Purpose: Bladder preservation chemoradiotherapy (CRT) in patients with a clinical complete response (cCR) following cisplatin-based neoadjuvant chemotherapy (NAC) is a promising treatment strategy for muscle-invasive bladder urothelial carcinoma (MIBC). A combined analysis of raw data from two prospective phase II studies was performed to better evaluate the feasibility of selective bladder preservation CRT. Materials and Methods: The analysis was based on primary efficacy data from two independent studies, including 76 MIBC patients receiving NAC followed by bladder preservation CRT. The efficacy data included metastasis-free survival (MFS) and disease-free survival (DFS). For the present analysis, starting point of survival was defined as the date of commencing CRT. Results: Among 76 patients, 66 had a cCR following NAC. Sixty-four patients received gemcitabine and cisplatin (GC) combination chemotherapy in neoadjuvant setting, and 12 received nivolumab plus GC. Bladder preservation CRT following NAC was generally well-tolerated, with low urinary tract symptoms being the most common late complication. With a median follow-up of 64 months, recurrence was recorded in 43 patients (57%): intravesical only (n=20), metastatic only (n=16), and both (n=7). In 27 patients with intravesical recurrence, transurethral resection, and Bacillus Calmette-Guerin treatment was given to 17 patients. Salvage cystectomy was performed in 10 patients. Median DFS was 46.3 (95% confidence interval [CI], 25.1 to 67.5) months, and the median MFS was not reached. Neither DFS nor MFS appeared to be affected by any of the baseline characteristics. However, DFS was significantly longer in patients with a cCR than in those without (hazard ratio, 0.465; 95% CI, 0.222 to 0.976). Conclusion The strategy of NAC followed by selective bladder preservation CRT based on the cCR is feasible in the treatment of MIBC. A standardized definition of cCR is needed to better assess disease status post-NAC.

Purpose: The activity and safety of neoadjuvant nivolumab plus gemcitabine/cisplatin (N+GC) were tested in patients with muscle-invasive bladder urothelial carcinoma (MIBC). Materials and Methods: In a prospective phase II trial, patients with cT2-T4a N0 MIBC who were eligible for cisplatin and medically appropriate to undergo radical cystectomy (RC) were enrolled. Treatment with nivolumab 3 mg/kg on days 1 and 15 plus GC (cisplatin 70 mg/m2 on day 1, and gemcitabine 1,000 mg/m2 on days 1, 8, and 15) was repeated every 28 days up to 3 or 4 cycles, depending on the surgery schedules. The primary endpoint was pathologic complete response (pCR, ypT0). Secondary endpoints included pathologic downstaging (≤ ypT1), disease-free survival (DFS), and safety. Results: Between September 2019 and October 2020, 51 patients were enrolled. Neoadjuvant N+GC was well tolerated. Among 49 patients who completed neoadjuvant N+GC, clinical complete response (cCR) was achieved in 59% of intent-to-treat (ITT) population. RC was performed in 34 (69%) patients. pCR was achieved in 24% (12/49) of ITT population and 35% (12/34) of RC patients. Median DFS was not reached. Over a median follow-up of 24 months, 12 patients experienced disease recurrence and were treated with palliative therapy or surgery. Although 12 patients declined surgery and were treated with concurrent chemoradiotherapy, DFS was longer in patients with cCR after neoadjuvant therapy than those without. Preoperative programmed death-ligand 1 (PD-L1) did not correlate with pCR or pathologic downstaging rates. Conclusion Neoadjuvant N+GC was feasible and provided meaningful pathologic responses in patients with MIBC, regardless of baseline PD-L1 expression (ONO-4538-X41; CRIS.nih.go.kr, KCT0003804).

Background/Aims: The prospective Crohn’s Disease Clinical Network and Cohort Study is a nationwide multicenter cohort study of patients with Crohn’s disease (CD) in Korea, aiming to prospectively investigate the clinical features and long-term prognosis associated with CD. Methods: Patients diagnosed with CD between January 2009 and September 2019 were prospectively enrolled. They were divided into two cohorts according to the year of diagnosis: cohort 1 (diagnosed between 2009 and 2011) versus cohort 2 (between 2012 and 2019). Results: A total of 1,175 patients were included, and the median follow-up duration was 68 months (interquartile range, 39.0 to 91.0 months). The treatment-free durations for thiopurines (p<0.001) and anti-tumor necrosis factor agents (p=0.018) of cohort 2 were shorter than those of cohort 1. Among 887 patients with B1 behavior at diagnosis, 149 patients (16.8%) progressed to either B2 or B3 behavior during follow-up. Early use of thiopurine was associated with a reduced risk of behavioral progression (adjusted hazard ratio [aHR], 0.69; 95% confidence interval [CI], 0.50 to 0.90), and family history of inflammatory bowel disease was associated with an increased risk of behavioral progression (aHR, 2.29; 95% CI, 1.16 to 4.50). One hundred forty-one patients (12.0%) underwent intestinal resection, and the intestinal resection-free survival time was significantly longer in cohort 2 than in cohort 1 (p=0.003). The early use of thiopurines (aHR, 0.35;95% CI, 0.23 to 0.51) was independently associated with a reduced risk of intestinal resection. Conclusions The prognosis of CD in Korea appears to have improved over time, as evidenced by the decreasing intestinal resection rate. Early use of thiopurines was associated with an improved prognosis represented by a reduced risk of intestinal resection.

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.

Purpose: Carcinoma arising from Crohn disease (CD) is rare, and there is no clear guidance on how to properly screen for at-risk patients and choose appropriate care. This study aimed to evaluate the clinicopathological characteristics, treatment, and oncologic outcomes of CD patients diagnosed with colorectal cancer (CRC). Methods: Using medical records, we retrospectively enrolled a single-center cohort of 823 patients who underwent abdominal surgery for CD between January 2006 and December 2015. CD-associated CRC patients included those with adenocarcinoma, lymphoma, or neuroendocrine tumors of the colon and rectum. Results: Nineteen patients (2.3%) underwent abdominal surgery to treat CD-associated CRC. The mean duration of CD in the CD-associated CRC group was significantly longer than that in the benign CD group (124.7 ± 77.7 months vs. 68.9 ± 60.2 months, P = 0.006). The CD-associated CRC group included a higher proportion of patients with a history of perianal disease (73.7% vs. 50.2%, P = 0.035) and colonic location (47.4% vs. 6.5%, P = 0.001). Among 19 CD-associated CRC patients, 17 (89.5%) were diagnosed with adenocarcinoma, and of the 17 cases, 15 (88.2%) were rectal adenocarcinoma. On multivariable analyses for developing CRC, only colonic location was a risk factor (relative risk, 7.735; 95% confidence interval, 2.862–20.903; P = 0.001). Conclusion Colorectal malignancy is rare among CD patients, even among patients who undergo abdominal surgery. Rectal adenocarcinoma accounted for most of the CRC, and colonic location was a risk factor for developing CRC.

Purpose: Upper gastrointestinal (GI) tract involvement in Crohn disease (CD) is rare and effectiveness of surgical treatment is limited. The aim of this study was to evaluate characteristics and surgical outcomes of upper GI CD. Methods: Medical records of 811 patients who underwent intestinal surgery for CD between January 2006 and December 2015 at a single institution were reviewed. Upper GI CD was defined by involvement of the stomach to the fourth portion of duodenum, with or without concomitant small/large bowel CD involvement according to a modification of the Montreal classification. Results: We identified 24 patients (21 males, 3 females) who underwent surgery for upper GI CD. The mean age at diagnosis was 27 ± 12 years, the mean age at surgery was 33 ± 11 years, and the mean duration of CD was 73.6 ± 56.6 months.Fifteen patients (62.5%) had history of previous perianal surgery. Ten patients (41.7%) had duodenal or gastric stricture and 14 patients (58.3%) had penetrating fistula; patients with fistula were significantly more likely to develop complications (57.1% vs. 20.0%, P = 0.035). One patient with stricture had surgical recurrence. In seven patients with fistula, fistula was related to previous anastomosis. Patients with fistula had significantly longer hospital stays than those with stricture (16 days vs. 11 days, P = 0.01). Conclusion Upper GI CD is rare among CD types (2.96%). In patients with upper GI CD, penetrating fistula was associated with longer hospital stay and more complications.

PURPOSE: To compare biopsy performance of 2 approaches for multiparametric magnetic resonance imaging (MRI) guided biopsy and transrectal ultrasonography (TRUS)-guided biopsy with 2nd and 3rd repeat biopsy patients in prostate cancer detection. MATERIALS AND METHODS: This retrospective study reviewed 2,868 patients who was performed prostate biopsy between September 2013 to March 2017 at Samsung Medical Center, Seoul, Korea with TRUS-guided random biopsy and MRI fusion, MRI cognitive, and MRI-guided biopsy as 2nd and 3rd repeat biopsy and propensity matching was applied to reduce bias. Detection rate of each study was compared with 1:1 matching. RESULTS: Among 265 patients who performed TRUS 2nd biopsy, positivity rate for prostate cancer (PCa) was 18.49% (n=49/265) while 54.72% (n=145/265) for MRI-guided biopsy. In 3rd biopsy, positivity rate for PCa of TRUS biopsy was 17.74% (n=11/62) while 56.45% (n=35/62) for MRI guided biopsy. There was no significant difference in the detection rate for the patient with Gleason score 8 or more. CONCLUSIONS: MRI-guided biopsy was associated with a higher detection rate of prostate cancer with especially in patients with prior negative biopsy.
Bias (Epidemiology) ; Biopsy ; Cohort Studies ; Humans ; Korea ; Magnetic Resonance Imaging ; Neoplasm Grading ; Passive Cutaneous Anaphylaxis ; Propensity Score ; Prostate ; Prostatic Neoplasms ; Retrospective Studies ; Seoul ; Ultrasonography

BACKGROUND/AIMS: Previous studies from Korea have described chronic intestinal pseudo-obstruction (CIPO) patients with transition zone (TZ) in the colon. In this study, we evaluated the pathological characteristics and their association with long-term outcomes in Korean colonic pseudo-obstruction (CPO) patients with TZ. METHODS: We enrolled 39 CPO patients who were refractory to medical treatment and underwent colectomy between November 1989 and April 2016 (median age at symptoms onset: 45 [interquartile range, 29–57] years, males 46.2%). The TZ was defined as a colonic segment connecting a proximally dilated and distally non-dilated segment. Detailed pathologic analysis was performed. RESULTS: Among the 39 patients, 37 (94.9%) presented with TZ and 2 (5.1%) showed no definitive TZ. Median ganglion cell density in the TZ adjusted for the colonic circumference was significantly decreased compared to that in proximal dilated and distal non-dilated segments in TZ (+) patients (9.2 vs 254.3 and 150.5, P < 0.001). Among the TZ (+) patients, 6 showed additional pathologic findings including eosinophilic ganglionitis (n = 2), ulcers with combined cytomegalovirus infection (n = 2), diffuse ischemic changes (n = 1), and heterotropic myenteric plexus (n = 1). During follow-up (median, 61 months), 32 (82.1%) TZ (+) patients recovered without symptom recurrence after surgery. The presence of pathological features other than hypoganglionosis was an independent predictor of symptom recurrence after surgery (P = 0.046). CONCLUSIONS: Hypoganglionosis can be identified in the TZ of most Korean CPO patients. Detection of other pathological features in addition to TZ-associated hypoganglionosis was associated with poor post-operative outcomes.
Cell Count ; Colectomy ; Colon ; Colonic Pseudo-Obstruction ; Cytomegalovirus Infections ; Eosinophils ; Follow-Up Studies ; Ganglion Cysts ; Humans ; Intestinal Pseudo-Obstruction ; Korea ; Male ; Myenteric Plexus ; Pathology ; Recurrence ; Ulcer

BACKGROUND/AIMS: We aimed to evaluate the clinical characteristics and prognosis of Crohn's disease (CD) in patients who showed proximal small bowel involvement using a nationwide Korean CD cohort. METHODS: We reviewed the data from a cohort of patients diagnosed with CD. The clinical outcomes of patients were evaluated according to the presence of proximal small bowel involvement. RESULTS: Among 1,329 patients with CD for whom complete disease location data were available, 222 patients (16.7%) showed involvement of the proximal small bowel. Compared to patients without proximal small bowel involvement, those with small bowel involvement were more likely to display stricturing behavior (19.8% vs 12.7%, p=0.020). The surgery-free survival of patients who showed proximal small bowel involvement was inferior to that of patients without proximal small bowel involvement (10-year surgery-free survival: 58.4% vs 67.7%, respectively, p < 0.001). Additionally, upper gastrointestinal involvement was more common in patients with proximal small bowel involvement than in those without involvement (odds ratio, 1.643; 95% confidence interval, 1.008 to 2.677). CONCLUSIONS: Proximal small bowel involvement is a poor prognostic factor for the surgery-free survival of Korean patients with CD. Proximal small bowel involvement should be evaluated in patients with CD for predicting long-term clinical outcomes.
Cohort Studies ; Crohn Disease ; Humans ; Jejunum ; Prognosis

PURPOSE: We compared biopsy results and surgical outcomes of magnetic resonance imaging (MRI)-guided biopsy with transrectal ultrasonography (TRUS)-guided biopsy to demonstrate efficacy of MRI-guided biopsy on previous biopsy negative patients. MATERIALS AND METHODS: We retrospectively reviewed data of 120 patients who were categorized into MRI-guided biopsy groups (n=20) and TRUS-guided biopsy groups (n=100). All patients were diagnosed with prostate cancer (PCa) and had undergone radical prostatectomy (RP) after MRI-guided or TRUS-guided repeat biopsy between January 2010 and March 2016. Detection rate of significant cancer and Gleason score upgrading and downgrading were examined, in addition to biopsy results and subsequent RP outcomes. RESULTS: Median values for prostate-specific antigen level of the TRUS-guided biopsy group and the MRI-guided biopsy group were 6.67 and 5.86 ng/mL (p=0.303), respectively. Median prostate volume of each group (34.1 mL vs. 23.5 mL, p=0.007), number of positive cores (2.0 vs. 3.0, p=0.001) and maximum cancer/core rate (30.0% vs. 60.0%, p<0.001) were statistically different. Positive core rates of each group were 21.9% and 87.1%, respectively. Pathologic T stage was the only variable that showed difference in surgical outcomes (p=0.002). Most of PCa was confirmed as clinically significant PCa after RP in MRI-guided biopsy group (95%). CONCLUSIONS: MRI-guided biopsy showed higher positive core rate and detection rate of clinically significant PCa than TRUS-guided biopsy in repeat biopsy setting. Prospective multicenter large-scale study and accumulation of data is expected to further define superiority of the MRI-guided biopsy.
Biopsy* ; Humans ; Magnetic Resonance Imaging ; Neoplasm Grading ; Passive Cutaneous Anaphylaxis ; Prospective Studies ; Prostate ; Prostate-Specific Antigen ; Prostatectomy ; Prostatic Neoplasms ; Retrospective Studies ; Ultrasonography