Platinum Priority – Bladder Cancer Editorial by Willem Oosterlinck and Karel Decaestecker on pp. 517–518 of this issue Sequential Combination of Mitomycin C Plus Bacillus Calmette-Gue ´ rin (BCG) Is More Effective but More Toxic Than BCG Alone in Patients with Non–Muscle-invasive Bladder Cancer in Intermediate- and High-risk Patients: Final Outcome of CUETO 93009, a Randomized Prospective Trial Eduardo Solsona a, *, Rosario Madero b , Venancio Chantada c , Jesus M. Fernandez d , Juan A. Zabala e , Jose ´ A. Portillo f , Jose M. Alonso g , Ander Astobieta h , Miguel Unda i , Luis Martinez-Pin ˜eiro j , Mariano Rabadan k , Antonio Ojea l , Jesus Rodriguez-Molina m , Pastora Beardo n , Pedro Muntan ˜ola o , Matias Gomez p , Manuel Montesinos q , Jose A. Martinez Pin ˜eiro r , members of Club Urolo ´gico Espan ˜ol de Tratamiento Oncolo ´gico a Department of Urology, Instituto Valenciano de Oncologı´a, Valencia, Spain; b Department of Statistics, Hospital La Paz, Madrid, Spain; c Department of Urology, Complejo Hospitalario Universitario a Corun ˜a, La Corun ˜a, Spain; d Department of Urology, Hospital Central de Asturias, Oviedo, Spain; e Department of Urology, Hospital Cruces, Bilbao, Spain; f Department of Urology, Hospital Universitario Marques de Valdecilla, Santander, Spain; g Department of Urology, Hospital Universitario La Paz, Madrid, Spain; h Department of Urology, Hospital de Galdakao, Bilbao, Spain; i Department of Urology, Hospital de Basurto, Bilbao, Spain; j Department of Urology, Hospital Princesa Sofia, Madrid, Spain; k Department of Urology, Hospital de la Princesa, Madrid, Spain; l Department of Urology, Hospital Xeral, Vigo, Spain; m Department of Urology, Hospital Universitario de San Carlos, Madrid, Spain; n Department of Urology, Hospital General, Jerez de la Frontera, Spain; o Department of Urology, Hospital Alvarez Buylla, Mieres, Spain; p Department of Urology, Hospital Negrin, Las Palmas de Gran Canaria, Spain; q Department of Urology, Hospital Virgen del Camino, Pamplona, Spain; r Department of Urology, Clı´nica La Luz, Madrid, Spain EUROPEAN UROLOGY 67 (2015) 508–516 available at www.sciencedirect.com journal homepage: www.europeanurology.com Article info Article history: Accepted September 18, 2014 Keywords: BCG MMC plus BCG Intermediate- to high-risk groups Randomized trial Subgroup analysis Abstract Background: Intravesical bacillus Calmette-Gue ´ rin (BCG) is an effective therapy in non– muscle-invasive bladder cancer (NMIBC), but it has limitations in terms of recurrence and toxicity. Objective: To determine whether the sequential combination of mitomycin C (MMC) and BCG is superior to BCG alone in increasing a disease-free interval (DFI). Design, setting, and participants: We conducted a prospective randomized trial includ- ing 407 patients with intermediate- to high-risk NMIBC and allocated 211 to the MMC and BCG arm and 196 to the BCG-alone arm. Outcome measurements and statistical analysis: The trial was designed to provide concurrently a power of 80% for the detection of a relative risk reduction of 35% (hazard ratio [HR]: 0.65) of disease relapse with a type I error of 0.05. Times to events were estimated using cumulative incidence functions and compared using the Cox regression model. We used the Kaplan-Meier technique to estimate survival curves. * Corresponding author. Department of Urology, Instituto Valenciano de Oncologı ´a, C/Prof. Beltran Baguena 8, 46009 Valencia, Spain. Tel. +34 961114030; Fax: +34 961114346. E-mail address: solsona@pulso.com (E. Solsona). http://dx.doi.org/10.1016/j.eururo.2014.09.026 0302-2838/# 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.