There are currently five programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) inhibitors approved for the treatment of locally advanced or metastatic urothelial carcinoma (UC) of the bladder. For platinum-ineligible patients, testing of tumor specimens for PD-L1 expression is required. However, scoring of PD-L1 immunohistochemistry is complex due to different antibodies used, the requirement to score expression in different cellular compartments and intratumoral heterogeneity. It can also be difficult to obtain and test longitudinal tumor samples, which would be desirable to monitor treatment responses and tumor evolution under treatment-induced selective pressure. In the present proof-of concept study, we provide evidence that PD-L1 can be detected in the urine of patients with non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC). Urine PD-L1 levels were significantly higher in NMIBC and MIBC patients when compared to patients with various non-malignant urological diseases. Further prospective and independent studies are required to assess the value of PD-L1 in the urine as a novel biomarker with potential for the early detection, prediction and therapeutic monitoring of patients with UC of the bladder.
Purpose Focal therapy (FT) offers an alternative approach for prostate cancer (PCa) treatment in selected patients. However, little is known on its actual establishment in health care reality. Patients and methods We defined FT as high-intensity focused ultrasound (HIFU), hyperthermia ablation, cryotherapy, transurethral ultrasound ablation (TULSA) or vascular-targeted photodynamic therapy (VTP) TOOKAD®. We analyzed the nationwide German hospital billing database for a PCa diagnosis in combination with FT. For analyses on the hospital level, we used the reimbursement.INFO tool based on hospitals’ quality reports. The study period was 2006 to 2019. Results We identified 23,677 cases of FT from 2006 to 2019. Considering all PCa cases with surgery, radiotherapy or FT, the share of FT was stable at 4%. The annual caseload of FT increased to a maximum of 2653 cases in 2008 (p < 0.001) and then decreased to 1182 cases in 2014 (p < 0.001). Since 2015, the cases of FT remained on a plateau around 1400 cases per year. The share of HIFU was stable at 92–96% from 2006 to 2017 and decreased thereafter to 75% in 2019 (p = 0.015). In 2019, VTP-TOOKAD® increased to 11.5% and TULSA to 6%. In 2006, 21% (62/299) of urological departments performed FT and 20 departments reached > 20 FT procedures. In 2019, 16% (58/368) of urological departments performed FT and 7 departments reached > 20 FT. In 2019, 25 urological departments offered FT other than HIFU: 5 centers hyperthermia ablation, 11 centers VTP TOOKAD®, 3 centers cryotherapy, 6 centers TULSA. Conclusion The FT development in Germany followed the Gartner hype cycle. While HIFU treatment is the most commonly performed FT, the share of newer FT modalities such as VTP-TOOKAD® and TULSA is remarkably increasing.
Purpose To describe the change in upper urinary tract stone management in Germany over a 14-year period. Methods Using remote data processing we analyzed the nationwide German billing data from 2006 to 2019. To analyze the clinics’ case numbers and regional trends, we used the reimbursement.INFO tool based on standardized quality reports of all German hospitals. To also cover shock wave lithotripsy (SWL) as an outpatient procedure, we analyzed the research database of the Institute for Applied Health Research with a representative anonymous sample of 4 million insured persons. Results The number of inpatient interventional therapies for upper tract urolithiasis in Germany increased from 70,099 cases in 2006 to 94,815 cases in 2019 (trend p < 0.0001). In-hospital SWL declined from 41,687 cases in 2006 to 10,724 cases in 2019 (decline of 74%; trend p < 0.0001). The percentage of SWL as an outpatient procedure increased between 2013 and 2018 from 36 to 46% of all performed SWL, while total SWL case numbers declined. Contrarily, the number of ureteroscopies increased from 32,203 cases in 2006 to 78,125 cases in 2019 (increase of 143%; trend p < 0.0001). The number of percutaneous nephrolithotomy also increased from 1673 cases in 2006 to 8937 in 2019 (increase of 434%; trend p < 0.0001). Conclusion We observed an increase in interventional therapy for upper tract urolithiasis in Germany with a dramatic shift from SWL to endoscopic/percutaneous treatment. These changes may be attributed to enormous technological advances of the endoscopic armamentarium and to reimbursement issues.
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