Purpose: Limited treatment options exist for patients with metastatic castration-resistant prostate cancer (mCRPC) after the failure of taxane-based chemotherapy and novel hormonal therapy. Here, we report the safety and efficacy of ifosfamide and mesna in patients with mCRPC after the failure of taxane-based chemotherapy and novel hormonal therapy (NCT06236789). Materials and Methods: Patients with histologically confirmed prostate cancer who had failed taxane-based chemotherapy and novel hormonal therapy received ifosfamide 2,500 mg/m2 and mesna 1,500 mg/m2 on days 1–3, repeated every 21 days. Safety, objective response rate, disease control rate, reduction in serum prostate-specific antigen (PSA) concentration by >50% (PSA50) or >90% (PSA90), radiographic progression-free survival (rPFS), and overall survival (OS) were analyzed. Results: A total of 47 patients with mCRPC were included in the study. The median number of lines of treatment was 5 (range, 3 to 7). All patients were previously administered docetaxel and novel hormonal therapies including abiraterone (51.1%) and/or enzalutamide (61.7%). Thirty-eight patients (80.9%) were administered cabazitaxel. The objective response and disease control rates were 21.3% and 80.9%, respectively. PSA50 and PSA90 were achieved in 31.9% and 10.6%, respectively. During a median follow-up duration of 54.3 months, rPFS and OS were 5.0 and 9.0 months, respectively. All the patients experienced treatment-related adverse events of any grades; however, no new safety signs were detected. Genomic biomarker analysis revealed that alterations in the TP53 pathway were associated with inferior rPFS and OS. Conclusion Ifosfamide and mesna showed appreciable efficacy and manageable safety profiles in heavily treated patients with mCRPC.

Background: The purpose of this study was to compare the histologic outcomes of rotator cuff (RC) repair with demineralized bone matrix (DBM) augmentation and those without DBM augmentation and to evaluate the role of DBM for tendon-to-bone (TB) healing in a rabbit model. Methods: Twenty-six adult male New Zealand white rabbits were randomly allocated to the control group (n = 13) or the DBM group (n = 13). Repair was performed 8 weeks after complete transection of the right supraspinatus tendon of all rabbits. In the control group, RC repair was achieved by a standard transosseous technique. In the DBM group, RC repair was achieved using the same technique, and DBM was interposed between the cuff and bone. After 8 weeks, the RC tendon entheses from all rabbits were processed for gross and histologic examination. Results: On gross TB healing, 2 of 11 specimens in the control group were unhealed and no specimen was grossly unhealed in the DBM group (p = 0.421). In the control group, the tendon midsubstance was disorganized with randomly and loosely arranged collagen fibers and rounded fibroblastic nuclei. The TB interface was predominantly fibrous with small regions of fibrocartilage, especially mineralized fibrocartilage. In the DBM group, the tendon midsubstance appeared normal and comprised densely arranged collagen fibers, with orientated crimped collagen fibers running in the longitudinal direction of the tendon. These fibers were interspersed with elongated fibroblast nuclei. The TB interface consisted of organized collagen fibers with large quantities of fibrocartilage and mineralized fibrocartilage. Conclusions The use of DBM for TB interface healing in rabbit experiments showed good results in gross and histologic analysis. However, it is difficult to draw a solid conclusion because the sample size is small. Further evaluation in the in vivo setting is necessary to determine clinical recommendations.

Background: The purpose of this study was to compare the histologic outcomes of rotator cuff (RC) repair with demineralized bone matrix (DBM) augmentation and those without DBM augmentation and to evaluate the role of DBM for tendon-to-bone (TB) healing in a rabbit model. Methods: Twenty-six adult male New Zealand white rabbits were randomly allocated to the control group (n = 13) or the DBM group (n = 13). Repair was performed 8 weeks after complete transection of the right supraspinatus tendon of all rabbits. In the control group, RC repair was achieved by a standard transosseous technique. In the DBM group, RC repair was achieved using the same technique, and DBM was interposed between the cuff and bone. After 8 weeks, the RC tendon entheses from all rabbits were processed for gross and histologic examination. Results: On gross TB healing, 2 of 11 specimens in the control group were unhealed and no specimen was grossly unhealed in the DBM group (p = 0.421). In the control group, the tendon midsubstance was disorganized with randomly and loosely arranged collagen fibers and rounded fibroblastic nuclei. The TB interface was predominantly fibrous with small regions of fibrocartilage, especially mineralized fibrocartilage. In the DBM group, the tendon midsubstance appeared normal and comprised densely arranged collagen fibers, with orientated crimped collagen fibers running in the longitudinal direction of the tendon. These fibers were interspersed with elongated fibroblast nuclei. The TB interface consisted of organized collagen fibers with large quantities of fibrocartilage and mineralized fibrocartilage. Conclusions The use of DBM for TB interface healing in rabbit experiments showed good results in gross and histologic analysis. However, it is difficult to draw a solid conclusion because the sample size is small. Further evaluation in the in vivo setting is necessary to determine clinical recommendations.

Thermodynamically immiscible poly(lactic acid) (PLA) and poly(ε-caprolactone) (PCL) were blended and solution-cast by adding the 3% compatibilizer (tributyl citrate, TBC) of the PCL weight. In the PLA/PCL composition range of 99/1–95/5 wt%, mechanical properties of the PLA/PCL films with TBC were always superior to those of the films without TBC. The tensile strength of 42.9 ± 3.5 MPa and the elongation at break of 10.3 ± 2.7% were observed for the 93/7 PLA/PCL films without TBC, indicating that PCL addition is effective for strength and ductility. However, the tensile strength of 54.1 ± 3.4 MPa and the elongation at break of 8.8 ± 1.8% were found for the 95/5 PLA/PCL with TBC, indicating that the effect of co-addition of PCL and TBC on mechanical properties of the films is more pronounced. No cytotoxicity was observed for the PLA/PCL films regardless of TBC addition.
Cell Proliferation ; Citric Acid ; Tensile Strength

STUDY DESIGN: A noninterventional, multicenter, cross-sectional study. PURPOSE: We investigated the prevalence of neuropathic pain (NP) and patient-reported outcomes (PROs) of the quality of life (QoL) and functional disability in Korean adults with chronic low back pain (CLBP). OVERVIEW OF LITERATURE: Among patients with CLBP, 20%–55% had NP. METHODS: Patients older than 20 years with CLBP lasting for longer than three months, with a visual analog scale (VAS) pain score higher than four, and with pain medications being used for at least four weeks before enrollment were recruited from 27 general hospitals between December 2014 and May 2015. Medical chart reviews were performed to collect demographic/clinical features and diagnosis of NP (douleur neuropathique 4, DN4). The QoL (EuroQoL 5-dimension, EQ-5D; EQ-VAS) and functional disability (Quebec Back Pain Disability Scale, QBPDS) were determined through patient surveys. Multiple linear regression analyses were performed to compare PROs between the NP (DN4≥4) and non-NP (DN4 < 4) groups. RESULTS: A total of 1,200 patients (females: 65.7%; mean age: 63.4±13.0 years) were enrolled. The mean scores of EQ-5D, EQ-VAS, and QBPDS were 0.5±0.3, 55.7±19.4, and 40.4±21.1, respectively. Among all patients, 492 (41.0%; 95% confidence interval, 38.2%–43.8%) suffered from NP. The prevalence of NP was higher in male patients (46.8%; p < 0.01), in patients who had pain based on radiological and neurological findings (59.0%; p < 0.01), and in patients who had severe pain (49.0%; p < 0.01). There were significant mean differences in EQ-5D (NP group vs. non-NP group: 0.4±0.3 vs. 0.5±0.3; p < 0.01) and QBPDS (NP group vs. non-NP group: 45.8±21.2 vs. 36.3±20.2; p < 0.01) scores. In the multiple linear regression, patients with NP showed lower EQ-5D (β=−0.1; p < 0.01) and higher QBPDS (β=7.0; p < 0.01) scores than those without NP. CONCLUSIONS: NP was highly prevalent in Korean patients with CLBP. Patients with CLBP having NP had a lower QoL and more severe dysfunction than those without NP. To enhance the QoL and functional status of patients with CLBP, this study highlights the importance of appropriately diagnosing and treating NP.
Adult* ; Back Pain ; Cross-Sectional Studies ; Diagnosis ; Hospitals, General ; Humans ; Linear Models ; Low Back Pain* ; Male ; Neuralgia* ; Prevalence* ; Quality of Life ; Visual Analog Scale

OBJECTIVE: To evaluate the feasibility of angled cool-tip electrode for radiofrequency ablation of small superficial subcapsular liver tumors abutting abdominal wall, in order to traverse normal liver parenchyma, and thereby, obtain favorable configuration of ablation margin. MATERIALS AND METHODS: In this study, we retrospectively analyzed 15 small superficial subcapsular liver tumors abutting abdominal wall in 15 patients, treated with radiofrequency ablation from March 2013 to June 2015 using a cool-tip electrode manually modified to create 25-35° angle at the junction between exposed and insulated segments. The tumors were hepatocellular carcinoma (n = 13) and metastases (n = 2: cholangiocellular carcinoma and rectosigmoid cancer), with maximum diameter of 10-26 mm (mean, 15.68 ± 5.29 mm). Under ultrasonographic guidance, the electrode tip was advanced to the depth of the tumors' epicenter about 1 cm from the margin. The tip was re-directed to penetrate the tumor for radiofrequency ablation. Minimal ablation margin was measured at immediate post-treatment CT. Radiological images and medical records were evaluated for success rate, length of minimal ablation margin and complications. RESULTS: Technical success rate of obtaining complete necrosis of the tumors was 100%, with no procedure-related complication. Minimal ablation margin ranged from 3-12 mm (mean, 7.07 ± 2.23 mm). CT/MRI follow-up at 21-1022 days (mean, 519.47 ± 304.51 days) revealed no local recurrence, but distant recurrence in 9 patients. CONCLUSION: Using an angled cool-tip electrode for radiofrequency ablation of small superficial subcapsular tumors abutting abdominal wall may be a feasible technique for obtaining adequate ablation margin and lower complication rate.
Abdominal Wall ; Carcinoma, Hepatocellular ; Catheter Ablation* ; Cholangiocarcinoma ; Electrodes* ; Feasibility Studies* ; Follow-Up Studies ; Humans ; Liver* ; Medical Records ; Necrosis ; Neoplasm Metastasis ; Recurrence ; Retrospective Studies

OBJECTIVE: To evaluate the feasibility, safety, and clinical outcomes of plug-assisted retrograde transvenous obliteration (PARTO) to treat gastric variceal hemorrhage in patients with portal hypertension. MATERIALS AND METHODS: From May 2012 to June 2014, 19 patients (11 men and 8 women, median age; 61, with history of gastric variceal hemorrhage; 17, active bleeding; 2) who underwent PARTO using a vascular plug and a gelfoam pledget were retrospectively analyzed. Clinical and laboratory data were examined to evaluate primary (technical and clinical success, complications) and secondary (worsening of esophageal varix [EV], change in liver function) end points. Median follow-up duration was 11 months, from 6.5 to 18 months. The Wilcoxon signed-rank test was used to compare laboratory data before and after the procedure. RESULTS: Technical success (complete occlusion of the efferent shunt and complete filling of gastric varix [GV] with a gelfoam slurry) was achieved in 18 of 19 (94.7%) patients. The embolic materials could not reach the GV in 1 patient who had endoscopic glue injection before our procedure. The clinical success rate (no recurrence of gastric variceal bleeding) was the same because the technically failed patient showed recurrent bleeding later. Acute complications included fever (n = 2), fever and hypotension (n = 2; one diagnosed adrenal insufficiency), and transient microscopic hematuria (n = 3). Ten patients underwent follow-up endoscopy; all exhibited GV improvement, except 2 without endoscopic change. Five patients exhibited aggravated EV, and 2 of them had a bleeding event. Laboratory findings were significantly improved after PARTO. CONCLUSION: PARTO is technically feasible, safe, and effective for gastric variceal hemorrhage in patients with portal hypertension.
Aged ; Balloon Occlusion ; Embolization, Therapeutic ; Endoscopy, Digestive System ; Esophageal and Gastric Varices/complications/radiography/*therapy ; Female ; Gastrointestinal Hemorrhage/therapy ; Gelatin Sponge, Absorbable/chemistry ; Humans ; Hypertension, Portal/complications ; Male ; Middle Aged ; Retrospective Studies ; Tomography, X-Ray Computed

PURPOSE: We evaluated the correlation of postoperative clinical outcomes and radiologic findings using computed tomography and simple X-ray in intra-articular calcaneal fractures. MATERIALS AND METHODS: The current study is based on 41 feet, 38 patients with displaced intra-articular fracture who underwent surgical treatment with at least one year of follow-up. Evaluation of clinical outcome included American Orthopaedic Foot and Ankle Society (AOFAS) ankle-hindfoot score, visual analogue scale (VAS) score, and subjective satisfaction. A simple X-ray was used in evaluation of preoperative and postoperative Gissane angle, Bohler angle, and calcaneal fracture width. Computed tomography scan was performed for evaluation of preoperative and postoperative articular step-off and articular gap in all cases. Finally, we evaluated the correlation of the postoperative clinical outcomes and radiologic findings based on the measurement. RESULTS: The average postoperative AOFAS score and VAS score was 84.1+/-8.5 and 2.2+/-2.2. Subjective satisfaction was excellent in 15 cases, good in 19 cases, and fair in seven cases. The average Bohler angle was restored from 11.1degrees to 24.7degrees (p<0.05), Gissane angle was changed from 121.0degrees to 119.0degrees (p>0.05), and the average width was restored from 45.8 to 35.0 mm (p<0.05). The average articular step-off and gap were decreased from 6.3 to 2.0 mm and from 11.1 to 4.6 mm, respectively (p<0.05). No significant correlations were observed between the clinical outcome and Gissane angle, Bohler angle, and width, and there was no significant correlation between the clinical outcome and Sanders classification. However, postoperative articular step-off showed correlation with VAS and AOFAS score and articular gap showed correlation with VAS score. CONCLUSION: The clinical outcome did not show correlation with Bohler angle and Gissane angle but did show correlation with anatomical reduction of the posterior facet joint.
Ankle ; Classification ; Follow-Up Studies ; Foot ; Humans ; Intra-Articular Fractures ; Zygapophyseal Joint

PURPOSE: There is no established standard second-line chemotherapy for patients with advanced or metastatic urothelial carcinoma (UC) who failed gemcitabine and cisplatin (GC) chemotherapy. This study was conducted in order to investigate the efficacy and toxicity of modified methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) in patients with metastatic UC previously treated with GC. MATERIALS AND METHODS: We retrospectively analyzed 28 patients who received modified MVAC between November 2004 and November 2012. All patients failed prior, first-line GC chemotherapy. RESULTS: The median age of patients was 64.0 years (range, 33.0 to 77.0 years), and 23 (82.1%) patients had an Eastern Cooperative Oncology Group performance status of 0 or 1. The overall response rate and the disease control rate were 36.0% and 64.0%, respectively. After a median follow-up period of 38 weeks (range, 5 to 182 weeks), median progression free survival was 21.0 weeks (95% confidence interval [CI], 6.3 to 35.7 weeks) and median overall survival was 49.0 weeks (95% CI, 18.8 to 79.3 weeks). Grade 3 or 4 hematological toxicities included neutropenia (n=21, 75.0%) and anemia (n=9, 32.1%). Grade 3 or 4 non-hematological toxicities did not occur and there was no treatment-related death. CONCLUSION: Modified MVAC appears to be a safe and active chemotherapy regimen in patients with stable physical status and adequate renal function after GC treatment.
Anemia ; Cisplatin* ; Disease-Free Survival ; Doxorubicin ; Drug Therapy ; Follow-Up Studies ; Humans ; Methotrexate ; Neutropenia ; Retrospective Studies ; Vinblastine