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A randomized Phase III study comparing Immucyst® versus Oncotice®: The BCG strain used makes a difference!
Abstract: 1672
Date & Time: May 22, 2012 10:30 AM
Session Title: Bladder Cancer: Superficial I
Sources of Funding: none
Introduction and Objectives
Immune modulation with intravesical BCG remains the mainstay in the treatment of non muscle invasive bladder cancer. The question whether the strain used may have an influence on recurrence and survival rate is still under debate. We report on a randomized Phase III study comparing the 2 strains used most frequently in Europe Connaught versus Tice.
Methods
This study was performed with the approval of the Cantonal Ethical Committee of the Canton Bern. Patients (n=149) underwent transurethral resection of all visible bladder tumors and random bladder biopsies in case of a positive bladder wash cytology. TaG3 and T1G3 tumors underwent a second resection. Patients were randomized to receive intravesical instillations with either 5x108 CFU Onco-Tice (Arm A) or 1.5 - 5x108 CFU ImmuCyst (BCG Connaught) (Arm B) dissolved in 50 ml of saline according to manufacturers recommendations in weekly intervals for 6 weeks, the first instillation being performed 2 to 15 days after TURBT. Six weeks after the end of the treatment the pa¬tients were evaluated by cystoscopy and bladder wash cytology. Patients were followed in 3-monthly intervals for 3yrs, then in 6-monthly intervals. All cystoscop¬ically visible lesions were biopsied. A relapse was diagnosed only if the lesion was confirmed histologically. An intravenous urography or CT scan was performed after 1 and 3 yrs. Cox regression analysis was performed and if possible in addition a Logrank Test (survdiff).
Results
Tumor stage and grade were well balanced between the 2 treatment arms (p=0.38). Median follow up was 25 months (range: 0.3-136). Side effects did not differ between the two treatment arms (p=0.42). Age and gender did not have an impact on treatment response (p=0.71). Five year recurrence-free survival for all patients was 61%. Patients treated with Connaught had significantly less recurrences than patients treated with OncoTice (p<0.002). Five year recurrence-free survival was 75% and 46% for Connaught and Oncotice treated patients, respectively. Median recurrence-free survival was 28 months (range: 0.6-136) for Connaught and 22 months (range: 0.3-122) for OncoTice treated patients. There was no significant difference in overall survival. Progression-free survival was not significantly different between the two treatment arms. The 5-year progression-free survival was 87% and 95% for Connaught and OncoTice, respectively (p=0.059).
Conclusions
The BCG strain used has a significant impact on recurrence, but not on overall survival in the treatment of non muscle invasive bladder cancer.
Date & Time: May 22, 2012 10:30 AM
Session Title: Bladder Cancer: Superficial I
Sources of Funding: none
Introduction and Objectives
Immune modulation with intravesical BCG remains the mainstay in the treatment of non muscle invasive bladder cancer. The question whether the strain used may have an influence on recurrence and survival rate is still under debate. We report on a randomized Phase III study comparing the 2 strains used most frequently in Europe Connaught versus Tice.
Methods
This study was performed with the approval of the Cantonal Ethical Committee of the Canton Bern. Patients (n=149) underwent transurethral resection of all visible bladder tumors and random bladder biopsies in case of a positive bladder wash cytology. TaG3 and T1G3 tumors underwent a second resection. Patients were randomized to receive intravesical instillations with either 5x108 CFU Onco-Tice (Arm A) or 1.5 - 5x108 CFU ImmuCyst (BCG Connaught) (Arm B) dissolved in 50 ml of saline according to manufacturers recommendations in weekly intervals for 6 weeks, the first instillation being performed 2 to 15 days after TURBT. Six weeks after the end of the treatment the pa¬tients were evaluated by cystoscopy and bladder wash cytology. Patients were followed in 3-monthly intervals for 3yrs, then in 6-monthly intervals. All cystoscop¬ically visible lesions were biopsied. A relapse was diagnosed only if the lesion was confirmed histologically. An intravenous urography or CT scan was performed after 1 and 3 yrs. Cox regression analysis was performed and if possible in addition a Logrank Test (survdiff).
Results
Tumor stage and grade were well balanced between the 2 treatment arms (p=0.38). Median follow up was 25 months (range: 0.3-136). Side effects did not differ between the two treatment arms (p=0.42). Age and gender did not have an impact on treatment response (p=0.71). Five year recurrence-free survival for all patients was 61%. Patients treated with Connaught had significantly less recurrences than patients treated with OncoTice (p<0.002). Five year recurrence-free survival was 75% and 46% for Connaught and Oncotice treated patients, respectively. Median recurrence-free survival was 28 months (range: 0.6-136) for Connaught and 22 months (range: 0.3-122) for OncoTice treated patients. There was no significant difference in overall survival. Progression-free survival was not significantly different between the two treatment arms. The 5-year progression-free survival was 87% and 95% for Connaught and OncoTice, respectively (p=0.059).
Conclusions
The BCG strain used has a significant impact on recurrence, but not on overall survival in the treatment of non muscle invasive bladder cancer.
Authors
Birkhaeuser, Frederic D. (Bern, Switzerland); Rentsch, Cyrill A.; Studer, Urs E.; Albert, Matthew L.; Thalmann, George N.