Are data from general practices suitable for survival analyses in the field of breast cancer? A retrospective study conducted in the United Kingdom, France and Germany.

The aim of the present study was to investigate the suitability of data obtained from general practices in the UK, France, and Germany for survival analyses in the field of breast cancer (BC). This study included women diagnosed with BC between 2004 and 2008 in 416, 322 and 210 general practices in the UK (n=4,085), France (n=1,198) and Germany (n=2,934), respectively. The outcomes of the study were the mean duration of follow-up in years and the proportion of participants followed for at least 5 years. The mean duration of follow-up was 7.5-9.6 years in the UK, 7.4-8.8 years in France and 6.3-8.5 years in Germany. The proportion of patients followed for at least 5 years was 80-91% in the UK, 68-78% in France, and 55-76% in Germany. The data obtained in general practices in the UK appeared to be more suitable for survival analyses in the field of BC when compared with those obtained in France and Germany.

Patient characteristics and initiation of mineralocorticoid receptor antagonists in patients with chronic kidney disease in routine clinical practice in the US: a retrospective cohort study.

BACKGROUND: Steroidal mineralocorticoid receptor antagonists (MRAs) are recommended for the treatment of heart failure (HF) and resistant hypertension, both common comorbidities in patients with diabetes and chronic kidney disease (CKD). This study explored the clinical characteristics of, and steroidal MRA use in, patients with CKD with and without type 2 diabetes mellitus (T2D) and/or HF. METHODS: This retrospective cohort study used PharMetrics Plus US claims database data (October 2009-September 2014) to identify two patient populations aged ≥18 years with a first diagnosis of CKD or a first prescription for steroidal MRAs. Demographic characteristics, comorbidities, clinical events, medication use and healthcare costs were reported by population and stratified by diagnosis: CKD, CKD + T2D (DKD), CKD + HF and DKD + HF. The CKD population cohorts were further stratified by steroidal MRA treatment duration (no MRAs, < 6 and ≥ 6 months' treatment). RESULTS: The CKD and MRA populations comprised 229,004 patients and 5899 patients, respectively. Median age and the proportion of men were similar in the CKD and MRA populations across disease cohorts. Disease burden increased across the cohorts as comorbidity and clinical event incidences increased. Hypertension was reported in 70-92% of patients, irrespective of disease cohort or population. In the CKD population, MRA use was low but increased with disease burden: CKD, 1.2%; DKD, 1.8%; CKD + HF, 6.5%; and DKD + HF, 6.6%. Moreover, MRA users presented with higher rates of comorbidities and medication use, and higher healthcare costs than MRA non-users. Longer MRA treatment duration was associated with reduced polypharmacy, lower event rates and lower healthcare costs. In the MRA population, patients almost exclusively received spironolactone (≥ 96%; median dose across all groups 25 mg; one-year persistence, ≤ 43%); up to 16% of patients had end-stage renal disease at baseline despite steroidal MRAs being contraindicated. CONCLUSIONS: Steroidal MRA use was low across all cohorts, but increased with disease severity, driven particularly by HF. Steroidal MRAs were used in patients with advanced CKD, despite being contraindicated. The persistent morbidity and clinical event rates in CKD and DKD patients highlight the disease burden and the need for treatments that effectively target both cardio-vascular and kidney-related events.

A Real-World Data Study to Evaluate Treatment Patterns, Clinical Characteristics and Survival Outcomes for First- and Second-Line Treatment in Locally Advanced and Metastatic Urothelial Cancer Patients in Germany.

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 of real-world treatment patterns and outcomes among palliatively treated patients with UC in Germany. The findings were generally consistent with the poor treatment outcomes observed globally, underscoring the need for effective 1L and 2L treatment for advanced UC or mUC.

Evaluation of real-world treatment outcomes in patients with distant metastatic Merkel cell carcinoma following second-line chemotherapy in Europe.

BACKGROUND AND AIMS: Merkel cell carcinoma (MCC) is a rare, aggressive skin cancer; few treatments exist for patients with advanced disease. Once tumors metastasize to distant sites, patients generally receive chemotherapy, but response duration and progression-free survival (PFS) are typically short. Few studies have assessed the efficacy of second-line chemotherapy for metastatic MCC. Here, we studied outcomes in patients who received ≥ 2 lines of chemotherapy for metastatic MCC. MATERIALS AND METHODS: Patients in an MCC-specific registry diagnosed with stage IV MCC between November 1, 2004, and September 15, 2015, and treated with second-line or later chemotherapy were analyzed retrospectively. Patient records, including baseline characteristics, immunocompetent status, and responses to prior chemotherapy, were evaluated. Patients meeting eligibility criteria were followed through December 31, 2015. RESULTS: Of 29 patients with metastatic MCC and immunocompetent status who had received ≥ 2 lines of chemotherapy, 3 achieved a partial response, for an objective response rate (ORR) of 10.3% (95% CI, 2.2-27.4). In the overall population including patients with immunocompetent and immunocompromised status (n = 34), the ORR was 8.8% (95% CI, 1.9-23.7). The median duration of response was 1.9 months (range, 1.3-2.1 months; 95% CI, 1.3-2.1). In the immunocompetent population, median PFS and overall survival were 3.0 months (95% CI, 2.5-6.0) and 5.3 months (95% CI, 4.3-6.0), respectively. CONCLUSIONS: The low response rates and limited durability confirm previous reports of the ineffectiveness of second-line or later chemotherapy in patients with metastatic MCC and provide a benchmark for assessing clinical benefit of new treatments.