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UP-3.039: Intravesical Bacillus Calmette-Guérin (BCG) Instillation for Primary And Recurring T1G3 Bladder Cancers
UNMODERATED POSTER SESSIONS
prognostic and predictive implications in future. UP-3.039 Intravesical Bacillus Calmette-Gue´rin (BCG) Instillation for Primary And Recurring T1G3 Bladder Cancers Okamura T1, Akita H1, Nishio H1, Moritoki Y1, Hirose Y1, Kato T1, Tozawa K2, Kohri K2 1 J.A. Aichi Anjo Kosei Hospital, Anjo, Japan; 2Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan Introduction and Objective: T1G3 bladder cancer is considered as high risk case, and the treatment option is still controversial for bladder preservation treatment or total cystectomy. In this study, a clinical evaluation of the efficacy of intravesical instillation of bacillus Calmette-Guerin (BCG) for prophylaxis of T1G3 bladder cancer recurrence after TUR-Bt and further BCG treatment of recurrent but not progressive lesions was performed. Materials and Methods: A total of 30 patients with T1G3 bladder cancers (excluding cases with previous upper urinary tract urothelial cancers or undergoing general chemotherapy) received 6 to 8 weekly instillations of 40, 60 or 80mg of Tokyo strain BCG (40mg : 60mg : 80mg ⫽ 3 : 1 : 26) followed in some cases by further applications at monthly intervals. The age range was from 50 to 83 (average 67.0 y.o.), and the male: female ratio was 28 : 2. Primary cases numbered 24 and recurrent cases were 6, seven patients having single and 23 having multiple tumors. Follow-up periods were between 14 and 125 months (average of 66.1 months). Results: Recurrence occurred in 13 cases and further BCG treatment was again performed unless muscle invasive change had occurred. There were 6 patients with confirmed progression, and total cystectomy was performed for 5 of these cases, one subsequently dying of further recurrence. The other case received radiation and urinary diversion. Further BCG-containing bladder preservation treatment was performed for 7 patients, and all of them were alive at the end of the follow up period. Finally, bladder preservation using BCG treatment proved successful in 24 of 30 T1G3 cases. Conclusions: Intravesical instillation of BCG for high risk T1G3 cases, including additional BCG treatment for non-progressive recurrent cases was effective and satisfactory in our series. Therefore this treatment option warrants emphasis in
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discussion with patients as to relative merit compared to total cystectomy, focusing on maintaining quality of life.
UP-3.040 Mistletoe Extract as an Adjuvant Therapy after Resection of Superficial Bladder Cancer: Prospective Clinical Randomized Study Ibrahiem E, Hekal I Urology and Nephrology Center, Mansoura, Egypt Introduction and Objectives: To the date, BCG still is the best treatment against superficial bladder tumor (SBT) recurrence. Considerable side effects of BCG therapy raised the needs for other alternative drugs. Evaluation of the efficacy of Mistletoe extract in prevention of SBT recurrence and evaluation of the safety of the drug regimen. Material and Methods: A prospective randomized study was carried out over sixty patients. After 1-2 weeks of complete TURBT of SBT (Ta, T1 of Grade 1-2), the patients were randomly divided into two groups. The group (A) received Mistletoe extract, while group (B) received BCG therapy (as standard treatment). Course and dose of both drugs were given according to prescribed regimen. Regularly every 3 months; complete Lab., cystoscopy and urine cytology were performed until the end of the treatment course. The recurrence rate, progression of the tumor and side effects were recorded in each group. Results: Between Dec. 2006 and June 2008, consecutive 60 patients after TURBT of SBT were randomly treated. Mean age in group (A and B) was 58.7and 53.4 years respectively. Stage pTa, T1 were 24, 36 cases respectively. 49/60 (81.7%) were Grade 2. Local recurrence rate was 73.3 and 30 % in group A and B respectively (p⬍0.05). 46.4 % of group A developed recurrence at the first check cystoscopy (p⬍0.05). Invasive bladder cancer developed in 5 cases in each group. Recurrence necessitated TURBT in 14, 5 cases in A and B respectively (p⬍0.05). Stage and grade Progression was noticed in 14 and 4 cases of A& B group (P⫽0.016, 0.273 for stage and grade respectively). Intravesical administrated Mistletoe extract was tolerable, without biochemical or hematological changes. In BCG group, 23 (76 %) cases had a painful bladder sensation. One case of group A showed lymphadenopathy and hepatic metastasis, all cases show self-limited local skin reaction after first subcutaneous dose. Neither severe toxicity, nor laboratory
significant changes were detected in both groups. Conclusion: Mistletoe extract is tolerable and safely administrated on 10.000 ng lectin concentrations but this is not sufficient to prevent local recurrence of the tumor. Further studies and optimization of the effective dose are required. UP-3.041 Laparoscopic Radical Cystectomy with Extracorporal Neobladder in the Treatment of Invasive Bladder Cancer Dubrovin V, Tabakov A, Egoshin A, Novoselova O, Sharov V, Shakirov R, Michailovskyi O Republic Clinical Hospital, Yoshkar-Ola, Russia Introduction and Objective: Radical cystectomy is gold standard in the treatment of muscle invasive bladder cancer. We report our results of laparoscopic cystectomy with low-invasive laparotomy and extraperitoneal formation of the neobladder by modification of Studer. Materials and Methods: The 5-year results of using the method are evaluated; 7 patients with mean age of 57 (51– 64) underwent a laparoscopic cystectomy under the general anesthesia with prolonged peridural anesthesia at our hospital. All patients were male. The stage of cancer was T2N0M0 G1-2. The procedure consist of two parts: 1 - laparoscopic mobilization of the bladder, ureters, prostate gland and vesicles; 2 – low invasive laparotomy (length 4 – 5 cm) with special tools and illumination, extraction of the bladder and formation of the neobladder by modification of Studer’s method, allowing remove in mini-laparotomy wound only separate area of the intestine segment for imposition necessary anastomosis. Results: The mean time of procedure was 505 (430 – 570) min. Blood loss was between 150 –300 ml. There were not serious postoperative complications. Function of intestines is restored for 4 days. Drainages of the ureters are removed for 14 days; urethral catheters are removed for 16 days. Urodynamic studies after procedure was revealed Q max – 18.4 (17 – 19) ml/sec. There was not cancer progression in all patients. One man had obstruction of the urethra-intestine anastomosis, which is successfully executed TUR procedure. At annual examination all patients hold the urine, have a satisfactory flow Q max – 11.3 (9.2-14) ml/sec. Conclusions: Our results indicate that a laparoscopic cystectomy is an effective surgical method and represents good alternative for open surgery.
UROLOGY 74 (Supplment 4A), October 2009
prognostic and predictive implications in future. UP-3.039 Intravesical Bacillus Calmette-Gue´rin (BCG) Instillation for Primary And Recurring T1G3 Bladder Cancers Okamura T1, Akita H1, Nishio H1, Moritoki Y1, Hirose Y1, Kato T1, Tozawa K2, Kohri K2 1 J.A. Aichi Anjo Kosei Hospital, Anjo, Japan; 2Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan Introduction and Objective: T1G3 bladder cancer is considered as high risk case, and the treatment option is still controversial for bladder preservation treatment or total cystectomy. In this study, a clinical evaluation of the efficacy of intravesical instillation of bacillus Calmette-Guerin (BCG) for prophylaxis of T1G3 bladder cancer recurrence after TUR-Bt and further BCG treatment of recurrent but not progressive lesions was performed. Materials and Methods: A total of 30 patients with T1G3 bladder cancers (excluding cases with previous upper urinary tract urothelial cancers or undergoing general chemotherapy) received 6 to 8 weekly instillations of 40, 60 or 80mg of Tokyo strain BCG (40mg : 60mg : 80mg ⫽ 3 : 1 : 26) followed in some cases by further applications at monthly intervals. The age range was from 50 to 83 (average 67.0 y.o.), and the male: female ratio was 28 : 2. Primary cases numbered 24 and recurrent cases were 6, seven patients having single and 23 having multiple tumors. Follow-up periods were between 14 and 125 months (average of 66.1 months). Results: Recurrence occurred in 13 cases and further BCG treatment was again performed unless muscle invasive change had occurred. There were 6 patients with confirmed progression, and total cystectomy was performed for 5 of these cases, one subsequently dying of further recurrence. The other case received radiation and urinary diversion. Further BCG-containing bladder preservation treatment was performed for 7 patients, and all of them were alive at the end of the follow up period. Finally, bladder preservation using BCG treatment proved successful in 24 of 30 T1G3 cases. Conclusions: Intravesical instillation of BCG for high risk T1G3 cases, including additional BCG treatment for non-progressive recurrent cases was effective and satisfactory in our series. Therefore this treatment option warrants emphasis in
S306
discussion with patients as to relative merit compared to total cystectomy, focusing on maintaining quality of life.
UP-3.040 Mistletoe Extract as an Adjuvant Therapy after Resection of Superficial Bladder Cancer: Prospective Clinical Randomized Study Ibrahiem E, Hekal I Urology and Nephrology Center, Mansoura, Egypt Introduction and Objectives: To the date, BCG still is the best treatment against superficial bladder tumor (SBT) recurrence. Considerable side effects of BCG therapy raised the needs for other alternative drugs. Evaluation of the efficacy of Mistletoe extract in prevention of SBT recurrence and evaluation of the safety of the drug regimen. Material and Methods: A prospective randomized study was carried out over sixty patients. After 1-2 weeks of complete TURBT of SBT (Ta, T1 of Grade 1-2), the patients were randomly divided into two groups. The group (A) received Mistletoe extract, while group (B) received BCG therapy (as standard treatment). Course and dose of both drugs were given according to prescribed regimen. Regularly every 3 months; complete Lab., cystoscopy and urine cytology were performed until the end of the treatment course. The recurrence rate, progression of the tumor and side effects were recorded in each group. Results: Between Dec. 2006 and June 2008, consecutive 60 patients after TURBT of SBT were randomly treated. Mean age in group (A and B) was 58.7and 53.4 years respectively. Stage pTa, T1 were 24, 36 cases respectively. 49/60 (81.7%) were Grade 2. Local recurrence rate was 73.3 and 30 % in group A and B respectively (p⬍0.05). 46.4 % of group A developed recurrence at the first check cystoscopy (p⬍0.05). Invasive bladder cancer developed in 5 cases in each group. Recurrence necessitated TURBT in 14, 5 cases in A and B respectively (p⬍0.05). Stage and grade Progression was noticed in 14 and 4 cases of A& B group (P⫽0.016, 0.273 for stage and grade respectively). Intravesical administrated Mistletoe extract was tolerable, without biochemical or hematological changes. In BCG group, 23 (76 %) cases had a painful bladder sensation. One case of group A showed lymphadenopathy and hepatic metastasis, all cases show self-limited local skin reaction after first subcutaneous dose. Neither severe toxicity, nor laboratory
significant changes were detected in both groups. Conclusion: Mistletoe extract is tolerable and safely administrated on 10.000 ng lectin concentrations but this is not sufficient to prevent local recurrence of the tumor. Further studies and optimization of the effective dose are required. UP-3.041 Laparoscopic Radical Cystectomy with Extracorporal Neobladder in the Treatment of Invasive Bladder Cancer Dubrovin V, Tabakov A, Egoshin A, Novoselova O, Sharov V, Shakirov R, Michailovskyi O Republic Clinical Hospital, Yoshkar-Ola, Russia Introduction and Objective: Radical cystectomy is gold standard in the treatment of muscle invasive bladder cancer. We report our results of laparoscopic cystectomy with low-invasive laparotomy and extraperitoneal formation of the neobladder by modification of Studer. Materials and Methods: The 5-year results of using the method are evaluated; 7 patients with mean age of 57 (51– 64) underwent a laparoscopic cystectomy under the general anesthesia with prolonged peridural anesthesia at our hospital. All patients were male. The stage of cancer was T2N0M0 G1-2. The procedure consist of two parts: 1 - laparoscopic mobilization of the bladder, ureters, prostate gland and vesicles; 2 – low invasive laparotomy (length 4 – 5 cm) with special tools and illumination, extraction of the bladder and formation of the neobladder by modification of Studer’s method, allowing remove in mini-laparotomy wound only separate area of the intestine segment for imposition necessary anastomosis. Results: The mean time of procedure was 505 (430 – 570) min. Blood loss was between 150 –300 ml. There were not serious postoperative complications. Function of intestines is restored for 4 days. Drainages of the ureters are removed for 14 days; urethral catheters are removed for 16 days. Urodynamic studies after procedure was revealed Q max – 18.4 (17 – 19) ml/sec. There was not cancer progression in all patients. One man had obstruction of the urethra-intestine anastomosis, which is successfully executed TUR procedure. At annual examination all patients hold the urine, have a satisfactory flow Q max – 11.3 (9.2-14) ml/sec. Conclusions: Our results indicate that a laparoscopic cystectomy is an effective surgical method and represents good alternative for open surgery.
UROLOGY 74 (Supplment 4A), October 2009