Impact of postoperative complications on long-term survival in bladder cancer patients.

OBJECTIVE: To determine the impact of postoperative complications on long-term survival outcomes in patients with bladder cancer undergoing radical cystectomy. METHODS: This retrospective multi-institutional study included 766 bladder cancer patients who underwent radical cystectomy between 2011 and 2017. Patient characteristics, perioperative outcomes, all complications within 90 days after surgery and survival outcomes were collected. Each complication was graded based on the Clavien-Dindo system, and grouped using a standardized grouping method. The Comprehensive Complication Index, which incorporates all complications into a single formula weighted by their severity, was utilized. Overall survival and recurrence-free survival (local, distant or urothelial recurrences) were stratified by Comprehensive Complication Index (high: ≥26.2; low: <26.2). A multivariate model was utilized to identify independent prognostic factors. RESULTS: The incidence of any and major complications (≥Clavien-Dindo grade III) was 70 and 24%, respectively. In terms of Comprehensive Complication Index, 34% (261/766) of the patients had ≥26.2. Patients with Comprehensive Complication Index ≥ 26.2 had shorter overall survival (4-year, 59.5 vs. 69.8%, respectively, log-rank test, P = 0.0037) and recurrence free survival (51.9 vs. 60.1%, respectively, P = 0.0234), than those with Comprehensive Complication Index < 26.2. The Cox multivariate model identified the age, performance status, pT-stage, pN-stage and higher CCI (overall survival: HR = 1.35, P = 0.0174, recurrence-free survival: HR = 1.26, P = 0.0443) as independent predictors of both overall survivial and recurrence-free survival. CONCLUSIONS: Postoperative complications assessed by Comprehensive Complication Index had adverse effects on long-term survival outcomes. Physicians should be aware that major postoperative complications can adversely affect long-term disease control.

Efficacy of nivolumab plus ipilimumab as first-line therapy for primary tumors in patients with renal cell carcinoma.

OBJECTIVES: With the emergence of several effective combination therapies, information on their effects at the primary site will be crucial for planning future cytoreductive nephrectomy (CN). The present study focused exclusively on changes in primary tumor sizes following treatment with nivolumab plus ipilimumab and investigated the clinical factors associated with a good response in primary tumors. METHODS AND MATERIALS: We retrospectively assessed 27 patients diagnosed with advanced renal cell carcinoma (RCC) who started treatment with nivolumab plus ipilimumab. Changes in tumor sizes at the primary site were described using waterfall and spider plots, respectively. We analyzed the correlation of tumor shrinkage between primary and metastatic site. The parameters analyzed between responders and non-responders according to primary tumor sizes were International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk scores, peripheral blood markers, and CRP. RESULTS: The median age and follow-up period were 66 years and 9.3 months, respectively. The median IMDC risk score was 3 (range: 1-6). Nineteen patients were diagnosed with clear-cell RCC (ccRCC) and 8 patients with non-ccRCC. Among ccRCC patients, 9 (47.4%) achieved a significant response with a maximum reduction of 30% or more in the size of the primary tumor from baseline within 4 months, while 3 (37.5%) out of 8 patients with non-ccRCC achieved a significant response. Shrinkage of the primary tumor correlated with the metastatic tumors in both ccRCC and non-ccRCC cases. Of note, 6 patients underwent CN and no viable tumor cells were detected in the surgical specimens of 3 patients whose primary tumors shrank by approximately 50%-60% with a reduction to 4 cm or less. Among ccRCC patients, the neutrophil-to-lymphocyte ratio and monocyte-to-lymphocyte ratio were slightly lower in responders than in non-responders (P = 0.0944 and P = 0.0691). The platelet-to-lymphocyte ratio was significantly lower in responders than in non-responder (P = 0.0391). CONCLUSIONS: Significant responses in primary tumors to nivolumab plus ipilimumab were observed in 50% of ccRCC patients, while responses varied among non-ccRCC patients. Inflammation markers may be predictive factors of treatment responses in primary tumors. Although further studies are needed, the present results suggest the importance of considering CN from radiological and pathological viewpoints.

Comparative study of postoperative complications after radical cystectomy during the past two decades in Japan: Radical cystectomy remains associated with significant postoperative morbidities.

OBJECTIVES: During the past 2 decades, in order to improve perioperative and oncological outcomes, a minimally invasive approach, neoadjuvant chemotherapy (NAC), and an enhanced postoperative recovery program after surgery have been introduced into routine clinical practice of radical cystectomy (RC). Our aim was to examine the differences in clinical practice and postoperative complications after RC by comparing our previous and current cohorts. MATERIALS AND METHODS: A retrospective multi-institutional study. We collected all complications within 90 days after surgery between 2011 and 2017 (current cohort), and categorized them according to a standardized methodology. Then, we compared the outcomes with those in our previous study (previous cohort, 1997-2010). A multivariate logistic regression model was utilized to determine predictors of complications in the current cohort. RESULTS: A total of 838 patients were newly collected (current cohort), and 919 from the previous cohort were included in the subsequent analyses. In the current cohort, the rate of performing NAC was significantly higher (13% vs. 4%, respectively, P < 0.0001), and 26% (222/838) underwent laparoscopic RC (LRC, without robotic assistance: n = 210, with robotic assistance: n = 12). There was no significant difference in the overall complication [69% (580/838) vs. 68% (629/919), respectively, P = 0.7284] or major complication (Grades 3-5) [25% (211/838) vs. 22% (201/919), respectively, P = 0.1022] rates between the 2 cohorts. In both cohorts, the most frequent categories were infectious, gastrointestinal, wound-related, and genitourinary. In the current cohort, the performance status (odds ratio, OR = 2.11, P = 0.0013) and operative time (OR = 1.003, P = 0.0016) remained significant predictors of major complications. NAC was not associated with any or major complications. CONCLUSIONS: Surgical complications related to RC still remain significant problems, despite the recent improvements in surgical techniques and perioperative care. NAC did not increase the complications.

Prognostic impact of local radiotherapy on metastatic urothelial carcinoma patients receiving systemic chemotherapy.

OBJECTIVE: To clarify the prognostic impact of local radiotherapy on metastatic urothelial carcinoma patients treated by systemic chemotherapy. METHODS: Of the 228 metastatic urothelial carcinoma patients treated with systemic chemotherapy, 97 received radiotherapy mainly to metastatic sites. In patients for whom the purpose of radiotherapy was not specified, more than 50 Gy irradiation was considered to be for disease consolidation for survival analysis, while less than 50 Gy was categorized as palliation. According to the Kaplan-Meier method, we analysed overall survival from the initiation of treatment for metastatic urothelial carcinoma until death or the last follow-up, using the log-rank test to assess the significance of differences. The Cox model was applied for prognostic factor analysis. RESULTS: Overall, there was no significant difference in survival between patients with and those without radiotherapy (P = 0.1532). When analysing the patients undergoing consolidative radiotherapy separately, these 25 patients showed significantly longer survival than the 72 patients with palliative radiotherapy (P = 0.0047), with a 3-year overall survival of 43.3%. Of the present cohort, 22 underwent metastasectomy for disease consolidation, and there was no overlapping case between the metastasectomy cohort and cohort receiving consolidative radiotherapy. After controlling for four independent prognostic factors (sex, performance status, haemoglobin level and number of organs with metastasis) in our previous study, radiotherapy for disease consolidation showed a marginal value (hazard ratio = 0.666, P = 0.0966), while metastasectomy remained significant (hazard ratio = 0.358, P = 0.0006). CONCLUSIONS: In the selected patients, long-term disease control could be achieved after consolidative radiotherapy for metastatic urothelial carcinoma disease. Our observations suggest that local ablative therapy (surgery or radiotherapy) could facilitate long-term disease control. However, the treatment decision should be individualized because of the lack of randomized control trials.

Outcome and prognostic factors in metastatic urothelial carcinoma patients receiving second-line chemotherapy: an analysis of real-world clinical practice data in Japan.

OBJECTIVES: The objective of the present study was to investigate the survival outcome and prognostic factors of metastatic urothelial carcinoma patients treated with second-line systemic chemotherapy in real-world clinical practice. METHODS: Overall, 114 patients with metastatic urothelial carcinoma undergoing second-line systemic chemotherapy were included in this retrospective analysis. The dominant second-line chemotherapy was a paclitaxel-based combination regimen (60%, 68/114). We assessed the progression-free survival and overall survival times using the Kaplan-Meier method. The Cox proportional hazards model was applied to identify the factors affecting overall survival. RESULTS: The median progression-free survival and overall survival times were 4 and 9 months, respectively. In the multivariate analysis, an Eastern Cooperative Oncology Group performance status score greater than 0 at presentation, C-reactive protein level ≧1 mg/dl and poor response to prior chemotherapy were adverse prognostic indicators. Patients with 0, 1, 2 and 3 of those risk factors had a median overall survival of 17, 12, 7 and 3 months, respectively. CONCLUSIONS: The Eastern Cooperative Oncology Group performance status at presentation, C-reactive protein level and response to prior chemotherapy were prognostic factors for metastatic urothelial carcinoma patients undergoing second-line chemotherapy. In the future, this information might help guide the choice of salvage treatment, such as second-line chemotherapy or immune checkpoint inhibitors, after the failure of first-line chemotherapy.

Long-term treatment outcomes of intermittent androgen deprivation therapy for relapsed prostate cancer after radical prostatectomy.

PURPOSE: Intermittent androgen deprivation therapy is an effective treatment for metastatic prostate cancer. However, no study to date has evaluated the long-term outcomes of this treatment among patients with prostate cancer after radical prostatectomy. We retrospectively examined the treatment outcomes of patients with prostate-specific antigen recurrence who underwent radical prostatectomy at our department. MATERIALS AND METHODS: Of the 690 patients who underwent radical prostatectomy for local prostate cancer between 1988 and 2011, 129 patients who received androgen deprivation therapy for prostate-specific antigen recurrence were included in this study. Patient characteristics, luteinizing hormone-releasing hormone agonist administration, and outcomes were compared between the intermittent androgen deprivation group (n = 66) and the continuous androgen deprivation therapy group (n = 63). The non-recurrence and overall survival rates were compared between groups. RESULTS: Thirty-six patients (27.9%) experienced recurrence after luteinizing hormone-releasing hormone agonist administration. The 5-year non-recurrence rate and 10-year overall survival rate were higher in the intermittent group (92.9%) than in the continuous group (92.9 vs 57.9%, P < 0.001; and 95.9% vs 84.3%, P = 0.047, respectively). Furthermore, 63 patients (48.8%) showed a PSA nadir of less than 0.01 ng/mL after initiation of luteinizing hormone-releasing hormone agonist; among these patients, the non-recurrence rate was significantly higher in the intermittent androgen deprivation group (P = 0.003). CONCLUSIONS: Intermittent androgen deprivation therapy for prostate specific antigen recurrence after radical prostatectomy contributed to improvement of the non-recurrence rate and overall survival, and can be considered an effective therapy for better prognosis.

Everolimus in pregnancy: Case report and literature review.

There have been few reports on the effects of everolimus on the fetus, but none of six infants with documented everolimus exposure in utero had congenital malformations. A 32-year-old nulliparous woman on everolimus (5.0 mg/day) for renal angiomyolipoma (AML) due to tuberous sclerosis complex (TSC) was found to be pregnant at gestational week (GW) 7-5/7, at which time everolimus was withheld. To control AML in this patient, transarterial embolization was performed in the right and left kidneys at GW 21 and 24, respectively, and everolimus was reinitiated at GW 25. The patient gave birth at GW 37 to a normally formed infant weighing 3057 g, but who had cardiac tumors thought to be rhabdomyomas due to inherited TSC. Thus, although data are still limited, everolimus may be promising with respect to teratogenicity. Everolimus concentration in the maternal and umbilical cord blood at birth was 1.1 ng/mL and 1.0 ng/mL, respectively.

Outcome of metastatic urothelial carcinoma treated by systemic chemotherapy: Prognostic factors based on real-world clinical practice in Japan.

AIM: To clarify prognostic factors of metatstatic urothelial carcinoma treated by systemic chemotherapy in real-world clinical practice in the Japanese population. MATERIALS AND METHODS: A total of 228 patients with metastatic urothelial carcinoma undergoing systemic chemotherapy between 2000 and 2013 were included in the present multi-institutional study. The gemcitabine plus cisplatin regimen was administered as first-line chemotherapy to 131 patients, whereas methotrexate, vinblastine, doxorubicin, and cisplatin or its modified regimen was given to 71 patients. Of the 228 patients, 119 received at least 2 different regimens and 22 underwent resection of metastases (metastasectomy). Multivariate survival analysis was performed using the Cox proportional hazards model. The characteristics included were age, sex, Eastern Cooperative Oncology Group performance status (PS), primary site, pathology of primary site, hemoglobin levels, lactate dehydrogenase levels, C-reactive protein levels, corrected calcium levels, estimated glomerular filtration rate levels, history of prior chemotherapy, metastatic sites, resection of primary site, number of metastatic organs, and metastasectomy. RESULTS: The median overall survival (OS) time was 17 months. On multivariate analysis, female sex, good Eastern Cooperative Oncology Group PS at presentation, hemoglobin level≥10g/dl, and single organ metastasis were significant independent predictors of prolonged OS. For the survival effect of metastasectomy, the median OS time of the 22 patients with metastasectomy was 53 months, which was significantly longer when compared with patients not undergoing metastasectomy (15mo). After adjustment for the 4 aforementioned prognostic factors, metastasectomy still remained significant (hazard ratio: 0.364, P = 0.0008). CONCLUSIONS: Female sex, more favorable PS at presentation, hemoglobin level>10g/dl, and single organ metastasis were favorable prognostic factors. In addition, metastasectomy was associated with long-term disease control.

Laparoscopic resection of paraaortic/paracaval neurogenic tumors: surgical outcomes and technical tips.

BACKGROUND: Due to variations in location and size, laparoscopic surgery for paraaortic or paracaval neurogenic tumors is challenging. We evaluated the surgical outcomes, as well as surgical tips and tricks. METHODS: Between 2000 and 2015, 25 procedures were performed in 24 patients. One patient underwent second surgery due to the recurrence of paraganglioma. Data were collected on the tumor diameter, tumor location, perioperative outcomes, pathology, and last-known disease status. Regarding the operative procedures, we reviewed the operative charts or videos to identify surgical tips and tricks. RESULTS: The median tumor diameter was 5.0 cm (range 1.5-10). The tumor location was suprahilar in 10, hilar in 6, and infrahilar in 9 cases. Regarding the approach, a transperitoneal approach was selected in 24 cases and retroperitoneal approach in 1. The median operative time and blood loss were 208 min (range 73-513) and 10 mL (range 0-1020), respectively. No patient required blood transfusion or conversion to open surgery. Pathological examination revealed paraganglioma in 12, ganglioneuroma in 7, and schwannoma in 6 cases. At the last follow-up, 23 patients were free of disease, while one patient developed metastatic multiple recurrence of paraganglioma 54 months after the second laparoscopic surgery. A review of the surgical records revealed several tips and tricks, including taping the vena cava/renal vein (n = 2) being helpful for detaching a retrocaval tumor from these great vessels, or rotating the kidney to provide a favorable operative view of tumors behind the renal hilum (n = 2). In recent cases, 3D-CT was helpful for preoperative planning. CONCLUSIONS: Laparoscopic resection of paraaortic or paracaval neurogenic tumors is feasible in experienced hands. Surgeons should be familiar with detaching maneuvers around great vessels and the mobilization of adjacent organs. Careful preoperative planning is mandatory.

Diagnostic outcome of ureteroscopy in urothelial carcinoma of the upper urinary tract: Incidence of later cancer detection and its risk factors after the first examination.

BACKGROUND: To determine the incidence of later cancer detection and its risk factors after the first diagnostic ureteroscopy. METHODS: One hundred and sixty-six patients undergoing diagnostic ureteroscopy based on the suspicion of urothelial carcinoma of the upper urinary tract (UC of the UUT) between 1995 and 2012 were included. We examined the diagnostic outcome of the initial ureteroscopy. Thereafter, we collected follow-up data on patients who had not been diagnosed with UC of the UUT at the first examination, and evaluated the incidence of later cancer detection and its risk factors using Cox hazard models. RESULTS: Of the 166 patients, 76 (45.8%) were diagnosed with UC of the UUT at the first diagnostic ureteroscopy. The remaining 90 (54.2%) were diagnosed with other malignancies (n = 22), non-malignant disorders (n = 18), or without disorders (n = 50). Of these 90 patients, follow-up data were available in 65 patients (median: 41 months, range: 3-170). During the follow-up, carcinoma was detected in 6 patients (6/65, 9.2%) at a median of 43.5 months (range: 10-59). Episodes of gross hematuria (p = 0.0048) and abnormal cytological findings (p = 0.0335) during the follow-up and a male sex (p = 0.0316) were adverse risk factors. CONCLUSION: Later cancer detection of UC of the UUT was not uncommon after the first examination. The risk analysis revealed the aforementioned characteristics.

Outcome of regional lymphadenectomy in accordance with primary tumor location on laparoscopic nephroureterectomy for urothelial carcinoma of the upper urinary tract: a prospective study.

PURPOSE: To determine the appropriate template of regional lymph node dissection (LND) at the time of laparoscopic nephroureterectomy (LNU) for patients with clinically node- negative urothelial carcinoma of the upper urinary tract. PATIENTS AND METHODS: This prospective study included 45 patients undergoing LND with LNU in accordance with our prospective rules regarding the area of LND. Perioperative, pathologic, and follow-up data were collected. Micrometastasis in lymph nodes (LNs) was later evaluated by immunohistochemistry (IHC). Recurrence-free survival (RFS) was calculated with the Kaplan-Meier method. RESULTS: The median number of LNs removed was 14 (range 1-33). One patient with pT3 disease had node metastasis based on routine pathologic examination, and IHC revealed micrometastases in two additional patients (pT2 in one and pT3 in one). Therefore, 15% (3/20) of patients with ≥pT2 disease had node disease. After surgery, six patients experienced minor complications (Grade 1 or 2), and Grade 5 gastrointestinal bleeding after aspiration pneumonia developed in one elderly male patient on the 45th postoperative day, which was not considered to be associated with LND. At the last follow-up, lung metastasis developed in four patients (pT1 in one, pT2 in one, and pT3 in two), and presacral lymph node metastasis developed in one patient with a lower ureteral tumor (pT2), which was not included in our prospective template for a lower ureteral tumor. LN recurrence within/ near the LND area was not observed in patients with pelvic/upper ureteral carcinoma. The 2-year nonurothelial RFS rate was 84%. CONCLUSIONS: We consider that the present template represents regional LNs for patients with clinically node-negative pelvic/upper ureteral carcinoma, while presacral LNs may be incorporated into the regional LND template for patients with clinically node-negative lower ureteral carcinoma.

Comparison of 90-day complications between ileal conduit and neobladder reconstruction after radical cystectomy: a retrospective multi-institutional study in Japan.

OBJECTIVE: To determine the differences in the type, incidence, and severity of 90-day morbidity after radical cystectomy between two different methods of urinary diversion, ileal conduit and neobladder. METHODS: We carried out a retrospective multi-institutional study by reviewing the records of 668 patients treated with open radical cystectomy, and ileal conduit (n = 493) or neobladder substitution (n = 175) between 1997 and 2010. All complications within 90 days after surgery were divided into 11 specific categories as reported by the Memorial-Sloan Kettering Cancer Center, and graded according to the modified Clavien system. Type, incidence and severity of the 90-day morbidity between the two different types of urinary diversions were compared. RESULTS: There was no significant difference in the overall complication rates between the two groups (ileal conduit: 72% [353/493], neobladder: 74% [129/175], P = 0.5909), whereas the neobladder group had fewer major (grade 3 or more) complications (13 vs 20%, respectively, P = 0.0271). The neobladder group had more infectious complications (43 vs 31%, respectively, P = 0.0037), mainly as a result of urinary tract infection, whereas the ileal conduit group had more wound-related complications (24 vs 14%, respectively, P = 0.0068), mainly as a result of surgical site infection. The 90-day mortality rates were 1.1% (2/175) in the neobladder group and 1.6% (8/493) in the ileal conduit group (P = 0.6441). CONCLUSIONS: There was no significant difference in the overall complication rates between the two methods, and patients with neobladder had fewer major complications. The neobladder group had more infectious complications, whereas the ileal conduit group had more wound-related complications.

Long-term renal function outcomes in bladder cancer after radical cystectomy.

PURPOSE: To evaluate postoperative renal function and risk factors for the loss of renal function in patients who had undergone radical cystectomy. MATERIALS AND METHODS: A retrospective single institutional study evaluated 70 patients, including 54 men and 16 women who underwent radical cystectomy. The median follow-up period was 34.5 months (range, 12 to 228 months). In this cohort, four types of urinary diversions were studied, including ileal neobladder (n = 24), ileocecal neobladder (n = 12), ileal conduit (n = 25), and cutaneous ureterostomy (n = 9). Postoperative changes in renal function were reviewed, and the estimated serum creatinine-based glomerular filtration rate (eGFR) was calculated. The variables analyzed were age, a prior history of hypertension or diabetes mellitus, pre-operative renal function, type of urinary diversion, the postoperative occurrence of acute pyelonephritis, and the presence of chemotherapy. RESULTS: The mean eGFR was 74.6 (range, 15.2 to 155.1) mL/min/1.73 m² before surgery and 63.6 (range, 8.7 to 111.5) mL/min/1.73 m² at the last follow-up. The 10-year renal deterioration-free interval was 63.8%. Multivariate analysis showed that a postoperative episode of acute pyelonephritis [Odds Ratio (OR), 3.21; 95% Confidence Interval (CI), 1.14 to 9.02; P = .03] and the presence of chemotherapy (OR, 3.27; 95% CI, 1.33 to 8.01; P = .01) were significant adverse factors. CONCLUSION: Twenty-four (34.2%) patients demonstrated reduced renal function during the follow-up period. Postoperative episodes of acute pyelonephritis and the presence of chemotherapy were found to be significant adverse factors.

Is Memorial Sloan-Kettering Cancer Center risk classification appropriate for Japanese patients with metastatic renal cell carcinoma in the cytokine era?

OBJECTIVES: We investigated the prognosis of Japanese patients with metastatic renal cell carcinoma (RCC), and analyzed the validity of Memorial Sloan-Kettering Cancer Center (MSKCC) risk classification. MATERIALS AND METHODS: The endpoint of the present study was overall survival. Relationships between overall survival and potential prognostic factors were assessed using the Cox proportional hazard model with a step-wise procedure. Prognostic assessment was also performed according to the MSKCC risk classification. The predictive accuracy of the MSKCC risk classification was measured employing the concordance index. RESULTS: The median survival for all patients was 22 months (95% CI, 19-28 months). The eight factors were identified as independent prognostic factor; time from initial diagnosis to metastasis, low hemoglobin (Hb), lactate dehydrogenase (LDH), corrected serum calcium (cCa), C-reactive protein (CRP), and the presence or absence of liver metastasis, bone metastasis, and lymph node metastasis. When the MSKCC risk classification was applied to patients, the median overall survival was not reached and 26 and 10 months in the patients classified as favorable, intermediate, and poor risk, respectively. The c-index was 0.73. CONCLUSIONS: The prognosis of Japanese metastatic renal cell carcinoma patients may be better than that of previous studies from North America or Europe. Although there are some differences in the rate of patients in the risk groups and survival time by risk group between these patients, the MSKCC risk classification may be applicable for Japanese patients with metastatic renal cell carcinoma.

Peri-operative morbidity and mortality related to radical cystectomy: a multi-institutional retrospective study in Japan.

UNLABELLED: What's known on the subject? and What does the study add? Radical cystectomy remains associated with comparatively high perioperative morbidity and mortality, despite improvements in surgical techniques and perioperative care. At present, most studies on the complications associated with open radical cystectomy were derived from Western academic high-volume centres, and data from Japan and other Asian countries were very limited. Using the modified Clavien grading system and 11 category grouping reported from MSKCC, we observed that 68% of patients experienced at least one complication within 90 days of surgery, and 17% of patients experienced major complications (90-day mortality rate = 2%), which were compatible with reports from Western high-volume centres. As far as we know, our report is the largest one regarding perioperative morbidity and mortality in Asian patients who underwent radical cystectomy. OBJECTIVE: To determine the type, incidence and severity of 90-day morbidity after radical cystectomy in our institution and our affiliated hospitals in accordance with a standard reporting methodology. At present, most studies on complications associated with open radical cystectomy are derived from Western academic high-volume centres and data from Japan and other Asian countries remain very limited. PATIENTS AND METHODS: The study comprised a retrospective multi-institutional study. The records were reviewed of 928 patients who underwent open radical cystectomy between 1997 and 2010. All complications within 90 days of surgery were categorized into 11 specific categories and graded in accordance with the modified Clavien system. Multivariate regression models were used to determine predictors of complications. RESULTS: At least one complication was observed in 635 (68%) patients and a major (grade 3-5) complication was observed in 156 (17%) patients. The most common complication categories were infectious (30%), gastrointestinal (26%), wound-related (21%) and genitourinary (15%). The 30-day mortality rate was 0.8% and the 90-day mortality rate was 2%. A multivariate regression model showed that previous cardiovascular comorbidity and type of urinary diversion (i.e. ileal conduit or neobladder) were significant factors for any and major complications. CONCLUSIONS: Surgical complication-related radical cystectomy is significant and both previous cardiovascular comorbidity and the type of urinary diversion were found to be significant factors for any and major complications. The 90-day mortality rate was 2%, which is compatible with reports from Western high-volume centres.

Renal hypothermia with ice slush in laparoscopic partial nephrectomy: the outcome of renal function.

PURPOSE: To investigate changes in renal function after retroperitoneal laparoscopic partial nephrectomy (LPN) with renal hypothermia induced by ice-slush cooling. PATIENTS AND METHODS: Seventy-one patients undergoing retroperitoneal LPN with renal hypothermia were included. Perioperative outcomes were reviewed retrospectively. The total renal function was evaluated by an estimated glomerular filtration rate (eGFR) preoperatively and 6 months postoperatively in 69 patients. Split renal function (SRF) was also evaluated by 99mTc-mercaptoacetyltriglycine scintigraphy preoperatively and 6 months postoperatively in 61 patients. RESULTS: The median operative time was 246 minutes (range, 155-424). The median cold ischemic time, including the initial 15 minutes of hypothermia, was 57 minutes (range, 34-112). In the 21 patients whose renal temperature was monitored, median lowest renal temperature was 20.7°C (range, 12.1-27.6). The median baseline eGFR and 6-month postoperative eGFR were 77.2 mL/min/1.73 m(2) (range, 36.1-121.3) and 68.3 mL/min/1.73 m(2) (range, 33.2-103.4), and the median baseline SRF and 6-month postoperative SRF of the affected kidney were 49.3% (range, 40.3-57.6) and 40.7% (range, 13.8-54.5). Using multivariate analysis, the baseline eGFR (p<0.0001) and the ischemic time (p=0.0073) were associated with the 6-month postoperative eGFR, and the 6-month postoperative SRF was only associated with a baseline SRF (p=0.0185). CONCLUSIONS: Ice-slush cooling could provide renal hypothermia also under LPN. The decrease in renal function was small, whereas our ischemic time was longer than experts' warm ischemic series. These observations suggested the protective effect of our cooling methods against ischemic injury.

Influence of baseline renal function and dose reduction of nephrotoxic chemotherapeutic agents on the outcome of metastatic urothelial carcinoma: a retrospective study.

OBJECTIVES: To investigate the influence of baseline renal function and dose reduction of chemotherapeutic agents on the outcome of metastatic urothelial carcinoma patients with renal impairment. METHODS: A total of 57 patients with metastatic urothelial carcinoma treated by systemic chemotherapy were included in the present study. The 24 h-creatinine clearance was measured before each cycle and dose reduction was carried out according to our guidelines. Patients were divided into two groups according to baseline 24 h-creatinine clearance: fit group (60 mL/min/1.48 m(2) ≤) and unfit group (60 mL/min/1.48 m(2) >). Clinical characteristics and final outcomes were compared between the two groups. RESULTS: There was no significant difference in the total number of chemotherapy cycles of each patient between the two groups (fit group: median 5; unfit group: median 4; P=0.7466), although dose reduction was carried out significantly more often in the unfit group than in the fit group during treatment (fit group: median 0 cycles; unfit group: median 3.5 cycles; P=0.0016). Overall, the median survival was 16 months. There was a significant survival difference between the two groups (fit group: median 17 months; unfit group: median 10 months; P=0.0419). On multivariate analyses, impaired renal function at the baseline remained an adverse factor (HR 2.27, P=0.01). CONCLUSIONS: "Unfit" was a poor prognostic factor for metastatic urothelial carcinoma. The dose reduction strategy contributed to continuous treatment in the unfit group. However, its contribution to the prognosis of unfit patients is uncertain.

Interferon-α-based immunotherapy in metastatic renal cell carcinoma patients with the primary tumor in situ.

OBJECTIVE: We reviewed the outcomes of metastatic renal cell carcinoma patients with the primary tumor in situ who initially underwent interferon-α-based immunotherapy to evaluate the effect of this therapy on metastatic sites as well as primary kidney tumor and survival. METHODS: Thirty-one patients, for whom upfront cytoreductive nephrectomy was considered to be inappropriate because of poor performance status and far-advanced disease, were the subject of the present study. Tumor response and reduction in the size of metastatic sites and primary kidney tumor were assessed. Overall survival distributions were estimated using the Kaplan-Meier method with the significance determined using the log-rank test. RESULTS: Partial response was observed in 11 patients, yielding an overall response rate of 35%. Seventeen patients had regression or stabilization of metastatic sites, while progression of metastatic sites was observed in the remaining 14 patients. Regarding the maximum response of primary kidney tumor, a reduction in kidney primary tumor size was observed in 42% of the patients and the mean reduction rate in these patients was 18.2% (range: 3-36%). Furthermore, the reduction in the size of metastatic sites was significantly associated with that in the size of primary kidney tumor (R(2)= 0.432, P< 0.0001). The median survival for the 31 patients was 17 months. The median survival was 42 months in patients with regression or stabilization of metastatic sites and 7 months in those without (P< 0.001). CONCLUSIONS: The present study suggests that metastatic sites as well as primary kidney tumor respond to interferon-α-based immunotherapy in metastatic renal cell carcinoma patients with primary tumor in situ.