This study provides a contemporary real-world assessment of treatment patterns among USA patients with MIBC undergoing RC in the immunotherapy era. The introduction of perioperative immunotherapy, particularly following the FDA approval of adjuvant nivolumab in August 2021, has expanded management options for MIBC. However, in this study, use of adjuvant treatment remained limited, with only about 10% of all RC-treated patients and fewer than 20% of those at high risk of recurrence after RC receiving it.
Previous real-world studies have reported varying treatment patterns before the contemporary immunotherapy era, providing a benchmark for comparison with the outcomes observed in the present cohort. In a large real-world cohort of patients with MIBC undergoing RC between 2008 and mid-2023 derived from community oncology practice settings and predating widespread adjuvant ICI use, only 8 of 783 patients received adjuvant nivolumab, consistent with findings from the present cohort which also demonstrated limited use of adjuvant nivolumab following RC [17]. These results suggest that uptake of adjuvant nivolumab in routine clinical practice has been modest, reflecting the relatively recent approval of immunotherapy in this setting as well as potential barriers such as patient selection, postoperative recovery, and access to treatment. In a retrospective study based on the SEER Medicare database, 53.6% of patients underwent RC alone, comparable to the proportion observed in the present cohort (48.6%) [16]. In that study, cisplatin + gemcitabine and MVAC were the most used neoadjuvant regimens, mirroring the treatment patterns observed in this study’s population [16]. However, adjuvant nivolumab use could not be evaluated in the SEER-Medicare analysis because the data cutoff (2020) preceded the FDA approval of nivolumab in this setting [16]. Importantly, neither study specifically examined treatment patterns in the contemporary postadjuvant immunotherapy era. The current analysis therefore extends existing evidence by demonstrating that overall treatment distributions remain broadly consistent with historical patterns, while also capturing real-world uptake of adjuvant immunotherapy in routine practice. Patient demographics in the current study were consistent with these previous analyses, such as the proportion of male (81.9% male, 18.1% female in the present study versus 74.8% male, 25.2% female [16] and 78.8% male, 21.2% female [17]) and White patients (83.2% in the present study versus 86.1% [16] and 87.6% [17]). These similarities indicate that the patient cohort included in the present study is broadly representative of previously studied MIBC populations, supporting the generalizability of our findings.
Similar trends have been observed internationally [19, 20]. Following European Medicines Agency (EMA) approval in March 2022 [21], adjuvant nivolumab use was reported in 14% of RC-treated patients with MIBC in France and only 3.8% of RC-treated patients with MIBC in Germany [19, 20]. Together, these findings highlight a modest global uptake of adjuvant immunotherapy despite regulatory approvals and demonstrated disease-free survival benefit.
The pCR rate reported in this study (32.8%) was consistent with findings from previous studies, including a metaanalysis of 886 patients across 13 clinical trials, which reported a pCR rate of 28.6% [22]. This consistency supports the internal validity of our data and reflects real-world treatment effectiveness in community practice.
Strengths and LimitationsThe N‑Power Medicine® LHN® cohort represents patients managed predominantly in community‑based oncology practices, providing critical insight into real‑world treatment patterns within an evolving therapeutic landscape. Although some clinical variables, such as PD-L1 expression, were unavailable and the study is subject to the inherent limitations of data accuracy and completeness in electronic health records, the robust chart‑abstraction methods and quality‑control procedures used in the N‑Power Medicine® LHN® improved data validity and completeness, supporting research‑grade analytics and allowing for reliable treatment pattern analyses.
Nonetheless, because the dataset primarily includes community health systems across limited USA regions, findings may not be generalizable to populations that are not represented in the dataset, or to patients treated in academic centers. The relatively small sample size underscores the need for cautious interpretation of these results. Given the recency of the dataset, follow‑up was insufficient to allow robust assessment of clinical endpoint such as recurrence and overall survival. Consequently, these outcomes were not reported in the current analysis.
Overall, this study provides a contemporary overview of real-world treatment patterns in the USA among patients with MIBC, including those at high risk of disease recurrence post RC, thereby adding to the existing body of evidence.
Future ResearchFuture analyses in patients with MIBC are warranted to further inform immunotherapy uptake and effectiveness in the real-world setting. Additional clinical variables (for example, PD-L1 expression) should be reported in future studies, as these data may further clarify the relationship between PD-L1 status and treatment selection and identify patterns of use across subgroups. Finally, studies with larger patient populations and longer follow-up will enable evaluation of long-term clinical outcomes, such as disease-free survival and overall survival, in adjuvant immunotherapy subpopulations.
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