin-based chemotherapy (NAC) is considered the standard of care (SOC) for patients with muscle-invasive bladder cancer (MIBC). However, approximately 50% of patients are cisplatin-ineligible (CI) and often proceed directly to surgery. We initiated a phase Ib/IIa trial to evaluate high-dose intravenous ascorbate (IVC) with gemcitabine/carboplatin (Gem/Carbo) as NAC for patients with CI-MIBC (NCT04046094). Patients and Methods: Patients with newly diagnosed CI-MIBC received a single cycle of Gem (1000 mg/m2 D1, 8)/Carbo (AUC 5 d 1) and IVC (25–125 g titrated to 350–400 mg/dL blood concentrations 2 × per week for 21 days) followed by definitive cystectomy. The primary outcome was pathological downstaging (