A Phase 3 Randomized Clinical Trial to Compare Efficacy and Safety between Combination Therapy and Monotherapy in Elderly Patients with Advanced Gastric Cancer (KCSG ST13-10) / Journal of the Korean Cancer Association, 대한암학회지

Purpose@#This study evaluated whether combination therapy is more effective than monotherapy in elderly patients with metastatic or recurrent gastric cancer (MRGC) as first-line chemotherapy. @*Materials and Methods@#Elderly (≥ 70 years) chemo-naïve patients with MRGC were allocated to receive either combination therapy (group A: 5-fluorouracil [5-FU]/oxaliplatin, capecitabine/oxaliplatin, capecitabine/cisplatin, or S-1/cisplatin) or monotherapy (group B: 5-FU, capecitabine, or S-1). In group A, starting doses were 80% of standard doses, and they could be escalated to 100% at the discretion of the investigator. Primary endpoint was to confirm superior overall survival (OS) of combination therapy vs. monotherapy. @*Results@#After 111 of the planned 238 patients were randomized, enrollment was terminated due to poor accrual. In the full-analysis population (group A [n=53] and group B [n=51]), median OS of combination therapy vs. monotherapy was 11.5 vs. 7.5 months (hazard ratio [HR], 0.86; 95% confidence interval [CI], 0.56 to 1.30; p=0.231). Median progression-free survival (PFS) was 5.6 vs. 3.7 months (HR, 0.53; 95% CI, 0.34 to 0.83; p=0.005). In subgroup analyses, patients aged 70-74 years tended to have superior OS with combination therapy (15.9 vs. 7.2 months, p=0.056). Treatment-related adverse events (TRAEs) occurred more frequently in group A vs. group B. However, among severe TRAEs (≥ grade 3), there were no TRAEs with a frequency difference of > 5%. @*Conclusion@#Combination therapy was associated with numerically improved OS, although statistically insignificant, and a significant PFS benefit compared with monotherapy. Although combination therapy showed more frequent TRAEs, there was no difference in the frequency of severe TRAEs.

Real-World Experience of Nivolumab in Non-small Cell Lung Cancer in Korea / Journal of the Korean Cancer Association, 대한암학회지

Purpose@#The introduction of immune checkpoint inhibitors represents a major advance in the treatment of lung cancer, allowing sustained recovery in a significant proportion of patients. Nivolumab is a monoclonal anti–programmed death cell protein 1 antibody licensed for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy. In this study, we describe the demographic and clinical outcomes of patients with advanced NSCLC treated with nivolumab in the Korean expanded access program. @*Materials and Methods@#Previously treated patients with advanced non-squamous and squamous NSCLC patients received nivolumab at 3 mg/kg every 2 weeks up to 36 months. Efficacy data including investigator-assessed tumor response, progression data, survival, and safety data were collected. @*Results@#Two hundred ninety-nine patients were treated across 36 Korean centers. The objective response rate and disease control rate were 18% and 49%, respectively; the median progression-free survival was 2.1 months (95% confidence interval [CI], 1.87 to 3.45), and the overall survival (OS) was 13.2 months (95% CI, 10.6 to 18.9). Patients with smoking history and patients who experienced immune-related adverse events showed a prolonged OS. Cox regression analysis identified smoking history, presence of immune-related adverse events as positive factors associated with OS, while liver metastasis was a negative factor associated with OS. The safety profile was generally comparable to previously reported data. @*Conclusion@#This real-world analysis supports the use of nivolumab for pretreated NSCLC patients, including those with an older age.

Phase II Study of Irinotecan and Cisplatin Combination Chemotherapy in Metastatic, Unresectable Esophageal Cancer / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: The objective of this multicenter phase II study was to evaluate the efficacy and safety of irinotecan and cisplatin combination chemotherapy in metastatic, unresectable esophageal cancer. MATERIALS AND METHODS: Patients were treated with irinotecan 65 mg/m² and cisplatin 30 mg/m² on days 1 and 8 of each 21-day treatment cycle. The primary endpoint was response rate, and secondary endpoints were survival, duration of response, initial metabolic response rate, and toxicity. RESULTS: A total of 27 patients with squamous cell histology were enrolled in the study. The median age of the patients was 61 years. The objective response rate of the 20 patients in the perprotocol group was 30.0% (90% confidence interval [CI], 13.2 to 46.9). The median follow-up duration was 10.0 months, and the median progression-free survival and overall survival were 4.5 months (95% CI, 1.6 to 6.2) and 8.8 months (95% CI, 4.7 to 10.5), respectively. Four of 13 patients (30.8%) evaluated showed initial metabolic response. The median duration of response for partial responders was 5.0 months (range, 3.4 to 8.0 months). The following grade 3/4 treatment-related hematologic toxicities were reported: neutropenia (40.7%), anaemia (22.2%), and thrombocytopenia (7.4%). Two patients experienced febrile neutropenia. The most common grade 3/4 non-hematologic toxicities were asthenia (14.8%) and diarrhoea (11.1%). CONCLUSION: Irinotecan and cisplatin combination chemotherapy showed modest anti-tumour activity and manageable toxicity for patients with metastatic, unresectable esophageal cancer.

CKD-712, (S)-1-(alpha-naphthylmethyl)-6,7-dihydroxy-1,2,3,4-tetrahydroisoquinoline, Inhibits the NF-kappaB Activation and Augments Akt Activation during TLR4 Signaling

Since CKD-712 has been developed as an anti-inflammatory agent, we examined the effect of CKD-712 during TLR4 signaling. Using HEK293 cells expressing TLR4, CKD-712 was pre-treated 1 hr before LPS stimulation. Activation of NF-kappaB was assessed by promoter assay. The activation of ERK, JNK, p38, IRF3 and Akt was measured by western blotting. CKD-712 inhibited the NF-kappaB signaling triggered by LPS. The activation of ERK, JNK, p38 or IRF3 was not inhibited by CKD-712. On the contrary the activation of these molecules was augmented slightly. The activation of Akt with stimulation of LPS was also enhanced with CKD-712 pre-treatment at lower concentration, but was inhibited at higher concentration. We suggest that during TLR4 signaling CKD-712 inhibits NF-kappaB activation. However, CKD-712 augmented the activation of Akt as well as Map kinases. Therefore, we suggest that CKD-712 might have a role as an immunomodulator.

Prognosis of pN3 Stage Gastric Cancer / Journal of the Korean Cancer Association, 대한암학회지

PURPOSE: The aim of this study was to determine the prognosis of pN3 stage gastric cancer patients after they have undergone curative resection, and we also wanted to identify the prognostic factors according to the clinico-pathologic features. MATERIALS AND METHODS: Between January 2000 and December 2004, we retrospectively reviewed the medical records of the patients with histologically confirmed pN3 stage gastric cancer. They underwent both gastrectomy and lymphadenectomy with a curative aim. We categorized the pN3 stage patients into 2 groups; one with pN3 only (pN3M0) and the other with pN3 combined with M1 stage (pN3M1) that included peritoneal seeding, hepatic metastasis or para-aortic LN metastasis. RESULTS: Out of 467 patients with stage IV gastric adenocarcinoma who received surgery, 260 patients underwent curative resection and they were pathologically staged as N3. Among these 260 patients, 78 patients were classified as the pN3/M1 stage. For all the patients, the median follow-up period was 19 months (range: 1~108 months) and the median overall survival time was 16.2 months (95% CI, 14.1~18.3%). The 5-year survival rate of the pN3/M0 group was significantly higher than that of the pN3/M1 group (12.6% vs. 2.6%, respectively, p<0.0001). The identified predictor for a worse prognosis was an advanced T4 stage (HR: 3.38, 95% CI, 1.4~8.3, p=0.008) for the pN3 patients. CONCLUSION: The survival for the pN3 gastric cancer patients after curative gastrectomy was significantly longer in the pN3/M0 group as compared to that of the pN3/M1 group. An advanced T stage was a predictor for a poor prognosis for the pN3 patients. Therefore, diverse treatment strategies for these heterogeneous pN3 gastric cancer patients are needed for improving their survival.

Monoclonal Proteinuria as a Prognostic Factor for Multiple Myeloma Patients with Intact Immunoglobulin Type

BACKGROUND: Urine/serum protein electrophoresis (PEP) and immunofixation electrophoresis (IEP) for monoclonal protein (M-protein) are used for initial evaluation in patients with multiple myeloma. We evaluated the prognostic significance of M-proteinuria status and its association with other prognostic factors. METHODS: Between December 2002 and December 2004, 64 de novo symptomatic multiple myeloma patients with intact immunoglobulin (Ig) type were divided into two groups according to their initial urine PEP/IEP findings. RESULTS: Twenty-seven patients with undetectable or free light-chains only were classified into F group, and 37 with whole Ig with or without light-chains were classified into W group. The two groups were similar in sex, age, performance, azotemia, beta2-microglobulin, stage and treatment, but M-protein concentration was significantly higher in the W than in F group (5.1 vs 1.3g/dL, P<0.01). The overall response rate was significantly higher in F group than in W group (80.8% vs 63.6%, P=0.02), whereas the 2-year OS rate did not differ significantly between the groups (81.0% vs 57.7%, P=0.15). CONCLUSION: Monoclonal proteinuria is helpful in identifying patients with advanced disease and poorer prognosis in multiple myeloma.

A Phase II Study of Cetuximab (Erbitux(R)) plus FOLFIRI for Irinotecan and Oxaliplatin-refractory Metastatic Colorectal Cancer

We have evaluated the efficacy and safety of cetuximab plus FOLFIRI for irinotecan and oxaliplatin-refractory colorectal cancers. From September 2004 to February 2006, 31 patients with metastatic colorectal cancer were treated with cetuximab (400 mg/m2 intravenously [IV] over 2 hr on day 1 followed by weekly 1-hr infusions of 250 mg/m2) plus bi-weekly FOLFIRI (irinotecan 150 mg/m2 IV over 90 min, and leucovorin 100 mg/m2 IV over 2 hr, followed by 5-FU 400 mg/m2 IV bolus on day 1, and followed by 5-FU 2,400 mg/m2 by continuous IV over 46 hrs). Patients received a median of four cycles (range: 1-23). Eight (25.8%) patients had confirmed partial responses and 10 (32.2%) had stable disease. After a median follow-up of 13.2 months for surviving patients, the median time to progression was 2.9 months, the median duration of response was 5.4 months, and the median overall survival was 10.9 months. Skin toxicity was observed in 25 patients (80.4%) including grade 3 in 6 patients (19.4%). Other common non-hematologic toxicities of all grades were mucositis (32.3%), asthenia (22.6%), diarrhea (12.9%), and paronychial cracking (12.9%). The combination of cetuximab with FOLFIRI was effective and tolerable in colorectal cancer patients heavily pretreated with a number of chemotherapy regimens.

A Case of Leukemic Pleural Infiltration in Atypical Chronic Myeloid Leukemia

Pleural effusion in chronic myeloid leukemia (CML) is poorly understood and rarely reported in the literature. When the pleural effusion is caused by leukemic pleural infiltration, the differential white blood cell count of the effusion is identical to that of the peripheral blood, and the fluid cytology reveals leukemic blasts. We report here a case of bilateral pleural involvement of atypical CML in an 83-yr old male diagnosed with pancreatic cancer with abdominal wall metastasis and incidental peripheral leukocytosis. Based on bone marrow examination, chromosome analysis and polymerase chain reaction he was diagnosed with Philadelphia chromosome negative, BCR/ABL gene rearrangement negative CML. Following 3 months of treatment with gemcitabine for pancreatic cancer, he developed bilateral pleural effusions. All stages of granulocytes and a few blasts were present in both the pleural fluid and a peripheral blood smear. After treatment with hydroxyurea and pleurodesis, the pleural effusion resolved.

A Gastric Hyperplastic Polyp with Intramucosal Adenocarcinoma / 대한소화기내시경학회지

Adenomatous polyps have been well known to be premalignant, but it is still controversial how to treat and follow them up. Up to date, endoscopic resection has been the choice of treatment, particularly exceeding 2 cm, though there is no concensus on the indications for the excision of hyperplastic polyps. The incidence of malignant tissue found in hyperplastic polyps has been reported to be less than 3%, which is considerably lower than the incidence of greater than 6% reported in adenomas. There have been few reports of hyperplastic polyps in which malignant changes developed during endoscopic surveillance. We report a case of hyperplastic gastric polyp with intramucosal, well-differentiated adenocarcinoma with reviewing references.

A Case of Multiple Gastric Carcinoids Associated with Chronic Atrophic Gastritis and Hypergastrinemia / 대한소화기내시경학회지

Gastric carcinoid tumors are so rare that they constitute less than 1% of total primary gastric tumors. They are classified into 3 types: (1) gastric carcionoid associated with chronic atrophic gastritis (type I), (2) gastric carcinoids associated with Zollinger-Ellison syndrome (ZES) or multiple endocrine neoplasm (MEN) type 1 (type II), and (3) sporadic gastric carcinoid (type III). A 55-year-old man underwent a medical check-up. Five polypoid masses were incidentally detected in the cardia, fundus and midbody whose size ranged from 0.5 cm to 1.6 cm in diameter. Tumor cells were strongly positive for cytokeratin, synaptophysin and chromogranin staining. Biopsies from the body and fundus showed severe atrophy. Fasting serum gastrin level was highly increased, 1,098 pg/mL. There was, however, no evidence of the presence of ZES or MEN type 1. The patient underwent total gastrectomy for complete resection and has remained free of any complications with normal serum gastrin level.

A Case of Esophageal Squamous Cell Carcinoma Misconceived as Submucosal Tumor / 대한내과학회지

No abstract available.

Congenital Ocular Motor Apraxia with Cerebellar Vermian Hypoplasia

Congenital ocular motor apraxia is characterized by impaired voluntary saccades and abnormal head thrusts to induce a fixation. We report a case of a 7-year-old boy who shows typical finding of congenital ocular motor apraxia. He had a history of spasmus nutans. His developmental milestones were delayed. Brain MRI demonstrated cerebellar vermian hypoplasia, especially in the inferior portion. We report on a case of congenital ocular motor apraxia associated with cerebellar vermian hypoplasia.

Congenital Ocular Motor Apraxia with Cerebellar Vermian Hypoplasia

Congenital ocular motor apraxia is characterized by impaired voluntary saccades and abnormal head thrusts to induce a fixation. We report a case of a 7-year-old boy who shows typical finding of congenital ocular motor apraxia. He had a history of spasmus nutans. His developmental milestones were delayed. Brain MRI demonstrated cerebellar vermian hypoplasia, especially in the inferior portion. We report on a case of congenital ocular motor apraxia associated with cerebellar vermian hypoplasia.

The Survey for The Standards of Care in Rehabilitation Nurse Specialist / 재활간호학회지

The purpose of this study is to develop the standards of care in rehabilitation nurse specialist. This study was a descriptive survey. The data were collected 143 nurses who were worked in rehabilitation unit at 4 university hospital and 3 rehabilitation center in Korea from Aug. to Nov. 2000. The questionnaire was consisted of 78 items developed by the standards of care in rehabilitation nurse specialist in A.R.N. and the practice contents of care at rehabilitation unit in Korea. Collected data were analyzed by frequency, percentage, mean, S.D. ANOVA The results are as follows 1. For the adequency of the practice contents of rehabilitation nursing, area of skin care is the highest score, and safety, elimination, emotion, respiration, was ordered. 2. The adequency of the practice contents of rehabilitation nursing according to age, educational level. position. clinical experience, clinical experience in rehabilitation unit were significant difference.

Development of a Curriculum for Rehabilitation Nurse Specialist Program / 재활간호학회지

The purpose of this study is to develop a systematic and efficient curriculum for the rehabilitation nurse specialist program. This research was carried out as a group work of 15 experts in order to share vanous opinions about the curriculum. and also through literature review. Articles. curriculums of other Clinical Nurse Specialist Programs. medical laws guidelines. as well as Clinical Nurse Specialist Program from the Korean Nurses Association were reviewed, and the issue was discussed throughly via group meetings. The developed cunicul urn is as follows: 1. Educational philosophy lies in the fact that the rehabilitation nurses support the patients to maximize their potential and functional level. so that they could maintain healthy state and re-adapt to changed environment. Furthermore the rehabilitation nurses are disposed of arbitrary decision power under their own responsibility. thus they take charge of we]fare and healthy environment of the local society through the patients (subjects) and local resources. 2. Educational goals are to train rehabilitation nurse specialist. who correspond to the social needs. so to say. those who have the know]edge and skills for nursing practice, education and research. 3. The curriculum consists of 37 credits, of which 24 credits are based on lectures and 13 credits based on clinical practice. General courses are 3 subjects (5 credits): nursing theory, nursing research. and laws/ethics, Mandatory courses are 8 subjects with 19 credits: advanced physical assessment, pharmacology, pathophysiology, issues in rehabilitation nursing, advanced rehabilitation nursing intervention I. advanced rehabilitation nursing intervention II. sports physiology. special rehabilitation nursing intervention. As for the clinical practice courses, assesment and evaluation for rehabilitation (64 hours), community and home based rehabilitation nursing(128 hours), hospital based rehabilitation nursing(l28 hours), institution based rehabilitation nursing(96 hours) would be treated. 4. Contents of the courses were developed to correspond with the courses' objectives and specific items. 5. Evaluation would be carried out both in the lecure and in the clinical practice. The knowledge and skills of the students would be measured to ensure full validity and credibility. However this developed curriculum should be continuously modified and updated in more desirable direction.

Evaluation of sympathetic innervation in cardiomyophathy with I-MIBG / 대한핵의학회잡지

No abstract available.

Clinical study of corrosive esophagitis / 대한이비인후과학회지

No abstract available.

Relationship between Degree of Aortic Regurgitation Graded by 2-D Color Doppler Echocardiography and Diastolic Fluttering of Anterior Mitral Leaflet

In 25 aortic regurgitation patients relationship between degree of aortic regurgitation graded by 2-D color Doppler echocardiography and diastolic fluttering of anterior mitral leaflet on M-mode echocardiography was evaluated. The results were that all 13 aortic regurgitation patients, not associated with mitral stenosis, showed diastolic fluttering of anterior mitral leaflet; but only 3 patients among 12 patients (25%), associated with mitral stenosis, had characteristic mitral fluttering. On the whole, regardless of associated mitral stenosis, the sensitivity was 64%. In severe aortic regurgitation (Grade 3, 4 group) 12/13 patients revealed diastolic fluttering of anterior mitral leaflet (sensitivity of 92%); in mild to moderate aortic regurgitation (Grade 1, 2 group), only 4/12 patients (sensitivity of 33%). In conclusion, 2-D color Doppler echocardiography is a very useful method for detection of aortic regurgitation without difficulty. And in aortic regurgitation, not associated with mitral stenosis, fine fluttering of anterior mitral leaflet is a very sensitive sign of existence of aortic regurgitation, though there may be some false positive findings in normal individuals.