You have accessJournal of UrologyBladder Cancer1 Apr 20121771 TREATMENT WITH INTRACUTANEOUS AND INTRAVESICAL KEYHOLE LIMPET HEMOCYANIN IS INFERIOR TO INTRAVESICAL MITOMYCIN-C FOR PREVENTION OF RECURRENCES IN PATIENTS WITH NON-MUSCLE-INVASIVE BLADDER CANCER: RESULTS FROM A PROSPECTIVE RANDOMIZED PHASE III TRIAL Rianne J.M. Lammers, Wim P.J. Witjes, Maria H.C. Janzing-Pastors, Christien T.M. Caris, and J. Alfred Witjes Rianne J.M. LammersRianne J.M. Lammers Nijmegen, Netherlands More articles by this author , Wim P.J. WitjesWim P.J. Witjes Arnhem, Netherlands More articles by this author , Maria H.C. Janzing-PastorsMaria H.C. Janzing-Pastors Arnhem, Netherlands More articles by this author , Christien T.M. CarisChristien T.M. Caris Arnhem, Netherlands More articles by this author , and J. Alfred WitjesJ. Alfred Witjes Nijmegen, Netherlands More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2012.02.1788AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Despite current treatment after transurethral resection of a bladder tumor (TURBT), there remains a risk of recurrence and progression. Keyhole limpet hemocyanin (KLH) is a glycoprotein from a mollusk, which activates the humoral and cellular immune systems. KLH showed beneficial effects in earlier studies. In this study, safety and efficacy of KLH were compared to mitomycin-c (MMC). METHODS Patients with intermediate- and high-risk (according to EORTC risk tables) non-muscle-invasive bladder cancer (NMIBC), without carcinoma in situ, were included in a randomized phase III trial. Between July 2003 and November 2007, a total of 283 patients were randomized for 16 adjuvant intravesical instillations with 20 mg KLH after intracutaneous pre-immunization, and 270 patients were randomized for 11 adjuvant intravesical instillations with 40 mg MMC. Primary outcome measurement was the duration of recurrence-free survival (RFS). Secondary outcome measurements were recurrence rate, number of recurrent tumors, progression-free survival (PFS), adverse events (AE), and the effect of delayed type hypersensitivity (DTH) response on clinical outcome. RESULTS Patients in the MMC-group had significantly more pT1-tumors (p=0.01). Other patient- and tumor characteristics were comparable in both groups. In total, 163 (61%) patients developed a recurrence after KLH-instillations, compared with 87 (34%) after MMC-instillations (p<0.001). In uni- and multivariate analyses, KLH was less effective than MMC regarding RFS (both p<0.001; Figure 1). Number of recurrent tumors were higher after KLH-treatment. PFS was shorter after MMC-instillations, but progression was uncommon (n=20). AEs were common (72%) but mild. Fever, flu-like symptoms and fatigue occurred significantly more in the KLH-group (p=0.02). Allergic reactions and other skin disorders occurred significantly more in the MMC-group (p<0.001). Significantly more DTH-positive patients developed a recurrence than DTH-negative patients (p=0.031). CONCLUSIONS KLH had a different safety profile and was significantly less effective than MMC in preventing recurrences of NMIBC. © 2012 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 187Issue 4SApril 2012Page: e715 Advertisement Copyright & Permissions© 2012 by American Urological Association Education and Research, Inc.MetricsAuthor Information Rianne J.M. Lammers Nijmegen, Netherlands More articles by this author Wim P.J. Witjes Arnhem, Netherlands More articles by this author Maria H.C. Janzing-Pastors Arnhem, Netherlands More articles by this author Christien T.M. Caris Arnhem, Netherlands More articles by this author J. Alfred Witjes Nijmegen, Netherlands More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...