[What do urologist do in daily practice? : A first "unfiltered" look at patient care]. / Was machen Urologen in der Praxis? : Ein erster "ungefilterter" Blick auf die Versorgung.

The topic of routine medical care data and healthcare science has gained in relevance and provides an important basis for both healthcare policymakers and those providing care. Access to relevant data and the ability to analyze these is highly competitive as it yields the most compelling arguments and strong facts in any discourse on the ultimately limited resources of the entire healthcare sector. All randomized clinical trials and prospective data collections harbor the inherent similarity that they contain data within a predefined frame of data elements in order to control for any confounding factors. In addition, analyses using retrospective data collections use a predefined evaluation matrix and filter the existing data according to these established data elements. However, an unfiltered and un(pre)specified view to all data would be ideal. An approximation to this goal as part of this project could be the unfiltered collection of as much data as possible and their collection in a data pool, which then could be processed, in a constantly improving analyses algorithm. The automated self-extraction of data from the private-practice information technology (IT) system to UROscience will create a data pool which could be used to answer many different questions related to the reality of healthcare. The preliminary analyses presented here demonstrate that, on basis of the existing data, this versatile sample is available to provide insight into the treatment reality of urologic outpatient care.

SWITCH: A Randomised, Sequential, Open-label Study to Evaluate the Efficacy and Safety of Sorafenib-sunitinib Versus Sunitinib-sorafenib in the Treatment of Metastatic Renal Cell Cancer.

BACKGROUND: Understanding how to sequence targeted therapies for metastatic renal cell carcinoma (mRCC) is important for maximisation of clinical benefit. OBJECTIVES: To prospectively evaluate sequential use of the multikinase inhibitors sorafenib followed by sunitinib (So-Su) versus sunitinib followed by sorafenib (Su-So) in patients with mRCC. DESIGN, SETTING, AND PARTICIPANTS: The multicentre, randomised, open-label, phase 3 SWITCH study assessed So-Su versus Su-So in patients with mRCC without prior systemic therapy, and stratified by Memorial Sloan Kettering Cancer Center risk score (favourable or intermediate). INTERVENTION: Patients were randomised to sorafenib 400mg twice daily followed, on progression or intolerable toxicity, by sunitinib 50mg once daily (4 wk on, 2 wk off) (So-Su), or vice versa (Su-So). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint was improvement in progression-free survival (PFS) with So-Su versus Su-So, assessed from randomisation to progression or death during second-line therapy. Secondary endpoints included overall survival (OS) and safety. RESULTS AND LIMITATIONS: In total, 365 patients were randomised (So-Su, n=182; Su-So, n=183). There was no significant difference in total PFS between So-Su and Su-So (median 12.5 vs 14.9 mo; hazard ratio [HR] 1.01; 90% confidence interval [CI] 0.81-1.27; p=0.5 for superiority). OS was similar for So-Su and Su-So (median 31.5 and 30.2 mo; HR 1.00, 90% CI 0.77-1.30; p=0.5 for superiority). More So-Su patients than Su-So patients reached protocol-defined second-line therapy (57% vs 42%). Overall, adverse event rates were generally similar between the treatment arms. The most frequent any-grade treatment-emergent first-line adverse events were diarrhoea (54%) and hand-foot skin reaction (39%) for sorafenib; and diarrhoea (40%) and fatigue (40%) for sunitinib. CONCLUSIONS: Total PFS was not superior with So-Su versus Su-So. These results demonstrate that sorafenib followed by sunitinib and vice versa provide similar clinical benefit in mRCC. PATIENT SUMMARY: We investigated if total progression-free survival (PFS) is improved in patients with advanced/metastatic kidney cancer who are treated with sorafenib and then with sunitinib (So-Su), compared with sunitinib and then sorafenib (Su-So). We found that total PFS was not improved with So-Su compared with Su-So, but both treatment options were similarly effective in patients with advanced/metastatic kidney cancer. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00732914, www.clinicaltrials.gov.

Environmental exposure, chlorinated drinking water, and bladder cancer.

Environmental and/or occupational factors have been proposed to play a critical role in urological malignancies and, in particular, in bladder cancer. Epidemiological studies have demonstrated with sufficient evidence that factors such as smoking and exposure to aromatic amines, paints and solvents, leather dust, inks, some metals, polycyclic aromatic hydrocarbons, combustion products, or diesel exhaust fumes are associated with the development of bladder cancer. Candidates with an uncertain potential for inducing this type of cancer include dietary factors, specifically fats and cholesterol, and the exposure to contaminants in drinking water. This chapter will describe and discuss the respective literature on environmental and occupational factors linked to carcinogenesis in bladder cancer. For several reasons, the potential effects of tea and coffee consumption will also be considered. A solid epidemiological evaluation of environmental and occupational factors linked to carcinogenesis has to meet many challenges: the number of confounding factors is often large, exposure needs to be determined retrospectively, and elevation of the attributable risk is low in most cases. In view of the long-term exposure of the vast majority of the population to, for instance, drinking- water contaminants, however, the impact of even small elevations of risk warrants evaluation. This complex task needs comprehensive approaches on a large scale including modern analytical, molecular biological and epidemiological methods.

Evaluation of an unconventional treatment modality with mistletoe lectin to prevent recurrence of superficial bladder cancer: a randomized phase II trial.

PURPOSE: The indication for topic chemotherapy or immunotherapy for well differentiated, noninvasive superficial bladder cancer remains controversial. Side effects of these treatments promoted use of unconventional therapies with cytokines, immunomodulators and mistletoe extracts. However, there are no controlled clinical data available on the efficacy of these extracts for bladder cancer. We evaluate the influence of subcutaneously applicated mistletoe lectin on bladder tumor recurrence after transurethral resection. MATERIALS AND METHODS: The study consists of 45 patients with pTa G1-2 bladder cancer treated with transurethral resection during a 3-year period. Median patient age was 65 years and 33 patients were male. The study cohort was randomly divided into a treatment group receiving adjuvant therapy with mistletoe lectin and a control group receiving no additional treatment. Patients in the treatment group received mistletoe lectin according to schedule 2 weeks after transurethral resection. Clinical followup was assessed 3, 6, 9, 12 and 18 months after the initial resection, and included uretherocystoscopy. RESULTS: Both study arms comprised similar patients with regard to total number of previous tumors (mean 2.6 versus 2.9), number of primary lesions (14 versus 12) and number of recurrent tumors (8 versus 11). After followup of 18 months the recurrence-free interval in both study arms was similar (p = 0.76) and the total number of recurrences comparable (p = 0.48). CONCLUSIONS: Subcutaneous use of mistletoe lectin as adjuvant treatment after transurethral resection does not seem to affect the time to first recurrence, total number of recurrences or recurrence-free outcome.