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P034 Preoperative understaging of renal cell carcinoma with multidetector CT
posters / european urology supplements 11 (2012) 191–235
P032 Gene expression profiling for high risk progressive nonmuscle invasive urothelial cell carcinoma of the bladder A.G. Van Der Heijden1 , L. Mengual2 , M.J. Ribal2 , A. Alcaraz2 , J.J. Lozano3 , P.L. Fernandez4 , J.A. Schalken1 , J.A. Witjes1 . 1 Radboud University Nijmegen Medical Centre, Dept. of Urology, Nijmegen, The Netherlands; 2 Hospital Clinic; IDIBAPS; Universitat De Barcelona, Dept. of Urology, Barcelona, Spain; 3 Plataforma De Bioinform´ atica. Centro De Investigaci´ on Biom´edica En Red De Enfermedades, Dept. of Bioinformatics, Barcelona, Spain; 4 Hospital Clinic; IDIBAPS; Universitat De Barcelona, Dept. of Pathology, Barcelona, Spain Introduction & Objectives: Up to 15% of all patients with non-muscle invasive bladder cancer (NMIBC) show progression to muscle invasive bladder cancer (MIBC). Conventional histopathological evaluation is inadequate to accurately predict this progression and the cancer-specific survival is severely reduced when progression occurs. Therefore, especially patients at high risk for progression deserve careful attention. In this study a gene expression signature model to discriminate progressive from non-progressive NMIBC was composed. Material & Methods: Thirty patients, 15 recurrent nonprogressive high risk NMIBC patients with at least 2 years of follow up and 15 recurrent progressive high risk NMIBC patients (with at least six months between the transurethral resection showing NMIBC and the progression to MIBC), were included in this analysis. After marking the high risk tumours by the pathologist a macro dissection of the urothelial cell carcinoma in the paraffin block took place and RNA was isolated from the formalin-fixed, paraffin-embedded (FFPE) tissue using a commercially available kit. Total RNA was quantified by spectrophotometric analysis at 260 nm. Gene expression analysis was performed using the Whole-Genome Gene Expression DASL HT Assay according manufacturer’s instructions. A list of the most statistical significant regulated genes was computed using LIMMA R-package. A gene expression signature to distinguish non progressive from progressive NMIBC were obtained using PAM. Results: In total 887 transcripts were found significantly (p < 0.05) differentially expressed between recurrent nonprogressive and progressive high risk NMIBC. After PAM analysis we found an eighty gene expression model that was able to distinguish both groups with 100 % sensitivity and specificity. The gene signature will be validated in an independent cohort of patients using the Fluidigm Biomark real time PCR system. Conclusions: This analysis shows that gene expression patterns from FFPE samples are able to discriminate recurrent non-progressive from progressive high risk NMIBC. The discrimination of these patient groups shall improve patient treatment and outcome. P033 Differences in the clinical profile between clear-cell and papillary type I and II renal carcinomas in a sample of 315 patients B. Padilla-Fernandez1 , M.F. Lorenzo-Gomez1 , P. Antunez-Plaza2 , M.B. Garcia-Cenador3 , J.A. Miron-Canelo4 , A. Martin-Rodriguez1 , A. Gil-Vicente1 , J.M. Silva-Abuin1 , Instituto De Investigacion ´ Biomedica ´ De Salamanca. 1 Complejo Asistencial Universitario De Salamanca, Dept. of Urology, Salamanca, Spain; 2 Complejo Asistencial Universitario De Salamanca, Dept. of Pathological Anatomy, Salamanca, Spain; 3 Universidad De Salamanca, Dept. of Surgery, Salamanca, Spain; 4 Universidad De Salamanca, Dept. of Preventive Medicine and Public Health, Salamanca, Spain Introduction & Objectives: To investigate the differences in the clinical profile of patients with diagnosis of clear-cell (CCRC) and papillary type I (PIRC) and II (PIIRC) renal carcinoma in a sample of 315 patients.
201
Material & Methods: A retrospective analysis studying the clinical profile (gender, age, risk factors, tumoral stage and survival) of patients with diagnosis of CCRC, PIRC and PIIRC in our health area from January 2005 until December 2011 was performed. Descriptive statistics, Student’s t-test, Fischer’s exact test, Chi-Square and Kaplan–Meier survival curves were used. p < 0.05 was accepted as significant. Results: 249 patients (70.74%) were diagnosed with CCRC (Group A), 12 (3.41%) with PIRC (Group B) and 54 (15.34%) with PIIRC (Group C). Other tumor types diagnosed were chromophobe carcinoma (3.98%), papillary clear-cell carcinoma (0.7%), Xp11.2 translocation carcinoma (0.28%), tubule-papillary carcinoma (0.85%), carcinoma of the collecting ducts of Bellini (0.85%), mucinous tubular and spindle cell carcinoma (0.57%), multicystical (0.85%), unclassified carcinomas (0.85% sarcoma and 1.42% pleomorphic) and oncocytoma (5.11%). Between groups there were no clinical relevant differences regarding age (69.32, 71.83 and 66.25 respectively) or gender distribution (26, 20 and 30% of female patients respectively). Hematuria was more common (p < 0.0023) in CCRC than in PIRC and PIIRC. HTN and smoking habit were more frequent in CCRC (p > 0.0036) than in PIRC and PIIRC. The 3 groups were similar when analysing TNM stage (p = 0.9276) and histological grade (p = 0.2196) after surgery. The survival rate was inferior in the PIIRC group (p < 0.00036). Conclusions: We have found differences in the risk factors associated with the different histological types of renal carcinoma. CCRC appears more often with macroscopic hematuria, which is less common in PIRC and PIIRC, and it has a closer relationship with smoking habit and HTN. Wider studies are necessary in order to clear the meaning of the relationship between smoking habit and HTN in each of the different histopathological renal carcinoma’s types. P034 Preoperative understaging of renal cell carcinoma with multidetector CT O.B. Halawa Gonzalez ´ 1 , C. Galvez Garc´ıa2 , B.F. Balig Fawwaz1 , V. Del Rosario Rodriguez1 , C. Fumero Gorrin1 , J. Falcon ´ Barroso1 , J. Portero Navarro2 , J. Monllor Gisbert1 . 1 Hospital Universitario Nuestra Se˜ nora De Candelaria, Dept. of Urology, Santa Cruz De Tenerife, Spain; 2 Hospital Universitario Nuestra Se˜ nora De Candelaria, Dept. of Radiology, Santa Cruz De Tenerife, Spain Introduction & Objectives: Renal cell carcinoma (RCC) represents 2–3% of all cancers. RCC is the commonest solid lesion within the kidney and accounts for approximately 90% of all kidney malignancies. The evolution of CT technology and the introduction of multidetector computed tomography (MDCT) have provided higher spatial resolution and faster acquisition. Three-dimensional reformatting techniques enable easy performance of multiplanar reconstructions, which improves the staging capabilities for RCC. Tumor stage is the most important factor affecting the prognosis and survival of patients, and has an important bearing on planning treatment. The purpose of the present study was to evaluate the diagnostic accuracy of MDCT for preoperative staging of RCC using the 2009 TNM (tumor, node, metastasis) classification. Material & Methods: We conducted a retrospective review of MDCT in 25 consecutive patients with RCC performed for tumor staging before radical nephrectomy. The scanning protocol of MDCT consisted of unenhanced and biphasic contrast-enhanced scans during corticomedullary and nephrographic phases. MDCT and surgical-histopathologic staging were performed using the 2009 TNM staging system. The results of MDCT were compared with the histopathological results. Results: Consistency between MDCT and histopathologic staging was excellent for T1 (100%) and T2 staging (86%) and
202
posters / european urology supplements 11 (2012) 191–235
fair for T3 stage (44%) with an overall accuracy of 80% and 20% of understaging. Conclusions: MDCT results are indeterminate investigating venous involvement if there is a badly defined extension of locally advance masses and inferior vena cava tumour thrombus. P035 Non-cutaneous de novo malignancy following kidney and liver transplantation: A comparison in a single centre cohort of 2941 recipients F. Branco1 , V. Cavadas1 , L. Osorio ´ 1 , I. Braga2 , E. Cordeiro3 , 1 4 M. Silva-Ramos , A. Rocha , L. Martins2 , D. Silva5 , J.D. Silva5 , J. Daniel5 , A. Fraga1 . 1 Centro Hospitalar Do Porto, Dept. of Urology, Oporto, Portugal; 2 Centro Hospitalar Do Porto, Dept. of Nephrology, Oporto, Portugal; 3 AMC Hospital, Dept. of Urology, Amsterdam, The Netherlands; 4 Centro Hospitalar do Porto, Dept. of Nephrology, Oporto, Portugal; 5 Centro Hospitalar Do Porto, Dept. of General Surgery, Oporto, Portugal Introduction & Objectives: De novo malignancy after kidney and liver transplantation has become a major concern in recent years, being one of the most important causes of death in these patients. Herein we compare non-cutaneous de novo tumors arising in a single-centre cohort of renal and hepatic transplant recipients. Material & Methods: Renal and hepatic transplantation were initiated in January 1983 and May 1995, respectively, in our hospital. Until August 2011, 2016 kidney and 925 liver transplants were performed. Mean age at transplantation was 44 and 43 years for kidney and liver transplantation, respectively; 61% of kidney and 58% of liver recipients were male. Overall allograft survival at 5 and 10 years was 80 and 66% for kidney and 60 and 48% for liver, respectively. Our prospective database was surveyed to retrieve data for all patients who developed non-cutaneous de novo tumors. Kaplan–Meier survival was calculated for both kidney and liver recipients. Results: Eighty-four and 15 non-cutaneous de novo tumors were detected respectively in 2016 kidney (4.2%) and 925 liver transplant recipients (1.6%). Mean age at diagnosis was 55 years in both groups, after a mean follow-up until diagnosis of 142 and 58 months for renal and hepatic transplanted patients, respectively. The table depicts the type of neoplasms diagnosed in each group. Mean 1 and 5-year cancer-specific survival after diagnosis was 85 and 70% for kidney and 20 and 7% for liver recipients, respectively. Table 1. Non-cutaneous de novo malignancies in kidney and liver recipients. Kidney recipients
Gastrointestinal Gynecological Hematological Miscellaneous Urological Total
Liver recipients
Total
Death
Total
Death
16 21 14 18 15 84
8 3 6 2 4 23
6 1 1 6 1 15
6 1 1 6 1 15
Conclusions: In our cohort, non-cutaneous de novo tumors, despite being less frequent, are more aggressive in liver transplant recipients. Risk factors contributing for hepatic failure and the need of transplantation may be more important than immunosuppression in the development of de novo malignancy in this group of patients, when compared to kidney recipients.
P036 Bisphosphonates (Bis) combined with sunitinib (Su) may improve the response rate (RR), progression free survival (PFS) and overall survival (OS) of patients (pts) with bone metastases (mets) from renal cell carcinoma (RCC) D. Keizman1 , M. Ish-Shalom1 , N. Maimon1 , M. Gottfried1 , A. Peer2 , A. Neumann2 , H. Hayat3 , B. Boursi4 , S. Kovel5 , A. Sella5 , R. Pili6 , H. Hammers7 , V. Sinibaldi7 , M. Eisenberger7 , R. Berger4 , M. Carducci7 . 1 Meir Medical Center, Institute of Oncology, Kfar Saba, Israel; 2 Rambam Medical Center, Department of Oncology, Haifa, Israel; 3 Wolfson Medical Center, Department of Oncology, Holon, Israel; 4 Sheba Medical Center, Department of Oncology, Tel Hashomer, Israel; 5 Asaf Harofe Medical Center, Department of Oncology, Zerifin, Israel; 6 Roswell Park, Cancer Institute, Buffalo, United States of America; 7 Johns Hopkins, Sidney Kimmel Comprehensive Cancer Center, Baltimore, United States of America Introduction & Objectives: Bis are used to prevent skeletal events of bone mets, and may exhibit anti tumor effects. We aimed to evaluate whether Bis can bring a RR, PFS, and OS benefit to pts with bone mets from RCC that are treated with Su. Material & Methods: We performed an international multicenter retrospective study of pts with bone mets from RCC who were treated with Su. Pts were divided into Bis users (group 1) and nonusers (group 2). The effect of Bis on RR, PFS and OS, was tested with adjustment for known prognostic factors using a chisquare test from contingency table and partial likelihood test from Cox regression model. Results: Between 2004–2011, 244 pts with metastatic RCC were treated with Su. 92 pts had bone mets, 41 group 1 and 51 group 2. The groups were balanced regarding the following known prognostic factors: past nephrectomy, clear cell vs non clear cell histology, initial diagnosis to sunitinib treatment (tx) time, presence of ≥ 2 mets sites, presence of lung/liver mets, ECOG performance status, anemia, calcium level >10 mg/dL, elevated alkaline phosphatase (AP), pre-tx neutrophil to lymphocyte ratio (NLR) >3, sunitinib induced HTN, and the use of angiotensin system inhibitors. They were also balanced with regard to past cytokines/targeted tx, and mean sunitinib dose/cycle. Objective response was partial response/stable disease 85% (n = 35) vs 71% (n = 36), and progressive disease 15% (n = 6) vs 29% (n = 15) (OR 3.287, p = 0.07) in group 1 vs 2 respectively. Median PFS was 15 vs 5 months (HR 0.433, p = 0.035), and median OS not reached with a median folloup time of 43 mos vs 12 months (HR 0.398, p = 0.003), in favor of group 1. In multivariate analysis of the entire pt cohort (n = 92), factors associated with PFS were Bis use (HR = 0.433, p = 0.035), pre-tx NLR ≤3 (HR 0.405, p = 0.016), and elevated AP (HR = 3.63, p = 0.012). Factors associated with OS were Bis use (HR 0.32, p = 0.003), elevated AP (HR 3.18, p = 0.002), and Su induced HTN (HR 0.193, p < 0.001). Conclusions: Bis may improve the outcome of Su tx in RCC with bone mets. This should be investigated prospectively, and if validated applied in clinical practice and clinical trials. P037 Surgical management of renal cell carcinoma (RCC) with venous invasion in patients with distant metastases M.I. Davydov, V.B. Matveev, K.M. Figurin, M.I. Volkova, V.A. Chernyaev, K.A.V. Kimov. N.N. Blokhin Cancer Center, Dept. of Urology, Moscow, Russia Introduction & Objectives: To assess the results of surgical management of RCC with venous invasion in patients with distant metastases. Material & Methods: 127 consecutive patients with RCC T3abN0–2M1 with venous involvement were treated surgically at our institution between 1984 and 2010. Median age was 57±11.2 years, male to female ratio – 1.5. Right kidney was
P032 Gene expression profiling for high risk progressive nonmuscle invasive urothelial cell carcinoma of the bladder A.G. Van Der Heijden1 , L. Mengual2 , M.J. Ribal2 , A. Alcaraz2 , J.J. Lozano3 , P.L. Fernandez4 , J.A. Schalken1 , J.A. Witjes1 . 1 Radboud University Nijmegen Medical Centre, Dept. of Urology, Nijmegen, The Netherlands; 2 Hospital Clinic; IDIBAPS; Universitat De Barcelona, Dept. of Urology, Barcelona, Spain; 3 Plataforma De Bioinform´ atica. Centro De Investigaci´ on Biom´edica En Red De Enfermedades, Dept. of Bioinformatics, Barcelona, Spain; 4 Hospital Clinic; IDIBAPS; Universitat De Barcelona, Dept. of Pathology, Barcelona, Spain Introduction & Objectives: Up to 15% of all patients with non-muscle invasive bladder cancer (NMIBC) show progression to muscle invasive bladder cancer (MIBC). Conventional histopathological evaluation is inadequate to accurately predict this progression and the cancer-specific survival is severely reduced when progression occurs. Therefore, especially patients at high risk for progression deserve careful attention. In this study a gene expression signature model to discriminate progressive from non-progressive NMIBC was composed. Material & Methods: Thirty patients, 15 recurrent nonprogressive high risk NMIBC patients with at least 2 years of follow up and 15 recurrent progressive high risk NMIBC patients (with at least six months between the transurethral resection showing NMIBC and the progression to MIBC), were included in this analysis. After marking the high risk tumours by the pathologist a macro dissection of the urothelial cell carcinoma in the paraffin block took place and RNA was isolated from the formalin-fixed, paraffin-embedded (FFPE) tissue using a commercially available kit. Total RNA was quantified by spectrophotometric analysis at 260 nm. Gene expression analysis was performed using the Whole-Genome Gene Expression DASL HT Assay according manufacturer’s instructions. A list of the most statistical significant regulated genes was computed using LIMMA R-package. A gene expression signature to distinguish non progressive from progressive NMIBC were obtained using PAM. Results: In total 887 transcripts were found significantly (p < 0.05) differentially expressed between recurrent nonprogressive and progressive high risk NMIBC. After PAM analysis we found an eighty gene expression model that was able to distinguish both groups with 100 % sensitivity and specificity. The gene signature will be validated in an independent cohort of patients using the Fluidigm Biomark real time PCR system. Conclusions: This analysis shows that gene expression patterns from FFPE samples are able to discriminate recurrent non-progressive from progressive high risk NMIBC. The discrimination of these patient groups shall improve patient treatment and outcome. P033 Differences in the clinical profile between clear-cell and papillary type I and II renal carcinomas in a sample of 315 patients B. Padilla-Fernandez1 , M.F. Lorenzo-Gomez1 , P. Antunez-Plaza2 , M.B. Garcia-Cenador3 , J.A. Miron-Canelo4 , A. Martin-Rodriguez1 , A. Gil-Vicente1 , J.M. Silva-Abuin1 , Instituto De Investigacion ´ Biomedica ´ De Salamanca. 1 Complejo Asistencial Universitario De Salamanca, Dept. of Urology, Salamanca, Spain; 2 Complejo Asistencial Universitario De Salamanca, Dept. of Pathological Anatomy, Salamanca, Spain; 3 Universidad De Salamanca, Dept. of Surgery, Salamanca, Spain; 4 Universidad De Salamanca, Dept. of Preventive Medicine and Public Health, Salamanca, Spain Introduction & Objectives: To investigate the differences in the clinical profile of patients with diagnosis of clear-cell (CCRC) and papillary type I (PIRC) and II (PIIRC) renal carcinoma in a sample of 315 patients.
201
Material & Methods: A retrospective analysis studying the clinical profile (gender, age, risk factors, tumoral stage and survival) of patients with diagnosis of CCRC, PIRC and PIIRC in our health area from January 2005 until December 2011 was performed. Descriptive statistics, Student’s t-test, Fischer’s exact test, Chi-Square and Kaplan–Meier survival curves were used. p < 0.05 was accepted as significant. Results: 249 patients (70.74%) were diagnosed with CCRC (Group A), 12 (3.41%) with PIRC (Group B) and 54 (15.34%) with PIIRC (Group C). Other tumor types diagnosed were chromophobe carcinoma (3.98%), papillary clear-cell carcinoma (0.7%), Xp11.2 translocation carcinoma (0.28%), tubule-papillary carcinoma (0.85%), carcinoma of the collecting ducts of Bellini (0.85%), mucinous tubular and spindle cell carcinoma (0.57%), multicystical (0.85%), unclassified carcinomas (0.85% sarcoma and 1.42% pleomorphic) and oncocytoma (5.11%). Between groups there were no clinical relevant differences regarding age (69.32, 71.83 and 66.25 respectively) or gender distribution (26, 20 and 30% of female patients respectively). Hematuria was more common (p < 0.0023) in CCRC than in PIRC and PIIRC. HTN and smoking habit were more frequent in CCRC (p > 0.0036) than in PIRC and PIIRC. The 3 groups were similar when analysing TNM stage (p = 0.9276) and histological grade (p = 0.2196) after surgery. The survival rate was inferior in the PIIRC group (p < 0.00036). Conclusions: We have found differences in the risk factors associated with the different histological types of renal carcinoma. CCRC appears more often with macroscopic hematuria, which is less common in PIRC and PIIRC, and it has a closer relationship with smoking habit and HTN. Wider studies are necessary in order to clear the meaning of the relationship between smoking habit and HTN in each of the different histopathological renal carcinoma’s types. P034 Preoperative understaging of renal cell carcinoma with multidetector CT O.B. Halawa Gonzalez ´ 1 , C. Galvez Garc´ıa2 , B.F. Balig Fawwaz1 , V. Del Rosario Rodriguez1 , C. Fumero Gorrin1 , J. Falcon ´ Barroso1 , J. Portero Navarro2 , J. Monllor Gisbert1 . 1 Hospital Universitario Nuestra Se˜ nora De Candelaria, Dept. of Urology, Santa Cruz De Tenerife, Spain; 2 Hospital Universitario Nuestra Se˜ nora De Candelaria, Dept. of Radiology, Santa Cruz De Tenerife, Spain Introduction & Objectives: Renal cell carcinoma (RCC) represents 2–3% of all cancers. RCC is the commonest solid lesion within the kidney and accounts for approximately 90% of all kidney malignancies. The evolution of CT technology and the introduction of multidetector computed tomography (MDCT) have provided higher spatial resolution and faster acquisition. Three-dimensional reformatting techniques enable easy performance of multiplanar reconstructions, which improves the staging capabilities for RCC. Tumor stage is the most important factor affecting the prognosis and survival of patients, and has an important bearing on planning treatment. The purpose of the present study was to evaluate the diagnostic accuracy of MDCT for preoperative staging of RCC using the 2009 TNM (tumor, node, metastasis) classification. Material & Methods: We conducted a retrospective review of MDCT in 25 consecutive patients with RCC performed for tumor staging before radical nephrectomy. The scanning protocol of MDCT consisted of unenhanced and biphasic contrast-enhanced scans during corticomedullary and nephrographic phases. MDCT and surgical-histopathologic staging were performed using the 2009 TNM staging system. The results of MDCT were compared with the histopathological results. Results: Consistency between MDCT and histopathologic staging was excellent for T1 (100%) and T2 staging (86%) and
202
posters / european urology supplements 11 (2012) 191–235
fair for T3 stage (44%) with an overall accuracy of 80% and 20% of understaging. Conclusions: MDCT results are indeterminate investigating venous involvement if there is a badly defined extension of locally advance masses and inferior vena cava tumour thrombus. P035 Non-cutaneous de novo malignancy following kidney and liver transplantation: A comparison in a single centre cohort of 2941 recipients F. Branco1 , V. Cavadas1 , L. Osorio ´ 1 , I. Braga2 , E. Cordeiro3 , 1 4 M. Silva-Ramos , A. Rocha , L. Martins2 , D. Silva5 , J.D. Silva5 , J. Daniel5 , A. Fraga1 . 1 Centro Hospitalar Do Porto, Dept. of Urology, Oporto, Portugal; 2 Centro Hospitalar Do Porto, Dept. of Nephrology, Oporto, Portugal; 3 AMC Hospital, Dept. of Urology, Amsterdam, The Netherlands; 4 Centro Hospitalar do Porto, Dept. of Nephrology, Oporto, Portugal; 5 Centro Hospitalar Do Porto, Dept. of General Surgery, Oporto, Portugal Introduction & Objectives: De novo malignancy after kidney and liver transplantation has become a major concern in recent years, being one of the most important causes of death in these patients. Herein we compare non-cutaneous de novo tumors arising in a single-centre cohort of renal and hepatic transplant recipients. Material & Methods: Renal and hepatic transplantation were initiated in January 1983 and May 1995, respectively, in our hospital. Until August 2011, 2016 kidney and 925 liver transplants were performed. Mean age at transplantation was 44 and 43 years for kidney and liver transplantation, respectively; 61% of kidney and 58% of liver recipients were male. Overall allograft survival at 5 and 10 years was 80 and 66% for kidney and 60 and 48% for liver, respectively. Our prospective database was surveyed to retrieve data for all patients who developed non-cutaneous de novo tumors. Kaplan–Meier survival was calculated for both kidney and liver recipients. Results: Eighty-four and 15 non-cutaneous de novo tumors were detected respectively in 2016 kidney (4.2%) and 925 liver transplant recipients (1.6%). Mean age at diagnosis was 55 years in both groups, after a mean follow-up until diagnosis of 142 and 58 months for renal and hepatic transplanted patients, respectively. The table depicts the type of neoplasms diagnosed in each group. Mean 1 and 5-year cancer-specific survival after diagnosis was 85 and 70% for kidney and 20 and 7% for liver recipients, respectively. Table 1. Non-cutaneous de novo malignancies in kidney and liver recipients. Kidney recipients
Gastrointestinal Gynecological Hematological Miscellaneous Urological Total
Liver recipients
Total
Death
Total
Death
16 21 14 18 15 84
8 3 6 2 4 23
6 1 1 6 1 15
6 1 1 6 1 15
Conclusions: In our cohort, non-cutaneous de novo tumors, despite being less frequent, are more aggressive in liver transplant recipients. Risk factors contributing for hepatic failure and the need of transplantation may be more important than immunosuppression in the development of de novo malignancy in this group of patients, when compared to kidney recipients.
P036 Bisphosphonates (Bis) combined with sunitinib (Su) may improve the response rate (RR), progression free survival (PFS) and overall survival (OS) of patients (pts) with bone metastases (mets) from renal cell carcinoma (RCC) D. Keizman1 , M. Ish-Shalom1 , N. Maimon1 , M. Gottfried1 , A. Peer2 , A. Neumann2 , H. Hayat3 , B. Boursi4 , S. Kovel5 , A. Sella5 , R. Pili6 , H. Hammers7 , V. Sinibaldi7 , M. Eisenberger7 , R. Berger4 , M. Carducci7 . 1 Meir Medical Center, Institute of Oncology, Kfar Saba, Israel; 2 Rambam Medical Center, Department of Oncology, Haifa, Israel; 3 Wolfson Medical Center, Department of Oncology, Holon, Israel; 4 Sheba Medical Center, Department of Oncology, Tel Hashomer, Israel; 5 Asaf Harofe Medical Center, Department of Oncology, Zerifin, Israel; 6 Roswell Park, Cancer Institute, Buffalo, United States of America; 7 Johns Hopkins, Sidney Kimmel Comprehensive Cancer Center, Baltimore, United States of America Introduction & Objectives: Bis are used to prevent skeletal events of bone mets, and may exhibit anti tumor effects. We aimed to evaluate whether Bis can bring a RR, PFS, and OS benefit to pts with bone mets from RCC that are treated with Su. Material & Methods: We performed an international multicenter retrospective study of pts with bone mets from RCC who were treated with Su. Pts were divided into Bis users (group 1) and nonusers (group 2). The effect of Bis on RR, PFS and OS, was tested with adjustment for known prognostic factors using a chisquare test from contingency table and partial likelihood test from Cox regression model. Results: Between 2004–2011, 244 pts with metastatic RCC were treated with Su. 92 pts had bone mets, 41 group 1 and 51 group 2. The groups were balanced regarding the following known prognostic factors: past nephrectomy, clear cell vs non clear cell histology, initial diagnosis to sunitinib treatment (tx) time, presence of ≥ 2 mets sites, presence of lung/liver mets, ECOG performance status, anemia, calcium level >10 mg/dL, elevated alkaline phosphatase (AP), pre-tx neutrophil to lymphocyte ratio (NLR) >3, sunitinib induced HTN, and the use of angiotensin system inhibitors. They were also balanced with regard to past cytokines/targeted tx, and mean sunitinib dose/cycle. Objective response was partial response/stable disease 85% (n = 35) vs 71% (n = 36), and progressive disease 15% (n = 6) vs 29% (n = 15) (OR 3.287, p = 0.07) in group 1 vs 2 respectively. Median PFS was 15 vs 5 months (HR 0.433, p = 0.035), and median OS not reached with a median folloup time of 43 mos vs 12 months (HR 0.398, p = 0.003), in favor of group 1. In multivariate analysis of the entire pt cohort (n = 92), factors associated with PFS were Bis use (HR = 0.433, p = 0.035), pre-tx NLR ≤3 (HR 0.405, p = 0.016), and elevated AP (HR = 3.63, p = 0.012). Factors associated with OS were Bis use (HR 0.32, p = 0.003), elevated AP (HR 3.18, p = 0.002), and Su induced HTN (HR 0.193, p < 0.001). Conclusions: Bis may improve the outcome of Su tx in RCC with bone mets. This should be investigated prospectively, and if validated applied in clinical practice and clinical trials. P037 Surgical management of renal cell carcinoma (RCC) with venous invasion in patients with distant metastases M.I. Davydov, V.B. Matveev, K.M. Figurin, M.I. Volkova, V.A. Chernyaev, K.A.V. Kimov. N.N. Blokhin Cancer Center, Dept. of Urology, Moscow, Russia Introduction & Objectives: To assess the results of surgical management of RCC with venous invasion in patients with distant metastases. Material & Methods: 127 consecutive patients with RCC T3abN0–2M1 with venous involvement were treated surgically at our institution between 1984 and 2010. Median age was 57±11.2 years, male to female ratio – 1.5. Right kidney was