Bladder Cancer Single Postoperative Instillation of Gemcitabine in Patients with Non-muscle-invasive Transitional Cell Carcinoma of the Bladder: A Randomised, Double-blind, Placebo-controlled Phase III Multicentre Study Andreas Bo ¨hle a , Herbert Leyh b , Christian Frei b , Michael Ku ¨hn c , Reinhold Tschada d , Tobias Pottek e , Walter Wagner f , Helmut H. Knispel g , Wolfgang von Pokrzywnitzki h , Ferruh Zorlu i , Karin Helsberg j , Birgit Lu ¨bben j , Victoria Soldatenkova j , Clemens Stoffregen j , Hartwig Bu ¨ttner j, * on behalf of the S274 Study Group a Department of Urology, Helios Agnes Karll Hospital, Bad Schwartau, Germany (on behalf of the German AUO Trial Group) b Department of Urology, Klinikum Garmisch-Partenkirchen, Garmisch-Partenkirchen, Germany c Department of Urology, Johanniter Hospital, Stendal, Germany d Department of Urology, Diakonissenkrankenhaus Mannheim, Mannheim, Germany e Department of Urology, Klinikum Wedel, Wedel, Germany f Department of Urology, Bundeswehrkrankenhaus Hamburg, Hamburg, Germany g Department of Urology, St. Hedwig Hospital, Berlin, Germany h Department of Urology, Vivantes Klinikum am Urban, Berlin, Germany i SSK Tepecik Research and Education Hospital, Yenisehir Izmir, Turkey j Medical Department, Lilly Deutschland GmbH, Bad Homburg, Germany EUROPEAN UROLOGY 56 (2009) 495–503 available at www.sciencedirect.com journal homepage: www.europeanurology.com Article info Article history: Accepted June 9, 2009 Published online ahead of print on June 21, 2009 Keywords: Non-muscle-invasive bladder cancer Transurethral resection Gemcitabine Please visit www.eu-acme.org/ europeanurology to read and answer questions on-line. The EU-ACME credits will then be attributed automatically. Abstract Background: Recurrence prophylaxis with intravesical gemcitabine (GEM) was effective and safe in patients with non-muscle-invasive bladder cancer (NMIBC); efficacy as single-shot instillation remains to be proved. Objective: To compare the efficacy of a single GEM instillation versus placebo (PBO) immediately after transurethral resection (TUR) of tumour in patients with histologically confirmed NMIBC (pTa/pT1,G1–3). Design, setting, and participants: This was a double-blind, randomised, PBO- controlled study in patients with clinical evidence of primary or recurrent NMIBC (Ta/T1,G1–3). Of 355 patients randomised at 24 urologic centres, 328 underwent TUR and received instillation (92.4%; GEM/PBO: 166/162). In case of nonma- lignancy, carcinoma in situ (CIS), pT2 disease, or intraoperative complications, patients were discontinued. Intervention: We used a single, postoperative 30–40-min instillation of GEM (2000 mg/100 ml of saline) or PBO (100 ml of saline) followed by continuous * Corresponding author. Lilly Deutschland GmbH, Werner-Reimers-Straße 2-4, D-61352 Bad Homburg, Germany. Tel. +49 6172 273 2059; Fax: +49 6172 273 2520. E-mail address: buettnerh@lilly.com (H. Bu ¨ ttner). 0302-2838/$ – see back matter # 2009 European Association of Urology. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.eururo.2009.06.010