Bladder Cancer
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Jul 20 – Jul 27, 2026
Enfortumab Vedotin and Pembrolizumab in Cisplatin-Eligible Bladder Cancer.
NEW ENGL J MED · Q1 JOURNAL - RANK #2/332TOP-TIER
This phase 3 trial compared perioperative enfortumab vedotin-pembrolizumab (EV-P) versus neoadjuvant cisplatin-gemcitabine in 808 cisplatin-eligible muscle-invasive bladder cancer patients. At 33.6 months median follow-up, 2-year event-free survival was 79.4% with EV-P versus 66.2% with chemotherapy (HR 0.53; p<0.001), and overall survival was 86.9% versus 81.3% (HR 0.65; p=0.006). Pathological complete response rates were 55.8% versus 32.5% (p<0.001), though grade ≥3 adverse events were higher with EV-P (75.7% vs 67.2%). For bladder cancer practice, EV-P offers a chemotherapy-free perioperative alternative with superior efficacy, though the toxicity profile requires consideration in shared decision-making.
10.1056/NEJMoa2601486
Jul 13 – Jul 20, 2026
Single, early intravesical instillation of pirarubicin in the prevention of bladder recurrence after radical nephroureterectomy for upper tract urothelial carcinoma (JCOG1403): a multicentre, open-label, randomised, phase 3 trial.
LANCET ONCOL · Q1 JOURNAL - RANK #8/326TOP-TIER
This phase 3 randomized trial (JCOG1403) evaluated the efficacy of a single intravesical instillation of pirarubicin versus observation in preventing bladder recurrence for 304 patients following radical nephroureterectomy for upper tract urothelial carcinoma. Results demonstrated a significant improvement in 3-year relapse-free survival, which was 60.0% in the pirarubicin group compared to 47.0% in the observation group (HR 0.67; p=0.0066). The intervention directly addresses the high risk of metachronous bladder cancer, showing manageable toxicity with only 3% of patients experiencing grade 3-4 hematuria. These findings establish early postoperative pirarubicin instillation as an effective evidence-based strategy to reduce oncological recurrence in this patient population.
10.1016/S1470-2045(26)00130-0
Jun 01 – Jun 08, 2026
Neoadjuvant Sacituzumab Govitecan in Patients With Muscle-Invasive Bladder Cancer: Primary Results of the SURE-01 Trial.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
The phase II SURE-01 trial investigated neoadjuvant sacituzumab govitecan (SG) followed by radical cystectomy in 44 patients with muscle-invasive bladder cancer (MIBC) ineligible for or refusing standard chemotherapy. The study reported an overall ypT0N0-x rate of 29.5% (95% CI, 16.7 to 45.2), with enrichment in nonluminal subtypes (46% vs 14% in luminal), and a 24-month event-free survival rate of 71.4% (95% CI, 58 to 87.8). SG, at a reduced dose of 7.5 mg/kg, demonstrated activity and a manageable safety profile, corroborating TROP2 as a suitable target for MIBC treatment. This offers a promising neoadjuvant option for MIBC patients who cannot receive standard chemotherapy, potentially improving outcomes in a high-risk population.
10.1200/JCO-26-00142
May 25 – Jun 01, 2026
Addition of Intravesical Recombinant BCG to Perioperative Chemo-Immunotherapy in Muscle-Invasive Bladder Cancer: Primary Analysis of the Single-Arm Phase 2 Trial SAKK 06/19.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This single-arm phase II trial (SAKK 06/19) investigated neoadjuvant intravesical recombinant BCG (rBCG) combined with chemo-immunotherapy (atezolizumab, cisplatin/gemcitabine) in 47 patients with cT2-T4a N0-1 muscle-invasive bladder cancer (MIBC) prior to radical cystectomy. The primary endpoint, centrally reviewed pathological complete response (pCR), was 68% (27/40), with a pathological overall response (PaR) of 83% (33/40). These high response rates are clinically significant for MIBC, a cancer with substantial morbidity, suggesting a promising new neoadjuvant strategy. The findings warrant further investigation in prospective randomized trials to potentially improve outcomes for MIBC patients.
10.1200/JCO-26-00845
Neoadjuvant Durvalumab ± Tremelimumab in Combination With Dose-Dense Methotrexate, Vinblastine, Doxorubicin, and Cisplatin in Muscle-Invasive Bladder Carcinoma: Results of the Phase I/II NEMIO Study.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This phase I/II NEMIO study evaluated the efficacy and safety of neoadjuvant ddMVAC combined with durvalumab ± tremelimumab in 119 patients with muscle-invasive bladder cancer (MIBC) undergoing radical cystectomy. Key findings showed overall Bayesian posterior mean pathologic complete response (pCR) rates of 48.70% with doublet and 46.27% with triplet therapy, with PD-L1-high tumors achieving 68.25% pCR. Grade ≥3 treatment-related adverse events occurred in 40.95% overall (30.48% doublet; 49.63% triplet), while 2-year event-free and overall survival rates were encouraging. These results suggest neoadjuvant ddMVAC plus durvalumab is a promising chemoimmunotherapy strategy for localized MIBC, warranting further comparative trials, noting that adding tremelimumab increased toxicity without improving pCR.
10.1200/JCO-25-03045
May 18 – May 25, 2026
Bladder Adjuvant Radiotherapy: Phase III Multicenter Randomized Controlled Trial of Adjuvant Radiotherapy or Observation for Postcystectomy Muscle-Invasive Bladder Cancer.
J CLIN ONCOL · Q1 JOURNAL - RANK #6/326TOP-TIER
This multicenter, phase III randomized trial investigated adjuvant radiotherapy (RT) versus observation after radical cystectomy and chemotherapy in 153 high-risk muscle-invasive bladder cancer (MIBC) patients. After a median 47-month follow-up, adjuvant RT significantly improved 2-year locoregional recurrence-free survival (87.1% vs 76.0%, HR 0.43, p=.04). Trends for improved disease-free, bladder cancer-specific, and overall survival were also observed without additional severe toxicity. These findings suggest adjuvant pelvic IMRT can enhance locoregional control in high-risk MIBC, offering a crucial strategy to reduce recurrence in clinical practice.
10.1200/JCO-25-02093