Durvalumab (D) in combination with BCG induction and maintenance (I + M) therapy for BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): 5-year overall survival (OS) analysis and patient-reported outcomes (PROs) from POTOMAC. Durvalumab plus Bacillus Calmette-Guérin (BCG) induction and maintenance (I + M) therapy was found to significantly improve disease-free survival (DFS) vs BCG I + M alone in patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC) in the phase 3 POTOMAC trial. This study reported 5-year overall survival (OS) and patient-reported outcomes (PROs). At the data cutoff date of October 3, 2025, with a median follow-up of 72 months, 5-year OS rate was 87.6% (95% confidence interval [CI]: 83.5–90.8%) for the durvalumab plus BCG (I + M) arm vs 86.3% (95% CI: 82.1–89.6%) in the BCG (I + M) arm (hazard ratio [HR]: 0.81; 95% CI: 0.54–1.19). In both arms, median OS was not reached. At a data cutoff date of April 3, 2025 for the PRO analyses, adherence rates for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and EORTC QLQ-NMIBC24 were ≥74% and ≥79%, respectively; both arms showed similar baseline scores. Adjusted mean change from baseline EORTC QLQ-C30 scores deteriorated in both arms, and the durvalumab plus BCG (I + M) arm experienced clinically meaningful deterioration in fatigue, though the estimated difference of means between arms was small (4.0; 95% CI: 1.50–6.46). Adjusted mean change from baseline in EORTC QLQ-NMIBC24 scores were small and comparable between arms. PRO-Common Terminology Criteria for Adverse Events measures were also similar.
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Decision-making and regret after radical cystectomy in patients with bladder cancer: an international cross-sectional survey. Researchers surveyed patients with high-risk NMIBC or MIBC who underwent radical cystectomy (RC) ≥6 months ago to characterize decision-making, level of regret, and current impact of RC. A total of 222 patients with a mean age of 50 years were included. Most patients (70%) were male, and 23% had metastatic disease at the time of data collection. Mean time from RC was 2.3 years. Patients reported collaborative relationships with healthcare providers (HCPs), with 84% reporting that they were “very” or “somewhat” satisfied with the information provided for decision-making. The majority of patients (93%) reported receiving information on alternative treatments prior to RC, but 55% and 35% reported that they did not receive information on radiation therapy and systemic chemotherapy, respectively. After RC, 90% of patients reported some regret, and 36% reported moderate/severe regret. Impact on physical/mental health, quality of life, and issues with urinary diversion were common reasons for regret. Furthermore, bothersome current symptoms or functional impacts were reported by 93% of patients; impact on sex drive and pleasure, energy level, sleep quality, and ability to travel and do daily activities, among others, were reported by >50% of patients. Compared to patients with mild regret, those with moderate/severe regret reported significantly more impact to their daily lives. Most patients (95%) depended on caregivers for support, 48% had not returned to their usual health before diagnosis, and 41% had not returned to daily activities.
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The ratio of levels of insulin signaling system factors and diabetes markers in the blood of patients with non-muscle-invasive bladder cancer in the absence and presence of type 2 diabetes mellitus. In this study, researchers evaluated the levels of blood levels of insulin signaling system (ISS) factors and markers of diabetes in patients with NMIBC with and without type 2 diabetes mellitus (T2DM). Twenty patients with primary NMIBC, 20 with NMIBC and comorbid T2DM, and 12 with T2DM as well as 10 healthy donors were included for analysis. Among patients with primary NMIBC, blood levels of ISS factors were highly variable, with a coefficient of variation up to 273%. These patients showed normal insulin levels but C-peptide levels that ranged from 3.6- to 21-fold lower than the minimum donor value; additionally, an average 3.5-fold increase in insulin-like growth factor-binding protein 1 (IGFBP-1) was observed. These differences from minimum donor value were 2- to 6-times less pronounced among patients with NMIBC and T2DM. Patients with both NMIBC and T2DM exhibited levels of insulin-like growth factor 1 (IGF-1) and IGF-2 similar to donor values, whereas patients with NMIBC only or T2DM only had higher levels. IGF-1 levels were lowest among patients receiving effective metformin therapy for T2DM. In the NMIBC and comorbid T2DM group, there was a strong negative correlation between C-peptide and glucose levels (r=–0.845). Among metformin-treated patients with NMIBC and T2DM, IGF-1 and glucose levels were strongly, positively correlated (r=0.803). These findings highlight the variability of blood levels of ISS factors in NMIBC. Low IGF-1 expression and the correlation between IGF-1 and glucose levels among metformin-treated patients suggests a potential antitumor mechanism mediated through IGF-1 suppression.
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Rethinking the role of tumor size in bladder preservation: comparing survival outcomes of radical cystectomy (RC) and tri-modality therapy (TMT). Here, researchers assessed outcomes following trimodality therapy (TMT; maximal transurethral resection of bladder tumor followed by chemoradiation therapy) in patients with bladder cancer, and compared outcomes between RC and TMT based on tumor size. Data from the National Cancer Database spanning 2010 to 2022 were utilized. A total of 33,836 patients with T1 to T4, N0 to N3, M0 urothelial carcinoma of the bladder were included for analysis; 34% of patients received RC alone, 23% received neoadjuvant chemotherapy (NAC) plus RC, 22% received TMT, and 21% received RC and adjuvant chemotherapy. Factors independently associated with poor OS included tumor size >6 cm (vs 3cm; HR: 1.70; 95% CI: 1.62–1.77; P<0.001) and lymphovascular invasion (HR: 1.94; 95% CI: 1.87–2.00; P<0.001). NAC plus RC conferred the greatest OS benefit (HR: 0.67; 95% CI: 0.64–0.70; P=0.001), followed by RC plus adjuvant chemotherapy (HR: 0.72; 95% CI: 0.69–0.75; P=0.001). Compared to TMT, RC showed significantly superior OS in tumors <3 cm (HR: 1.27; 95% CI: 1.16–1.39; P=0.001) and 3 to 6 cm (HR: 1.08; 95% CI: 1.03–1.14; P=0.003), according to multivariate analysis. OS did not significantly differ between RC and TMT for tumors >6 cm (HR: 0.97; 95% CI: 0.88–1.06; P=0.468).
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Prognostic value of post-operative circulating tumor DNA (ctDNA) in real-world treatment and outcomes among patients (pts) with muscle invasive (MIBC) and locally advanced (LA) bladder cancer (BC). In this retrospective study, researchers assessed the prognostic utility of postoperative circulating tumor deoxyribonucleic acid (ctDNA) in MIBC and locally advanced bladder cancer (LABC). Patients in the Flatiron Health Research Database who were diagnosed on or after January 2015 (data cutoff: August 31, 2025) who underwent surgery and ctDNA testing were eligible for inclusion. Among 388 patients, median age at diagnosis was 70 years. Sixty-three percent of patients received neoadjuvant therapy and 49% received adjuvant therapy. Postsurgery residual disease was detected in 11% of patients. Ninety-seven patients had evaluable ctDNA results, with ctDNA positivity observed in 40 patients (10.3%) and ctDNA negativity observed in 57 (14.7%). Adjuvant therapy was administered to 43% of ctDNA-positive (ctDNA+) patients and 35% of ctDNA-negative (ctDNA–) patients. The ctDNA– group showed longer 12-month real-world OS (96.5%; 95% CI: 91.8–100.0%) and DFS (72.7%; 95% CI: 61.2–86.4%) compared to the ctDNA+ group (OS: 69.4% [95% CI: 53.8–89.6%]; DFS: 34.4% [95% CI: 20.8–56.8%]). Patients who achieved pathologic complete response (pCR) experienced favorable real-world survival outcomes. Among those without pCR, patients with ctDNA positivity had significantly shorter real-world OS (43.2% vs 100.0%; P<0.01) and DFS, (9.9% vs 64.2%; P=0.014) compared to patients with ctDNA negativity.
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