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Objective: To evaluate the efficacy and safety of gemcitabine and cisplatin in combination with sorafenib, a tyrosine-kinase inhibitor, compared with chemotherapy alone as first-line treatment in advanced urothelial cancer., Patients and Methods: The study was a randomized phase II trial. Its primary aim was to show an improvement in progression-free survival (PFS) of 4.5 months by adding sorafenib to conventional chemotherapy. Secondary objectives were objective response rate (ORR), overall survival (OS) and toxicity. The patients included in the trial had histologically confirmed locally advanced and/or metastatic urothelial cancer of the bladder or upper urinary tract. Chemotherapy with gemcitabine (1250 mg/qm on days 1 and 8) and cisplatin (70 mg/qm on day 1) repeated every 21 days, was administered to all patients in a double-blind randomization of additional sorafenib (400 mg twice daily) vs placebo (two tablets twice daily) on days 3-21. Treatment continued until progression or unacceptable toxicity, the maximum number of cycles was limited to eight. The response assessment was repeated after every two cycles., Results: Between October 2006 and October 2010, 98 of 132 planned patients were recruited. Nine patients were ineligible. The final analysis included 40 patients in the sorafenib and 49 patients in the placebo arm. There were no significant differences between the two arms concerning ORR (sorafenib: complete response [CR] 12.5%, partial response [PR] 40%; placebo: CR 12%, PR 35%), median PFS (sorafenib: 6.3 months, placebo: 6.1 months) or OS (sorafenib: 11.3 months, placebo: 10.6 months). Toxicity was moderately higher in the sorafenib arm. Diarrrhoea occurred significantly more often in the sorafenib arm and hand-foot syndrome occurred only in the sorafenib arm. The study was closed prematurely because of slow recruitment., Conclusion: Although the addition of sorafenib to standard chemotherapy showed acceptable toxicity, the trial failed to show a 4.5 months improvement in PFS., (© 2013 The Authors. BJU International © 2013 BJU International.)

With more than 85,000 newly diagnosed cancers per year, uro-oncology alone represents a significant part in the field of oncology in Germany. Therefore, the Task Group for Uro-Oncology (The Association of Urogenital Oncology, AUO) of the German Cancer Association (DKG) was founded in 1989 to enforce high quality in research on urological cancer. The main aim has been to improve the quality of clinical cancer studies. The board of the AUO reviews, certifies and gives accreditation to study protocols with respect to GCP standards, likelihood of realisation and scientific impact of the study objectives. To support enrolment of patients, the AUO initiated a study group of more than 85 clinical centers of excellence and publishes timely details on the different studies in the appropriate media. Moreover, the members of the AUO board organize seminars, scientific meetings and pharmaceutical hearings. In this article, the organisation's structure is described in detail. Various aspects of AUO work, carried out over the years, are highlighted, and data presented on the outcome of studies.