Insights into second-line (2L) systemic treatment (tx) receipt in patients (pts) with metastatic urothelial carcinoma (mUC): Results of a retrospective observational study in Germany

BackgroundContemporary, real-world data on eligible pts receiving systemic tx following progression on first-line (1L) mUC therapy are needed to inform tx algorithms and identify potential gaps in the mUC care pathway. The objective of this analysis was to determine the prevalence and predictors of 2L tx receipt in pts with mUC in Germany.MethodsThis study identified adults with incident mUC (ICD-10 C65-68 and C77-79) from Jan 2015 to Jun 2021, using data from 2 statutory health insurance claims databases (Jan 2013-Jun 2022; ≈8 million pts). Pts were observed for ≥12 mo post incident mUC diagnosis (index) or until death. Baseline (BL) characteristics were identified 24 mo before index, and multivariable logistic regression analyzed factors associated with receiving 2L tx.ResultsOf 4,290 pts with mUC who were identified, 1,779 (41.5%) received 1L tx (mean age, 69.1 y; male, 74.2%; mean Charlson Comorbidity Index [CCI] score, 5.6; mean follow-up [FU], 19.6 mo). Of these pts, 699 (39.3%) received 2L tx (mean age, 67.6 y; male, 75.3%; mean CCI score, 5.3; mean FU, 22.8 mo). The number of pts with incident mUC who received 2L tx increased over time (index year 2015: 78 pts [11.2%]; 2020: 132 pts [18.9%]). The most common 2L txs were immune checkpoint inhibitors (462 pts [66.1%]), followed by non–platinum-based chemotherapy (non-PBC) in 121 pts (17.3%), and PBC in 116 pts (16.6%). Younger pts and those without other primary malignancies at BL were more likely to receive 2L tx (Table).ConclusionsA high proportion of pts (60.7%) did not receive 2L tx. Pts who received 2L tx were generally younger and healthier with slightly lower CCI scores and fewer non-UC primary malignancies. Tx rates may be underestimated due to the potential for unaccounted txs from clinical trials. Further research is needed to clarify barriers to accessing 2L tx in this patient population. Table: 1995P Factors associated with receiving 2L tx in pts with mUC Variable Odds ratio (95% Cl) p value Age at index (continuous) 0.98 (0.97-0.99) <0.001 Diagnosis of non-UC primary malignant carcinomas (24-mo BL; binary) 0.81 (0.66-1.00) 0.028 Year of 1L tx initiation (reference year, 2015; categorical) 1.04 (0.99-1.10) 0.153 CCI (24-mo BL; continuous) 0.98 (0.95-1.01) 0.188 Female (binary) 0.87 (0.70-1.10) 0.203 Outpatient diagnosis setting (binary) 1.13 (0.92-1.37) 0.258 UC-related tx, surgeries, and interventions (24-mo BL; binary) 1.14 (0.90-1.45) 0.318 Multivariable logistic regression using 2L tx receipt as dependent variable. Editorial acknowledgementEditorial support was provided by Nucleus Global and was funded by Merck.Legal entity responsible for the studyMerck (CrossRef Funder ID: 10.13039/100009945), as part of a previous alliance between Merck and Pfizer.FundingThis study was sponsored by the healthcare business of Merck KGaA, Darmstadt, Germany (CrossRef Funder ID: 10.13039/100009945) and was previously conducted under an alliance between the healthcare business of Merck KGaA, Darmstadt, Germany and Pfizer.DisclosureG. Niegisch: Financial Interests, Personal, Invited Speaker: Roche, MEDAC, Pfizer, BMS, AstraZeneca, Astellas; Financial Interests, Personal, Advisory Board: Roche, Sanofi, BMS, Merck, Pfizer, Ipsen, Janssen; Financial Interests, Personal, Other, Travel, congress registrations: Roche, Pfizer, Merck. M. Kearney: Financial Interests, Personal, Full or part-time Employment: Merck ; Financial Interests, Personal, Stocks or ownership: Novartis, Merck, UCB. J. Krieger: Financial Interests, Personal, Full or part-time Employment: Cytel ; Financial Interests, Personal, Advisory Role: Merck. U. Osowski: Financial Interests, Personal, Full or part-time Employment: Merck Healthcare Germany GmbH, Weiterstadt, Germany, an affiliate of Merck KGaA; Financial Interests, Personal, Stocks/Shares: Merck. B. Deiters: Financial Interests, Personal, Full or part-time Employment: GWQ ServicePlus AG. U. Maywald: Financial Interests, Personal, Full or part-time Employment: AOK PLUS. T. Wilke: Financial Interests, Personal, Full or part-time Employment, Employment by IPAM, which received financial support from Cytel to conduct the claims data analyses: IPAM. M.J. Grimm: Financial Interests, Personal, Advisory Board: Astellas Pharma, AstraZeneca, Bayer/Vital, Bristol Myers Squibb, Eisai, Eusa Pharma, Gilead, Ipsen, MSD, Novartis, Pfizer, Roche Pharma AG, Takeda, Merck; Financial Interests, Personal, Other, travel, accommodations, and expenses: Bristol Myers Squibb, Merck; Financial Interests, Personal, Advisory Board, honoraria: Astellas Pharma, AstraZeneca, Bristol Myers Squibb, Eusa Pharma, Ipsen, MSD, Pfizer; Financial Interests, Personal, Research Funding: Bristol Myers Squibb, Intuitive Surgical.