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UP-2.097: Experiences and Practical Conclusions Concerning Temsirolimus Use and Adverse Event Management in Advanced Renal Cell Carcinoma Within a Compassionate Use Program in Germany
UNMODERATED POSTER SESSIONS
Conclusions: The specific operative strategy used in these patients appear to provide a survival benefit and prevent pulmonary embolism. In patients with atrial tumor thrombus distant metastases uro-cardiosurgical procedure present possibility of prolonged survival. We were planning to change indications to this procedure, because our results and new possibilities of the adjuvant chemoterapy. UP-2.096 Feasibility of Sequential Use of Sunitinib and Temsirolimus in Advanced Renal Cell Carcinoma Gerullis H1, Bergmann L2, Maute L2, Ecke T3, Eimer C1, Bagner J1, Otto T1 1 Department of Urology, Lukas Hospital Neuss, Neuss, Germany; 2Department of Internal Medicine II, Hematology and Oncology, JW Goethe-University, Frankfurt-Am-Main, Germany; 3Department of Urology, HELIOS Hospital, Bad Saarow, Germany Introduction and Objective: Targeted agents sunitinib and temsirolimus are effective in advanced renal cell carcinoma. Treatment algorithms for single-agent use have been proposed in order to optimize timing and type of therapy. The aim of this study was to investigate the tolerability and adverse event profile of patients who received sunitinib and temsirolimus in sequence. Materials and Methods: We performed a retrospective analysis of patients with advanced renal cell carcinoma who received temsirolimus after disease progression under sunitinib therapy. Dosages of both drugs were in accordance with the recommendations given by the respective manufacturers. Temsirolimus was provided before its official approval within a compassionate use program. Adverse event assessment followed the National Cancer Institute Common Toxicity Criteria. Results: Thirteen patients receiving temsirolimus after progression under sunitinib were identified. Overall treatment time with targeted drugs (sunitinib/temsirolimus) was 34.8 (17-78) weeks, treatment with sunitinib was 28.6 (12-72) and with temsirolimus 6.2 (2-16) weeks respectively whereas mean therapy interruption time between both approaches was 4.4 (2-12) weeks. Under sunitinib, we observed 52 transient adverse events, 49 (94.2%) were of grade I/II,whereas 3 (5.8%) were of grade III. Under temsirolimus 36 adverse events, only grade I/II in nature were remarked. Conclusions: Sequential use of temsirolimus after progression under sunitinib seems to be feasible and results in a pre-
dictable, medically manageable side effect profile. Further evaluation is necessary to define the oncological validity of this sequencing approach. UP-2.097 Experiences and Practical Conclusions Concerning Temsirolimus Use and Adverse Event Management in Advanced Renal Cell Carcinoma Within a Compassionate Use Program in Germany Gerullis H1, Bergmann L2, Maute L2, Bagner J1, Eimer C1, Otto T1 1 Department of Urology, Lukas Hospital Neuss, Neuss, Germany; 2Department of Internal Medicine II, Hematology and Oncology, JW Goethe-University, Frankfurt-Am-Main, Germany Introduction and Objective: To detail tolerance of temsirolimus in a routine practice setting within a compassionate use program for patients with renal cell carcinoma. Materials and Methods: We treated 32 patients with advanced renal cell carcinoma with temsirolimus within the German compassionate use program on an individual patient basis free of charge according to EU guidelines at our two institutions. Twenty-five milligrams of temsirolimus was applied weekly in an inpatient clinical setting. Adverse events were classified following National Cancer Institute Common Toxicity Criteria. Results: No dose modifcation or therapy interruptions were necessary due to adverse events. Adverse events like asthenia/ fatigue were observed in 43.8%, increased creatinine in 40.6%, mucositis in 31.3%, secondary diabetes in 28.1%, hypothyreosis in 12.5% and rash in 12.5%, hypercholesterolemia and hypertriglyceridemia in 9.3% of the patients. Conclusions: Therapy with temsirolimus in advanced renal cell carcinoma is well tolerated. In a routine practice setting it results in a predictable adverse event profile that can be managed medically. UP-2.098 Complete Laparoscopic Nephroureterectomy with Thermosealing System Hora M, Eret V, Urge T, Klecka J, Stransky P, Hes O, Chudacek Z, Ferda J University Hospital, Plzen, Czech Republic Introduction and Objective: Urologists are still looking for the best method to perform a nephroureterectomy (NUE). In 2007, “A sealed laparoscopic nephroure-
UROLOGY 74 (Supplment 4A), October 2009
terectomy” was described (Tsivian et al: Eur Urol, 2007, 52; 1015-9). We want to confirm reproducibility of this complete laparoscopic technique in everyday urological practice. Materials and Methods: Between April 2008 and March 2009, we performed 12 complete laparoscopic NUEs (CLNUE). We start procedure in flank position with laparoscopic nephrectomy (LNE) (through 4-left side - or 5 ports - right side). After completion of LNE, one more port is added to lower abdomen in middle line and ureter is liberated to the bladder and ureter is excised with ureterovesical junction with thermosealing system (Ligasure® Atlas). Specimen is extracted entrapped in bag through lower abdomen splitting incision. Results: Five women and seven men, mean age 66 ⫾ 8 (57 - 76) years. Eight times on the right side, 4x left. Mean time of operation 133 ⫾ 17 (105 - 160) min. Mean blood loss 71 ⫾ 61 m1 (0 - 200) ml. Histology 9 x urothelial cancers-5x pelvis, 4x ureter-2x distal. Category pT3 1x, pT2 1x, pT1 3x, pTa 3x, grading G3 2x, G2 2x, G1 5x. Other histologies were 1x clear RCC (pT3aG2), 1x oncocytoma, 1x xantogranulomatous pyelonephritis. No complications. In one case, CLNUE was performed in native kidney ipsilateral to a transplanted kidney. Discharge from hospital was on 6.7 ⫾ 2.0 (3-11) days. Follow up 6.8 ⫾ 3.3 (1-11) months. Conclusion: We have found complete laparoscopic NUE with thermosealing system as an excellent method from all points of view (mini-invasiveness, oncological safety, reproducibility, short time of operation, no need to change patient’s position). We have replaced with this technique former accesses to the distal ureter. The method can be applied in carefully selected patient with tumour of ureter as well, not only in pelvis tumour. Technique is appropriate for NUE of native kidney ipsilateral to a transplanted kidney too. Open approach is reserved for advanced tumours only.
UP-2.099 Prognostic Factors of Lymph Node Invasion in Patients with Localized and Locally Advanced Renal Cell Carcinoma Alekseev B, Kalpinskiy A, Rusakov I, Frank G, Andreeva Y, Nyushko K, Chissov V Moscow Hertzen Oncology Institute, Moscow, Russia
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Conclusions: The specific operative strategy used in these patients appear to provide a survival benefit and prevent pulmonary embolism. In patients with atrial tumor thrombus distant metastases uro-cardiosurgical procedure present possibility of prolonged survival. We were planning to change indications to this procedure, because our results and new possibilities of the adjuvant chemoterapy. UP-2.096 Feasibility of Sequential Use of Sunitinib and Temsirolimus in Advanced Renal Cell Carcinoma Gerullis H1, Bergmann L2, Maute L2, Ecke T3, Eimer C1, Bagner J1, Otto T1 1 Department of Urology, Lukas Hospital Neuss, Neuss, Germany; 2Department of Internal Medicine II, Hematology and Oncology, JW Goethe-University, Frankfurt-Am-Main, Germany; 3Department of Urology, HELIOS Hospital, Bad Saarow, Germany Introduction and Objective: Targeted agents sunitinib and temsirolimus are effective in advanced renal cell carcinoma. Treatment algorithms for single-agent use have been proposed in order to optimize timing and type of therapy. The aim of this study was to investigate the tolerability and adverse event profile of patients who received sunitinib and temsirolimus in sequence. Materials and Methods: We performed a retrospective analysis of patients with advanced renal cell carcinoma who received temsirolimus after disease progression under sunitinib therapy. Dosages of both drugs were in accordance with the recommendations given by the respective manufacturers. Temsirolimus was provided before its official approval within a compassionate use program. Adverse event assessment followed the National Cancer Institute Common Toxicity Criteria. Results: Thirteen patients receiving temsirolimus after progression under sunitinib were identified. Overall treatment time with targeted drugs (sunitinib/temsirolimus) was 34.8 (17-78) weeks, treatment with sunitinib was 28.6 (12-72) and with temsirolimus 6.2 (2-16) weeks respectively whereas mean therapy interruption time between both approaches was 4.4 (2-12) weeks. Under sunitinib, we observed 52 transient adverse events, 49 (94.2%) were of grade I/II,whereas 3 (5.8%) were of grade III. Under temsirolimus 36 adverse events, only grade I/II in nature were remarked. Conclusions: Sequential use of temsirolimus after progression under sunitinib seems to be feasible and results in a pre-
dictable, medically manageable side effect profile. Further evaluation is necessary to define the oncological validity of this sequencing approach. UP-2.097 Experiences and Practical Conclusions Concerning Temsirolimus Use and Adverse Event Management in Advanced Renal Cell Carcinoma Within a Compassionate Use Program in Germany Gerullis H1, Bergmann L2, Maute L2, Bagner J1, Eimer C1, Otto T1 1 Department of Urology, Lukas Hospital Neuss, Neuss, Germany; 2Department of Internal Medicine II, Hematology and Oncology, JW Goethe-University, Frankfurt-Am-Main, Germany Introduction and Objective: To detail tolerance of temsirolimus in a routine practice setting within a compassionate use program for patients with renal cell carcinoma. Materials and Methods: We treated 32 patients with advanced renal cell carcinoma with temsirolimus within the German compassionate use program on an individual patient basis free of charge according to EU guidelines at our two institutions. Twenty-five milligrams of temsirolimus was applied weekly in an inpatient clinical setting. Adverse events were classified following National Cancer Institute Common Toxicity Criteria. Results: No dose modifcation or therapy interruptions were necessary due to adverse events. Adverse events like asthenia/ fatigue were observed in 43.8%, increased creatinine in 40.6%, mucositis in 31.3%, secondary diabetes in 28.1%, hypothyreosis in 12.5% and rash in 12.5%, hypercholesterolemia and hypertriglyceridemia in 9.3% of the patients. Conclusions: Therapy with temsirolimus in advanced renal cell carcinoma is well tolerated. In a routine practice setting it results in a predictable adverse event profile that can be managed medically. UP-2.098 Complete Laparoscopic Nephroureterectomy with Thermosealing System Hora M, Eret V, Urge T, Klecka J, Stransky P, Hes O, Chudacek Z, Ferda J University Hospital, Plzen, Czech Republic Introduction and Objective: Urologists are still looking for the best method to perform a nephroureterectomy (NUE). In 2007, “A sealed laparoscopic nephroure-
UROLOGY 74 (Supplment 4A), October 2009
terectomy” was described (Tsivian et al: Eur Urol, 2007, 52; 1015-9). We want to confirm reproducibility of this complete laparoscopic technique in everyday urological practice. Materials and Methods: Between April 2008 and March 2009, we performed 12 complete laparoscopic NUEs (CLNUE). We start procedure in flank position with laparoscopic nephrectomy (LNE) (through 4-left side - or 5 ports - right side). After completion of LNE, one more port is added to lower abdomen in middle line and ureter is liberated to the bladder and ureter is excised with ureterovesical junction with thermosealing system (Ligasure® Atlas). Specimen is extracted entrapped in bag through lower abdomen splitting incision. Results: Five women and seven men, mean age 66 ⫾ 8 (57 - 76) years. Eight times on the right side, 4x left. Mean time of operation 133 ⫾ 17 (105 - 160) min. Mean blood loss 71 ⫾ 61 m1 (0 - 200) ml. Histology 9 x urothelial cancers-5x pelvis, 4x ureter-2x distal. Category pT3 1x, pT2 1x, pT1 3x, pTa 3x, grading G3 2x, G2 2x, G1 5x. Other histologies were 1x clear RCC (pT3aG2), 1x oncocytoma, 1x xantogranulomatous pyelonephritis. No complications. In one case, CLNUE was performed in native kidney ipsilateral to a transplanted kidney. Discharge from hospital was on 6.7 ⫾ 2.0 (3-11) days. Follow up 6.8 ⫾ 3.3 (1-11) months. Conclusion: We have found complete laparoscopic NUE with thermosealing system as an excellent method from all points of view (mini-invasiveness, oncological safety, reproducibility, short time of operation, no need to change patient’s position). We have replaced with this technique former accesses to the distal ureter. The method can be applied in carefully selected patient with tumour of ureter as well, not only in pelvis tumour. Technique is appropriate for NUE of native kidney ipsilateral to a transplanted kidney too. Open approach is reserved for advanced tumours only.
UP-2.099 Prognostic Factors of Lymph Node Invasion in Patients with Localized and Locally Advanced Renal Cell Carcinoma Alekseev B, Kalpinskiy A, Rusakov I, Frank G, Andreeva Y, Nyushko K, Chissov V Moscow Hertzen Oncology Institute, Moscow, Russia
S261