Ryuta Tanimoto1, Takashi Saika2,3, Shin Ebara2,3, Yasuyuki Kobayashi4,3, Ryoji Nasu5,3, Daisuke Yamada6,3, Hitoshi Takamoto7,3, Yoshiyuki Miyaji8,3, Yasutomo Nasu4,3, Tomoyasu Tsushima9,3, Hiromi Kumon4,3. 1. Department of Urology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Shikata-cho 2-5-1, Okayama, Okayama, 700-8558, Japan. tanimo10@gmail.com. 2. Department of Urology, Hiroshima City Hospital, Hiroshima, Hiroshima, Japan. 3. Okayama Urological Research Group (OURG), Okayama, Okayama, Japan. 4. Department of Urology, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University, Shikata-cho 2-5-1, Okayama, Okayama, 700-8558, Japan. 5. Department of Urology, Kochi Health Science Center, Kochi, Kochi, Japan. 6. Department of Urology, Mitoyo General Hospital, Kanonji, Kagawa, Japan. 7. Department of Urology, Kurashiki Medical Center, Kurashiki, Okayama, Japan. 8. Department of Urology, Iwakuni Clinical Center, Iwakuni, Yamaguchi, Japan. 9. Department of Urology, Okayama Medical Center, Oskayama, Okayama, Japan.
Abstract
PURPOSE: Single immediate intravesical instillation of chemotherapy after transurethral resection of bladder tumor (TURBT) has been the gold standard treatment for patients with low- and intermediate-risk non-muscle invasive bladder cancer (NMIBC). Herein, we conducted a multicenter prospective randomized controlled trial in Japan, comparing recurrence-free survival between single and two-time instillation of pirarubicin (THP) for solitary NMIBC. METHODS:Between 2005 and 2009, 257 patients with solitary NMIBC were enrolled and randomized to single instillation of THP (30 mg/50 mL) immediately after TURBT (Group A) or two-time instillation of THP immediately after and 1 day after TURBT (Group B). The primary endpoint was recurrence-free survival. Secondary endpoints included rates of recurrence and adverse effects, including hematuria, micturition pain, difficult urination, pollakiuria, systemic symptoms, and other complications. This study was registered as UMIN C000000266. RESULTS: Of 257 patients, 99 in Group A and 102 in Group B could be evaluated for recurrence. Median follow-up was 71 months. The overall recurrence rate was 39 and 31%, respectively (p = 0.2704). Although the 5-year recurrence-free survival rates were 55.9% and 67.7% in groups A and B, respectively, the difference between groups was not significant (p = 0.2031). No significant differences in adverse effects were observed between groups, except for pollakiuria (7 vs 22%, p = 0.0031). Multivariate analyses did not show that the treatment group was a significant risk factor for bladder cancer recurrence. CONCLUSIONS: Postoperative two-time intravesical instillation of THP was not superior to single immediate instillation for preventing recurrence after complete resection of a solitary NMIBC.
RCT Entities:
PURPOSE: Single immediate intravesical instillation of chemotherapy after transurethral resection of bladder tumor (TURBT) has been the gold standard treatment for patients with low- and intermediate-risk non-muscle invasive bladder cancer (NMIBC). Herein, we conducted a multicenter prospective randomized controlled trial in Japan, comparing recurrence-free survival between single and two-time instillation of pirarubicin (THP) for solitary NMIBC. METHODS: Between 2005 and 2009, 257 patients with solitary NMIBC were enrolled and randomized to single instillation of THP (30 mg/50 mL) immediately after TURBT (Group A) or two-time instillation of THP immediately after and 1 day after TURBT (Group B). The primary endpoint was recurrence-free survival. Secondary endpoints included rates of recurrence and adverse effects, including hematuria, micturition pain, difficult urination, pollakiuria, systemic symptoms, and other complications. This study was registered as UMIN C000000266. RESULTS: Of 257 patients, 99 in Group A and 102 in Group B could be evaluated for recurrence. Median follow-up was 71 months. The overall recurrence rate was 39 and 31%, respectively (p = 0.2704). Although the 5-year recurrence-free survival rates were 55.9% and 67.7% in groups A and B, respectively, the difference between groups was not significant (p = 0.2031). No significant differences in adverse effects were observed between groups, except for pollakiuria (7 vs 22%, p = 0.0031). Multivariate analyses did not show that the treatment group was a significant risk factor for bladder cancer recurrence. CONCLUSIONS: Postoperative two-time intravesical instillation of THP was not superior to single immediate instillation for preventing recurrence after complete resection of a solitary NMIBC.
Authors: Marko Babjuk; Andreas Böhle; Maximilian Burger; Otakar Capoun; Daniel Cohen; Eva M Compérat; Virginia Hernández; Eero Kaasinen; Joan Palou; Morgan Rouprêt; Bas W G van Rhijn; Shahrokh F Shariat; Viktor Soukup; Richard J Sylvester; Richard Zigeuner Journal: Eur Urol Date: 2016-06-17 Impact factor: 20.096
Authors: Richard J Sylvester; Willem Oosterlinck; Sten Holmang; Matthew R Sydes; Alison Birtle; Sigurdur Gudjonsson; Cosimo De Nunzio; Kikuo Okamura; Eero Kaasinen; Eduardo Solsona; Bedeir Ali-El-Dein; Can Ali Tatar; Brant A Inman; James N'Dow; Jorg R Oddens; Marek Babjuk Journal: Eur Urol Date: 2015-06-16 Impact factor: 20.096