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MP13-03 HRQOL IN PATIENTS UNDERWENT INTRAVESICAL INSTILLATION OF BCG OR MMC FOR NON-MUSCLE INVASIVE BLADDER CANCER
THE JOURNAL OF UROLOGYâ
e134
Vol. 195, No. 4S, Supplement, Friday, May 6, 2016
Bladder Cancer: Non-Invasive I Moderated Poster Friday, May 6, 2016
1:00 PM-3:00 PM
MP13-01 PREOPERATIVE NEUTROPHIL-TO-LYMPHOCYTE RATIO IS A USEFUL BIOMARKER FOR PREDICTING WORSE CLINICAL OUTCOME IN NON-MUSCLE INVASIVE BLADDER CANCER PATIENTS WITH A PREVIOUS HISTORY OF SMOKING. Koichiro Ogihara*, Eiji Kikuchi, Kazuyuki Yuge, Kazuhiro Matsumoto, Akira Miyajima, Tokyo, Japan; Hirotaka Asakura, Saitama, Japan; Mototsugu Oya, Tokyo, Japan INTRODUCTION AND OBJECTIVES: In a previous study we revealed that smoker patients with non-muscle invasive bladder cancer (NMIBC) had a significantly higher incidence of tumor recurrence and that refraining from smoking for more than 15 years could affect the prevention of subsequent tumor recurrence (2015 AUA). There is still no reliable biomarker for identifying a subgroup of patients with a smoking history and an inferior clinical outcome. We focused on the neutrophil-lymphocyte ratio (NLR), which is a simple index of systemic inflammation and a biomarker associated with tumor aggressiveness, and investigated whether elevated preoperative NLR (pre-NLR) could affect clinical outcome in NMIBC patients with a history of smoking. METHODS: We identified 301 cases who had a history of smoking and were treated by TURBT for NMIBC between 1999 and 2013. We evaluated the association between NLR and clinical outcome in patients who had a history of smoking. We defined patients in the elevated pre-NLR group using a cut-off of NLR of >2.5. The median follow-up period was 6.26 years. RESULTS: A total of 126 patients had elevated pre-NLR. The mean of cigarettes per day (CPD) and duration of smoking in patients with elevated pre-NLR were 1.09 and 34.4 years, respectively, values that were not significantly higher than those in their counterparts (1.06 and 34.5 years). There were no differences in clinico-pathological background between the patients with elevated pre-NLR and without elevated pre-NLR. Overall, 155 patients were former smokers. Of the former smokers, the mean duration of smoking cessation was 17.6 years in patients with elevated preNLR (N¼61), which was not significantly longer than that in their counterparts (14.7 years, p¼0.207). The 5-year recurrence free survival rates in patients with elevated pre-NLR was 19.2%, which was significantly lower than that in those without elevated pre-NLR (64.9%, p<0.001). Pre-NLR was an independent indicator for tumor recurrence (hazard ratio: HR, 3.38, p<0.001) in addition to not having undergone BCG therapy (HR, 1.78, p¼0.008). The 5-year progression free survival rate in patients with elevated pre-NLR was 89.6%, which was significantly lower than that in the patients without elevated pre-NLR (96.5%, p¼0.034). Pre-NLR (HR, 2.58, p¼0.048) and tumor multiplicity (HR, 4.74, p¼0.016) were independent indicators for progression. CONCLUSIONS: Pre-NLR might be a useful marker for identifying an inferior clinical outcome in NMIBC patients with a previous history of smoking.
MP13-02 IS RE-RESECTION NECESSARY? RE-RESECTION OF NONMUSCLE INVASIVE BLADDER CANCER AT A TERTIARY CARE CENTER Rano Matta*, Ashraf Al Matar, Bimal Bhindi, Alexander Zlotta, Neil Fleshner, Michael Jewett, Robert Hamilton, Antonio Finelli, Girish Kulkarni, Toronto, Canada INTRODUCTION AND OBJECTIVES: Re-staging transurethral resection (re-TUR) of T1 bladder tumors provides more accurate staging, and is associated with better local control. Re-TUR has been included in guidelines for management of non-muscle invasive bladder cancer since 2007. However, in practice, re-TUR has been questioned in the setting of perceived complete resection at initial TUR, amongst other patient and surgeon specific factors. We aimed to understand the practice patterns of re-TUR of T1 urothelial carcinoma at our center and its predictors. We also determined outcomes associated with re-TUR at a Canadian tertiary care center. METHODS: We retrospectively identified 358 consecutive patients with pT1 high grade urothelial carcinoma of the bladder who were treated at the University Health Network, Toronto, from 2000 to 2012. We excluded those who had metastatic disease on diagnosis, those treated primarily with cystectomy or chemotherapy/radiation after TURBT. Those treated with early cystectomy or chemotherapy/radiation after re-TUR were not included in the final cohort. Patients who did not undergo immediate/early cystectomy were offered adjuvant BCG therapy. The remaining 270 patients were included in the final analysis. We compared re-TUR rates in the pre- (2000-2008) and post-guideline (2009-2012) era. End points were time to recurrence, time to progression (defined as stage T2 or higher), and mortality. Univariate and multivariate analyses were used to determine any significant effect of patient specific factors (age, gender) and disease specific factors (associated CIS, muscle sampled, immediate chemotherapy) on proceeding for re-TUR. We also performed Cox-proportional hazard models to determine risk factors for recurrence, progression, and survival. RESULTS: The median age of the cohort was 68.9 years (1897) with a mean follow up 3.3 years (0.08-13.3 years). Re-TUR was performed in 109 patients (40%). The average re-TUR rate increased after 2008 from 31.6% to 51.3% (p¼0.038). There was residual tumor in 70% of re-TUR cases. Upstaging to T2 disease on re-TUR was seen in 16.5% of patients. There was residual pT1 in 29.4% of cases. Residual T1 disease at re-TUR was a significant risk factor for progression (HR 38.1; CI 5.9-246.6). Re-TUR was not a significant risk factor for recurrence, progression or mortality. CONCLUSIONS: Overall, re-TUR is an important therapy, decision-making and prognostication tool in NMIBC. However, in terms of the effectiveness of re-TUR on recurrence and progression, further prospective studies will provide more definitive information. Source of Funding: None.
MP13-03 HRQOL IN PATIENTS UNDERWENT INTRAVESICAL INSTILLATION OF BCG OR MMC FOR NON-MUSCLE INVASIVE BLADDER CANCER Salvatore Siracusano, Tommaso Silvestri*, Stefano Ciciliato, Laura Toffoli, Trieste, Italy; Francesco Visalli, Pordenone, Italy; Giacomo Di Cosmo, Renato Talamini, Trieste, Italy
Source of Funding: none INTRODUCTION AND OBJECTIVES: Non muscle-invasive bladder cancer (NMIBC) represents 70% of all bladder cancer (BC) and it is like a chronic disease due to its high recurrence rate, disease surveillance and treatment. In this context intravesical instillations and a long-term clinical monitoring goes to impact the Health-related Quality of Life (HRQoL) of the patients.
THE JOURNAL OF UROLOGYâ
Vol. 195, No. 4S, Supplement, Friday, May 6, 2016
Aim of this study was to evaluate HRQoL of patients affected by rin NMIBC underwent intravesical instillations of Bacillus Calmette-Gue (BCG) or Mytomicin C (MMC) with a short-term follow-up. METHODS: From December 2011 to December 2014 we recruited 108 consecutive patients in a single academic center with a first-time diagnosis of NMIBC at intermediate or high risk. The median age was 73 years (38-94) and 55.3% (N 57) patients underwent BCG and 44.7% (N 46) patients underwent MMC after TURBT respectively. The assessment of HRQoL was performed using two questionnaires from EORTC: QLQ-C30 and QLQ-BLS24 specific for NMIBC. Patients self-completed the questionnaires in three different times: T0 (before intravesical instillation), T1 (after intravesical instillation), T2 (at three months after last instillation). The above analysis was stratified by gender, age (?70 years and >70 years), tumour degree risk (intermediate and high risk) and type of intravesical therapy (MMC and BCG). Wilcoxon two sample test was used to verify differences. Statistical significance was achieved if pvalue was ¼0.05 (two-sides). RESULTS: Treatment was well tolerated in both groups of patients underwent intravesical instillations of BCG and MMC respectively. Grade I and II side effects, as CTCAE classification, were reported by 46.6% of patients at T1 and 47.5% at T2. 5 patients dropped out of the study (3 lost in follow-up and 2 developed side effects of BCG). At T1 we founded a drop in QoL, with reference to Physical, Role, Emotional and Social functioning domains and a worsening of urinary bladder symptoms with a generally decrease of Global Quality of Life Score. The sexual sphere was affected by adjuvant therapy with persistence or worsening of sexual disorders. At T2 patients showed a progressive return to baseline QoL, in particular in the Social and clinical symptoms domains. Male gender, age >70 years, high-risk tumours and BCG seem to be the factors that worsening HRQoL of these patients. CONCLUSIONS: Intravesical instillations seem to modify the HRQoL of these patients with a return at 3 months to baseline conditions.
e135
up the overall urinary pH for both before or after MMC instillation. Actually, the mean value of urinary pH before and after MMC instillation shifted from 6.000.65 to 6.470.72 and 6.490.62 to 7.260.45 following sodium bicarbonate administration. In spite of the urinary pH boosting effect of sodium bicarbonate, the concentration of active formed MMC did not altered significantly. As well as there was no correlation between urinary pH and the concentration of MMC, however voided urine volume had a correlation. No side effects graded > 2 of MMC instillation was observed during the study. CONCLUSIONS: The study showed that the urine alkalization using sodium bicarbonate was not helpful for the maintaining the intravesical concentration of MMC in NMIBC
Source of Funding: none
MP13-04 CONCENTRATION OF MITOMYCIN-C IN URINE ACCORDING TO URINE PH AFTER INTRAVESICAL INSTILLATION OF MITOMYCINC IN NON-MUSCLE INVASIVE BLADDER CANCER PATIENTS Sung Han Kim, Jae Young Joung, Jinsoo Chung, Kang Hyun Lee, Ho Kyung Seo*, Goyang, Korea, Republic of; Whi-An Kwon, Gunpo, Korea, Republic of; Sohee Kim, goyang, Korea, Republic of; Kyung-Ohk Ahn, Kyung-Chae Jeong, Sang-Jin Lee, Sooin Yun, Jungnam Joo, Sang-Hyun Hwang, Do-Hoon Lee, Goyang, Korea, Republic of; Dong Wan Sohn, Seoul, Korea, Republic of INTRODUCTION AND OBJECTIVES: The oral intake of sodium bicarbonate has been recommended to optimize intravesical mitomycin-C (MMC) therapy in non-muscle invasive bladder cancer (NMIBC). We investigated the efficacy of the oral bicarbonate to maintain the concentration of MMC METHODS: We prospectively enrolled 26 NMIBC patients after transurethral resection of a bladder tumor (TUR-BT). We excluded very high risk (T1G3 or CIS) and low risk (TaG1 and primary and single and <3cm and papillary) NMIBC. Urinary creatinine, pH and MMC concentration were determined just before and after intravesical MMC instillation. The patients were administered 1.5 gram of oral bicarbonate during the day before evening, in the morning and just before MMC instillation from the fourth cycle during six-cycled MMC instillation. The concentration of MMC was measured using HPLC and a spectrophotometer in extracted urine. The correlation between MMC concentration and urinary pH was analyzed with or without oral bicarbonate therapy. RESULTS: The median age of the patients was 69.5 (53-84) years old. Urinary pH was slightly increased after MMC instillation and the mean value before and after MMC instillaiton was 6.230.72 and 6.870.66, respectively. The oral intake of sodium bicarbonate forced
Source of Funding: This work was supported by two National Cancer Center Grants (NC1410550) of the Republic of Korea.
MP13-05 A RANDOMIZED TRIAL COMPARING TWO DIFFERENT RETENTION PERIODS OF INTRAVESICAL PIRARUBICIN INSTILLATION FOR INTERMEDIATE RISK NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) AFTER TRANSURETHRAL RESECTION. Ryoma Kurahashi*, Yutaka Kasejima, Yoshiaki Kawano, Wataru Takahashi, Takahiro Yamaguchi, Ken-ichiro Tanoue, Hiroshi Sakakida, Junji Yatsuda, Youji Murakami, Yutaka Sugiyama, Kumamoto, Japan; Masatoshi Eto, Fukuoka, Japan INTRODUCTION AND OBJECTIVES: Anthracyclines are recommended reagents for one immediate intravesical instillation after
e134
Vol. 195, No. 4S, Supplement, Friday, May 6, 2016
Bladder Cancer: Non-Invasive I Moderated Poster Friday, May 6, 2016
1:00 PM-3:00 PM
MP13-01 PREOPERATIVE NEUTROPHIL-TO-LYMPHOCYTE RATIO IS A USEFUL BIOMARKER FOR PREDICTING WORSE CLINICAL OUTCOME IN NON-MUSCLE INVASIVE BLADDER CANCER PATIENTS WITH A PREVIOUS HISTORY OF SMOKING. Koichiro Ogihara*, Eiji Kikuchi, Kazuyuki Yuge, Kazuhiro Matsumoto, Akira Miyajima, Tokyo, Japan; Hirotaka Asakura, Saitama, Japan; Mototsugu Oya, Tokyo, Japan INTRODUCTION AND OBJECTIVES: In a previous study we revealed that smoker patients with non-muscle invasive bladder cancer (NMIBC) had a significantly higher incidence of tumor recurrence and that refraining from smoking for more than 15 years could affect the prevention of subsequent tumor recurrence (2015 AUA). There is still no reliable biomarker for identifying a subgroup of patients with a smoking history and an inferior clinical outcome. We focused on the neutrophil-lymphocyte ratio (NLR), which is a simple index of systemic inflammation and a biomarker associated with tumor aggressiveness, and investigated whether elevated preoperative NLR (pre-NLR) could affect clinical outcome in NMIBC patients with a history of smoking. METHODS: We identified 301 cases who had a history of smoking and were treated by TURBT for NMIBC between 1999 and 2013. We evaluated the association between NLR and clinical outcome in patients who had a history of smoking. We defined patients in the elevated pre-NLR group using a cut-off of NLR of >2.5. The median follow-up period was 6.26 years. RESULTS: A total of 126 patients had elevated pre-NLR. The mean of cigarettes per day (CPD) and duration of smoking in patients with elevated pre-NLR were 1.09 and 34.4 years, respectively, values that were not significantly higher than those in their counterparts (1.06 and 34.5 years). There were no differences in clinico-pathological background between the patients with elevated pre-NLR and without elevated pre-NLR. Overall, 155 patients were former smokers. Of the former smokers, the mean duration of smoking cessation was 17.6 years in patients with elevated preNLR (N¼61), which was not significantly longer than that in their counterparts (14.7 years, p¼0.207). The 5-year recurrence free survival rates in patients with elevated pre-NLR was 19.2%, which was significantly lower than that in those without elevated pre-NLR (64.9%, p<0.001). Pre-NLR was an independent indicator for tumor recurrence (hazard ratio: HR, 3.38, p<0.001) in addition to not having undergone BCG therapy (HR, 1.78, p¼0.008). The 5-year progression free survival rate in patients with elevated pre-NLR was 89.6%, which was significantly lower than that in the patients without elevated pre-NLR (96.5%, p¼0.034). Pre-NLR (HR, 2.58, p¼0.048) and tumor multiplicity (HR, 4.74, p¼0.016) were independent indicators for progression. CONCLUSIONS: Pre-NLR might be a useful marker for identifying an inferior clinical outcome in NMIBC patients with a previous history of smoking.
MP13-02 IS RE-RESECTION NECESSARY? RE-RESECTION OF NONMUSCLE INVASIVE BLADDER CANCER AT A TERTIARY CARE CENTER Rano Matta*, Ashraf Al Matar, Bimal Bhindi, Alexander Zlotta, Neil Fleshner, Michael Jewett, Robert Hamilton, Antonio Finelli, Girish Kulkarni, Toronto, Canada INTRODUCTION AND OBJECTIVES: Re-staging transurethral resection (re-TUR) of T1 bladder tumors provides more accurate staging, and is associated with better local control. Re-TUR has been included in guidelines for management of non-muscle invasive bladder cancer since 2007. However, in practice, re-TUR has been questioned in the setting of perceived complete resection at initial TUR, amongst other patient and surgeon specific factors. We aimed to understand the practice patterns of re-TUR of T1 urothelial carcinoma at our center and its predictors. We also determined outcomes associated with re-TUR at a Canadian tertiary care center. METHODS: We retrospectively identified 358 consecutive patients with pT1 high grade urothelial carcinoma of the bladder who were treated at the University Health Network, Toronto, from 2000 to 2012. We excluded those who had metastatic disease on diagnosis, those treated primarily with cystectomy or chemotherapy/radiation after TURBT. Those treated with early cystectomy or chemotherapy/radiation after re-TUR were not included in the final cohort. Patients who did not undergo immediate/early cystectomy were offered adjuvant BCG therapy. The remaining 270 patients were included in the final analysis. We compared re-TUR rates in the pre- (2000-2008) and post-guideline (2009-2012) era. End points were time to recurrence, time to progression (defined as stage T2 or higher), and mortality. Univariate and multivariate analyses were used to determine any significant effect of patient specific factors (age, gender) and disease specific factors (associated CIS, muscle sampled, immediate chemotherapy) on proceeding for re-TUR. We also performed Cox-proportional hazard models to determine risk factors for recurrence, progression, and survival. RESULTS: The median age of the cohort was 68.9 years (1897) with a mean follow up 3.3 years (0.08-13.3 years). Re-TUR was performed in 109 patients (40%). The average re-TUR rate increased after 2008 from 31.6% to 51.3% (p¼0.038). There was residual tumor in 70% of re-TUR cases. Upstaging to T2 disease on re-TUR was seen in 16.5% of patients. There was residual pT1 in 29.4% of cases. Residual T1 disease at re-TUR was a significant risk factor for progression (HR 38.1; CI 5.9-246.6). Re-TUR was not a significant risk factor for recurrence, progression or mortality. CONCLUSIONS: Overall, re-TUR is an important therapy, decision-making and prognostication tool in NMIBC. However, in terms of the effectiveness of re-TUR on recurrence and progression, further prospective studies will provide more definitive information. Source of Funding: None.
MP13-03 HRQOL IN PATIENTS UNDERWENT INTRAVESICAL INSTILLATION OF BCG OR MMC FOR NON-MUSCLE INVASIVE BLADDER CANCER Salvatore Siracusano, Tommaso Silvestri*, Stefano Ciciliato, Laura Toffoli, Trieste, Italy; Francesco Visalli, Pordenone, Italy; Giacomo Di Cosmo, Renato Talamini, Trieste, Italy
Source of Funding: none INTRODUCTION AND OBJECTIVES: Non muscle-invasive bladder cancer (NMIBC) represents 70% of all bladder cancer (BC) and it is like a chronic disease due to its high recurrence rate, disease surveillance and treatment. In this context intravesical instillations and a long-term clinical monitoring goes to impact the Health-related Quality of Life (HRQoL) of the patients.
THE JOURNAL OF UROLOGYâ
Vol. 195, No. 4S, Supplement, Friday, May 6, 2016
Aim of this study was to evaluate HRQoL of patients affected by rin NMIBC underwent intravesical instillations of Bacillus Calmette-Gue (BCG) or Mytomicin C (MMC) with a short-term follow-up. METHODS: From December 2011 to December 2014 we recruited 108 consecutive patients in a single academic center with a first-time diagnosis of NMIBC at intermediate or high risk. The median age was 73 years (38-94) and 55.3% (N 57) patients underwent BCG and 44.7% (N 46) patients underwent MMC after TURBT respectively. The assessment of HRQoL was performed using two questionnaires from EORTC: QLQ-C30 and QLQ-BLS24 specific for NMIBC. Patients self-completed the questionnaires in three different times: T0 (before intravesical instillation), T1 (after intravesical instillation), T2 (at three months after last instillation). The above analysis was stratified by gender, age (?70 years and >70 years), tumour degree risk (intermediate and high risk) and type of intravesical therapy (MMC and BCG). Wilcoxon two sample test was used to verify differences. Statistical significance was achieved if pvalue was ¼0.05 (two-sides). RESULTS: Treatment was well tolerated in both groups of patients underwent intravesical instillations of BCG and MMC respectively. Grade I and II side effects, as CTCAE classification, were reported by 46.6% of patients at T1 and 47.5% at T2. 5 patients dropped out of the study (3 lost in follow-up and 2 developed side effects of BCG). At T1 we founded a drop in QoL, with reference to Physical, Role, Emotional and Social functioning domains and a worsening of urinary bladder symptoms with a generally decrease of Global Quality of Life Score. The sexual sphere was affected by adjuvant therapy with persistence or worsening of sexual disorders. At T2 patients showed a progressive return to baseline QoL, in particular in the Social and clinical symptoms domains. Male gender, age >70 years, high-risk tumours and BCG seem to be the factors that worsening HRQoL of these patients. CONCLUSIONS: Intravesical instillations seem to modify the HRQoL of these patients with a return at 3 months to baseline conditions.
e135
up the overall urinary pH for both before or after MMC instillation. Actually, the mean value of urinary pH before and after MMC instillation shifted from 6.000.65 to 6.470.72 and 6.490.62 to 7.260.45 following sodium bicarbonate administration. In spite of the urinary pH boosting effect of sodium bicarbonate, the concentration of active formed MMC did not altered significantly. As well as there was no correlation between urinary pH and the concentration of MMC, however voided urine volume had a correlation. No side effects graded > 2 of MMC instillation was observed during the study. CONCLUSIONS: The study showed that the urine alkalization using sodium bicarbonate was not helpful for the maintaining the intravesical concentration of MMC in NMIBC
Source of Funding: none
MP13-04 CONCENTRATION OF MITOMYCIN-C IN URINE ACCORDING TO URINE PH AFTER INTRAVESICAL INSTILLATION OF MITOMYCINC IN NON-MUSCLE INVASIVE BLADDER CANCER PATIENTS Sung Han Kim, Jae Young Joung, Jinsoo Chung, Kang Hyun Lee, Ho Kyung Seo*, Goyang, Korea, Republic of; Whi-An Kwon, Gunpo, Korea, Republic of; Sohee Kim, goyang, Korea, Republic of; Kyung-Ohk Ahn, Kyung-Chae Jeong, Sang-Jin Lee, Sooin Yun, Jungnam Joo, Sang-Hyun Hwang, Do-Hoon Lee, Goyang, Korea, Republic of; Dong Wan Sohn, Seoul, Korea, Republic of INTRODUCTION AND OBJECTIVES: The oral intake of sodium bicarbonate has been recommended to optimize intravesical mitomycin-C (MMC) therapy in non-muscle invasive bladder cancer (NMIBC). We investigated the efficacy of the oral bicarbonate to maintain the concentration of MMC METHODS: We prospectively enrolled 26 NMIBC patients after transurethral resection of a bladder tumor (TUR-BT). We excluded very high risk (T1G3 or CIS) and low risk (TaG1 and primary and single and <3cm and papillary) NMIBC. Urinary creatinine, pH and MMC concentration were determined just before and after intravesical MMC instillation. The patients were administered 1.5 gram of oral bicarbonate during the day before evening, in the morning and just before MMC instillation from the fourth cycle during six-cycled MMC instillation. The concentration of MMC was measured using HPLC and a spectrophotometer in extracted urine. The correlation between MMC concentration and urinary pH was analyzed with or without oral bicarbonate therapy. RESULTS: The median age of the patients was 69.5 (53-84) years old. Urinary pH was slightly increased after MMC instillation and the mean value before and after MMC instillaiton was 6.230.72 and 6.870.66, respectively. The oral intake of sodium bicarbonate forced
Source of Funding: This work was supported by two National Cancer Center Grants (NC1410550) of the Republic of Korea.
MP13-05 A RANDOMIZED TRIAL COMPARING TWO DIFFERENT RETENTION PERIODS OF INTRAVESICAL PIRARUBICIN INSTILLATION FOR INTERMEDIATE RISK NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC) AFTER TRANSURETHRAL RESECTION. Ryoma Kurahashi*, Yutaka Kasejima, Yoshiaki Kawano, Wataru Takahashi, Takahiro Yamaguchi, Ken-ichiro Tanoue, Hiroshi Sakakida, Junji Yatsuda, Youji Murakami, Yutaka Sugiyama, Kumamoto, Japan; Masatoshi Eto, Fukuoka, Japan INTRODUCTION AND OBJECTIVES: Anthracyclines are recommended reagents for one immediate intravesical instillation after