OBJECTIVES: Bladder cancer (BC) ranks among the most common cancers, with more than 570,000 incident cases worldwide in 2020. About two-thirds of cases present with non-muscle-invasive BC (NMIBC). Over 10 years, up to 75% and 33% of patients with NMIBC recur and progress, respectively, indicating a substantial unmet need.

METHODS: We reviewed the literature on epidemiology, the clinical, economic, and humanistic burden, and unmet need in NMIBC. Searches were implemented in PubMed, Embase, and Cochrane Library in January 2022.

RESULTS: The highest incidence rates for BC and, by extension, NMIBC are observed in Western and Southern Europe, the highest mortality rates in North Africa and Eastern Europe. Key risk factors include smoking, female sex, and older age – population ageing will likely contribute to an increase in cancer cases. Following diagnosis and treatment of NMIBC, patient quality of life (QoL) is generally reduced, especially due to disease itself and treatment effects on sexual functioning. Results including long-term treatment effects on QoL, however, remain conflicting. The evidence on the economic burden of NMIBC is more robust, with surveillance, recurrence and progression as key cost drivers. With intravesical Bacillus Calmette-Guérin (BCG), an effective, guideline-recommended treatment for intermediate- and high-risk NMIBC has been available for decades. In clinical practice, however, BCG use frequently deviates from guideline recommendations. In particular, maintenance treatment, if given at all, is often administered using non-optimal schedules. Treatment outcomes are further impaired by non-adherence, which may reach 30–40% over 1–3 years even in clinical trials, compounded further by a global shortage of BCG.

CONCLUSIONS: Despite the availability of effective therapies, NMIBC treatment is too often not guideline-compliant, leading to suboptimal outcomes. Recent efforts to standardize treatment, e.g., introducing the notion of adequate BCG, should be accompanied by improvements in guideline and treatment adherence among physicians and patients, respectively.