Early Experiences with Nivolumab in Patients with Metastatic Renal Cell Carcinoma and Failed Target Therapy

Jong Hoon Lee(이종훈),Minyong Kang(강민용),Jae Hoon Chung(정재훈),Hyun Hwan Sung(성현환),Hwang Gyun Jeon(전황균),Byung Chang Jeong(정병창),Seong Soo Jeon(전성수),Hyun Moo Lee(이현무),Se Hoon Park(박세훈),Binnari Kim(김빛나리),Ghee 대한비뇨기종양학회 2019 대한비뇨기종양학회지 Vol.17 No.2

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 ㎎/㎏, 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.

건강보험통계 기반 건강 수준 평점화 모형을 활용한 간편고지 상품 유형별 보험요율 차등화에 관한 연구

권혁성 ( Hyuksung Kwon ),오필재 ( Piljae Oh ),강민용 ( Minyong Kang ),우경석 ( Kyeongseok Woo ) 한국리스크관리학회 2021 리스크 管理硏究 Vol.32 No.4

본 연구는 2002년부터 2015년까지의 국민건강보험 코호트 2.0 데이터베이스를 활용하여 현재 보험시장에서 판매되고 있는 다양한 고지 형태의 간편심사 보험에서 적용되는 보험담보별 위험의 할증률 수준을 국민통계를 기초로 산출하였다. 분석을 위해 2011년 기준 전후 약 10년간 표본 코호트 상 진료DB 데이터가 존재하는 약 93만명의 데이터베이스를 활용하였고, 분석대상 간편심사 상품 형태 선정을 위해 현재 보험시장에 판매되고 있는 간편심사 보험을 언더라이팅 질문 형태에 따라 총 14가지 형태로 분류하고, 그 중 가장 일반적으로 판매되는 2가지 질문 형태와 향후 디지털 정보를 기반으로 한 자동화 언더라이팅에 부합하는 한 가지 질문 형태를 선정하였다. 선정된 세 형태의 간편심사 상품을 기준으로 산출된 할증률 결과를 3가지 질문만을 묻고 인수하는 일반적인 간편심사 보험과 비교함으로써 기존 회사별 경험통계를 기초로 산출되던 여러 간편심사 보험의 보험료 할증률 수준을 국민통계 기반 산출결과와 비교 분석하였다. 분석 결과 보험사의 경험통계를 기반으로 한 간편심사 할증률 대비 소폭 낮게 산출되었으며, 이에 대한 원인 분석과 향후 언더라이팅 질문에 따른 담보별 위험률 산출 방법의 방향성을 제시하였다. 이에 더하여 선행 연구에서 제시한 보험가입 시점 건강상태를 계량화한 건강수준 평점화 모형을 활용하여 3가지의 간편심사 상품 형태에 따른 건강등급별 질병 발생 위험의 차이를 도출하였다. 그 결과 보험에서 담보하는 사망ㆍ진단ㆍ입원ㆍ수술의 여러 담보를 기준으로 3가지의 간편심사 상품 형태 모두 선행 연구와 동일하게 건강등급별로 유의미한 질병 발생 위험 차이를 확인할 수 있었고, 이를 통해 표준체 대상 건강보험 이외에 다양한 형태의 간편심사 보험에서 보다 차등화된 보험요율 적용이 가능함을 제시하였다. This study uses the National Health Insurance Cohort 2.0 database from 2002 to 2015 to calculate the premium rate level of risk for each insurance policy that is applied in the various notification types of simplified issue insurance product currently sold in the insurance market, based on national statistics. For the analysis, a database of about 930,000 people with medical DB data in the sample cohort for about 10 years before and after 2011 was used. To select the simplified issue insurance product type for analysis, a total of 14 types were classified according to the type of underwriting question, and among them, the two most commonly sold question types and one question type suitable for automated underwriting based on digital information in the future were selected. By comparing the premium rate results calculated based on the selected three types of simplified issue insurance product with the general simplified issue insurance product that asks only three questions and takes over, the premium rate of various simplified issue insurance product, which were calculated based on the experience statistics of each existing company, was compared and analyzed with calculation results based on the national statistic. As a result of the analysis, it was calculated to be slightly lower than the simplified issue insurance product premium rate based on the experience statistics of insurance companies. Cause analysis and future direction of the risk rate calculation method for each collateral according to the underwriting question was presented. In addition, by using the health level grading model that quantified the health status at the time of insurance subscription suggested in the previous study, the difference in the risk of disease occurrence by health grade was derived according to the three types of simplified issue insurance product. As a result, it was possible to confirm a significant difference in the risk of disease occurrence by health grade in all three simplified issue insurance product types based on various insurance coverages for death, diagnosis, hospitalization, and surgery. In addition to insurance, it is suggested that more differentiated insurance rates can be applied in various types of simplified issue insurance product other than health insurance for standard.

Node-Positive Bladder Cancer After Neoadjuvant Chemotherapy Followed by Radical Cystectomy: A Single-Center Retrospective Study

Jang Ho Cho(조장호),Ghee-Young Kwon(권기영),Minyong Kang(강민용),Hyun Hwan Sung(성현환),Hwang Gyun Jeon(전황균),Byong Chang Jeong(정병창),Seong Il Seo(서성일),Seong Soo Jeon(전성수),Hyun Moo Lee(이현무),Han-Yong Choi(최한용),Su Ji 대한비뇨기종양학회 2020 대한비뇨기종양학회지 Vol.18 No.3

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.

임상적으로 유의미한 전립선암의 예측 향상을 위한 Prostate Health Index와 PI-RADS Version 2 조합의 유용성

송완(Wan Song),이충언(Chung Un Lee),정재훈(Jae Hoon Chung),강민용(Minyong Kang),성현환(Hyun Hwan Sung),전황균(Hwang Gyun Jeon),정병창(Byong Chang Jeong),서성일(Seong Il Seo),전성수(Seong Soo Jeon),이현무(Hyun Moo Lee) 대한비뇨기종양학회 2022 대한비뇨기종양학회지 Vol.20 No.2

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]<SUP>1/2</SUP>). 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.

Predictive Factors for Acute Urinary Retention After Transperineal Template-Guided Mapping Biopsy

Si Hyun Sung(성시현),Chung Un Lee(이충언),Jae Hoon Chung(정재훈),Wan Song(송완),Minyong Kang(강민용),Hyun Hwan Sung(성현환),Byong Chang Jeong(정병창),Seong Il Seo(서성일),Seong Soo Jeon(전성수),Hyun Moo Lee(이현무),Hwang Gyun Jeo 대한비뇨기종양학회 2021 대한비뇨기종양학회지 Vol.19 No.3

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.

단일기관에서 시행한 1,002예의 로봇보조복강경하 부분신장절제술의 주술기 및 종양학적 결과

김태진(Taejin Kim),정재훈(Jae Hoon Chung),성현환(Hyun Hwan Sung),전황균(Hwang Gyun Jeon),정병창(Byong Chang Jeong),전성수(Seong Soo Jeon),이현무(Hyun Moo Lee),강민용(Minyong Kang),서성일(Seong Il Seo) 대한비뇨기종양학회 2021 대한비뇨기종양학회지 Vol.19 No.3

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. All-cause 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 large-scale 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.

Prognostic Significance of Systemic Inflammatory Response in Patients with Synchronous and Metachronous Metastatic Renal Cell Carcinoma Receiving First-Line Tyrosine Kinase Inhibitors

Joongwon Choi(최중원),Tae Jin Kim(김태진),Hyun Hwan Sung(성현환),Hwang Gyun Jeon(전황균),Byong Chang Jeong(정병창),Seong Soo Jeon(전성수),Hyun Moo Lee(이현무),Han Yong Choi(최한용),Minyong Kang(강민용),Seong Il Seo(서성일) 대한비뇨기종양학회 2019 대한비뇨기종양학회지 Vol.17 No.3

Purpose: To determine whether systemic inflammatory response (SIR), particularly platelet-lymphocyte ratio (PLR) and neutrophil-lymphocyte ratio (NLR), has different prognostic role between patients with metastatic renal cell carcinoma (mRCC) receiving first-line tyrosine kinase inhibitors (TKI). Materials and Methods: We retrospectively reviewed 547 patients with mRCC who were diagnosed and treated with a first-line TKI between 2007 and 2015. The primary endpoint was overall survival (OS) and secondary endpoint was progression-free survival (PFS). We evaluated differences in survival outcomes according to SIR and identified predictors of OS and PFS. Results: In synchronous mRCC, patients with a higher PLR had significantly worse OS and PFS. Moreover, a higher NLR was also associated with both worse OS and PFS in these patients. However, PLR was not associated with either OS or PFS in metachronous mRCC patients. While metachronous mRCC patients with a higher NLR had worse OS compared to those with lower NLR, there was no difference in PFS according to the status of NLR. On multivariate analysis, PLR was identified as predictive factor for OS (hazard ratio [HR], 1.55) as well as PFS (HR, 1.39) in patients with synchronous mRCC, but not in patients with metachronous mRCC. Additionally, higher NLR was also remained as predictive factor of both OS (HR, 1.83) and PFS (HR, 1.57) in patients with synchronous mRCC. Conclusions: Our study indicates that simple biomarkers of SIR, particularly PLR and NLR, can be more useful predictors of survival outcomes in patients with synchronous mRCC rather than metachronous mRCC.