Background: Worldwide, urothelial carcinoma (UC) is a common cause of morbidity and mortality. In particular, the incidence of bladder cancer varies widely across Europe; Germany has the ninth highest international age-standardized incidence. For advanced UC or metastatic UC (mUC), platinum-based combination chemotherapy is the standard first-line (1L) treatment; however, there is wide heterogeneity of second-line (2L) treatments, ranging from vinflunine in parts of Europe to taxanes and other agents elsewhere in Europe, in the United States and globally. Limited data exist on treatment patterns and outcomes in patients with advanced UC or mUC in the routine clinical setting in Germany. The objective of this study was to describe clinical characteristics, treatment patterns and subsequent outcomes in this setting.Methods: This retrospective observational cohort analysis evaluated 1L and 2L treatment patterns and overall survival (OS) in patients aged ≥18 years with advanced UC or mUC (T4b, N2-3 and/or M1) at office-based urology and academic as well as nonacademic urology clinics throughout Germany between 1 November 2009 and 2 June 2016. Data were obtained through the GermanOncology database and additional treatment centers using similar electronic case report forms.Results: Among the 435 patients included in the analysis, 435 received 1L treatment and 125 received 2L treatment. Median age at start of 1L treatment was 69 years, 75% of patients were male, 75% were current or ex-smokers, 15% had hemoglobin <10 g/dL and 44% had creatinine clearance<60 mL/min/1.73; proportions were similar with 2L treatment. Cardiovascular disease was the most frequently reported comorbidity (65%), followed by diabetes (19%). Most patients (77%) received 1L platinum-based combination treatment (most commonly gemcitabine + cisplatin, 83%). Of those treated with 2L treatment, 66% received a single agent (most commonly vinflunine, 71%). Median OS (95% CI) with 1L treatment was 16.1 months (13.7-19.2) overall and 17.7 months (14.4-24.2) with 1L cisplatin + gemcitabine. In the 1L setting, 12-month OS was 61%, 24-month OS was 39% and 36-month OS was 26%. Median (95% CI) OS with 2L treatment was 9.2 months (5.5-11.6) overall and 5.9 months (4.1-12.6) with 2L vinflunine. In the 2L setting, OS rates for the same time periods were 40%, 22% and 8%, respectively. Median (95% CI) progression-free survival was 7 months (6.4-8.1) and 4 months (3.0-4.8), respectively, in the 1L and 2L settings. Objective response rates were 34% in the 1L setting and 14% in the 2L setting. No difference in OS by sex or smoking status was noted. Patients with or without renal impairment had a 12-month OS of 54% or 69%, respectively. OS at 12 months was 63% among patients with an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1 vs 53% among patients with an ECOG PS of ≥2. Cox regression analysis found no difference in OS between vinflunine and other 2L treatments (P = 0.69).Conclusions: This study provides a contemporary multicenter assessment...
Purpose: To evaluate the clinical and economic burden of dry eye disease (DED) among affected patients in Germany. Methods: Adult patients (≥18 years) with ≥1 confirmed diagnosis of DED during the study period (2008)(2009)(2010)(2011)(2012)(2013)(2014)(2015) were identified from the medical claims of 3.6 million insured patients from Betriebskrankenkassen, a German statutory health insurance database. Prevalence (per 1000 patients) and incidence (per 1000 person-years at risk) were estimated, and demographic and clinical characteristics, treatment history (excluding over-the-counter tear supplements), healthcare resource use (HCRU) and costs were assessed. Results: In this population, the prevalence of DED increased from 20.24 in 2008 to 23.13 per 1000 patients in 2014. Overall incidence was 6.24 per 1000 personyears at risk (2008)(2009)(2010)(2011)(2012)(2013)(2014)(2015). Prevalence and incidence increased with age and were higher in women. Mean age at index was 63.4 years (incident cohort, n = 35 026). The most common ocular comorbidity was cataract (48.5%), and 36% of patients were dispensed a reimbursed DED-specific medication during the postindex periodmost commonly, corticosteroids alone (13.2%) or in combination with anti-infectives (21.8%). HCRU was high in patients with DED, mostly due to comorbidities. HCRU and associated costs were highest in patients ≥60 years. Total costs during the postindex period were higher in the DED cohort than among matched controls (€117 million versus €107 million; p < 0.001). Conclusion: This retrospective database analysis provides a better understanding of the epidemiology, clinical characteristics, real-world treatment patterns, HCRU and costs associated with DED in patients living in Germany.
checked if the regimens used in 2018 aligned with clinical guidelines and best clinical practices and conducted an expert review on the regimens' prescription rates. Results: Data set included 11,190 cases of antineoplastic pharmacotherapy both in inpatient hospitals and in day inpatient units. 3,327 cases (29.7%) carried no information on the regimen, in 940 cases (8.4%) prescribed regimens did not aligned with the clinical guidelines. The most frequently prescribed regimens are anti-PD-1 therapy (40.8% of cases), decarbazine alone (27.1%), interferon-alfa (9.6%). Expert estimation on best practice usage of the regimens are 47.8% for anti-PD-1, 0.5% for decarbazine alone, 33.1% for interferon-alfa. Conclusions: Preliminary results show rather low data encoding quality but we expect it to improve when hospitals get more experience with the new DRG system. Clinical specialists do not always take into account clinical guidelines or best clinical practices and might need more training. This can be made possible with the help of additional financial resources set aside to support the government cancer program.
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