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Purpose@#We aimed to investigate the risk factors and patterns of locoregional recurrence (LRR) after radical nephrectomy (RN) in patients with locally advanced renal cell carcinoma (RCC). @*Materials and Methods@#We retrospectively analyzed 245 patients who underwent RN for non-metastatic pT3-4 RCC from January 2006 to January 2016. We analyzed the risk factors associated with poor locoregional control using Cox regression. Anatomical mapping was performed on reference computed tomography scans showing intact kidneys. @*Results@#The median follow-up duration was 56 months (range, 1 to 128 months). Tumor extension to renal vessels or the inferior vena cava (IVC) and Fuhrman’s nuclear grade IV were identified as independent risk factors of LRR. The 5-year actuarial LRR rates in groups with no risk factor, one risk factor, and two risk factors were 2.3%, 19.8%, and 30.8%, respectively (p < 0.001). The locations of LRR were distributed as follows: aortocaval area (n=2), paraaortic area (n=4), retrocaval area (n=5), and tumor bed (n=11). No LRR was observed above the celiac axis (CA) or under the inferior mesenteric artery (IMA). @*Conclusion@#Tumor extension to renal vessels or the IVC and Fuhrman’s nuclear grade IV were the independent risk factors associated with LRR after RN for pT3-4 RCC. The locations of LRR after RN for RCC were distributed in the tumor bed and regional lymphatic area from the bifurcation of the CA to that of the IMA.
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Purpose@#To evaluate the performance of combining prostate health index (PHI) and Prostate Imaging Reporting and Data System version 2 (PI-RADSv2) for detection of clinically significant prostate cancer (csPCa). @*Materials and Methods@#We retrospectively reviewed patients who underwent prostate biopsy for elevated prostate-specific antigen (PSA) ≥2.5 ng/mL and/or abnormal digital rectal examination. Serum markers for PSA, free PSA (fPSA), and [-2] proPSA (p2PSA) were measured, and PHI was calculated as ([p2PSA/fPSA]×[PSA]1/2). Multiparametric magnetic resonance imaging was performed using a 3.0T scanner and scored using PI-RADSv2. csPCa was defined as either grade group (GG) ≥2 disease or GG1 cancer detected in >2 cores or >50% of positive on biopsy. Univariable and multivariable logistic regression modelling, along with receiver-operating characteristic (ROC) curve analysis was used to predict the probability of csPCa. @*Results@#Of the total 358 patients, 159 (44.4%) were diagnosed with csPCa. On univariable analysis, age, PSA density (PSAD), PHI and PI-RADSv2 were associated with csPCa. The area under the ROC curve (AUC) of baseline model incorporating age and PSAD was 0.663. The AUC of combining PHI and PI-RADSv2 to baseline model was higher than that of PHI alone to baseline model (0.884 vs. 0.807, p<0.0001) and PI-RADSv2 alone to baseline model (0.884 vs. 0.846, p=0.0002), respectively. If biopsy was restricted to patients with PI-RADS 5 as well as PI-RADS 3 or 4 and PHI ≥27, 36.0% of unnecessary biopsy could be avoided at the cost of missing 4.7% of csPCa. @*Conclusions@#The combination of PHI and PI-RADSv2 to baseline model incorporating age and PSAD had higher accuracy for detection of csPCa compared with PHI or PI-RADSv2 alone.
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Purpose@#We investigated the predictive factors for acute urinary retention (AUR) after transperineal template-guided mapping biopsy (TTMB). @*Materials and Methods@#We retrospectively reviewed the records of 459 patients who had undergone TTMB between May 2017 and July 2020. Overall complications after TTMB were analyzed and categorized according to the Clavien-Dindo classification. Factors that were likely to affect AUR were analyzed using a logistic regression model. @*Results@#Overall complications after TTMB were observed in 95 of the 459 patients (20.7%), of which AUR was the most commonly reported (17.4%, n=80), followed by hematuria (3.1%, n=14). Hematuria in one patient was categorized as Clavien-Dindo grade IIIa. All remaining complications were Clavien-Dindo grade I. In the multivariate regression model, age ≥65 (odds ratio, 2.44; 95% confidence interval [CI], 1.42–4.17; p=0.001), prostate volume ≥30 mL (odds ratio, 3.72; 95% CI, 1.19–11.62; p<0.02), and number of biopsy cores ≥30 (odds ratio, 2.89; 95% CI, 1.29–6.43; p=0.01) were identified as the predictors for AUR after TTMB. @*Conclusions@#AUR is the most common complication after TTMB. Age ≥65 years, prostate volume ≥30 mL, and number of biopsy cores ≥30 were significant predictors of AUR following TTMB.
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Purpose@#To analyze and compare the results of robotic partial nephrectomy (RPN) at a single center with the previous large-scale studies in terms of perioperative and oncological outcomes. @*Materials and Methods@#We retrospectively evaluated 1,013 cases of RPN in our center database from December 2008 to August 2018. Total 11 cases were excluded in final analysis. We evaluated perioperative outcomes as the Trifecta achievement, which is defined as no positive surgical margin (PSM), no perioperative complications greater than Clavien-Dindo classification I and a warm ischemia time of <25 minutes. In addition, we analyzed pathological and oncological outcomes; recurrence, metastasis, all-cause deaths, cancer-specific deaths, and 5-year survival rates. @*Results@#In 1,002 cases, the Trifecta achievement was 61.1% (n=612). The postoperative complication was 18.4% (n=184) but most were grade 2 or less (14.9%, n=145). Ninety-three cases (9.28%) had benign and 907 cases (90.5%) had malignant pathologies. A local recurrence were 14 cases (1.54%) and distant metastasis were 20 cases (2.2%) during follow-up periods. Allcause death rate was 1.2% (n=11) and cancer-specific death rate was 0.2% (n=2). The median follow-up period was 39 months. A 5-year recurrence-free survival rate, cancer-specific survival rate, and overall survival rate were 95.2%, 99.7%, and 98.4%. @*Conclusions@#In summary, our data shows comparable perioperative outcomes to other largescale studies of RPN in terms of the Trifecta achievement with similar baseline characteristics. In terms of oncological outcomes, there was lower rate of PSM and similar recurrence free survival rate.
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Purpose@#We compared success rates of 3 surgical techniques (holmium laser enucleation of the prostate [HoLEP], transurethral resection of the prostate [TURP], and photoselective laser vaporization prostatectomy [PVP]) for treatment of benign prostatic obstruction (BPO). We aimed to identify preoperative clinical variables and urodynamic parameters that predict surgical success. @*Methods@#A total of 483 patients who underwent surgical treatment for BPO at Samsung Medical Center between 2006 and 2017 were retrospectively analyzed; of these 361, 81, and 41 patients underwent HoLEP, TURP, and PVP, respectively. Prostate-specific antigen, prostate volume, urodynamic parameters, and International Prostate Symptom Score (IPSS)/quality of life (QoL) index were evaluated preoperatively; uroflowmetry, postvoid residual urine, and IPSS/QoL index were measured 6 months postoperatively. Surgical success was defined based on IPSS, maximum flow rate, and QoL index and predictive factors were identified using multiple logistic regression analyses. @*Results@#Success rates of HoLEP, TURP, and PVP were 67.6%, 65.4%, and 34.1%, respectively, and the HoLEP and TURP groups were not significantly different. Regression analysis revealed prostate volume ≥50 mL and bladder outlet obstruction index (BOOI) ≥40 to be independent factors predicting HoLEP success. Only high preoperative QoL could predict the success of TURP, whereas other urodynamic parameters remained unrelated. @*Conclusions@#Patients treated with HoLEP and TURP displayed equivalent efficacies, but PVP was relatively less efficient than both. Preoperative variables of prostate volume ≥50 mL and BOOI ≥40 were independent predictive factors for the success of HoLEP but not of TURP.
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Purpose@#This study aimed to evaluate the effects of bladder cuff method on oncological outcomes in patients who underwent radical nephroureterectomy (RNU) for upper tract urothelial carcinoma. @*Materials and Methods@#The records of 1,095 patients treated with RNU performed at our hospital between 1994 and 2018 were retrospectively reviewed; 856 patients with no bladder tumor history were enrolled in the present study. The management of bladder cuff was divided into two categories: extravesical ligation (EL) or transvesical resection (TR). Survival was analyzed using the Kaplan-Meier method and Cox regression analyses were performed to determine which factors were associated with intravesical recurrence (IVR)–free survival (IVRFS), cancer-specific survival (CSS), and overall survival (OS). @*Results@#The mean patient age was 64.8 years and the median follow-up was 37.7 months. Among the 865 patients, 477 (55.7%) underwent the TR and 379 (44.3%) the EL. Significantly higher IVRFS (p=0.001) and OS (p=0.013) were observed in the TR group. In multivariable analysis, IVR, CSS, and OS were independently associated with the EL. Among 379 patients treated with the EL, eight underwent remnant ureterectomy. Based on radical cystectomy–free survival, significant difference was not observed between the two groups. However, significantly higher IVRFS was observed in the TR group when the tumor was located in the renal pelvis. @*Conclusion@#Intramural complete excision of the distal ureter during RNU should be the gold standard approach compared with EL for the management of distal ureter in terms of oncological outcomes.
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Purpose@#We compared success rates of 3 surgical techniques (holmium laser enucleation of the prostate [HoLEP], transurethral resection of the prostate [TURP], and photoselective laser vaporization prostatectomy [PVP]) for treatment of benign prostatic obstruction (BPO). We aimed to identify preoperative clinical variables and urodynamic parameters that predict surgical success. @*Methods@#A total of 483 patients who underwent surgical treatment for BPO at Samsung Medical Center between 2006 and 2017 were retrospectively analyzed; of these 361, 81, and 41 patients underwent HoLEP, TURP, and PVP, respectively. Prostate-specific antigen, prostate volume, urodynamic parameters, and International Prostate Symptom Score (IPSS)/quality of life (QoL) index were evaluated preoperatively; uroflowmetry, postvoid residual urine, and IPSS/QoL index were measured 6 months postoperatively. Surgical success was defined based on IPSS, maximum flow rate, and QoL index and predictive factors were identified using multiple logistic regression analyses. @*Results@#Success rates of HoLEP, TURP, and PVP were 67.6%, 65.4%, and 34.1%, respectively, and the HoLEP and TURP groups were not significantly different. Regression analysis revealed prostate volume ≥50 mL and bladder outlet obstruction index (BOOI) ≥40 to be independent factors predicting HoLEP success. Only high preoperative QoL could predict the success of TURP, whereas other urodynamic parameters remained unrelated. @*Conclusions@#Patients treated with HoLEP and TURP displayed equivalent efficacies, but PVP was relatively less efficient than both. Preoperative variables of prostate volume ≥50 mL and BOOI ≥40 were independent predictive factors for the success of HoLEP but not of TURP.
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Purpose@#This study aimed to evaluate the effects of bladder cuff method on oncological outcomes in patients who underwent radical nephroureterectomy (RNU) for upper tract urothelial carcinoma. @*Materials and Methods@#The records of 1,095 patients treated with RNU performed at our hospital between 1994 and 2018 were retrospectively reviewed; 856 patients with no bladder tumor history were enrolled in the present study. The management of bladder cuff was divided into two categories: extravesical ligation (EL) or transvesical resection (TR). Survival was analyzed using the Kaplan-Meier method and Cox regression analyses were performed to determine which factors were associated with intravesical recurrence (IVR)–free survival (IVRFS), cancer-specific survival (CSS), and overall survival (OS). @*Results@#The mean patient age was 64.8 years and the median follow-up was 37.7 months. Among the 865 patients, 477 (55.7%) underwent the TR and 379 (44.3%) the EL. Significantly higher IVRFS (p=0.001) and OS (p=0.013) were observed in the TR group. In multivariable analysis, IVR, CSS, and OS were independently associated with the EL. Among 379 patients treated with the EL, eight underwent remnant ureterectomy. Based on radical cystectomy–free survival, significant difference was not observed between the two groups. However, significantly higher IVRFS was observed in the TR group when the tumor was located in the renal pelvis. @*Conclusion@#Intramural complete excision of the distal ureter during RNU should be the gold standard approach compared with EL for the management of distal ureter in terms of oncological outcomes.
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Purpose@#We investigated the predictive factors for acute urinary retention (AUR) after transperineal template-guided mapping biopsy (TTMB). @*Materials and Methods@#We retrospectively reviewed the records of 459 patients who had undergone TTMB between May 2017 and July 2020. Overall complications after TTMB were analyzed and categorized according to the Clavien-Dindo classification. Factors that were likely to affect AUR were analyzed using a logistic regression model. @*Results@#Overall complications after TTMB were observed in 95 of the 459 patients (20.7%), of which AUR was the most commonly reported (17.4%, n=80), followed by hematuria (3.1%, n=14). Hematuria in one patient was categorized as Clavien-Dindo grade IIIa. All remaining complications were Clavien-Dindo grade I. In the multivariate regression model, age ≥65 (odds ratio, 2.44; 95% confidence interval [CI], 1.42–4.17; p=0.001), prostate volume ≥30 mL (odds ratio, 3.72; 95% CI, 1.19–11.62; p<0.02), and number of biopsy cores ≥30 (odds ratio, 2.89; 95% CI, 1.29–6.43; p=0.01) were identified as the predictors for AUR after TTMB. @*Conclusions@#AUR is the most common complication after TTMB. Age ≥65 years, prostate volume ≥30 mL, and number of biopsy cores ≥30 were significant predictors of AUR following TTMB.
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Purpose@#To analyze and compare the results of robotic partial nephrectomy (RPN) at a single center with the previous large-scale studies in terms of perioperative and oncological outcomes. @*Materials and Methods@#We retrospectively evaluated 1,013 cases of RPN in our center database from December 2008 to August 2018. Total 11 cases were excluded in final analysis. We evaluated perioperative outcomes as the Trifecta achievement, which is defined as no positive surgical margin (PSM), no perioperative complications greater than Clavien-Dindo classification I and a warm ischemia time of <25 minutes. In addition, we analyzed pathological and oncological outcomes; recurrence, metastasis, all-cause deaths, cancer-specific deaths, and 5-year survival rates. @*Results@#In 1,002 cases, the Trifecta achievement was 61.1% (n=612). The postoperative complication was 18.4% (n=184) but most were grade 2 or less (14.9%, n=145). Ninety-three cases (9.28%) had benign and 907 cases (90.5%) had malignant pathologies. A local recurrence were 14 cases (1.54%) and distant metastasis were 20 cases (2.2%) during follow-up periods. Allcause death rate was 1.2% (n=11) and cancer-specific death rate was 0.2% (n=2). The median follow-up period was 39 months. A 5-year recurrence-free survival rate, cancer-specific survival rate, and overall survival rate were 95.2%, 99.7%, and 98.4%. @*Conclusions@#In summary, our data shows comparable perioperative outcomes to other largescale studies of RPN in terms of the Trifecta achievement with similar baseline characteristics. In terms of oncological outcomes, there was lower rate of PSM and similar recurrence free survival rate.
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Purpose@#The Advanced Prostate Cancer Consensus Conference (APCCC) 2015 was based on topics withcontroversy in the field of advanced prostate cancer. To understand the Korean urologists perspective regardingthe issues, we have conducted a questionnaire named Prostate Cancer Summit (PCAS) 2016, with 9 importantsubtopics. @*Materials and Methods@#Total 9 subtopics have been decided and questions were developed regarding eachsubtopic. The questions were based on that of APCCC 2015 and translated into Korean for better understanding.Total 51 panelists have voted online on 85 different questions. @*Results@#The survey concluded that testosterone should be measured as a diagnostic criterion for castrationresistance prostate cancer (CRPC) and that consensus was reached on issues such as the use of androgenreceptor pathway inhibitors in the treatment of predocetaxel and postdocetaxel in CRPC patients. In addition,76% of the participants agreed that imaging tests were needed before new treatment in CRPC patients, anda majority of participants agreed that periodic imaging tests are necessary regardless of symptoms during treatmentfor CRPC. However, some issues, such as the use of prostate-specific antigen-based triggers for remediationin CRPC patients, the endocrine manipulation in nonmetastatic CRPC patients, and the onset of treatment inasymptomatic metastatic CRPC patients, were not agreed. @*Conclusions@#The results from PCAS 2016 has addressed some of the issues with controversy. Although thevoting results are subjective, it will help guide treatment decisions in topics with less evidence.
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Purpose@#To assess awareness of prostate cancer and prostate cancer screening in high risk Korean men 40 years and older. @*Materials and Methods@#The Korean Urological Oncology Society implemented an online survey of 600 men aged 40 years or older from July 30 to August 6, 2019 to ask questions about prostate cancer and screening. @*Results@#Of the 600 respondents, 96.5% (579 of 600) were aware of prostate cancer and 49.8% (299 of 600) thought they were at risk. Men in their 60s, men with a family history and men with urological conditions were more concerned about prostate cancer. Most respondents (83.3%, 500 of 600) had never received prostate cancer screening. When asked why they had not, (multiple choices: first, second and third priority), the most common responses were: “They had no symptoms of prostate cancer”; “They were in good health”; “Cost burden of screening”; and “They thought screening was included in the National Health Examination Program.” Only 9.7% (58 of 600) were aware of prostate-specific antigen (PSA). After being informed about PSA, 97.7% (586 of 600) wanted it to be included in national cancer screening. @*Conclusions@#In this survey, 96.5% of respondents were aware of prostate cancer, and 44.2% recognized the need for early screening. However, only 16.7% had received screening. Awareness of prostate cancer risks tended to be high in elderly people, people with a family history and people with urological conditions. The results also indicate that there is support for national-level management and early screening programs for prostate cancer. (Korean J Urol Oncol 2020;18:40-46)
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Background@#To evaluate the strategy for detection of prostate cancer (PCa) with low prostate specific antigen (PSA) level (2.5–4.0 ng/mL), prostate biopsy patients with low PSA were assessed. We evaluated the risk of low PSA PCa and the strategy for screening low-PSA patients. @*Methods@#We retrospectively analyzed the patients who underwent prostate biopsy with low PSA level. Baseline characteristics, PSA level before prostate biopsy, prostate volume, prostate specific antigen density (PSAD), and pathological data were assessed. @*Results@#Among the 1986 patients, 24.97% were diagnosed with PCa. The PSAD was 0.12 ± 0.04 ng/mL2 in the PCa-diagnosed group and 0.10 ± 0.04 ng/mL2 in non-cancer-diagnosed group (P < 0.001). Of the 496 patients diagnosed with PCa, 302 (60.89%) were in the intermediate- or high-risk group. PSAD was 0.13 ± 0.04 ng/mL2 in the intermediate- or highrisk group and 0.11 ± 0.03 ng/mL2 in the very low- and low-risk group (P < 0.001). Of 330 patients who underwent radical prostatectomy, 85.15% were diagnosed as having significant cancer. There was significant correlation between PSAD and PCa (r = 0.294, P < 0.001).PSAD with a specificity of 80.00% of a clinically significant cancer diagnosis was assessed at 0.1226 ng/mL2 . @*Conclusion@#The PCa detection rate in the low-PSA group was not lower than that of previous studies of patients with PSA from 4.0 to 10.0 ng/mL. Further, it may be helpful to define a strategy for PCa detection using PSAD in the low-PSA group.
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Purpose@#There remains a lot of unmet need to increase understanding of node-positive (ypN+) muscle invasive bladder cancer (MIBC) after neoadjuvant chemotherapy and radical cystectomy to decide the appropriate therapeutics. @*Materials and Methods@#In a retrospective study using the center cancer chemotherapy registry, we found 113 MIBC patients who were treated with neoadjuvant chemotherapy involving gemcitabine and cisplatin (GP) followed by radical cystectomy between 2010 and 2014. Disease-free survival (DFS) and overall survival (OS) were compared according to the pathologic node positivity (ypN- vs. ypN+). Among a total of 165 patients with MIBC who received neoadjuvant chemotherapy involving GP, 118 underwent radical cystectomy. In 46 patients with ypN+ disease, DFS and OS were evaluated according to administration of adjuvant GP. @*Results@#After neoadjuvant chemotherapy and radical cystectomy, 41% of patients had ypN+ disease, which showed significantly shorter DFS (median, 7.4 months; 95% confidence interval [CI], 5.3–9.6 months) and OS (median, 20.0 months; 95% CI, 13.4–26.6 months) compared to those with ypN- disease. The patients with ypN+ disease had a high risk of recurrence or death, regardless of the administration of adjuvant chemotherapy or adjuvant regimen. @*Conclusions@#Within the limitations of this retrospective study, MIBC patients with ypN+ disease despite neoadjuvant chemotherapy and radical cystectomy had a poor prognosis. Further studies involving novel, effective adjuvant treatment including immunotherapy agents are needed to reduce the high risk of recurrence or death in these patients.
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BACKGROUND@#The objective of this study was to investigate whether androgen deprivation therapy (ADT) with gonadotropin-releasing hormone agonist (GnRHa) in prostate cancer (Pca) patients is associated with cardiovascular disease in the cohort based from the entire Korean population.@*METHODS@#Using the Korean National Health Insurance database, we conducted an observational study of 579,377 men who sought treatment for Pca between January 1, 2012 and December 31, 2016. After excluding patients with previously diagnosed cardiovascular disease or who had undergone chemotherapy, we extracted the data from 2,053 patients who started GnRHa (GnRHa users) and 2,654 men who were newly diagnosed with Pca (GnRHa nonusers) between July 1, 2012, and December 31, 2012, with follow-up through December 31, 2016. The primary outcomes were cerebrovascular attack (CVA) and ischemic heart disease (IHD).@*RESULTS@#GnRHa users were older, were more likely to reside in rural areas, had lower socioeconomic status, and had more comorbidities than nonusers (all P < 0.050). Although GnRHa users had an increased incidence of CVA and IHD (P = 0.013 and 0.048, respectively) in univariate analysis, GnRHa use was not associated with the outcomes in multivariate analysis. Furthermore, the cumulative duration of ADT was not associated with the outcomes whereas the associations between age at diagnosis with all diseases were significant.@*CONCLUSION@#Our complete enumeration of the Korean Pca population shows that ADT is not associated with increased risks of cardiovascular disease.
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BACKGROUND@#The objective of this study was to investigate whether androgen deprivation therapy (ADT) with gonadotropin-releasing hormone agonist (GnRHa) in prostate cancer (Pca) patients is associated with cardiovascular disease in the cohort based from the entire Korean population.@*METHODS@#Using the Korean National Health Insurance database, we conducted an observational study of 579,377 men who sought treatment for Pca between January 1, 2012 and December 31, 2016. After excluding patients with previously diagnosed cardiovascular disease or who had undergone chemotherapy, we extracted the data from 2,053 patients who started GnRHa (GnRHa users) and 2,654 men who were newly diagnosed with Pca (GnRHa nonusers) between July 1, 2012, and December 31, 2012, with follow-up through December 31, 2016. The primary outcomes were cerebrovascular attack (CVA) and ischemic heart disease (IHD).@*RESULTS@#GnRHa users were older, were more likely to reside in rural areas, had lower socioeconomic status, and had more comorbidities than nonusers (all P < 0.050). Although GnRHa users had an increased incidence of CVA and IHD (P = 0.013 and 0.048, respectively) in univariate analysis, GnRHa use was not associated with the outcomes in multivariate analysis. Furthermore, the cumulative duration of ADT was not associated with the outcomes whereas the associations between age at diagnosis with all diseases were significant.@*CONCLUSION@#Our complete enumeration of the Korean Pca population shows that ADT is not associated with increased risks of cardiovascular disease.
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Purpose@#There remains a lot of unmet need to increase understanding of node-positive (ypN+) muscle invasive bladder cancer (MIBC) after neoadjuvant chemotherapy and radical cystectomy to decide the appropriate therapeutics. @*Materials and Methods@#In a retrospective study using the center cancer chemotherapy registry, we found 113 MIBC patients who were treated with neoadjuvant chemotherapy involving gemcitabine and cisplatin (GP) followed by radical cystectomy between 2010 and 2014. Disease-free survival (DFS) and overall survival (OS) were compared according to the pathologic node positivity (ypN- vs. ypN+). Among a total of 165 patients with MIBC who received neoadjuvant chemotherapy involving GP, 118 underwent radical cystectomy. In 46 patients with ypN+ disease, DFS and OS were evaluated according to administration of adjuvant GP. @*Results@#After neoadjuvant chemotherapy and radical cystectomy, 41% of patients had ypN+ disease, which showed significantly shorter DFS (median, 7.4 months; 95% confidence interval [CI], 5.3–9.6 months) and OS (median, 20.0 months; 95% CI, 13.4–26.6 months) compared to those with ypN- disease. The patients with ypN+ disease had a high risk of recurrence or death, regardless of the administration of adjuvant chemotherapy or adjuvant regimen. @*Conclusions@#Within the limitations of this retrospective study, MIBC patients with ypN+ disease despite neoadjuvant chemotherapy and radical cystectomy had a poor prognosis. Further studies involving novel, effective adjuvant treatment including immunotherapy agents are needed to reduce the high risk of recurrence or death in these patients.
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Subject(s)
Humans , Male , Antineoplastic Agents , Cardiovascular Diseases , Cohort Studies , Comorbidity , Diagnosis , Drug Therapy , Follow-Up Studies , Gonadotropin-Releasing Hormone , Incidence , Morinda , Multivariate Analysis , Myocardial Ischemia , National Health Programs , Observational Study , Passive Cutaneous Anaphylaxis , Prostate , Prostatic Neoplasms , Social ClassABSTRACT
PURPOSE: Treatment targeting immune checkpoint with programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors has demonstrated efficacy and tolerability in the treatment of metastatic urothelial carcinoma (mUC). We investigated the efficacy and safety of atezolizumab in mUC patients who failed platinum-based chemotherapy. MATERIALS AND METHODS: A retrospective study using the Samsung Medical Center cancer chemotherapy registry was performed on 50 consecutive patients with mUC treated with atezolizumab, regardless of their PD-L1(SP142) status, as salvage therapy after chemotherapy failure between May 2017 and June 2018. Endpoints included overall response rate (RR), progression-free survival (PFS), and safety. RESULTS: Among 50 patients, men constituted 76% and the median age was 68 years (range, 46 to 82 years). Twenty-three patients (46%) received atezolizumab as second-line therapy. PD-L1 (SP142) status IC0/1 and IC2/3 were found in 21 (42%) and 21 (42%) of patients, respectively; in eight patients (16%), PD-L1 (SP142) expression was not available. Atezolizumab was generally well tolerated, with pruritus and fatigue being the most commonly observed toxicities. As a result, partial response was noted in 20 patients (40%), with 12 (24%) stable diseases. RRwas higherin IC2/3 (62%) than in IC0/1 patients (24%, p=0.013). The median PFS was 7.4 months (95% confidence interval, 3.4 to 11.4 months). As expected, PFS also was significantly longer in IC2/3 patients than in IC0/1 (median, 12.7 vs. 2.1 months; p=0.005). PFS was not significantly influenced by age, sex, performance status, number of previous chemotherapy, site of metastases, or any of the baseline laboratory parameters. CONCLUSION: In this retrospective study, atezolizumab demonstrated clinically efficacy and tolerability in unselected mUC patients who failed platinum-based chemotherapy.
Subject(s)
Humans , Male , Disease-Free Survival , Drug Therapy , Fatigue , Neoplasm Metastasis , Pruritus , Retrospective Studies , Salvage TherapyABSTRACT
PURPOSE: The efficacy of nivolumab in metastatic renal cell carcinoma (mRCC) has been proven. However, the nivolumab experience in Korean patients with mRCC is still poorly reported. We report initial experiences with the efficacy and safety of nivolumab in patients with mRCC. MATERIALS AND METHODS: We retrospectively reviewed records for 25 patients with mRCC who had failed targeted therapy and were treated by nivolumab (2 mg/kg, every 2 weeks) at a single institution. The primary endpoint was objective response rate (ORR), and secondary endpoints were progression-free survival (PFS), safety profiles, and ORR in a programmed cell death receptor ligand 1 (PD-L1) expression subgroup. RESULTS: The median age was 60 years and 16 patients (64%) were male. Objective responses were achieved in 8 patients (32.0%) (complete response, 1; partial response, 7). Median PFS was 3.0 months (95% confidence interval, 1.46–4.53). Treatment-related adverse events (AEs) of any grade were observed in 19 patients (76.0%) with 6 (24.0%) experiencing grade 3 to 4 treatment-related AEs. In subgroups by PD-L1 expression levels classified as 1% or greater and less than 1%, ORR was 50% and 0%, respectively. CONCLUSIONS: This study showed the efficacy and safety of initial experiences with nivolumab in Korean patients with mRCC who had failed targeted therapy. Our results were comparable to recent clinical trials on nivolumab in mRCC.