Bacillus Calmette Guerin (BCG) has been the mainstay of intravesical treatment, however, its clinical effectiveness is accompanied by a wide range of adverse events. Gemcitabine has a good safety profile with promising features for the use against intermediate risk non-muscle invasive bladder cancer (NMIBC). It can be a potential chemotherapeutic drug for high- risk patients. The aim of this study was to evaluate the safety and efficacy of adjuvant intravesical gemcitabine versus BCG in the treatment of intermediate and high -risk NMIBC. Patients and methods: Between May 2006 and April 2008, a total of 57 patients were randomized into 2 groups; group I: 28 patients, were treated with six weekly intravesical instillation of BCG and group II: 29 patients, received six weekly intravesical grmcitabine. Patients were evaluated for response, at 8 weeks, then every 3 months. Outcome measures were response rate, overall recurrence rate, progression rate, median recurrence free period, median progression free period and 1-year recurrence free survival. Treatment related complications were also evaluated. Results: For intermediate risk patients, there was no significant difference between the two groups in the complete response (CR) rate (93.3% vs. 87.5%), the overall recurrence rate (33.3%vs.25%), the progression rate (6.7% vs. 6.2%), and the median progression free period (13 vs. 16 months). However, the median recurrence free period was longer for group I compared to group II (18.5 vs. 15 months) and the difference was statistically significant. Kaplan-Meier curve showed that there was no significant difference between the two groups in the 1-year recurrence free survival (95.3% vs. 98.7%) and the median recurrence free survival (22 vs.18 months). For high risk patients there was no significant difference between the 2groups in CR rate (61.5% vs. 76.9%), the progression rate (15.4% for both groups) the median recurrence free period (15 vs. 14 months) and the median progression free period (17 vs. 15 months). However, the overall recurrence rate of group I was lower than that of group II (7.7% vs. 30.8%) and the difference was statistically significant. Kaplan-Meier curve showed that there was no significant difference between the two groups in the 1-year recurrence free survival (76.9% vs. 69.2%) and the median recurrence free survival (18 vs.15 months). The adverse events of group I were more marked than that of group II. Conclusion: Gemcitabine is active and well tolerated for intravesical instillation.It is considered to be an efficient treatment for intermediate risk NMIBC. However, for high- risk group, it is inferior to BCG, but owing to its favorable toxicity profile, it may be useful for patients intolerant to BCG. [

Bacillus Calmette Guerin (BCG) has been the mainstay of intravesical treatment, however, its clinical effectiveness is accompanied by a wide range of adverse events. Gemcitabine has a good safety profile with promising features for the use against intermediate risk non-muscle invasive bladder cancer (NMIBC). It can be a potential chemotherapeutic drug for high- risk patients. The aim of this study was to evaluate the safety and efficacy of adjuvant intravesical gemcitabine versus BCG in the treatment of intermediate and high -risk NMIBC. Patients and methods: Between May 2006 and April 2008, a total of 57 patients were randomized into 2 groups; group I: 28 patients, were treated with six weekly intravesical instillation of BCG and group II: 29 patients, received six weekly intravesical grmcitabine. Patients were evaluated for response, at 8 weeks, then every 3 months. Outcome measures were response rate, overall recurrence rate, progression rate, median recurrence free period, median progression free period and 1-year recurrence free survival. Treatment related complications were also evaluated. Results: For intermediate risk patients, there was no significant difference between the two groups in the complete response (CR) rate (93.3% vs. 87.5%), the overall recurrence rate (33.3%vs.25%), the progression rate (6.7% vs. 6.2%), and the median progression free period (13 vs. 16 months). However, the median recurrence free period was longer for group I compared to group II (18.5 vs. 15 months) and the difference was statistically significant. Kaplan-Meier curve showed that there was no significant difference between the two groups in the 1-year recurrence free survival (95.3% vs. 98.7%) and the median recurrence free survival (22 vs.18 months). For high risk patients there was no significant difference between the 2groups in CR rate (61.5% vs. 76.9%), the progression rate (15.4% for both groups) the median recurrence free period (15 vs. 14 months) and the median progression free period (17 vs. 15 months). However, the overall recurrence rate of group I was lower than that of group II (7.7% vs. 30.8%) and the difference was statistically significant. Kaplan-Meier curve showed that there was no significant difference between the two groups in the 1-year recurrence free survival (76.9% vs. 69.2%) and the median recurrence free survival (18 vs.15 months). The adverse events of group I were more marked than that of group II. Conclusion: Gemcitabine is active and well tolerated for intravesical instillation.It is considered to be an efficient treatment for intermediate risk NMIBC. However, for high- risk group, it is inferior to BCG, but owing to its favorable toxicity profile, it may be useful for patients intolerant to BCG. [

Background: BCG is the standard treatment for non-muscle invasive bladder cancer (NMIBC). However, the high recurrence rates and the significant local and systemic toxicity have led to increased interest in alternative intravesical therapies. Docetaxel has been shown to be a safe and effective intravesical therapy with no systemic absorption and minimal toxicity. Objectives: To compare the efficacy and safety of intravesical BCG and docetaxel for intermediate and high-risk NMIBC. Patients and methods: 82 patients with NMIBC were randomized into 2 groups; and treated with six weekly intravesical BCG (group I, 40 patients) and docetaxel (group II, 42 patients). Outcome measures were overall recurrence rate, progression rate, 1-year recurrence free and progression free survival. Treatment related toxicities were also evaluated. Results: No difference between the 2 groups in recurrence rate (32.5% vs. 42.9%), progression rate (20% vs. 28.6%), 1-year recurrence free survival (72.5% vs. 61.9%), 1-year progression free survival (80% vs.71.4%). No difference for intermediate and high risk patients in BCG group and their counterparts of docetaxel group in recurrence rate (16.7% vs. 42.9%) and (39.3% vs. 42.9%), progression rate (16.7% vs. 14.3%) and (21.4% vs. 35.7%), 1-year recurrence free survival (83.3% vs. 76.9%) and (67.9% vs. 53.6%), 1-year progression free survival (83.3% vs. 84.6%) and (78.6% vs. 65.5). Age, grade and multiplicity were independent predictive factors for recurrence while grade was the independent factor for progression. The adverse events of BCG group were more marked. Conclusions: Intravesical docetaxel demonstrate significant efficacy and minimal toxicity for the management of NMIBC. In comparison to BCG, there was no significant difference in terms of disease recurrence, progression or survival, and the decision to use either agent may be based on adverse events and cost. The results of this study support the role of intravesical docetaxel for intermediate risk patients and it can be of major concern for high risk patients, however, randomized multi-institutional trials should be considered.

Background: BCG is the standard treatment for non-muscle invasive bladder cancer (NMIBC). However, the high recurrence rates and the significant local and systemic toxicity have led to increased interest in alternative intravesical therapies. Docetaxel has been shown to be a safe and effective intravesical therapy with no systemic absorption and minimal toxicity. Objectives: To compare the efficacy and safety of intravesical BCG and docetaxel for intermediate and high-risk NMIBC. Patients and methods: 82 patients with NMIBC were randomized into 2 groups; and treated with six weekly intravesical BCG (group I, 40 patients) and docetaxel (group II, 42 patients). Outcome measures were overall recurrence rate, progression rate, 1-year recurrence free and progression free survival. Treatment related toxicities were also evaluated. Results: No difference between the 2 groups in recurrence rate (32.5% vs. 42.9%), progression rate (20% vs. 28.6%), 1-year recurrence free survival (72.5% vs. 61.9%), 1-year progression free survival (80% vs.71.4%). No difference for intermediate and high risk patients in BCG group and their counterparts of docetaxel group in recurrence rate (16.7% vs. 42.9%) and (39.3% vs. 42.9%), progression rate (16.7% vs. 14.3%) and (21.4% vs. 35.7%), 1-year recurrence free survival (83.3% vs. 76.9%) and (67.9% vs. 53.6%), 1-year progression free survival (83.3% vs. 84.6%) and (78.6% vs. 65.5). Age, grade and multiplicity were independent predictive factors for recurrence while grade was the independent factor for progression. The adverse events of BCG group were more marked. Conclusions: Intravesical docetaxel demonstrate significant efficacy and minimal toxicity for the management of NMIBC. In comparison to BCG, there was no significant difference in terms of disease recurrence, progression or survival, and the decision to use either agent may be based on adverse events and cost. The results of this study support the role of intravesical docetaxel for intermediate risk patients and it can be of major concern for high risk patients, however, randomized multi-institutional trials should be considered.

Background: Local pelvic recurrence after radical cystectomy for muscle invasive bilharzial related squamous cell carcinoma accounts for 75% of treatment failures even in organ confined tumors. Despite the proven value of lymphadenectomy, up to 60% of patients undergoing cystectomy do not have it. These factors are in favor of adjuvant radiotherapy reevaluation. objectives: to evaluate the effect of adjuvant radiotherapy on disease free survival in muscle invasive bilharzial related squamous cell carcinoma of the urinary bladder and to test the predictability of radio-sensitivity using the anti apoptotic protein Bcl-XL. Methods: The study prospectively included 71 patients, (47 males, 24 females) with muscle invasive bilharzial related squamous cell carcinoma of the bladder (Stage pT2a-T3N0-N3M0) who underwent radical cystectomy in Assiut university hospitals between January 2005 and December 2006. Thirty eight patients received adjuvant radiotherapy to the pelvis in the dose of 50Gy/25 fractions/5 weeks (Group 1), while 33 patients did not receive adjuvant radiotherapy (group 2). Immunohistochemical characterization for bcl-xL expression was done. Follow up was done every 3 months for 12 to 36 months with a mean of 16 ± 10 months. All data were analyzed using SPSS version 16. Three years cumulative disease free survival was calculated and adjusted to Bcl-XL expression and side effects of the treatment were recorded. Results: The disease free cumulative survival was 48% for group 1 and 29% for group 2 (log rank p value 0.03). The multivariate predictors of tumor recurrence were the positive Bcl-XL expression (odd ratio 41.1, 95% CI 8.4 102.3, p 0.0001) and radiotherapy (odd ratio 0.19, 95% CI 0.05 - 0.78, p 0.02). With Cox regression, the only independent multivariate predictor of radio-sensitivity was the Bcl-XL expression with odd ratio 4.6 and a p value 0.0001. All patients tolerated the treatment with no life threatening or late complications during the period of follow up. Conclusions: Adjuvant radiotherapy for muscle invasive bilharzial related squamous cell carcinoma of the urinary bladder has potential effectiveness and minor side effects. Moreover, Bcl-XL expression is a valuable tool for predicting those who might not respond to this adjuvant treatment. B

Background: Local pelvic recurrence after radical cystectomy for muscle invasive bilharzial related squamous cell carcinoma accounts for 75% of treatment failures even in organ confined tumors. Despite the proven value of lymphadenectomy, up to 60% of patients undergoing cystectomy do not have it. These factors are in favor of adjuvant radiotherapy reevaluation. objectives: to evaluate the effect of adjuvant radiotherapy on disease free survival in muscle invasive bilharzial related squamous cell carcinoma of the urinary bladder and to test the predictability of radio-sensitivity using the anti apoptotic protein Bcl-XL. Methods: The study prospectively included 71 patients, (47 males, 24 females) with muscle invasive bilharzial related squamous cell carcinoma of the bladder (Stage pT2a-T3N0-N3M0) who underwent radical cystectomy in Assiut university hospitals between January 2005 and December 2006. Thirty eight patients received adjuvant radiotherapy to the pelvis in the dose of 50Gy/25 fractions/5 weeks (Group 1), while 33 patients did not receive adjuvant radiotherapy (group 2). Immunohistochemical characterization for bcl-xL expression was done. Follow up was done every 3 months for 12 to 36 months with a mean of 16 ± 10 months. All data were analyzed using SPSS version 16. Three years cumulative disease free survival was calculated and adjusted to Bcl-XL expression and side effects of the treatment were recorded. Results: The disease free cumulative survival was 48% for group 1 and 29% for group 2 (log rank p value 0.03). The multivariate predictors of tumor recurrence were the positive Bcl-XL expression (odd ratio 41.1, 95% CI 8.4 102.3, p 0.0001) and radiotherapy (odd ratio 0.19, 95% CI 0.05 - 0.78, p 0.02). With Cox regression, the only independent multivariate predictor of radio-sensitivity was the Bcl-XL expression with odd ratio 4.6 and a p value 0.0001. All patients tolerated the treatment with no life threatening or late complications during the period of follow up. Conclusions: Adjuvant radiotherapy for muscle invasive bilharzial related squamous cell carcinoma of the urinary bladder has potential effectiveness and minor side effects. Moreover, Bcl-XL expression is a valuable tool for predicting those who might not respond to this adjuvant treatment. B

Background: Local pelvic recurrence after radical cystectomy for muscle invasive bilharzial related squamous cell carcinoma accounts for 75% of treatment failures even in organ confined tumors. Despite the proven value of lymphadenectomy, up to 60% of patients undergoing cystectomy do not have it. These factors are in favor of adjuvant radiotherapy reevaluation. objectives: to evaluate the effect of adjuvant radiotherapy on disease free survival in muscle invasive bilharzial related squamous cell carcinoma of the urinary bladder and to test the predictability of radio-sensitivity using the anti apoptotic protein Bcl-XL. Methods: The study prospectively included 71 patients, (47 males, 24 females) with muscle invasive bilharzial related squamous cell carcinoma of the bladder (Stage pT2a-T3N0-N3M0) who underwent radical cystectomy in Assiut university hospitals between January 2005 and December 2006. Thirty eight patients received adjuvant radiotherapy to the pelvis in the dose of 50Gy/25 fractions/5 weeks (Group 1), while 33 patients did not receive adjuvant radiotherapy (group 2). Immunohistochemical characterization for bcl-xL expression was done. Follow up was done every 3 months for 12 to 36 months with a mean of 16 ± 10 months. All data were analyzed using SPSS version 16. Three years cumulative disease free survival was calculated and adjusted to Bcl-XL expression and side effects of the treatment were recorded. Results: The disease free cumulative survival was 48% for group 1 and 29% for group 2 (log rank p value 0.03). The multivariate predictors of tumor recurrence were the positive Bcl-XL expression (odd ratio 41.1, 95% CI 8.4 102.3, p 0.0001) and radiotherapy (odd ratio 0.19, 95% CI 0.05 - 0.78, p 0.02). With Cox regression, the only independent multivariate predictor of radio-sensitivity was the Bcl-XL expression with odd ratio 4.6 and a p value 0.0001. All patients tolerated the treatment with no life threatening or late complications during the period of follow up. Conclusions: Adjuvant radiotherapy for muscle invasive bilharzial related squamous cell carcinoma of the urinary bladder has potential effectiveness and minor side effects. Moreover, Bcl-XL expression is a valuable tool for predicting those who might not respond to this adjuvant treatment. B

Background: Local pelvic recurrence after radical cystectomy for muscle invasive bilharzial related squamous cell carcinoma accounts for 75% of treatment failures even in organ confined tumors. Despite the proven value of lymphadenectomy, up to 60% of patients undergoing cystectomy do not have it. These factors are in favor of adjuvant radiotherapy reevaluation. objectives: to evaluate the effect of adjuvant radiotherapy on disease free survival in muscle invasive bilharzial related squamous cell carcinoma of the urinary bladder and to test the predictability of radio-sensitivity using the anti apoptotic protein Bcl-XL. Methods: The study prospectively included 71 patients, (47 males, 24 females) with muscle invasive bilharzial related squamous cell carcinoma of the bladder (Stage pT2a-T3N0-N3M0) who underwent radical cystectomy in Assiut university hospitals between January 2005 and December 2006. Thirty eight patients received adjuvant radiotherapy to the pelvis in the dose of 50Gy/25 fractions/5 weeks (Group 1), while 33 patients did not receive adjuvant radiotherapy (group 2). Immunohistochemical characterization for bcl-xL expression was done. Follow up was done every 3 months for 12 to 36 months with a mean of 16 ± 10 months. All data were analyzed using SPSS version 16. Three years cumulative disease free survival was calculated and adjusted to Bcl-XL expression and side effects of the treatment were recorded. Results: The disease free cumulative survival was 48% for group 1 and 29% for group 2 (log rank p value 0.03). The multivariate predictors of tumor recurrence were the positive Bcl-XL expression (odd ratio 41.1, 95% CI 8.4 102.3, p 0.0001) and radiotherapy (odd ratio 0.19, 95% CI 0.05 - 0.78, p 0.02). With Cox regression, the only independent multivariate predictor of radio-sensitivity was the Bcl-XL expression with odd ratio 4.6 and a p value 0.0001. All patients tolerated the treatment with no life threatening or late complications during the period of follow up. Conclusions: Adjuvant radiotherapy for muscle invasive bilharzial related squamous cell carcinoma of the urinary bladder has potential effectiveness and minor side effects. Moreover, Bcl-XL expression is a valuable tool for predicting those who might not respond to this adjuvant treatment. B

Background: Local pelvic recurrence after radical cystectomy for muscle invasive bilharzial related squamous cell carcinoma accounts for 75% of treatment failures even in organ confined tumors. Despite the proven value of lymphadenectomy, up to 60% of patients undergoing cystectomy do not have it. These factors are in favor of adjuvant radiotherapy reevaluation. objectives: to evaluate the effect of adjuvant radiotherapy on disease free survival in muscle invasive bilharzial related squamous cell carcinoma of the urinary bladder and to test the predictability of radio-sensitivity using the anti apoptotic protein Bcl-XL. Methods: The study prospectively included 71 patients, (47 males, 24 females) with muscle invasive bilharzial related squamous cell carcinoma of the bladder (Stage pT2a-T3N0-N3M0) who underwent radical cystectomy in Assiut university hospitals between January 2005 and December 2006. Thirty eight patients received adjuvant radiotherapy to the pelvis in the dose of 50Gy/25 fractions/5 weeks (Group 1), while 33 patients did not receive adjuvant radiotherapy (group 2). Immunohistochemical characterization for bcl-xL expression was done. Follow up was done every 3 months for 12 to 36 months with a mean of 16 ± 10 months. All data were analyzed using SPSS version 16. Three years cumulative disease free survival was calculated and adjusted to Bcl-XL expression and side effects of the treatment were recorded. Results: The disease free cumulative survival was 48% for group 1 and 29% for group 2 (log rank p value 0.03). The multivariate predictors of tumor recurrence were the positive Bcl-XL expression (odd ratio 41.1, 95% CI 8.4 102.3, p 0.0001) and radiotherapy (odd ratio 0.19, 95% CI 0.05 - 0.78, p 0.02). With Cox regression, the only independent multivariate predictor of radio-sensitivity was the Bcl-XL expression with odd ratio 4.6 and a p value 0.0001. All patients tolerated the treatment with no life threatening or late complications during the period of follow up. Conclusions: Adjuvant radiotherapy for muscle invasive bilharzial related squamous cell carcinoma of the urinary bladder has potential effectiveness and minor side effects. Moreover, Bcl-XL expression is a valuable tool for predicting those who might not respond to this adjuvant treatment. B

Background: Local pelvic recurrence after radical cystectomy for muscle invasive bilharzial related squamous cell carcinoma accounts for 75% of treatment failures even in organ confined tumors. Despite the proven value of lymphadenectomy, up to 60% of patients undergoing cystectomy do not have it. These factors are in favor of adjuvant radiotherapy reevaluation. objectives: to evaluate the effect of adjuvant radiotherapy on disease free survival in muscle invasive bilharzial related squamous cell carcinoma of the urinary bladder and to test the predictability of radio-sensitivity using the anti apoptotic protein Bcl-XL. Methods: The study prospectively included 71 patients, (47 males, 24 females) with muscle invasive bilharzial related squamous cell carcinoma of the bladder (Stage pT2a-T3N0-N3M0) who underwent radical cystectomy in Assiut university hospitals between January 2005 and December 2006. Thirty eight patients received adjuvant radiotherapy to the pelvis in the dose of 50Gy/25 fractions/5 weeks (Group 1), while 33 patients did not receive adjuvant radiotherapy (group 2). Immunohistochemical characterization for bcl-xL expression was done. Follow up was done every 3 months for 12 to 36 months with a mean of 16 ± 10 months. All data were analyzed using SPSS version 16. Three years cumulative disease free survival was calculated and adjusted to Bcl-XL expression and side effects of the treatment were recorded. Results: The disease free cumulative survival was 48% for group 1 and 29% for group 2 (log rank p value 0.03). The multivariate predictors of tumor recurrence were the positive Bcl-XL expression (odd ratio 41.1, 95% CI 8.4 102.3, p 0.0001) and radiotherapy (odd ratio 0.19, 95% CI 0.05 - 0.78, p 0.02). With Cox regression, the only independent multivariate predictor of radio-sensitivity was the Bcl-XL expression with odd ratio 4.6 and a p value 0.0001. All patients tolerated the treatment with no life threatening or late complications during the period of follow up. Conclusions: Adjuvant radiotherapy for muscle invasive bilharzial related squamous cell carcinoma of the urinary bladder has potential effectiveness and minor side effects. Moreover, Bcl-XL expression is a valuable tool for predicting those who might not respond to this adjuvant treatment. B