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PD17-11 THE IMPACT OF DIFFERENT BCG STRAINS ON OUTCOME IN A LARGE COHORT OF T1G3 PATIENTS TREATED WITH BCG.
THE JOURNAL OF UROLOGYâ
Vol. 193, No. 4S, Supplement, Saturday, May 16, 2015
for inclusion in the study. Patients who refused consent, those with coagulation disorders and those who had prior resection within two weeks were excluded. Eligible patients were randomized into two groups: Bipolar Group underwent transurethral resection of the bladder tumor with bipolar plasma kinetic energy and Monopolar group underwent conventional monopolar transurethral resection. Intraoperative and postoperative outcomes were recorded including the incidence of bladder perforation, obturator reflex, postoperative bleeding, hemoglobin decrease and resection time. RESULTS: A total of 311 transurethral resections were performed during the study period. Of them, 164 patients were eligible for randomization. Eighty-three patients were included in the monopolar resection group versus 81 in the bipolar group. Patients’ demographics were similar between both groups. The incidence of bladder perforation was greater in the monopolar group (13.2% vs. 2.4%, p ¼ 0.02). Similarly, obturator reflex occurred more frequently in the monopolar group (26.5% vs. 4.8% p¼0.01). Postoperative persistent bleeding and urine retention requiring reoperation occurred in one patient in the monopolar group. No statistically significant differences were observed between both groups with regards to resection time and hemoglobin deficit. CONCLUSIONS: Bipolar transurethral resection of bladder tumors is associated with lower incidence of obturator reflex and bladder perforation compared to monopolar resection. These findings support the benefit of bipolar over monopolar resection in management of laterally located bladder tumors. Source of Funding: none
PD17-11 THE IMPACT OF DIFFERENT BCG STRAINS ON OUTCOME IN A LARGE COHORT OF T1G3 PATIENTS TREATED WITH BCG. Paolo Gontero*, turin, Italy; Richard Sylvester, Bruxelles, Belgium; Francesca Pisano, Turin, Italy; Guido Dalbagni, New York, NY; Sharok Shariat, Vienna, Austria; Jeffrey Karnes, rochester, NY; Steven joniau, leuven, Belgium; Vincenzo Serretta, Palermo, Italy; Jouan Palou, Barcelona, Spain; Savino Di Stasi, Rome, Italy; , Oxford, United Kingdom; Renzo Colombo, Milan, Italy; Stephane Larre Marek Babjuk, Praga, Czech Republic; Per Uno Malmstrom, Uppsala, Sweden; Jaques Irani, Poitiers, France; Nuria Malats, madrid, Spain; Jack Baniel, Tel Aviv, Israel; Tommaso Cai, Trento, Italy; Eugene Cha, New York, NY; Petere Ardelt, Freiburg, Germany; Jhon varkarakis, Atene, Greece; Riccardo Bartoletti, Florence, Italy; Marthin Sphan, Wurtzburg, Germany; J Alfred Witjes, Nijmegen, Netherlands INTRODUCTION AND OBJECTIVES: There are few RCT’s comparing different BCG strains. As a consequence, there is limited information available on the difference in their efficacy in the treatment of patients with NMIBC. A trial from 1995 showed that an induction course BCG RIVM significantly reduced the number of recurrences compared to an induction course of BCG Tice [Vegt et al, J Urol 1995]. A recently published trial [Rentsch et al, Eur Urol 2014] also found an induction course of BCG Connaught to be significantly better in the reduction of recurrences than an induction course of BCG Tice. We retrospectively compared the outcomes after BCG Connaught and BCG Tice in a large study cohort of high risk NMIBC patients, and looked at recurrence, progression and cancer specific survival (CSS). METHODS: In a large multicenter retrospective cohort of 2451 primary T1G3 patients, information on the BCG strain was available for 2099 patients: 1546 on Connaught and 553 on TICE. 765 patients received maintenance BCG, 560 (36%) on Connaught and 205 (37%) on TICE. 1334 patients (64%) did not receive maintenance. Since there are imbalances in the distribution of prognostic factors in this non randomized comparison, multivariate analyses were done to adjust for the most important variables. RESULTS: When no maintenance was given, Connaught was more effective than TICE for the time to first recurrence (HR ¼ 1.34, p¼0.004) with a trend towards a longer time to death due to bladder cancer (HR ¼ 1.46, p ¼ 0.09). When maintenance was given, TICE was more effective than Connaught for the time to first recurrence (HR ¼
e385
0.64, p¼0.01) and the time to death due to bladder cancer (HR ¼ 0.37, p ¼ 0.04). Maintenance BCG reduced the risk of recurrence (p < 0.001) for both strains. For the time to progression, Connaught and TICE had a similar efficacy, however maintenance reduced the risk of progression compared to no maintenance only in the patients receiving TICE. CONCLUSIONS: We can confirm that, when no maintenance is used, BCG Connaught results in a lower recurrence rate as compared to BCG Tice. However, the opposite is true when maintenance is given. Rentsch et al suggested that the superiority of BCG Connaught is due to a superior immunogenicity, as they demonstrated in mice. Additionally they found genetic differences that may explain the differential efficacy of the two BCG strains. This is in line with findings by Secanella et al [J Urol 2013], showing Russian and Connaught BCG strains (an evolutionary early and late substrain) to be most effective in cell proliferation inhibition and cytokine response as compared to 6 other BCG strains, amongst which Tice BCG. Source of Funding: None
PD17-12 PATIENT COMPLIANCE WITH INTRAVESICAL MAINTENANCE PROTOCOLS FOR NON-MUSCLE INVASIVE BLADDER CANCER Alex Helfand*, Tel Aviv, Israel; Liat Shavit Grievink, Daniel Kedar, Ofer Yossepowitch, Andrei Nadu, Eli Rosenbaum, Jack Baniel, David Margel, Petah Tikva, Israel INTRODUCTION AND OBJECTIVES: Intravesical therapy with Bacillus Calmette-Guerin (BCG) or Mitomycin C (MMC) is the mainstay of treatment for non-muscle invasive urothilial carcinoma of the bladder after initial transurethral resection. Evidence suggests that after an initial induction course maintenance protocols, typically given on a monthly or Lam (three weeks out of every three months) schedule, are important to reduce recurrence and progression. Limited data exists on patient compliance to maintenance protocols outside of clinical trials. We report our “real-life” experience with compliance to intravesical maintenance. METHODS: We have compiled data on a cohort of patients who received intravesical therapy at Beilinson Hospital between 2000-2013. Patients were stratified to those treated with MMC and those treated with BCG. The primary outcome was patient compliance with maintenance treatment. “Non-compliance” was defined as termination of intravesical treatment without evidence of bladder tumor recurrence or progression. The possible predictors were patient related: age, gender, distance from hospital and ethnicity; as well as disease related: stage, grade and prior history of bladder cancer. We performed uni- and multivariable regression analyses to predict compliance to different maintenance protocols. RESULTS: During the study period 1117 patients received intravesical treatment at our institution ( 713 (59.3%) with BCG and 441 (36.7%) with MMC ). There was no difference (84% vs. 86%) in the rate of completion of six weeks of induction between patients treated with BCG vs. MMC. Within the BCG cohort, 242 (33.9%) patients commenced the Lam maintenance protocol after induction and 24 (9.9% of the Lam group) completed all 21 Lam treatment over three years. A monthly protocol for BCG was started by 118 BCG patients (16.5%) and 61 of them (52%) completed all nine treatments. MMC therapy was started in 441 patients, 134 of whom (30.4%) commenced monthly maintenance treatment, and 62 (46.3% of 134) completed nine months of treatment. MMC patients received a mean of 6.62 monthly treatments and BCG patients received a mean of 6.87 monthly treatments, but the average patient on the BCG Lam protocol received a mean of 9.71 treatments. On multi-variable analysis, the only variable that was independently associated with compliance to maintenance protocol was a history of bladder cancer. This was noted for BCG, as well as MMC. CONCLUSIONS: We demonstrated that compliance with maintenance protocols is poor. Further research is required to test whether compliance is also associated with outcome. Source of Funding: none
Vol. 193, No. 4S, Supplement, Saturday, May 16, 2015
for inclusion in the study. Patients who refused consent, those with coagulation disorders and those who had prior resection within two weeks were excluded. Eligible patients were randomized into two groups: Bipolar Group underwent transurethral resection of the bladder tumor with bipolar plasma kinetic energy and Monopolar group underwent conventional monopolar transurethral resection. Intraoperative and postoperative outcomes were recorded including the incidence of bladder perforation, obturator reflex, postoperative bleeding, hemoglobin decrease and resection time. RESULTS: A total of 311 transurethral resections were performed during the study period. Of them, 164 patients were eligible for randomization. Eighty-three patients were included in the monopolar resection group versus 81 in the bipolar group. Patients’ demographics were similar between both groups. The incidence of bladder perforation was greater in the monopolar group (13.2% vs. 2.4%, p ¼ 0.02). Similarly, obturator reflex occurred more frequently in the monopolar group (26.5% vs. 4.8% p¼0.01). Postoperative persistent bleeding and urine retention requiring reoperation occurred in one patient in the monopolar group. No statistically significant differences were observed between both groups with regards to resection time and hemoglobin deficit. CONCLUSIONS: Bipolar transurethral resection of bladder tumors is associated with lower incidence of obturator reflex and bladder perforation compared to monopolar resection. These findings support the benefit of bipolar over monopolar resection in management of laterally located bladder tumors. Source of Funding: none
PD17-11 THE IMPACT OF DIFFERENT BCG STRAINS ON OUTCOME IN A LARGE COHORT OF T1G3 PATIENTS TREATED WITH BCG. Paolo Gontero*, turin, Italy; Richard Sylvester, Bruxelles, Belgium; Francesca Pisano, Turin, Italy; Guido Dalbagni, New York, NY; Sharok Shariat, Vienna, Austria; Jeffrey Karnes, rochester, NY; Steven joniau, leuven, Belgium; Vincenzo Serretta, Palermo, Italy; Jouan Palou, Barcelona, Spain; Savino Di Stasi, Rome, Italy; , Oxford, United Kingdom; Renzo Colombo, Milan, Italy; Stephane Larre Marek Babjuk, Praga, Czech Republic; Per Uno Malmstrom, Uppsala, Sweden; Jaques Irani, Poitiers, France; Nuria Malats, madrid, Spain; Jack Baniel, Tel Aviv, Israel; Tommaso Cai, Trento, Italy; Eugene Cha, New York, NY; Petere Ardelt, Freiburg, Germany; Jhon varkarakis, Atene, Greece; Riccardo Bartoletti, Florence, Italy; Marthin Sphan, Wurtzburg, Germany; J Alfred Witjes, Nijmegen, Netherlands INTRODUCTION AND OBJECTIVES: There are few RCT’s comparing different BCG strains. As a consequence, there is limited information available on the difference in their efficacy in the treatment of patients with NMIBC. A trial from 1995 showed that an induction course BCG RIVM significantly reduced the number of recurrences compared to an induction course of BCG Tice [Vegt et al, J Urol 1995]. A recently published trial [Rentsch et al, Eur Urol 2014] also found an induction course of BCG Connaught to be significantly better in the reduction of recurrences than an induction course of BCG Tice. We retrospectively compared the outcomes after BCG Connaught and BCG Tice in a large study cohort of high risk NMIBC patients, and looked at recurrence, progression and cancer specific survival (CSS). METHODS: In a large multicenter retrospective cohort of 2451 primary T1G3 patients, information on the BCG strain was available for 2099 patients: 1546 on Connaught and 553 on TICE. 765 patients received maintenance BCG, 560 (36%) on Connaught and 205 (37%) on TICE. 1334 patients (64%) did not receive maintenance. Since there are imbalances in the distribution of prognostic factors in this non randomized comparison, multivariate analyses were done to adjust for the most important variables. RESULTS: When no maintenance was given, Connaught was more effective than TICE for the time to first recurrence (HR ¼ 1.34, p¼0.004) with a trend towards a longer time to death due to bladder cancer (HR ¼ 1.46, p ¼ 0.09). When maintenance was given, TICE was more effective than Connaught for the time to first recurrence (HR ¼
e385
0.64, p¼0.01) and the time to death due to bladder cancer (HR ¼ 0.37, p ¼ 0.04). Maintenance BCG reduced the risk of recurrence (p < 0.001) for both strains. For the time to progression, Connaught and TICE had a similar efficacy, however maintenance reduced the risk of progression compared to no maintenance only in the patients receiving TICE. CONCLUSIONS: We can confirm that, when no maintenance is used, BCG Connaught results in a lower recurrence rate as compared to BCG Tice. However, the opposite is true when maintenance is given. Rentsch et al suggested that the superiority of BCG Connaught is due to a superior immunogenicity, as they demonstrated in mice. Additionally they found genetic differences that may explain the differential efficacy of the two BCG strains. This is in line with findings by Secanella et al [J Urol 2013], showing Russian and Connaught BCG strains (an evolutionary early and late substrain) to be most effective in cell proliferation inhibition and cytokine response as compared to 6 other BCG strains, amongst which Tice BCG. Source of Funding: None
PD17-12 PATIENT COMPLIANCE WITH INTRAVESICAL MAINTENANCE PROTOCOLS FOR NON-MUSCLE INVASIVE BLADDER CANCER Alex Helfand*, Tel Aviv, Israel; Liat Shavit Grievink, Daniel Kedar, Ofer Yossepowitch, Andrei Nadu, Eli Rosenbaum, Jack Baniel, David Margel, Petah Tikva, Israel INTRODUCTION AND OBJECTIVES: Intravesical therapy with Bacillus Calmette-Guerin (BCG) or Mitomycin C (MMC) is the mainstay of treatment for non-muscle invasive urothilial carcinoma of the bladder after initial transurethral resection. Evidence suggests that after an initial induction course maintenance protocols, typically given on a monthly or Lam (three weeks out of every three months) schedule, are important to reduce recurrence and progression. Limited data exists on patient compliance to maintenance protocols outside of clinical trials. We report our “real-life” experience with compliance to intravesical maintenance. METHODS: We have compiled data on a cohort of patients who received intravesical therapy at Beilinson Hospital between 2000-2013. Patients were stratified to those treated with MMC and those treated with BCG. The primary outcome was patient compliance with maintenance treatment. “Non-compliance” was defined as termination of intravesical treatment without evidence of bladder tumor recurrence or progression. The possible predictors were patient related: age, gender, distance from hospital and ethnicity; as well as disease related: stage, grade and prior history of bladder cancer. We performed uni- and multivariable regression analyses to predict compliance to different maintenance protocols. RESULTS: During the study period 1117 patients received intravesical treatment at our institution ( 713 (59.3%) with BCG and 441 (36.7%) with MMC ). There was no difference (84% vs. 86%) in the rate of completion of six weeks of induction between patients treated with BCG vs. MMC. Within the BCG cohort, 242 (33.9%) patients commenced the Lam maintenance protocol after induction and 24 (9.9% of the Lam group) completed all 21 Lam treatment over three years. A monthly protocol for BCG was started by 118 BCG patients (16.5%) and 61 of them (52%) completed all nine treatments. MMC therapy was started in 441 patients, 134 of whom (30.4%) commenced monthly maintenance treatment, and 62 (46.3% of 134) completed nine months of treatment. MMC patients received a mean of 6.62 monthly treatments and BCG patients received a mean of 6.87 monthly treatments, but the average patient on the BCG Lam protocol received a mean of 9.71 treatments. On multi-variable analysis, the only variable that was independently associated with compliance to maintenance protocol was a history of bladder cancer. This was noted for BCG, as well as MMC. CONCLUSIONS: We demonstrated that compliance with maintenance protocols is poor. Further research is required to test whether compliance is also associated with outcome. Source of Funding: none