An accurate prediction of progression is critically important in the management of non‐muscle‐invasive bladder cancer. At present, three risk models are widely known for prediction of the risk of tumor recurrence and progression of non‐muscle‐invasive bladder cancer: the European Organization for Research and Treatment of Cancer, Club Urológico Español de Tratamiento Oncológico, and new European Organization for Research and Treatment of Cancer models. Bladder neck involvement has been shown to be one of the significant predictors for progression in non‐muscle‐invasive bladder cancer, and a new scoring model (Tokyo Medical and Dental University model) consisting of bladder neck involvement, tumor grade, and stage has been developed and externally validated. However, the predictive abilities of these models are still unsatisfactory, and more precise models are necessary for accurate individual prediction of prognosis. Until now, time‐fixed analysis has been used for most studies predicting the prognosis and outcome of non‐muscle‐invasive bladder cancer patients. In order to predict progression more precisely, time‐dependent models should be developed using multiple‐event analytical techniques, as non‐muscle‐invasive bladder cancer often progresses to muscle‐invasive bladder cancer after multiple recurrences and changes in tumor characteristics over a long natural history. Integration of molecular markers is also a promising approach. A validated model that accurately predicts the risk of progression would help urologists and patients decide whether and when to choose radical cystectomy on an individual basis.

Nivolumab plus ipilimumab (NIVO+IPI) demonstrated superior efficacy over sunitinib (SUN) for previously untreated advanced renal cell carcinoma (aRCC) in CheckMate 214, with a manageable safety profile. We report efficacy and safety with extended follow-up amongst Japanese patients. CheckMate 214 patients received NIVO (3 mg/kg) plus IPI (1 mg/kg) every 3 weeks for four doses, then NIVO (3 mg/kg) every 2 weeks; or SUN (50 mg) once daily for 4 weeks (6-week cycle). This subgroup analysis assessed overall survival (OS), objective response rate (ORR) and progression-free survival (PFS) per investigator in International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) intermediate/poor-risk and intent-to-treat (ITT) patients and safety (ITT patients). Of 550 and 546 patients randomized to NIVO+IPI and SUN, 38 and 34, respectively, were Japanese. Of these, 31 (NIVO+IPI) and 29 (SUN) patients were IMDC intermediate/poor-risk. In IMDC intermediate/poor-risk patients with 30 months’ minimum follow-up, there was a delayed trend in OS benefit with NIVO+IPI (hazard ratio [HR] 0.56; 95% confidence interval [CI]: 0.19–1.59; P = 0.2670), and 24-month OS probability favoured NIVO+IPI (84%) versus SUN (76%). The ORR was 39% with NIVO+IPI and 31% with SUN (P = 0.6968). PFS was similar in both treatment arms (HR 1.17; 95% CI: 0.62–2.20; P = 0.6220). Efficacy in ITT patients was similar to IMDC intermediate/poor-risk patients. Grade 3–4 treatment-related adverse event incidence was lower with NIVO+IPI versus SUN (58 versus 91%). Japanese patients with untreated aRCC in the NIVO+IPI arm had a numerically higher ORR and improved safety profile versus patients in the SUN arm. A delayed OS benefit appears to be emerging with NIVO+IPI. Longer follow-up is needed. https://clinicaltrials.gov/ct2/show/NCT02231749?term=NCT02231749&rank=1 identifier: NCT02231749.