Neoadjuvant Chemotherapy or Immunotherapy for Clinical T2N0 Muscle-invasive Bladder Cancer: Time to Change the Paradigm?

摘要: A 41-yr-old, otherwise healthy, premenopausal woman presented at our uro-oncology clinic with a diagnosis of muscle-invasive bladder cancer following transurethral resection the performed another center. After thorough discussion patient, she was enrolled in phase II PURE-01 trial (NCT02736266), testing three cycles neoadjuvant pembrolizumab (200mg) every 3 wk before radical cystectomy. Before treatment, imaging studies were obtained as per protocol using computed tomography (CT), [18F]fluorodeoxyglucose positron emission tomography/CT, and multiparametric magnetic resonance bladder, defining clinically localized T2N0M0 stage. As protocol, potential biomarkers assessed, including PD-L1 expression (84% combined positive score), tumor mutational burden (16.67 mut/Mb), genomic profiling (FoundationONE assay; somatic mutation TP53, EZH2, APC, TERT, CDKN1A, CDKN1B, ARID1A genes, truncation BRCA2 gene). immunotherapy, patient underwent robot-assisted cystectomy extended pelvic lymph node dissection. The final pathology report revealed absence residual disease (ie, pathological complete response, ypT0ypN0). During follow-up, only relevant permanent immune-mediated adverse event hypothyroidism secondary to an autoimmune thyroiditis. It appeared 2 mo after it managed successfully hormonal replacement therapy. Two years is asymptomatic free from recurrence. PATIENT SUMMARY: Increasing evidence suggests that frontline immunotherapy may be beneficial for patients diagnosed non-locally advanced, (cT2N0), fewer drawbacks than traditional chemotherapy. Although further are needed support, this vision opens opportunity future clinical trials incremental benefits utility novel biomarker- imaging-based strategies assess response