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CO-morbidity scores predict mortality but not morbidity in patients undergoing radical nephrectomy
437 A PHASE II TRIAL WITH MONOCLONAL ADVANCED RENAL CELL CARCINOMA
ANTIBODY
WX-G250
IN
Bleumer I.‘, Beck J.2, Hofmann R.‘, Kruit W.4, Wamaar S.4, Mala C.‘, Ullrich S.S. Huber C.5, Debruyne F.M.J.r, Oosterwijk E.‘, Mulders P.F.A.’ ‘Urology, University Hospital, Nijmegen, The Netherlands, ZUrology, JohannesGutenberg University, Mainz, Germany, aUrology, Philpps University, Marburg, Germany, 4Urology, University Hospital, Rotterdam, The Netherlands, 5Research, Wilex AG, Munich, Germany* INTRODUCTION & OBJECTIVES: cc250 (WXG250) is a IgGl kappa light-chain chimeric monoclonal antibody that binds to a cell surface antigen found on 95% of clear cell renal cancer. A multicenter phase II study was performed to evaluate the safety and efficacy of repeated doses of WX-G250. MATERIAL & METHODS: 36 patients (median age 64 year, IOF, 26M) with metastatic RCC were included. All patients were nephrectomised for the primary tumour; target lesions were mostly lung lesions and lymph nodes. The individual lesions were between I and 5 cm in diameter. 22 patients were pretreated (e.g. with IL-2, interferon alpha), 14 patients were untreated. A weekly dose of 50 mg WXG250 was given by iv infusion for 12 weeks. Patients with stable disease or tumour response after 12 weeks of treatment could receive additional treatment for 8 more weeks. RESULTS: None of the 36 enrolled patients had any G250 grade III or IV toxicity. Only 3 patients had grade II toxicity possibly related to the study medication (1 had gastritis, 2 vomiting). ELISA testing gave no evidence for Human Anti-Chimeric Anttbodies (HACA). 32 patients were treated for more than 6 weeks and are evaluable for efficacy assessment by CT. Nine patients presented with stable disease and were eligible for extension treatment. After the end of the study in the follow-up period, one patient demonstrated a CR in week 38 (regression started in week 20) and another patient with stable disease showed a significant reduction of the overall tumour load in week 44 with gradual remission first observed in week 16. Both patients had multiple pulmonary target lesions. 5 additional patients with progressive disease at study entry were stable for more than 6 months after treatment start; none of them received additional tumour therapy in the meantime. CONCLUSIONS: The weekly schedule of iv WX-G250 in patients with metastatic RCC was safe, very well tolerated and non-immunogenic in a 12 weeks treatment regimen. WX-G250 showed anti-tumour activity. Further follow-up of these patients is in progress to determine time to relapse. WXG250 is currently under investigation in various phase II trials.
438 LAPAROSCOPIC RESULTS
RENAL
CRYOABLATION:
Cestari A., Guazzoni G., Nava L., Bellinzoni P., Losa A., Zanoni M., Rigatti P. Department of Urology, Hospital, Milan, Italy
Casa di Cura Privata
“Ville Turro”
Jakse Gerhardi , Drafz Susanner,
MORTALITY BUT NOT RADICAL NEPHRECTOMY
Rohde Detlef’ , Reinecke Torsten*
‘Clinic of Urology, University Clinic Aachen, Aachen, Biometry, University Clinic Aachen, Aachen, Germany INTRODUCTION & OBJECTIVES: perioperative morbidity and mortality nephrectomy
Determination in patients
Germany,
MATERIALS & METHODS: Since September 2001, 25 patients (mean age 64 years; range 29-80) underwent laparoscopic renal cryoablation for TC or MRI documented renal masses. Mean lesion diameter was 27.3 mm (range 18. 55 mm). According to tumour position, in 14 cases the procedure was performed transperitoneally and in 11 patients with a retroperitoneoscopic approach. RESULTS: In all the patients two rapid freezing/thawing cycles were performed with a mean diameter of the ice ball of 47.1 mm. All the procedures were successfully performed laparoscopically, except one that was converted into open surgery. Mean surgical time was 205 mm with mean intraoperative blood loss of 150.8 cc (range 20-900 cc). Postoperative stay was medially 3.7 days (range 3-7) while postoperative complicances included three cases of transient hyperpirexia. one case of small perirenal hematoma. and one case of gross hematuria, treated conservatively. Hystopatological evaluation of the intraoperative needle biopsies revealed the presence of renal cell carcinoma in 19 cases, 3 cases of oncocytoma, 2 cases of angiomyolipoma and 1 case “indefinite”. MRI scan on postoperative day one documented a mean lesion of 48.3 mm. At I month (all the patients), 3 months (19 patients), 6 months (13 patients) and I year (2 patients) follow-up the mean reduction of the lesions was respectively 29,48,77 and 95%. Percutaneous biopsies of the lesion performed at 6 months follow-up revealed no presence of tumoural cells. CONCLUSION: Laparoscopic renal cryoablation of small renal masses, in selected cases, appears to be a safe, reproducible, minimally invasive technique. Although limited, follow up in our series is encouraging and further studies and prolonged follow-up is needed to access properly the role of this approach for the treatment of small renal masses.
440
of risk factors for undergoing radical
for renal cell cancer.
MATERIALS & METHODS: 268 patients underwent transabdominal radical nephrectomy for renal cell carcinoma. A chart review was performed. Risk factors were assessed by the anaesthesiologist, by the weighted index of comorbidity (Charlson et al, 1987) and age-comorbidity score (Hutchinson et al, 1982). Univariate and multivariate analysis was performed. RESULTS: 79 patients were judged to have an increased risk by the anaesthesiologist. 81 patients had a co-morbidity score >2, indicating an increased risk. An age-comorbidity score of >3 was noted in 99 patients. The postoperative complication rate was 9.7%. Operative revision was necessary in 0.7% patients. The mortality rate was 1.9%. On multivariate analysis the localisation of the tumour and venous thrombus were significant variables for postoperative morbidity. Mortality was associated with age and tumour size. None of the scores was associated with intraoperative or perioperative morbidity. However, the comorbidity score as well as age-comorbidity score were significantly correlated to mortality. CONCLUSION: To assess the risk of a patient to develop serious complications after radical nephrectomy simple clinical parameters can be used. One third of our patients had an increased risk for postoperative mortality, 6% of these died. This risk is at best assessed by the age-comorbidity score. European Urology Supplements 1 (2002) No. 1, pp. 112
PSYCHOLOGICAL, SOCIAL WELL-BEING STATUS AFTER SURGICAL TREATMENT CELL CARCINOMA
AND GENERAL HEALTH FOR LOCALISED RENAL
Ficarra Vincenzo, Cerruto Maria Angela, Novella Giovanni. Sarti Alessandra, Artibani Walter *Institute of
San Raffaele
INTRODUCTION: In selected cases, laparoscopic renal cryoablation of small renal neoplasm (less than 4 cm in diameter) aims to obtain the same oncological results as in open nephron sparing surgery, with all the typical advantages of minimally invasive surgery.
439 CO-MORBIDITY SCORES PREDICT MORBIDITY IN PATIENTS UNDERGOING
PRELIMINARY
Department
Ballario Riccardo,
of Urology, University of Verona, Verona, Italy
INTRODUCTION & OBJECTIVES: The aim of this study is to assess comparatively the psychological, social well-being and general health status in a group of patients undergone an elective nephron-sparing surgery (NSS) or radical nephrectomy (RN) for stage I RCC (according to TNM, 1997). MATERIALS & METHODS: We performed a cross-sectional study to evaluate the health-related quality of life (HR.QoL) in 88 patients undergone radical nephrectomy and in 56 patients undergone elective NSS. The collecting phase of the QoL data has been preceded by a socio-demographic evaluation of the patients. The measurement of the main QoL components has been made using domain-specific questionnaires tested and validated. Each questionnaire has been self-administrated during the medical examination made as a follow-up of the neoplasia. For statical analysis we used t-Student test and chi-square test to compare patients mean values and characteristics rates and the Mann-Whitney U-test to compare the mean values of each questionnaire administered. RESULTS: We did not find any significant difference between the 2 analysed groups regarding age, sex, civil status, educational level, profession and mean follow-up (58 months for NSS and 62 for RN). Low-grade anxiety level was documented in 1 I .4% of patients undergone RN and in I .8% of those undergone elective NSS. The mean score difference between the 2 mean values was statistically significant (p=O.O03). A mild depression was recorded in 7% of patients undergone RN and in 2.3% of those undergone NSS. The mean score difference was statistically significant (p=O.Ol). The general state of health was compromised in 12.5% of cases after radical nephrectomy and in 7% after elective NSS. Social problems were present in 18% of patients undergone radical nephrectomy and in 18% undergone NSS. No statistical difference between the 2 groups has been found in terms of mean scores of General Health questionnaire and Social Problem Questionnaire. CONCLUSION: The HR.QoL in patients undergone surgery for RCC is not negatively influenced by the treatment. The comparative analysis of the results showed that, at a long-term follow-up, the radical treatment may cause a more relevant compromising of the psychological well-being than the conservative surgical treatment.
ANTIBODY
WX-G250
IN
Bleumer I.‘, Beck J.2, Hofmann R.‘, Kruit W.4, Wamaar S.4, Mala C.‘, Ullrich S.S. Huber C.5, Debruyne F.M.J.r, Oosterwijk E.‘, Mulders P.F.A.’ ‘Urology, University Hospital, Nijmegen, The Netherlands, ZUrology, JohannesGutenberg University, Mainz, Germany, aUrology, Philpps University, Marburg, Germany, 4Urology, University Hospital, Rotterdam, The Netherlands, 5Research, Wilex AG, Munich, Germany* INTRODUCTION & OBJECTIVES: cc250 (WXG250) is a IgGl kappa light-chain chimeric monoclonal antibody that binds to a cell surface antigen found on 95% of clear cell renal cancer. A multicenter phase II study was performed to evaluate the safety and efficacy of repeated doses of WX-G250. MATERIAL & METHODS: 36 patients (median age 64 year, IOF, 26M) with metastatic RCC were included. All patients were nephrectomised for the primary tumour; target lesions were mostly lung lesions and lymph nodes. The individual lesions were between I and 5 cm in diameter. 22 patients were pretreated (e.g. with IL-2, interferon alpha), 14 patients were untreated. A weekly dose of 50 mg WXG250 was given by iv infusion for 12 weeks. Patients with stable disease or tumour response after 12 weeks of treatment could receive additional treatment for 8 more weeks. RESULTS: None of the 36 enrolled patients had any G250 grade III or IV toxicity. Only 3 patients had grade II toxicity possibly related to the study medication (1 had gastritis, 2 vomiting). ELISA testing gave no evidence for Human Anti-Chimeric Anttbodies (HACA). 32 patients were treated for more than 6 weeks and are evaluable for efficacy assessment by CT. Nine patients presented with stable disease and were eligible for extension treatment. After the end of the study in the follow-up period, one patient demonstrated a CR in week 38 (regression started in week 20) and another patient with stable disease showed a significant reduction of the overall tumour load in week 44 with gradual remission first observed in week 16. Both patients had multiple pulmonary target lesions. 5 additional patients with progressive disease at study entry were stable for more than 6 months after treatment start; none of them received additional tumour therapy in the meantime. CONCLUSIONS: The weekly schedule of iv WX-G250 in patients with metastatic RCC was safe, very well tolerated and non-immunogenic in a 12 weeks treatment regimen. WX-G250 showed anti-tumour activity. Further follow-up of these patients is in progress to determine time to relapse. WXG250 is currently under investigation in various phase II trials.
438 LAPAROSCOPIC RESULTS
RENAL
CRYOABLATION:
Cestari A., Guazzoni G., Nava L., Bellinzoni P., Losa A., Zanoni M., Rigatti P. Department of Urology, Hospital, Milan, Italy
Casa di Cura Privata
“Ville Turro”
Jakse Gerhardi , Drafz Susanner,
MORTALITY BUT NOT RADICAL NEPHRECTOMY
Rohde Detlef’ , Reinecke Torsten*
‘Clinic of Urology, University Clinic Aachen, Aachen, Biometry, University Clinic Aachen, Aachen, Germany INTRODUCTION & OBJECTIVES: perioperative morbidity and mortality nephrectomy
Determination in patients
Germany,
MATERIALS & METHODS: Since September 2001, 25 patients (mean age 64 years; range 29-80) underwent laparoscopic renal cryoablation for TC or MRI documented renal masses. Mean lesion diameter was 27.3 mm (range 18. 55 mm). According to tumour position, in 14 cases the procedure was performed transperitoneally and in 11 patients with a retroperitoneoscopic approach. RESULTS: In all the patients two rapid freezing/thawing cycles were performed with a mean diameter of the ice ball of 47.1 mm. All the procedures were successfully performed laparoscopically, except one that was converted into open surgery. Mean surgical time was 205 mm with mean intraoperative blood loss of 150.8 cc (range 20-900 cc). Postoperative stay was medially 3.7 days (range 3-7) while postoperative complicances included three cases of transient hyperpirexia. one case of small perirenal hematoma. and one case of gross hematuria, treated conservatively. Hystopatological evaluation of the intraoperative needle biopsies revealed the presence of renal cell carcinoma in 19 cases, 3 cases of oncocytoma, 2 cases of angiomyolipoma and 1 case “indefinite”. MRI scan on postoperative day one documented a mean lesion of 48.3 mm. At I month (all the patients), 3 months (19 patients), 6 months (13 patients) and I year (2 patients) follow-up the mean reduction of the lesions was respectively 29,48,77 and 95%. Percutaneous biopsies of the lesion performed at 6 months follow-up revealed no presence of tumoural cells. CONCLUSION: Laparoscopic renal cryoablation of small renal masses, in selected cases, appears to be a safe, reproducible, minimally invasive technique. Although limited, follow up in our series is encouraging and further studies and prolonged follow-up is needed to access properly the role of this approach for the treatment of small renal masses.
440
of risk factors for undergoing radical
for renal cell cancer.
MATERIALS & METHODS: 268 patients underwent transabdominal radical nephrectomy for renal cell carcinoma. A chart review was performed. Risk factors were assessed by the anaesthesiologist, by the weighted index of comorbidity (Charlson et al, 1987) and age-comorbidity score (Hutchinson et al, 1982). Univariate and multivariate analysis was performed. RESULTS: 79 patients were judged to have an increased risk by the anaesthesiologist. 81 patients had a co-morbidity score >2, indicating an increased risk. An age-comorbidity score of >3 was noted in 99 patients. The postoperative complication rate was 9.7%. Operative revision was necessary in 0.7% patients. The mortality rate was 1.9%. On multivariate analysis the localisation of the tumour and venous thrombus were significant variables for postoperative morbidity. Mortality was associated with age and tumour size. None of the scores was associated with intraoperative or perioperative morbidity. However, the comorbidity score as well as age-comorbidity score were significantly correlated to mortality. CONCLUSION: To assess the risk of a patient to develop serious complications after radical nephrectomy simple clinical parameters can be used. One third of our patients had an increased risk for postoperative mortality, 6% of these died. This risk is at best assessed by the age-comorbidity score. European Urology Supplements 1 (2002) No. 1, pp. 112
PSYCHOLOGICAL, SOCIAL WELL-BEING STATUS AFTER SURGICAL TREATMENT CELL CARCINOMA
AND GENERAL HEALTH FOR LOCALISED RENAL
Ficarra Vincenzo, Cerruto Maria Angela, Novella Giovanni. Sarti Alessandra, Artibani Walter *Institute of
San Raffaele
INTRODUCTION: In selected cases, laparoscopic renal cryoablation of small renal neoplasm (less than 4 cm in diameter) aims to obtain the same oncological results as in open nephron sparing surgery, with all the typical advantages of minimally invasive surgery.
439 CO-MORBIDITY SCORES PREDICT MORBIDITY IN PATIENTS UNDERGOING
PRELIMINARY
Department
Ballario Riccardo,
of Urology, University of Verona, Verona, Italy
INTRODUCTION & OBJECTIVES: The aim of this study is to assess comparatively the psychological, social well-being and general health status in a group of patients undergone an elective nephron-sparing surgery (NSS) or radical nephrectomy (RN) for stage I RCC (according to TNM, 1997). MATERIALS & METHODS: We performed a cross-sectional study to evaluate the health-related quality of life (HR.QoL) in 88 patients undergone radical nephrectomy and in 56 patients undergone elective NSS. The collecting phase of the QoL data has been preceded by a socio-demographic evaluation of the patients. The measurement of the main QoL components has been made using domain-specific questionnaires tested and validated. Each questionnaire has been self-administrated during the medical examination made as a follow-up of the neoplasia. For statical analysis we used t-Student test and chi-square test to compare patients mean values and characteristics rates and the Mann-Whitney U-test to compare the mean values of each questionnaire administered. RESULTS: We did not find any significant difference between the 2 analysed groups regarding age, sex, civil status, educational level, profession and mean follow-up (58 months for NSS and 62 for RN). Low-grade anxiety level was documented in 1 I .4% of patients undergone RN and in I .8% of those undergone elective NSS. The mean score difference between the 2 mean values was statistically significant (p=O.O03). A mild depression was recorded in 7% of patients undergone RN and in 2.3% of those undergone NSS. The mean score difference was statistically significant (p=O.Ol). The general state of health was compromised in 12.5% of cases after radical nephrectomy and in 7% after elective NSS. Social problems were present in 18% of patients undergone radical nephrectomy and in 18% undergone NSS. No statistical difference between the 2 groups has been found in terms of mean scores of General Health questionnaire and Social Problem Questionnaire. CONCLUSION: The HR.QoL in patients undergone surgery for RCC is not negatively influenced by the treatment. The comparative analysis of the results showed that, at a long-term follow-up, the radical treatment may cause a more relevant compromising of the psychological well-being than the conservative surgical treatment.