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Introduction: Real-world data reflects treatments and outcomes in clinical practice in contrast with controlled clinical trials. This study evaluates real-life multiple myeloma (MM) patients receiving proteasome inhibitor (PI)-based treatments in the second or third therapy line in 2017 in Germany. Methods: This is a retrospective chart review on adult relapsed/refractory MM patients treated with ≥1 dose of a PI-based regimen in either the second or the third line of therapy. Participating physicians had ≥3 years of clinical experience in treating symptomatic MM patients and used PI according to the label. Results: Distinct patient profiles for each PI-based regimen emerged. Younger, fitter, transplant-eligible patients received novel PI triplets such as carfilzomib in combination with lenalidomide and dexamethasone (KRd) or IRd. Patients receiving lenalidomide in first-line therapy mostly received lenalidomide-free regimens in second-line therapy. In high-risk patients, no clear treatment patterns could be ascertained. The complete response rates were highest with KRd (13.0%), followed by carfilzomib in combination with dexamethasone (Kd) (5.7%) and bortezomib (4.8%). The very good partial response rates were highest with IRd (76.9%), followed by KRd (53.7%), Kd (25.7%), and bortezomib (20.5%). None of the KRd- or IRd-treated patients responded below a partial response. Discussion/Conclusion: Clear patient profiles for each PI type were observed. In second-line therapy, younger, fitter, transplant-eligible patients received novel-PI-based triplets, e.g., KRd or IRd. Patients treated with lenalidomide in first-line therapy mostly received lenalidomide-sparing regimens in second-line therapy. In high-risk patients no clear treatment patterns could be ascertained due to the limited sample size. [ABSTRACT FROM AUTHOR]

Background: There is limited data on the real-life situation and outcomes of patients with metastatic triple-negative breast cancer (mTNBC) in Germany. The aim of this chart review was to describe the current treatment patterns, resource use and outcomes in this patient group. Methods: Retrospective data collection in 30 gyneco-oncological sites (hospitals and office-based) across Germany between January and April 2017. Index date was defined as initiation of treatment with gemcitabine, vinorelbin, capecitabine or eribulin therapy following discontinuation of taxane and/or anthracycline therapy. Results: In the 91 evaluable patients, median time between primary diagnosis and index date was 20.9 months (range 0-187 months). Ten percent of patients had no distant metastases, while 57% had newly diagnosed metastases. Cancer stage at index date was mostly IV (82 patients). A number of 135 different regimens (monotherapy or combination therapy) were used. For first-line chemo treatment, 29 patients received monotherapy and 54 patients combination therapy. Bevacizumab and paclitaxel were also the most frequently used single substances among all therapy lines together and for first-line therapy. While taxanes were at least occasionally administered for second-line therapy, no patient received taxanes for third-line therapy. Chemotherapy modifications in terms of dose reduction or treatment interruption were rare. However, the therapy was terminated in more than two thirds of all cases. Fifty-nine patients were hospitalized at least once. For first-, second- and third-line therapy, median overall survival was 19.1/10.8/14.6 months, and median progression-free survival was 7.7/2.5/5.6 months. Conclusion: In clinical routine, a wide variety of treatment approaches is applied, while outcomes in terms of survival are poor. New treatment options are needed for this challenging tumor type. [ABSTRACT FROM AUTHOR]

Background: A substantial share of type 2 diabetes mellitus (T2DM) patients receive insulin. However, little is known about the real-world treatment patterns around insulin initiation. Methods: This was a retrospective claims data analysis. T2DM patients who initiated an insulin therapy between 01/01/2013 and 31/12/2015 were identified in the German AOK PLUS dataset. For validation of results, additional data on a similar T2DM patient population were collected in a Germany-wide medical chart review. Results: A total of 284,878 T2DM patients were identified. Of these, 27,340 (9.6%) initiated an insulin treatment during the inclusion period (mean age: 72.2 years; 51.4% female). Mean/median weight and BMI of patients with available clinical data was 85.8/84.0 kg (SD:18.9) and 30.6/29.8 kg/m2, (SD:6.1), respectively at baseline. Mean/median HbA1c-value at baseline was 8.4/8.0% (SD: 1.8). Most commonly prescribed antidiabetic drugs (AD) within 6 months before insulin initiation were metformin (MET; 54.0%), DPP-4 inhibitors (DPP-4i; 37.6%), and sulfonylureas (SU; 29.5%). As high as 23.2% of the patients did not receive any AD prescription within 6 months before insulin initiation. A total of 10,953 of above 27,340 insulin starters (40.1%) initiated their insulin therapy without concomitant ADs (insulin monotherapy); 43% of these patients did not receive any AD before insulin initiation. Of the remaining 16,387 patients (59.9%), 4070 patients (14.9%) received MET only as concomitant AD, 6385 (23.4%) received MET plus at least one further AD, and 5932 (21.7%) received at least one further AD excluding MET. Throughout the first year of treatment, prescribed insulin dosage increased over time, resulting in approximately 43.3–77.9 IUs per observed patient day after 12 months of insulin treatment. Conclusions: Characteristics of German T2DM patients initiating insulin deviate substantially from the average German population, especially in terms of weight. We identified an unexpectedly high number of patients without previous AD therapy receiving insulin monotherapy, which is not in line with the clinical guidelines. [ABSTRACT FROM AUTHOR]

Objective: To assess incidence of urinary tract infection (UTI) among patients with recent spinal cord injury (SCI) who initiated intermittent catheterization (IC). Design: Retrospective chart review. Setting: Two European SCI rehabilitation centers. Participants: Seventy-three consecutive patients with recent SCI who initiated IC. Outcome measures: Incidence of UTI, using six different definitions, each based on microbiology ± symptomatology ± mention of UTI . Rates were expressed in terms of numbers of UTIs per 100 patient-months (PMs). Attention was focused on first-noted UTI during the three-month follow-up, as assessed with each of the six definitions. Results: Fifty-eight percent of patients ( n  = 33) met ≥1 definitions for UTI during follow-up (rate: 31.5 UTIs per 100 PMs), ranging from 14% (5.3 per 100 PMs; definition requiring bacteriuria, pyuria, and presence of symptoms) to 45% (22.7 per 100 PMs; definition requiring "mention of UTI"). Ten cases were identified using the definition that required bacteriuria, pyuria, and symptoms, whereas definitions that required bacteriuria and either pyuria or symptoms resulted in the identification of 20-25 cases. Median time to UTI ranged from 42 days ("mention of UTI") to 81 days (definition requiring bacteriuria and ≥100 leukocytes/mm 3 ). Conclusion: Depending on definition, 14% to 45% of patients with recent SCI experience UTI within three months of initiating IC. Definitions requiring bacteriuria and either pyuria or symptoms consistently identified about twice as many cases as those that required all three conditions. Standardizing definitions may help improve detection, treatment, and prevention of UTI within this vulnerable population.

Objective: To describe treatment patterns and resource utilisation in France, Germany, Spain and the United Kingdom (UK) in patients with unresectable locally advanced and/or metastatic gastro-oesophageal adenocarcinoma (GEA), who failed first-line fluoropyrimidine/platinum treatment., Methods: Treating physicians completed a web-based chart review (2013-2015). Eligible patients were ≥ 18 years old; had unresectable locally advanced and/or metastatic gastric adenocarcinoma including the gastro-oesophageal junction; received first-line fluoropyrimidine/platinum-based therapy; and had ≥ 3 months of follow-up after first-line discontinuation. Data were summarised descriptively for each country., Results: There were n = 201 patients in France, n = 202 in Germany, n = 208 in Spain and n = 200 in the UK whose charts were reviewed. Percentages of patients receiving second-line therapy were 55% (France), 48% (Germany), 54% (Spain) and 29% (UK). At the start of second-line therapy, most patients had an ECOG performance status of 1 (range 0-3). Second-line therapy was primarily monotherapy, but agents used varied within and across countries. Supportive care use and resource utilisation were frequent whether receiving additional therapy or not; >60% patients had clinic visits unrelated to chemotherapy administration, and > 30% has ≥ 1 hospital admission., Conclusions: For the time of study, established GEA treatment guidelines were generally followed. However, therapies varied widely in the second-line setting., (© 2019 John Wiley & Sons Ltd.)