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1771 RANDOMISED PROSPECTIVE EVALUATION OF FLUORESCENCE FOR TRANSURETHRAL RESECTION OF THE BLADDER: WHAT IS THE REAL GAIN FOR DIAGNOSIS?
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THE JOURNAL OF UROLOGY姞
METHODS: Following Institutional Review Board approval, the records of 42 patients restaged within 3 months of initial ⱕT1 disease diagnosis were reviewed. Early cystectomy or conservative management was offered according to disease features at restaging TURBT (residual tumor volume, multifocality, presence of carcinoma in situ, lymphovascular invasion), or patient’s preference. We defined early cystectomy as cystectomy performed within a 3-month landmark after restaging TURBT. Other management (intravesical bacillus CalmetteGuerin, surveillance, or cystectomy after the landmark) was considered conservative. Overall and differences in survival probabilities were estimated using Kaplan-Meier methods and log rank test, respectively, starting at the landmark time. Confidence intervals (CI) for survival differences were estimated using bootstrap resampling. RESULTS: Median patient age was 68 years (range 40-93). Male to female ratio was 3.7:1. At restaging TURBT, stage distribution was 14 T0 (33%), 2 high-grade Ta (5%), 9 Tis (21%), and 17 highgrade T1 (41%). Eighteen (43%) patients underwent early cystectomy; 24 (57%) were managed conservatively. Rates of T0 stage upon restaging TURBT were similar (33% vs. 33%, p ⫽ 1) in both groups. Median follow-up time from landmark was 3.2 years for survivors. Kaplan-Meier estimate of 5-year survival probability (Figure 1) was 72% in the early cystectomy group (dashed line) and 69% in the conservative treatment group (solid line), with an absolute difference of 3% (95% CI: -21%, 14%). No significant differences in survival probabilities between the two groups was found throughout follow-up using the log rank test (p ⫽ 1). CONCLUSIONS: In our cohort of patients with T1 non-muscleinvasive micropapillary UC there was no significant difference in survival among patients treated conservatively or undergoing early cystectomy.
Vol. 189, No. 4S, Supplement, Tuesday, May 7, 2013
number of tumours detected using white (WL) and fluorescent (FL) light and their pathological features were recorded and compared between the two arms. RESULTS: One hundred and thirty-three men and 18 women (11.9%) aged 74 ⫾ 14 years had a first TURB, including 72 (47.7%) with HAL. The number of tumours visualised in WL and FL in patients with HAL was 2.66 ⫾ 2.26 and 3.04 ⫾ 2.54 respectively. In the 79 patients without HAL, 2.42 ⫾ 1.72 tumours were seen in WL. Twentytwo patients and 6 patients who had a cystectomy, respectively, for a muscle-invasive tumour or a T1G3 ⫹ CIS tumour diagnosed by the first TURB, 5 patients T0, 15 patients refusing the 2nd TURB (including 5 for Ta tumours of low grade and 5 due to worsening of their general condition), 2 intercurrent deaths from cardiac causes and 8 patients lost to follow-up have not had a 2nd TURB. Ninety-three patients (62%) had a 2nd REV. The number of tumours visualised in WL and FL in 43 patients who underwent the first TURB with HAL was 2.02 ⫾ 1.66 and 2.56 ⫾ 2.10 respectively. For the 50 patients who had the first TURB without HAL, the number of tumours visualised in WL and FL was 1.90 ⫾ 2.29 and 2.06 ⫾ 2.45 respectively. CONCLUSIONS: TURB with HAL fluorescence in patients with high grade urine cytology provides a gain in the number of tumours diagnosed compared to WL alone. This gain was observed during the first and 2nd with TURB with HAL. However, the differences observed in this prospective randomised study were not significant. With HAL when 1st TURB 74 ⫾ 14 years
Age % women
Without HAL when 1st TURB 74 ⫾ 14 years
p⫽ 0.93
11.1%
12.7%
0.77
Tumours (WL) 1st TURB
2.66 ⫾ 2.26
2.42 ⫾ 1.72
0.65
n (%) T2 diagnosed by 1st TURB
10 (14.3%)
15 (19.2%)
0.69
n (%) T2 diagnosed by 2nd TURB
1 (2.3%)
2 (4.0%)
0.54
n (%) cis diagnosed by 1st TURB
15 (21.7%)
13 (16.9%)
0.84
n (%) cis diagnosed by 2nd TURB
9 (20.9%)
14 (29.8%)
0.47
1,97 ⫾ 1,79
2,20 ⫾ 2,26
0.63
n (%) T0 diagnosed by 1st TURB
3 (4.6%)
5 (6.8%)
0.72
n (%) T0 diagnosed by 2nd TURB
23 (53.5%)
25 (48.0%)
0.25
Tumours (WL) 2nd TURB
Source of Funding: None
1772 REFLEX FLUORESCENCE IN-SITU HYBRIDIZATION (FISH) ASSAY FOR ATYPICAL URINARY CYTOLOGY IN BLADDER CANCER PATIENTS UNDERGOING SURVEILLANCE CYSTOSCOPY Source of Funding: None
1771 RANDOMISED PROSPECTIVE EVALUATION OF FLUORESCENCE FOR TRANSURETHRAL RESECTION OF THE BLADDER: WHAT IS THE REAL GAIN FOR DIAGNOSIS? Yann NEUZILLET*, Charlotte METHORST, Suresnes, France; Marc SCHNEIDER, Colmar, France; Mathieu ROUANNE, Thierry LEBRET, Henry BOTTO, Suresnes, France INTRODUCTION AND OBJECTIVES: To evaluate the gain provided by fluorescence for diagnostic cystoscopy during transurethral resection of bladder (TURB) in patients with at least one bladder tumor diagnosed by endoscopy, a priori non-muscle invasive, and high grade urine cytology. METHODS: Randomised prospective study. From November 2009 to September 2012, 151 patients were randomised in two centres for the first TURB with or without fluorescence using Hexaminolevulinate (HAL) instilled at least 1 hour before TURB. A second TURB with fluorescence was systematically programmed 6 weeks afterwards. The
Philip H. Kim*, Ranjit Sukhu, Billy H. Cordon, John P. Sfakianos, Daniel D. Sjoberg, Oscar Lin, Guido Dalbagni, Harry W. Herr, New York, NY INTRODUCTION AND OBJECTIVES: Chromosomal changes in normal appearing urothelium may precede visual evidence of recurrence or progression in patients on surveillance for non-muscle invasive bladder cancer (NMIBC). We report the results of reflex UroVysion FISH testing in NMIBC patients with atypical cytology but negative cystoscopy. METHODS: Patients on surveillance for NMIBC were followed with office flexible cystoscopy and urinary cytology every three to six months. Between March 2007 and February 2012, all surveillance patients with atypical cytology underwent reflexive FISH analysis. FISH was deemed uninformative if the submitted specimen did not have enough cells for analysis. All relevant clinical and pathologic data were reviewed. Recurrence-free (RFS) and progression-free survival (PFS) were estimated using Kaplan Meier analysis. Predictors for recurrence and progression were evaluated using univariate and multivariate Cox regression analyses. RESULTS: Of 500 patients who had FISH ordered reflexively for atypical cytology results during surveillance for NMIBC, 243 also
THE JOURNAL OF UROLOGY姞
METHODS: Following Institutional Review Board approval, the records of 42 patients restaged within 3 months of initial ⱕT1 disease diagnosis were reviewed. Early cystectomy or conservative management was offered according to disease features at restaging TURBT (residual tumor volume, multifocality, presence of carcinoma in situ, lymphovascular invasion), or patient’s preference. We defined early cystectomy as cystectomy performed within a 3-month landmark after restaging TURBT. Other management (intravesical bacillus CalmetteGuerin, surveillance, or cystectomy after the landmark) was considered conservative. Overall and differences in survival probabilities were estimated using Kaplan-Meier methods and log rank test, respectively, starting at the landmark time. Confidence intervals (CI) for survival differences were estimated using bootstrap resampling. RESULTS: Median patient age was 68 years (range 40-93). Male to female ratio was 3.7:1. At restaging TURBT, stage distribution was 14 T0 (33%), 2 high-grade Ta (5%), 9 Tis (21%), and 17 highgrade T1 (41%). Eighteen (43%) patients underwent early cystectomy; 24 (57%) were managed conservatively. Rates of T0 stage upon restaging TURBT were similar (33% vs. 33%, p ⫽ 1) in both groups. Median follow-up time from landmark was 3.2 years for survivors. Kaplan-Meier estimate of 5-year survival probability (Figure 1) was 72% in the early cystectomy group (dashed line) and 69% in the conservative treatment group (solid line), with an absolute difference of 3% (95% CI: -21%, 14%). No significant differences in survival probabilities between the two groups was found throughout follow-up using the log rank test (p ⫽ 1). CONCLUSIONS: In our cohort of patients with T1 non-muscleinvasive micropapillary UC there was no significant difference in survival among patients treated conservatively or undergoing early cystectomy.
Vol. 189, No. 4S, Supplement, Tuesday, May 7, 2013
number of tumours detected using white (WL) and fluorescent (FL) light and their pathological features were recorded and compared between the two arms. RESULTS: One hundred and thirty-three men and 18 women (11.9%) aged 74 ⫾ 14 years had a first TURB, including 72 (47.7%) with HAL. The number of tumours visualised in WL and FL in patients with HAL was 2.66 ⫾ 2.26 and 3.04 ⫾ 2.54 respectively. In the 79 patients without HAL, 2.42 ⫾ 1.72 tumours were seen in WL. Twentytwo patients and 6 patients who had a cystectomy, respectively, for a muscle-invasive tumour or a T1G3 ⫹ CIS tumour diagnosed by the first TURB, 5 patients T0, 15 patients refusing the 2nd TURB (including 5 for Ta tumours of low grade and 5 due to worsening of their general condition), 2 intercurrent deaths from cardiac causes and 8 patients lost to follow-up have not had a 2nd TURB. Ninety-three patients (62%) had a 2nd REV. The number of tumours visualised in WL and FL in 43 patients who underwent the first TURB with HAL was 2.02 ⫾ 1.66 and 2.56 ⫾ 2.10 respectively. For the 50 patients who had the first TURB without HAL, the number of tumours visualised in WL and FL was 1.90 ⫾ 2.29 and 2.06 ⫾ 2.45 respectively. CONCLUSIONS: TURB with HAL fluorescence in patients with high grade urine cytology provides a gain in the number of tumours diagnosed compared to WL alone. This gain was observed during the first and 2nd with TURB with HAL. However, the differences observed in this prospective randomised study were not significant. With HAL when 1st TURB 74 ⫾ 14 years
Age % women
Without HAL when 1st TURB 74 ⫾ 14 years
p⫽ 0.93
11.1%
12.7%
0.77
Tumours (WL) 1st TURB
2.66 ⫾ 2.26
2.42 ⫾ 1.72
0.65
n (%) T2 diagnosed by 1st TURB
10 (14.3%)
15 (19.2%)
0.69
n (%) T2 diagnosed by 2nd TURB
1 (2.3%)
2 (4.0%)
0.54
n (%) cis diagnosed by 1st TURB
15 (21.7%)
13 (16.9%)
0.84
n (%) cis diagnosed by 2nd TURB
9 (20.9%)
14 (29.8%)
0.47
1,97 ⫾ 1,79
2,20 ⫾ 2,26
0.63
n (%) T0 diagnosed by 1st TURB
3 (4.6%)
5 (6.8%)
0.72
n (%) T0 diagnosed by 2nd TURB
23 (53.5%)
25 (48.0%)
0.25
Tumours (WL) 2nd TURB
Source of Funding: None
1772 REFLEX FLUORESCENCE IN-SITU HYBRIDIZATION (FISH) ASSAY FOR ATYPICAL URINARY CYTOLOGY IN BLADDER CANCER PATIENTS UNDERGOING SURVEILLANCE CYSTOSCOPY Source of Funding: None
1771 RANDOMISED PROSPECTIVE EVALUATION OF FLUORESCENCE FOR TRANSURETHRAL RESECTION OF THE BLADDER: WHAT IS THE REAL GAIN FOR DIAGNOSIS? Yann NEUZILLET*, Charlotte METHORST, Suresnes, France; Marc SCHNEIDER, Colmar, France; Mathieu ROUANNE, Thierry LEBRET, Henry BOTTO, Suresnes, France INTRODUCTION AND OBJECTIVES: To evaluate the gain provided by fluorescence for diagnostic cystoscopy during transurethral resection of bladder (TURB) in patients with at least one bladder tumor diagnosed by endoscopy, a priori non-muscle invasive, and high grade urine cytology. METHODS: Randomised prospective study. From November 2009 to September 2012, 151 patients were randomised in two centres for the first TURB with or without fluorescence using Hexaminolevulinate (HAL) instilled at least 1 hour before TURB. A second TURB with fluorescence was systematically programmed 6 weeks afterwards. The
Philip H. Kim*, Ranjit Sukhu, Billy H. Cordon, John P. Sfakianos, Daniel D. Sjoberg, Oscar Lin, Guido Dalbagni, Harry W. Herr, New York, NY INTRODUCTION AND OBJECTIVES: Chromosomal changes in normal appearing urothelium may precede visual evidence of recurrence or progression in patients on surveillance for non-muscle invasive bladder cancer (NMIBC). We report the results of reflex UroVysion FISH testing in NMIBC patients with atypical cytology but negative cystoscopy. METHODS: Patients on surveillance for NMIBC were followed with office flexible cystoscopy and urinary cytology every three to six months. Between March 2007 and February 2012, all surveillance patients with atypical cytology underwent reflexive FISH analysis. FISH was deemed uninformative if the submitted specimen did not have enough cells for analysis. All relevant clinical and pathologic data were reviewed. Recurrence-free (RFS) and progression-free survival (PFS) were estimated using Kaplan Meier analysis. Predictors for recurrence and progression were evaluated using univariate and multivariate Cox regression analyses. RESULTS: Of 500 patients who had FISH ordered reflexively for atypical cytology results during surveillance for NMIBC, 243 also