Purpose: The aim of this study is to evaluate the safety and efficacy of ex vivo activated and expanded natural killer (NK) cell therapy (SNK01) plus pembrolizumab in a randomized phase I/IIa clinical trial. Materials and Methods: Overall, 18 patients with advanced non–small cell lung cancer (NSCLC) and a programmed death ligand 1 tumor proportion score of 1% or greater who had a history of failed frontline platinum-based therapy were randomized (2:1) to receive pembrolizumab every 3 weeks +/– 6 weekly infusions of SNK01 at either 2×109 or 4×109 cells per infusion (pembrolizumab monotherapy vs. SNK01 combination). The primary endpoint was safety, whereas the secondary endpoints were the objective response rate (ORR), progression-free survival (PFS), overall survival, and quality of life. Results: Since no dose-limiting toxicity was observed, the maximum tolerated dose was determined as SNK01 4×109 cells/dose. The safety data did not show any new safety signals when SNK01 was combined with pembrolizumab. The ORR and the 1-year survival rate in the NK combination group were higher than those in patients who underwent pembrolizumab monotherapy (ORR, 41.7% vs. 0%; 1-year survival rate, 66.7% vs. 50.0%). Furthermore, the median PFS was higher in the SNK01 combination group (6.2 months vs. 1.6 months, p=0.001). Conclusion Based on the findings of this study, the NK cell combination therapy may consider as a safe treatment method for stage IV NSCLC patients who had a history of failed platinum-based therapy without an increase in adverse events.

We present a case of perivascular epithelioid cell tumors (PEComas) in the abdominal cavity at the falciform ligament. A 30-yr-old Korean man visited to hospital for the evaluation of a growing, palpable abdominal mass. He had felt the mass growing over 6 months. There was no family or personal history of tuberous sclerosis. The resected specimen showed a mass of 8.0x7.0x5.5 cm in size. Histological examination showed sheets of spindle-to-epithelioid cells with clear-to-eosinophilic cytoplasm. Immunohistochemically, tumor cells were positive for HMB-4 (gp100) and smooth muscle actin. They were also positive for the S-100, which is a marker of neurogenic and melanocytic tumors. Patient was treated with radical resection of tumor without any adjuvant therapy. He is well and on follow-up visits without tumor recurrence.
Abdominal Neoplasms/*diagnosis/pathology/surgery ; Actins/metabolism ; Adult ; Antigens, Neoplasm/metabolism ; Humans ; *Ligaments/pathology ; Male ; Neoplasm Proteins/metabolism ; Perivascular Epithelioid Cell Neoplasms/*diagnosis/pathology/surgery ; S100 Proteins/metabolism ; Tomography, X-Ray Computed

Epithelial ovarian carcinoma rarely metastasizes to the parenchyma of the stomach. A 55-years-old woman presented with epigastric pain and a feeling of fullness for one month. A subsequent contrast-enhanced CT scan demonstrated a 4.5 x 4 cm submucosal mass with focal ulceration in the gastric antrum, and this finding was suggestive of GIST. After gastric antrectomy, the final pathology showed metastatic gastric tumor from a primary ovarian serous carcinoma. Because epithelial ovarian carcinoma is usually spread along the peritoneal surface, stomach involvement is rare. Furthermore, transmural gastric metastasis is very rare in a patient with primary ovarian carcinoma. Until now, there has been no reported case of stomach involvement at presentation in a patient with primary ovarian carcinoma. We present here a case of ovarian carcinoma with gastric metastasis that mimicked GIST.
Female ; Gastrointestinal Stromal Tumors ; Humans ; Hydrazines ; Neoplasm Metastasis ; Pyloric Antrum ; Stomach ; Ulcer

BACKGROUND/AIMS: Palliative endoscopic or percutaneous internal drainage is widely used for treating hilar cholangiocarcinoma. Yet unilateral biliary drainage does not completely improve jaundice and it can induce acute cholangitis by the undrained contrast media. To investigate this technique's technical and clinical effectiveness, a newly devised Y-configured dual stent was used for treating advanced hilar malignancies. METHODS: From May, 2005 to May, 2007, 20 hilar malignancies (men: women=9:11, age=70.5 yr) that were not suitable for surgical resection were included in this study. For bilateral metal stent placement, a biliary stent with a wide open central mesh was first inserted. After this, another stent without a hole was inserted into the contralateral hepatic duct through the open central mesh of the first stent. RESULTS: Bilateral metal stent insertion was done in 14 of 20 patients. Among the 14 patients in whom bilateral stents were successfully placed, the rate of functional success was 100%. There were no early complications. As a late complication, stent occlusion occurred in 4 of 14 patients (28.5%), and one of these patients had a plastic stent inserted. The other 3 patients were treated with percutaneous transhepatic biliary drainage. The median stent patency period was 231 days. CONCLUSION: The bilateral metal stent method using the Y stent is safe and effective for bilateral biliary drainage in patients with unresectable hilar malignancies.
Cholangiocarcinoma ; Cholangitis ; Contrast Media ; Drainage ; Hepatic Duct, Common ; Humans ; Jaundice ; Plastics ; Stents

BACKGROUND/AIMS: Recent studies have shown good performance for the detection of sources of gastrointestinal bleeding using multi-detector row computed tomography (MDCT). However, there are limited reports about the role of MDCT for localization of acute lower gastrointestinal (GI) bleeding. The purpose of this study was to evaluate the role of MDCT for detection and localization of acute lower gastrointestinal bleeding. METHODS: A total of 49 patients underwent MDCT examination for the evaluation of acute lower GI bleeding were investigated prospectively. Sensitivity, specificity, positive and negative predictive values of MDCT for the detection of acute lower GI bleeding were assessed. Colonoscopy, angiography, RBC scan or postoperative results were adopted as the reference standard. RESULTS: Sensitivity, specificity, positive and negative predictive values of MDCT for the detection of acute lower GI bleeding were 72.7%, 80%, 93.9% and 25%, respectively. Eighteen patients experienced massive bleeding and 5 of them could not undergo the colonoscopic examination due to massive bleeding. MDCT detected the bleeding focuses in all of 5 patients. CONCLUSIONS: MDCT is useful for the localization of acute lower GI bleeding. The procedure is brief, less invasive, and relatively accurate diagnostic method. Moreover, positive finding will allow directed therapeutic procedure such as angiography.
Acute Disease ; Angiography ; Gastrointestinal Hemorrhage/etiology/*radiography ; Humans ; Predictive Value of Tests ; Prospective Studies ; Reproducibility of Results ; *Tomography, Spiral Computed

BACKGROUND/AIMS: The use of self-expandable metal stents (SEMS) is a safe and efficacious method for palliating malignant gastric outlet obstruction. However, few reports have assessed clinical outcome after the insertion of SEMS for malignant gastric outlet obstruction caused by stomach cancer. The aim of this study was to assess the usefulness of uncovered SEMS in patients with malignant gastric outlet obstruction caused by stomach cancer. METHODS: We evaluated 62 patients with gastric outlet obstruction caused by stomach cancer treated by the implantation of uncovered SEMS. A total of 62 patients (43 males, 19 females) were treated between August 2000 and March 2007. A scoring system was used to grade the ability to eat. RESULTS: Stent implantation was successful in 61 (98.4%) patients. Relief of obstructive symptoms was achieved in 49 (80.3%) patients. The mean survival duration was 143 days. The mean stent patency time was 103.5 days. An improvement in the ability to eat using the scoring system was statistically significant (p<0.05). CONCLUSIONS: Endoscopic placement of uncovered SEMS is a safe and effective treatment for the palliation of patients with inoperable malignant gastric outlet obstruction caused by stomach cancer.
Gastric Outlet Obstruction ; Humans ; Male ; Stents ; Stomach ; Stomach Neoplasms

BACKGROUND/AIMS: The catheter probe endoscopic ultrasonography (EUS) system is widely used to evaluate upper gastrointestinal tract lesions. The depiction of the esophageal wall by probe EUS remains problematic due to the difficulty of the filling of water in the esophageal lumen. In addition, filling the esophagus with water can be associated with an increased risk of aspiration. To resolve such problems, we recently applied the use of probe EUS with the jelly-filled method for the evaluation of subepithelial lesions. The procedure is characterized by filling the esophageal lumen with jelly. In this study, we evaluated the efficacy of probe EUS by using the jelly-filled method for esophageal subepithelial lesions. METHODS: We analyzed the records of the patients with suspected subepithelial lesions at the time of endoscopy that was performed from November 2005 to June 2007. Esophageal subepithelial lesions with both EUS findings and pathological reports were retrospectively compared. RESULTS: The study included 181 patients (96 males, 85 females), with an average age of 55.5 years (age range, 29~78 years). Sixty-eight patients had lesions in the upper esophagus, 60 patients had lesions in the middle esophagus and 53 patients had lesions in the lower esophagus. Secondary layers of esophageal lesions were predominant (91/181) in the cases. Pathological findings were available for 34 patients. Compared with the pathological findings, the diagnostic accuracy of EUS was 91.1%. CONCLUSIONS: Probe EUS by using the jelly-filled method is convenient and safe to perform and provides clear and full-circumferential imaging of a lesion. It is an alternative method to use in place of previously used probe-EUS procedures for the assessment of esophageal subepithelial lesions.
Catheters ; Endoscopy ; Endosonography ; Esophagus ; Humans ; Hypogonadism ; Male ; Mitochondrial Diseases ; Ophthalmoplegia ; Retrospective Studies ; Upper Gastrointestinal Tract

OBJECTIVES: The aim of this study was to evaluate the morphometric changes in neuroforamen in grade I isthmic spondylolisthesis by anterior lumbar interbody fusion (ALIF). METHODS: Fourteen patients with grade I isthmic spondylolisthesis who underwent single level ALIF with percutaneous pedicle screw fixation were enrolled. All patients underwent standing lateral radiography and magnetic resonance imaging (MRI) before surgery and at 1 week after surgery. For quantitative analysis, the foraminal height, foraminal width, epidural foraminal height, epidural foraminal width, and epidural foraminal area were evaluated at the mid-portion of 28 foramens using T2-weighted sagittal MRI. For qualitative analysis, degree of neural compression in mid-portion of 28 foramens was classified into 4 grades using T2-weighted sagittal MRI. Clinical outcomes were assessed using Visual Analogue Sale (VAS) scores for leg pain and Oswestry disability index before surgery and at 1 year after surgery. RESULTS: The affected levels were L4-5 in 10 cases and L5-S1 in 4. The mean foraminal height was increased (p<0.001), and the mean foraminal width was decreased (p=0.014) significantly after surgery. The mean epidural foraminal height (p<0.001), epidural foraminal width (p<0.001), and epidural foraminal area (p<0.001) showed a significant increase after surgery. The mean grade for neural compression was decreased significantly after surgery (p<0.001). VAS scores for leg pain (p=0.001) and Oswestry disability index (p=0.001) was decreased significantly at one year after surgery. CONCLUSION: Foraminal stenosis in grade I isthmic spondylolisthesis may effectively decompressed by ALIF with percutaneous pedicle screw fixation.
Commerce ; Constriction, Pathologic ; Humans ; Leg ; Magnetic Resonance Imaging ; Radiography ; Spondylolisthesis*

OBJECTIVES: The Korean College of Neuropsychopharmacology and the Korean Academy of Schizophrenia developed the Korean algorithm project for schizophrenia to aid clinical decisions. The purpose of this study was to assess the feasibility of Korean Medication Algorithm for Schizophrenia patients in clinical settings in Korea. METHODS: A total of 108 schizophrenia and schizophreniform disorder patients were enrolled at 19 centers and treated according to the algorithm. PANSS (Positive and Negative Symptom Scale) and CGI (Clinical Global Impression) were used to evaluate symptom severity. Also UKU (UKU side effect rating scale) and LUNSERS (Liverpool University Neuroleptic Side Effect Rating Scale), DAI-10 (Drug Attitude Inventory-10), PPS (Patient Preference Scale), SWN (Subjective Well-Being under Neuroleptic treatment) and WHOQOL (World Health Organization Quality of Life) were used to evaluate tolerability and satisfaction of patient respectively. RESULTS: Overall ratings including symptom severity, compliance of medication, side effect of medication, quality of life were favorable. The treatment response (PANSS improvement > or = 20%) rate was 63%, 75% at the first Clinical decision point (CDP) and 4 month respectively. CONCLUSION: Symptom improvement, tolerability and quality of life were all favorable. These results suggest that this algorithm can be useful in clinical practices.
Compliance ; Humans ; Korea ; Psychotic Disorders ; Quality of Life ; Schizophrenia ; World Health Organization

OBJECTIVE: The efficacy, tolerability and safety of quetiapine in schizophrenia patients diagnosed by the diagnostic criteria of schizophrenia of the Diagnostic Statistical Manual 4th edition was studied in psychiatric department of 4 hospital in Korea. METHODS: Sixty-four patients (male 31, female 33;age 34.2+/-10.4 years; illness duration 8.1+/-8.3 years) who showed acute exacerbation, partial response, or intolerable adverse event to previous antipsychotic drugs were recruited. Doses of quetiapine were adjusted to maximize efficacy and minimize adverse events. Efficacy was assessed by the Brief Psychiatric Rating Scale (BPRS) and Clinical Global Impression (CGI) scale. Tolerability and safety were assessed by reports of adverse events, clinically significant abnormal laboratory values and changes from the baseline to week 8 in the Abnormal Involuntary Movement Scale (AIMS) and Simpson-Angus total score as index of extrapyramidal symptoms (EPS). RESULTS: Fiftythree patients completed the 8 weeks trial. The clinical symptoms indexed by BPRS were significantly improved (baseline score=37.9+/-13.0, score at the end=24.3+/-13.6;F=41.5, d.f.=2.4, p=0.000). The CGI score of severity of illness was also significantly reduced (baseline score=4.7+/-1.1, score at the end= 3.6+/-1.2;F=27.6, d.f.=2.2, p=0.000). The frequencies of the worsening of AIMS and Simpson-Angus scores at the end of study were 7.5% and 4.2%, respectively. The most common adverse events of at least moderate intensity were EPS (9.3%), constipation (6.3%), and sedation (4.7%). CONCLUSION: The results of this study suggest that quetiapine is effective, may have a favorable EPS, and has overall safe tolerability in the patients with schizophrenia, and schizophreniform disorder.
Antipsychotic Agents ; Brief Psychiatric Rating Scale ; Constipation ; Dyskinesias ; Female ; Humans ; Korea ; Psychotic Disorders ; Schizophrenia* ; Quetiapine Fumarate