Objective: To report real‐world rates of non‐muscle‐invasive bladder cancer (NMIBC) recurrence and progression within a European multicentre cohort with detailed information on intravesical instillation courses, as contemporary data on oncological outcomes in NMIBC are limited.Patients and methods: A total of 1918 patients with NMIBC treated with transurethral resection of bladder tumour (TURBT) were retrospectively identified from six tertiary‐referral European centres (2015–2022). Patients were stratified according to European Association of Urology 2021 criteria into low‐ (LR), intermediate‐ (IR), high‐ (HR) and very high‐risk (VHR) categories. Cumulative incidence plots and multivariable competing risks regression models addressing 5‐year rates of high‐grade (HG) recurrence and progression were fitted. Sensitivity analyses focused on patients receiving intravesical instillations and tested for the effect of adequate course (Bacillus Calmette‐Guérin: five or more induction + two or more maintenance instillations; mitomycin C: complete induction + ≥11 maintenance instillations).Results: Of all NMIBC patients identified, 467 (24.3%) were LR vs 582 (30.3%) IR vs 739 (38.5%) HR vs 130 (6.8%) VHR. The median (interquartile range) follow‐up after TURBT was 26 (12–46) months. The 5‐year HG recurrence rates were 7.2% in LR vs 17.3% in IR vs 26.7% in HR vs 30.9% in VHR patients, resulting in a three‐, five‐ and seven‐fold higher risk of IR, HR and VHR, respectively, relative to LR (all P < 0.001). The 5‐year progression rates were 3.9% in LR vs 5.2% in IR vs 13.6% in HR vs 31.6% in VHR patients, resulting in a six‐ and nine‐fold higher risk for HR and VHR, respectively, relative to LR (all P < 0.001). In all, 1001 (52.2%) patients underwent intravesical instillations. Those receiving adequate instillation course (244/1001 [24.3%]) had lower HG‐recurrence (hazard ratio 0.3, P < 0.001) and progression (hazard ratio 0.2, P = 0.001) risk.Conclusions: Patients with HR/VHR NMIBC face significantly higher HG recurrence and progression risks. While tailored treatment strategies are needed, adherence to adequate instillation course remains crucial for optimising oncological outcomes.
Cisplatin-based neoadjuvant chemotherapy followed by radical cystectomy is the current standard of care for muscle-invasive bladder cancer (MIBC). However, less than half of patients are candidates for this treatment, and 50% will develop metastatic disease. Adjuvant chemotherapy could be offered if neoadjuvant treatment has not been administered for suitable patients. It is important to reduce the risk of systemic recurrence and improve the prognosis of localized MIBC. Systemic therapy for metastatic urothelial carcinoma has evolved in recent years. Immune checkpoint inhibitors and targeted agents, such as antibody-drug conjugates or FGFR inhibitors, are new therapeutic alternatives and have shown their benefit in advanced disease. Currently, several clinical trials are investigating the role of these drugs, as monotherapy and in combination with chemotherapy, in the neoadjuvant and adjuvant settings with promising outcomes. In addition, the development of predictive biomarkers could predict responses to neoadjuvant therapies.
Prostate-specific antigen (PSA) has been the primary biomarker used for the detection and monitoring of prostate cancer for decades. However, its limited specificity and prognostic accuracy have led to the development of novel molecular and imaging biomarkers aimed at improving the clinical characterization of localized disease. This review critically examines recent advances in urinary biomarkers (e.g., PCA3, SelectMDx), tissue-based genomic assays (Oncotype DX Prostate, Prolaris, Decipher), and imaging techniques such as multiparametric magnetic resonance imaging (mpMRI) and prostate-specific membrane antigen positron emission tomography (PET-PSMA). We evaluate their diagnostic performance, prognostic value, and clinical utility in risk stratification and individualized treatment decision-making. Methodological and clinical barriers to their routine implementation are also discussed. Current evidence supports the multidisciplinary integration of these biomarkers to overcome the limitations of PSA, improve biopsy decision-making, better distinguish indolent from aggressive tumors, and optimize therapeutic strategies. Finally, future research directions aimed at validating and incorporating emerging biomarkers into clinical practice are outlined, with the goal of improving outcomes in patients with localized prostate cancer.