PURPOSE: To study the benefits of a single, early, intravesical instillation of mitomycin C(MMC) after transurethral bladder resection (TURB) in patients with low-risk non-muscle-invasive bladder cancer (NMIBC). METHODS: In this prospective randomised single-centre trial, 211 patients with primary and low-risk tumours were enrolled between 2000 and 2009. Patients were randomly allocated to receive MMC intravesically within 24 h of TUR or no further treatment. The primary end point was recurrence rate reduction. RESULTS: A total of 202 patients (97 in the MMC group and 105 in the control group) remained for analysis after exclusions. Median age was 61 years (IQR 42-78), and median follow-up was 90 months (IQR 3-112). No significant differences for patients' characteristics were observed between the two groups. During the study period, 10% (10/97) of the patients in the MMC group and 43% (46/105) in the control group experienced a recurrence (P = 0.0001). Four patients in the MMC group and 11 (P = 0.008) in the control group experienced an early recurrence (within 2 years). One patient in the control group presented a tumour progression (T2G3). MMC treatment was associated with a 31% absolute risk reduction of recurrence and a 3.26 numbers needed to treat to prevent one recurrence. CONCLUSIONS: In this single-centre, long-term follow-up, experience a single, early instillation of MMC after TUR for low-risk NMIBC is associated with a significant reduction in risk of early and late recurrences.
RCT Entities:
PURPOSE: To study the benefits of a single, early, intravesical instillation of mitomycin C(MMC) after transurethral bladder resection (TURB) in patients with low-risk non-muscle-invasive bladder cancer (NMIBC). METHODS: In this prospective randomised single-centre trial, 211 patients with primary and low-risk tumours were enrolled between 2000 and 2009. Patients were randomly allocated to receive MMC intravesically within 24 h of TUR or no further treatment. The primary end point was recurrence rate reduction. RESULTS: A total of 202 patients (97 in the MMC group and 105 in the control group) remained for analysis after exclusions. Median age was 61 years (IQR 42-78), and median follow-up was 90 months (IQR 3-112). No significant differences for patients' characteristics were observed between the two groups. During the study period, 10% (10/97) of the patients in the MMC group and 43% (46/105) in the control group experienced a recurrence (P = 0.0001). Four patients in the MMC group and 11 (P = 0.008) in the control group experienced an early recurrence (within 2 years). One patient in the control group presented a tumour progression (T2G3). MMC treatment was associated with a 31% absolute risk reduction of recurrence and a 3.26 numbers needed to treat to prevent one recurrence. CONCLUSIONS: In this single-centre, long-term follow-up, experience a single, early instillation of MMC after TUR for low-risk NMIBC is associated with a significant reduction in risk of early and late recurrences.
Authors: D A Tolley; M K Parmar; K M Grigor; G Lallemand; L L Benyon; J Fellows; L S Freedman; K M Grigor; R R Hall; T B Hargreave; K Munson; D W Newling; B Richards; M R Robinson; M B Rose; P H Smith; J L Williams; P Whelan Journal: J Urol Date: 1996-04 Impact factor: 7.450
Authors: Richard J Sylvester; Adrian P M van der Meijden; Willem Oosterlinck; J Alfred Witjes; Christian Bouffioux; Louis Denis; Donald W W Newling; Karlheinz Kurth Journal: Eur Urol Date: 2006-01-17 Impact factor: 20.096
Authors: Francesco Mistretta; Nicolò Maria Buffi; Giovanni Lughezzani; Giuliana Lista; Alessandro Larcher; Nicola Fossati; Alberto Abrate; Paolo Dell'Oglio; Francesco Montorsi; Giorgio Guazzoni; Massimo Lazzeri Journal: Biomed Res Int Date: 2014-05-08 Impact factor: 3.411