- Email: [email protected]
POD-06.09: Robotic Partial Nephrectomy for Complex Renal Cell Carcinoma
PODIUM SESSIONS
those that were completely ablated. However, none of the studied factors were found to predict local tumour recurrence during follow-up. Conclusions: Ultrasound guided percutaneous RFA is a feasible technique with the advantage of being reasonably easy to repeat if needed. Signs of local recurrence are occurring throughout the follow-up in a substantial proportion of treated patients, necessitating close and prolonged imaging surveillance in all of these patients.
POD-06.06 The Safety of Radiofrequency Ablation for Renal Tumor Based on Renal Biopsy After 6 Months Sung G, Kim T, Yoon JH Department of Urology, College of Medicine, Dong-A University, Busan, South Korea Purpose: To report safety of nephronsparing radiofrequency ablation (RFA) of renal tumor based on renal biopsy after 6 months. Materials and Methods: A total of 65 patients underwent radiofrequency ablation of renal tumor between June 2004 to October 2008. 55 cases of combined Computed tomography (CT) and ultrasonogram-guided percutaneous RFA and 10 intraoperative ultrasonograpy-guided laparoscopic RFA were performed. Kidney CT/MRI were performed at day 1, 1 week, 1 month, 3 months, 6 months, 1 year after ablation, thereafter, semi-annually. At 6 months, we performed the renal biopsy to patients underwent RFA for confirmation of remnant tumor. 37 of 65 patients were performed to renal biopsy at 6 month after RFA. The mean follow-up duration was 11.7 months (range, 6-16 months). The biopsy has done 7 cores around the site performed RFA. Results: The mean age was 61.3 years and mean tumor size was 3.1 cm. In 17 patients with confirmation of remnant tumor in follow up CT, repeat RFA has done at 1 or 3 months. The others has finished to one session. At 6 month follow up biopsy, 1 patient showed remnant tumor, the others showed no tumor. Conclusions: At the 2007 AUA meeting, one report showed high remnant tumor rate at 6 month renal biopsy after RFA. But, In our study, the result showed opposite data. In our center, the 6-month postoperative biopsy data of RFA lesion is on the way. The ultimate role of this modality will continue to evolve and warrant further studies.
POD-06.07 Rationale for a Less Aggressive Therapy for Small Renal Tumors Tsivian M, Mouraviev V, Kimura M, Mayes J, Albala D, Robertson C, Walther P, Polascik T Duke University Medical Center, Durham, NC, USA Introduction: Currently, most renal masses are detected incidentally on imaging for unrelated problems. Small renal masses, amenable to nephron-sparing procedures are frequently encountered. We evaluated the influence of tumor size on pathological characteristics of the lesion to determine whether less aggressive treatment may be appropriate for smaller renal lesions. Methods: We retrospectively reviewed medical records of patients who underwent a partial nephrectomy for a solitary enhancing lesion suspected to be renal cell carcinoma (RCC) between 2000-2008. Cases of known von Hippel Lindau syndrome were excluded from the analysis. Pathological features were analyzed and correlated to radiologically measured tumor size. Results: We identified 243 records matching the criteria. Mean tumor size was 2.93 (⫾1.60) cm. Pathology reports showed RCC in 179 (73.7%) specimens, benign tumors in 45 (18.5%) and no tumor in 19 (7.8%). Benign tumors were found in 25.5% of lesions ⬍2cm and 16.5% of larger lesions. No tumor was found in 14.5% of ⬍2cm lesions and 5.9% of larger lesions (p⫽0.021). RCC was pathologically confirmed in only 60% of smaller kidney lesions. Moreover, pathologically confirmed RCC lesions ⬍2cm by imaging had a significantly lower mean Fuhrman grade (1.09 vs 1.4, p⫽0.037). There were no grade 3 and 1 grade 4 RCC among tumors ⬍2cm. Conclusion: Among patients treated with partial nephrectomy, our experience reveals that solitary kidney lesions ⬍2cm suspected to be RCC are malignant by final pathology in only 60% of cases. Additionally, small sized RCC lesions are mostly low (1-2) grade. These findings suggest possible overtreatment of small suspicious lesions that may be adequately treated with less invasive modalities or even carefully followed.
POD-06.08 Transperitoneal Versus Retroperitoneal Laparoscopic Radical Nephrectomy: Comparison of Operative and Postoperative Course and Outcome Safwat A1, Bissada N2, Kumar U2, Madi R2, Miedema M2
UROLOGY 74 (Supplment 4A), October 2009
1
Assiut University, Assiut, Egypt, Assiut, Egypt; 2University of Arkansas for Medical Sciences, Little Rock, AR, USA Introduction and Objective: The aim of this study is to compare the outcome of transperitoneal versus retroperitoneal laparoscopic radical nephrectomy for renal cell carcinoma (RCC). Materials and Methods: A total of 82 patients (62 males and 20 females) underwent laparoscopic radical nephrectomy for stage T1 and T2 RCC from March 2002 to March 2007. Of the 82 patients, 46 (56%) were managed with retroperitoneal (RP-LRN) and 36 (44%) were managed with transperitoneal laparoscopic radical nephrectomy (TP-LRN). Both groups were compared regarding operative time, blood loss, complications, hospital stay and outcome. Results: Mean operative times for RP-LRN and TP-LRN were 186 and 231 min, and mean blood loss was 100 and 448.5 ml respectively. Mean hospital stay for RPLRN and TP-LRN were 2.8 and 3.4 days respectively. No complications were encountered for the RP-LRN group while intra-operative complications were encountered in 9 patients (25%) in the form of bleeding in 7, gall bladder injury in one and splenic lacerations in one patient. Intra-operative complications for TP-LRN were managed with conversion to hand assisted laparoscopic nephrectomy in five patients. Conclusions: RP-LRN by the same surgeons seems to result in shorter operative time, less blood loss, shorter hospital stay and fewer complications than TP-LRN. POD-06.09 Robotic Partial Nephrectomy for Complex Renal Cell Carcinoma Gong Y, Du C, Josephson D, Wilson T, Nelson R Department of Urology, 2nd Affiliated Hospital, Zhejiang University Medical College, Hangzhou, China Introduction and Objectives: Laparoscopic partial nephrectomy remains challenging to even experienced laparoscopists. Complex renal tumors add an additional challenge to a minimally invasive approach to nephron-sparing surgery. We represented our technique and results of robotic partial nephrectomy (RPN) for hilar, endophytic, and multiple renal tumors. Materials and Methods: Between May 2006 and March 2008, 29 patients with complex renal tumors underwent RPN, including hilar (n⫽14), endophytic (n⫽12) and multiple tumors (n⫽3). All the hilar vessels were clamped with lapa-
S19
PODIUM SESSIONS
roscopic bulldog with warm ischemia. The perioperative data and pathologic results were retrospectively reviewed. Results: Robotic partial nephrectomy procedures were performed successfully without complications. The mean diameter of tumors was 3.0 cm (range 2.0-4.0). The mean operative time was 197 minutes (range 172-259), and the mean blood loss was 220 mL (range 100 –370). The mean warm ischemia time was 25 minutes (range 16 – 43). The hospital stay averaged 2.5 days (range 2-3). Histopathology confirmed clear-cell renal cell carcinoma (n⫽21), chromophobe cell carcinoma (n⫽4), hybrid oncocytic tumor (n⫽2), oncocytoma (n⫽1), and cystic renal cell carcinoma (n⫽1). All cases had negative surgical margins. At the 3-23 months (mean of 15 mo) follow up, no patients experienced a significant change in serum creatinine level or estimated glomerular filtration rate compared to preoperative levels and there was no evidence of tumor recurrence. Conclusions: Robotic partial nephrectomy is a safe and feasible procedure. RPN is a preferred approach for complex renal tumors when nephron-sparing surgery is indicated. For complex and technical challenging renal tumors, robotic assistance may provide patients the benefit of minimally invasive surgery. POD-06.10 Partial or Radical Nephrectomy for Renal Cortical Tumours: Oncological and Functional Results Medina Polo J1, Romero Otero J1, Domı´nguez Esteban M1, Almonacid Grunert J1, Rodrı´guez Antolı´n A1, Passas Martı´nez J1, Castellano Gauna D1, Villacampa Auba´ F1, Go ´ mez Ca´mara A2, ´1 Lora Pablos D2, Leiva Galvis O 1 2 Department of Urology, Department of Epidemiology, Hospital Universitario 12 De Octubre, Madrid, Spain Introduction: Radical nephrectomy has been the gold standard treatment for localised renal cortical tumours for nearly 40 years. However, partial nephrectomy is currently an adequate treatment for small cortical tumours, without compromising safety and oncological efficacy. Our purpose is to evaluate the renal function and the oncologic results of both techniques. Materials and Methods: We did a retrospective study of 290 patients who underwent a nephrectomy for solitary renal cortical tumours lower than seven centimetres in our centre. We compared 174 radical nephrectomies performed between 1998 and 2008, and 116 partial
S20
nephrectomies performed between 1989 and 2008. Preoperative characteristics including body mass index (BMI), comorbidities and glomerular filtration rate prior to surgery were recorded to ensure no significant differences between both groups. Glomerular filtration rate was estimated with the abbreviated Modification of Diet in Renal Disease (MDRD4) study equation. Chronic kidney disease was defined mild, moderate and severe as an MDRD4 lower than 60, 40 y 20mL/min/ 1.73m2, respectively. We analyzed the mean change in glomerular filtration rate between both groups 6, 12, 24 y 36 months after the surgery. We compared the renal function curves for renal filtration of 60, 40 y 20mL/min/1.73m2. The oncologic results were evaluated using the overall survival rate and the cancer-specific survival rate. Results: Six months after the surgery, patients undergoing radical nephrectomy had a greater decrease in glomerular filtration rate than those undergoing partial nephrectomy (25 vs 7 mL/min/1.73m2). This difference remained throughout the time (p⬍0.0001). However, this decrease in glomerular filtration rate did not imply a higher probability of developing mild, moderate or severe chronic kidney failure. Patients undergoing partial nephrectomy had statistically significant higher overall survival rates (p⫽0.034); however the data indicated no significant difference in cancer-specific survival between patients undergoing partial nephrectomy and those who underwent radical nephrectomy (p⫽0.079). Conclusion: It is our conclusion that partial nephrectomy must be considered the first option in selected cases of renal cortical renal lower than seven centimetres. Partial nephrectomy provides equivalent oncological results, higher survival rate, and preserves kidney function.
Podium Session 7: Bladder Cancer Tuesday, November 3, 13:30-15:10 POD-07.01 Hexaminolevulinate New Data: Results from the Recurrence Study Grossman HB1, Mynderse L2, Stenzl A3, Burger M4, Fradet Y5, Soloway M6, Zaak D7, Kriegmair M8, Witjes A9
1
Department of Urology, MD Anderson Cancer Center, Houston, TX, USA; 2Department of Urology, Mayo Clinic, Rochester, MN, USA; 3Department of Urology, Eberhard Karls University, Tu ¨ bingen, Germany; 4Department of Urology at St. Josef’s Hospital, Regensburg University, Regensburg, Germany; 5Department of Urology, Universite´ Laval, Quebec City, QC, Canada; 6Department of Urology, University of Miami School of Medicine, Miami, FL, USA; 7In and Out Clinic for Urology, Ludwig-Maximilians-University, Munich, Germany; 8Clinic of Urology, Mu ¨ nchen-Planegg, Planegg, Germany; 9 Department of Urology, Radboud University Medical Centre, Nijmegen, The Netherlands Introduction and Objectives: This study was developed to determine if improved detection and resection of papillary tumors with hexaminolevulinate enabled fluorescence would decrease the rate of tumor recurrence compared to resection under white light. Endpoints included both detection and recurrence. Materials and Methods: This study is a prospective, randomized, multicenter international investigation of patients with papillary (Ta, T1) non-muscle invasive bladder cancer at high risk for recurrence. All patients were first examined under white light, and all bladder lesions were mapped. Patients randomized to receive hexaminolevulinate were instilled with hexaminolevulinate prior to the cystoscopic procedure and had a second inspection and mapping under blue light. All tumors were resected, and all suspicious lesions were biopsied. Patients who received hexaminolevulinate had the adequacy of tumor resection verified under blue light. Patients found to have T1, G3 tumors received 6 weeks of BCG. Surveillance cystoscopy was performed under white light 3, 6, and 9 months after initial resection. Tumor recurrences were verified by biopsy. Results: Seven hundred and sixty-six patients were randomized in 28 US and European centers and comprised the intent to treat population (ITT). For the detection endpoint, 16.4% of the 286 patients who had Ta or T1 disease randomized to receive hexaminolevulinate were found to have at least one additional Ta/T1 tumor (p⫽ 0.0011). Furthermore, among the patients randomized to hexaminolevulinate, CIS was found only under fluorescence conditions only in 13/41 (32%) patients with CIS. The recurrence endpoint was assessed in 551 patients with Ta or T1 tumors. Both in the ITT and per proto-
UROLOGY 74 (Supplment 4A), October 2009
those that were completely ablated. However, none of the studied factors were found to predict local tumour recurrence during follow-up. Conclusions: Ultrasound guided percutaneous RFA is a feasible technique with the advantage of being reasonably easy to repeat if needed. Signs of local recurrence are occurring throughout the follow-up in a substantial proportion of treated patients, necessitating close and prolonged imaging surveillance in all of these patients.
POD-06.06 The Safety of Radiofrequency Ablation for Renal Tumor Based on Renal Biopsy After 6 Months Sung G, Kim T, Yoon JH Department of Urology, College of Medicine, Dong-A University, Busan, South Korea Purpose: To report safety of nephronsparing radiofrequency ablation (RFA) of renal tumor based on renal biopsy after 6 months. Materials and Methods: A total of 65 patients underwent radiofrequency ablation of renal tumor between June 2004 to October 2008. 55 cases of combined Computed tomography (CT) and ultrasonogram-guided percutaneous RFA and 10 intraoperative ultrasonograpy-guided laparoscopic RFA were performed. Kidney CT/MRI were performed at day 1, 1 week, 1 month, 3 months, 6 months, 1 year after ablation, thereafter, semi-annually. At 6 months, we performed the renal biopsy to patients underwent RFA for confirmation of remnant tumor. 37 of 65 patients were performed to renal biopsy at 6 month after RFA. The mean follow-up duration was 11.7 months (range, 6-16 months). The biopsy has done 7 cores around the site performed RFA. Results: The mean age was 61.3 years and mean tumor size was 3.1 cm. In 17 patients with confirmation of remnant tumor in follow up CT, repeat RFA has done at 1 or 3 months. The others has finished to one session. At 6 month follow up biopsy, 1 patient showed remnant tumor, the others showed no tumor. Conclusions: At the 2007 AUA meeting, one report showed high remnant tumor rate at 6 month renal biopsy after RFA. But, In our study, the result showed opposite data. In our center, the 6-month postoperative biopsy data of RFA lesion is on the way. The ultimate role of this modality will continue to evolve and warrant further studies.
POD-06.07 Rationale for a Less Aggressive Therapy for Small Renal Tumors Tsivian M, Mouraviev V, Kimura M, Mayes J, Albala D, Robertson C, Walther P, Polascik T Duke University Medical Center, Durham, NC, USA Introduction: Currently, most renal masses are detected incidentally on imaging for unrelated problems. Small renal masses, amenable to nephron-sparing procedures are frequently encountered. We evaluated the influence of tumor size on pathological characteristics of the lesion to determine whether less aggressive treatment may be appropriate for smaller renal lesions. Methods: We retrospectively reviewed medical records of patients who underwent a partial nephrectomy for a solitary enhancing lesion suspected to be renal cell carcinoma (RCC) between 2000-2008. Cases of known von Hippel Lindau syndrome were excluded from the analysis. Pathological features were analyzed and correlated to radiologically measured tumor size. Results: We identified 243 records matching the criteria. Mean tumor size was 2.93 (⫾1.60) cm. Pathology reports showed RCC in 179 (73.7%) specimens, benign tumors in 45 (18.5%) and no tumor in 19 (7.8%). Benign tumors were found in 25.5% of lesions ⬍2cm and 16.5% of larger lesions. No tumor was found in 14.5% of ⬍2cm lesions and 5.9% of larger lesions (p⫽0.021). RCC was pathologically confirmed in only 60% of smaller kidney lesions. Moreover, pathologically confirmed RCC lesions ⬍2cm by imaging had a significantly lower mean Fuhrman grade (1.09 vs 1.4, p⫽0.037). There were no grade 3 and 1 grade 4 RCC among tumors ⬍2cm. Conclusion: Among patients treated with partial nephrectomy, our experience reveals that solitary kidney lesions ⬍2cm suspected to be RCC are malignant by final pathology in only 60% of cases. Additionally, small sized RCC lesions are mostly low (1-2) grade. These findings suggest possible overtreatment of small suspicious lesions that may be adequately treated with less invasive modalities or even carefully followed.
POD-06.08 Transperitoneal Versus Retroperitoneal Laparoscopic Radical Nephrectomy: Comparison of Operative and Postoperative Course and Outcome Safwat A1, Bissada N2, Kumar U2, Madi R2, Miedema M2
UROLOGY 74 (Supplment 4A), October 2009
1
Assiut University, Assiut, Egypt, Assiut, Egypt; 2University of Arkansas for Medical Sciences, Little Rock, AR, USA Introduction and Objective: The aim of this study is to compare the outcome of transperitoneal versus retroperitoneal laparoscopic radical nephrectomy for renal cell carcinoma (RCC). Materials and Methods: A total of 82 patients (62 males and 20 females) underwent laparoscopic radical nephrectomy for stage T1 and T2 RCC from March 2002 to March 2007. Of the 82 patients, 46 (56%) were managed with retroperitoneal (RP-LRN) and 36 (44%) were managed with transperitoneal laparoscopic radical nephrectomy (TP-LRN). Both groups were compared regarding operative time, blood loss, complications, hospital stay and outcome. Results: Mean operative times for RP-LRN and TP-LRN were 186 and 231 min, and mean blood loss was 100 and 448.5 ml respectively. Mean hospital stay for RPLRN and TP-LRN were 2.8 and 3.4 days respectively. No complications were encountered for the RP-LRN group while intra-operative complications were encountered in 9 patients (25%) in the form of bleeding in 7, gall bladder injury in one and splenic lacerations in one patient. Intra-operative complications for TP-LRN were managed with conversion to hand assisted laparoscopic nephrectomy in five patients. Conclusions: RP-LRN by the same surgeons seems to result in shorter operative time, less blood loss, shorter hospital stay and fewer complications than TP-LRN. POD-06.09 Robotic Partial Nephrectomy for Complex Renal Cell Carcinoma Gong Y, Du C, Josephson D, Wilson T, Nelson R Department of Urology, 2nd Affiliated Hospital, Zhejiang University Medical College, Hangzhou, China Introduction and Objectives: Laparoscopic partial nephrectomy remains challenging to even experienced laparoscopists. Complex renal tumors add an additional challenge to a minimally invasive approach to nephron-sparing surgery. We represented our technique and results of robotic partial nephrectomy (RPN) for hilar, endophytic, and multiple renal tumors. Materials and Methods: Between May 2006 and March 2008, 29 patients with complex renal tumors underwent RPN, including hilar (n⫽14), endophytic (n⫽12) and multiple tumors (n⫽3). All the hilar vessels were clamped with lapa-
S19
PODIUM SESSIONS
roscopic bulldog with warm ischemia. The perioperative data and pathologic results were retrospectively reviewed. Results: Robotic partial nephrectomy procedures were performed successfully without complications. The mean diameter of tumors was 3.0 cm (range 2.0-4.0). The mean operative time was 197 minutes (range 172-259), and the mean blood loss was 220 mL (range 100 –370). The mean warm ischemia time was 25 minutes (range 16 – 43). The hospital stay averaged 2.5 days (range 2-3). Histopathology confirmed clear-cell renal cell carcinoma (n⫽21), chromophobe cell carcinoma (n⫽4), hybrid oncocytic tumor (n⫽2), oncocytoma (n⫽1), and cystic renal cell carcinoma (n⫽1). All cases had negative surgical margins. At the 3-23 months (mean of 15 mo) follow up, no patients experienced a significant change in serum creatinine level or estimated glomerular filtration rate compared to preoperative levels and there was no evidence of tumor recurrence. Conclusions: Robotic partial nephrectomy is a safe and feasible procedure. RPN is a preferred approach for complex renal tumors when nephron-sparing surgery is indicated. For complex and technical challenging renal tumors, robotic assistance may provide patients the benefit of minimally invasive surgery. POD-06.10 Partial or Radical Nephrectomy for Renal Cortical Tumours: Oncological and Functional Results Medina Polo J1, Romero Otero J1, Domı´nguez Esteban M1, Almonacid Grunert J1, Rodrı´guez Antolı´n A1, Passas Martı´nez J1, Castellano Gauna D1, Villacampa Auba´ F1, Go ´ mez Ca´mara A2, ´1 Lora Pablos D2, Leiva Galvis O 1 2 Department of Urology, Department of Epidemiology, Hospital Universitario 12 De Octubre, Madrid, Spain Introduction: Radical nephrectomy has been the gold standard treatment for localised renal cortical tumours for nearly 40 years. However, partial nephrectomy is currently an adequate treatment for small cortical tumours, without compromising safety and oncological efficacy. Our purpose is to evaluate the renal function and the oncologic results of both techniques. Materials and Methods: We did a retrospective study of 290 patients who underwent a nephrectomy for solitary renal cortical tumours lower than seven centimetres in our centre. We compared 174 radical nephrectomies performed between 1998 and 2008, and 116 partial
S20
nephrectomies performed between 1989 and 2008. Preoperative characteristics including body mass index (BMI), comorbidities and glomerular filtration rate prior to surgery were recorded to ensure no significant differences between both groups. Glomerular filtration rate was estimated with the abbreviated Modification of Diet in Renal Disease (MDRD4) study equation. Chronic kidney disease was defined mild, moderate and severe as an MDRD4 lower than 60, 40 y 20mL/min/ 1.73m2, respectively. We analyzed the mean change in glomerular filtration rate between both groups 6, 12, 24 y 36 months after the surgery. We compared the renal function curves for renal filtration of 60, 40 y 20mL/min/1.73m2. The oncologic results were evaluated using the overall survival rate and the cancer-specific survival rate. Results: Six months after the surgery, patients undergoing radical nephrectomy had a greater decrease in glomerular filtration rate than those undergoing partial nephrectomy (25 vs 7 mL/min/1.73m2). This difference remained throughout the time (p⬍0.0001). However, this decrease in glomerular filtration rate did not imply a higher probability of developing mild, moderate or severe chronic kidney failure. Patients undergoing partial nephrectomy had statistically significant higher overall survival rates (p⫽0.034); however the data indicated no significant difference in cancer-specific survival between patients undergoing partial nephrectomy and those who underwent radical nephrectomy (p⫽0.079). Conclusion: It is our conclusion that partial nephrectomy must be considered the first option in selected cases of renal cortical renal lower than seven centimetres. Partial nephrectomy provides equivalent oncological results, higher survival rate, and preserves kidney function.
Podium Session 7: Bladder Cancer Tuesday, November 3, 13:30-15:10 POD-07.01 Hexaminolevulinate New Data: Results from the Recurrence Study Grossman HB1, Mynderse L2, Stenzl A3, Burger M4, Fradet Y5, Soloway M6, Zaak D7, Kriegmair M8, Witjes A9
1
Department of Urology, MD Anderson Cancer Center, Houston, TX, USA; 2Department of Urology, Mayo Clinic, Rochester, MN, USA; 3Department of Urology, Eberhard Karls University, Tu ¨ bingen, Germany; 4Department of Urology at St. Josef’s Hospital, Regensburg University, Regensburg, Germany; 5Department of Urology, Universite´ Laval, Quebec City, QC, Canada; 6Department of Urology, University of Miami School of Medicine, Miami, FL, USA; 7In and Out Clinic for Urology, Ludwig-Maximilians-University, Munich, Germany; 8Clinic of Urology, Mu ¨ nchen-Planegg, Planegg, Germany; 9 Department of Urology, Radboud University Medical Centre, Nijmegen, The Netherlands Introduction and Objectives: This study was developed to determine if improved detection and resection of papillary tumors with hexaminolevulinate enabled fluorescence would decrease the rate of tumor recurrence compared to resection under white light. Endpoints included both detection and recurrence. Materials and Methods: This study is a prospective, randomized, multicenter international investigation of patients with papillary (Ta, T1) non-muscle invasive bladder cancer at high risk for recurrence. All patients were first examined under white light, and all bladder lesions were mapped. Patients randomized to receive hexaminolevulinate were instilled with hexaminolevulinate prior to the cystoscopic procedure and had a second inspection and mapping under blue light. All tumors were resected, and all suspicious lesions were biopsied. Patients who received hexaminolevulinate had the adequacy of tumor resection verified under blue light. Patients found to have T1, G3 tumors received 6 weeks of BCG. Surveillance cystoscopy was performed under white light 3, 6, and 9 months after initial resection. Tumor recurrences were verified by biopsy. Results: Seven hundred and sixty-six patients were randomized in 28 US and European centers and comprised the intent to treat population (ITT). For the detection endpoint, 16.4% of the 286 patients who had Ta or T1 disease randomized to receive hexaminolevulinate were found to have at least one additional Ta/T1 tumor (p⫽ 0.0011). Furthermore, among the patients randomized to hexaminolevulinate, CIS was found only under fluorescence conditions only in 13/41 (32%) patients with CIS. The recurrence endpoint was assessed in 551 patients with Ta or T1 tumors. Both in the ITT and per proto-
UROLOGY 74 (Supplment 4A), October 2009