Purpose: We investigated the consistent efficacy and safety of eflapegrastim, a novel long-acting granulocyte-colony stimulating factor (G-CSF), in Koreans and Asians compared with the pooled population of two global phase 3 trials. Materials and Methods: Two phase 3 trials (ADVANCE and RECOVER) evaluated the efficacy and safety of fixed-dose eflapegrastim (13.2 mg/0.6 mL [3.6 mg G-CSF equivalent]) compared to pegfilgrastim (6 mg based on G-CSF) in breast cancer patients who received neoadjuvant or adjuvant docetaxel/cyclophosphamide. The primary objective was to demonstrate non-inferiority of eflapegrastim compared to pegfilgrastim in mean duration of severe neutropenia (DSN) in cycle 1, in Korean and Asian subpopulations. Results: Among a total of 643 patients randomized to eflapegrastim (n=314) or pegfilgrastim (n=329), 54 Asians (29 to eflapegrastim and 25 to pegfilgrastim) including 28 Koreans (14 to both eflapegrastim and pegfilgrastim) were enrolled. The primary endpoint, DSN in cycle 1 in the eflapegrastim arm was non-inferior to the pegfilgrastim arm in Koreans and Asians. The DSN difference between the eflapegrastim and pegfilgrastim arms was consistent across populations: –0.120 days (95% confidence interval [CI], –0.227 to –0.016), –0.288 (95% CI, –0.714 to 0.143), and –0.267 (95% CI, –0.697 to 0.110) for pooled population, Koreans and Asians, respectively. There were few treatment-related adverse events that caused discontinuation of eflapegrastim (1.9%) or pegfilgrastim (1.5%) in total and no notable trends or differences across patient populations. Conclusion This study may suggest that eflapegrastim showed non-inferior efficacy and similar safety compared to pegfilgrastim in Koreans and Asians, consistently with those of pooled population.

OBJECTIVE: Circulating cell-free tumor DNA (cfDNA) is the DNA released by apoptotic and necrotic cells of the primary tumor into the blood during the period of tumor development. The cfDNA reflects the genetic and epigenetic alterations of the original tumor. TP53 mutations are a defining feature of high-grade serous ovarian carcinoma. We optimized the methods for detecting TP53 mutations in cfDNA from blood samples. We confirmed the correlation of TP53 mutation in primary ovarian cancer tissue and it in cfDNA using digital polymerase chain reaction (dPCR). METHODS: We found 12 frequent mutation sites in TP53 using The Cancer Genome Atlas and Catalogue of Somatic Mutations in Cancer data and manufactured 12 primers. The mutations in tissues were evaluated in fresh-frozen tissue (FFT) and formalin-fixed paraffin-embedded tissue (FFPET). We performed a prospective analysis of serial plasma samples collected from 4 patients before debulking surgery. We extracted cfDNA and calculated its concentration in blood. dPCR was used to analyze TP53 mutations in cfDNA, and we compared TP53 mutations in ovarian cancer tissue with those in cfDNA. RESULTS: Ten primers out of 12 detected the presence of TP53 mutations in FFT, FFPET, and cfDNA. In FFT and FFPET tissue, there were no significant differences. The average cfDNA concentration was 2.12±0.59 ng/mL. We also confirmed that mutations of cfDNA and those of FFT were all in R282W site. CONCLUSION: This study developed detection methods for TP53 mutations in cfDNA in ovarian cancer patients using dPCR. The results demonstrated that there are the same TP53 mutations in both ovarian cancer tissue and cfDNA.
Biomarkers ; DNA* ; Epigenomics ; Genome ; Humans ; Ovarian Neoplasms* ; Plasma ; Polymerase Chain Reaction ; Prospective Studies

The Acknowledgements was published incorrectly.

Wernicke's encephalopathy (WE) is an acute neuropsychiatric syndrome resulting from thiamine deficiency. Traditionally, diagnosis of WE rests on a clinical symptom triad consisting of ocular signs, altered consciousness, and ataxia. However, the complete triad is only present in a fraction of cases, which means that WE tends to be under-diagnosed, especially in nonalcoholic patients. Brain MRI of WE patients usually shows symmetrical signal intensity alterations in the thalami, mammillary bodies, and periaqueductal area, because of cytotoxic edema in the same region. These typical findings are useful diagnostic leads in WE patients with atypical symptoms. However, atypical findings can occasionally be seen in the vermis of cerebellum and cerebellar nuclei. Notably, alterations of signal intensity in the cerebellar dentate nuclei, which is a typical finding of metronidazole-induced encephalopathy (MIE), need to be distinguished according to medication history and response to thiamine.
Ataxia ; Brain ; Cerebellar Nuclei ; Cerebellum ; Consciousness ; Edema ; Humans ; Mamillary Bodies ; Metronidazole ; Thiamine ; Thiamine Deficiency ; Wernicke Encephalopathy

Enteropathy-type T-cell lymphoma (ETL) or enteropathy-associated T-cell lymphoma is a very rare malignant intestinal tumor. ETL is usually diagnosed by surgery. Endoscopic findings of ETL are not well known, and there are few reports of findings from endoscopy that has been performed only using white light. Additionally, there are no definite treatment guidelines for ETL. Therefore, we report a case of ETL diagnosed by enteroscopy with imaging-enhanced endoscopy and also review recently developed treatment options.
Endoscopy ; Enteropathy-Associated T-Cell Lymphoma ; Humans ; Light ; Lymphoma, T-Cell ; T-Lymphocytes

BACKGROUND: There is a close connection between type 2 diabetes mellitus and the risk of cancers and related mortality. The principal objective of the present study was to explore the association between type 2 diabetes and colorectal cancer. METHODS: We retrospectively compared 1111 subjects (age > or = 30 years) who were subjected to colonoscopies between June 2006 and June 2009. We evaluated the anthropometric data, presenting symptoms and signs, history of diabetes, laboratory data, colonoscopy findings and biopsy results. We analyzed the correlation between colorectal cancer and influencing factors, and compared the incidence rates of colorectal cancer in the type 2 diabetes and control groups. RESULTS: Four hundreds and seven of the subjects had diabetes mellitus. The incidence of colorectal cancer was increased significantly in type 2 diabetes relative to the control group (7.4% vs. 3.4%, P < 0.05). Colorectal cancer was correlated significantly with age, type 2 diabetes, constipation, anemia, and gastrointestinal symptoms. Following logistic regression analysis, age and constipation were associated significantly with colorectal cancer. In the age below 65 years subgroup, the incidence of colorectal cancer was increased significantly in the type 2 diabetes group relative to the control group. CONCLUSION: Type 2 diabetes was associated with increased colorectal cancer risk. This association was more definite in the subjects younger than 65 years.
Anemia ; Biopsy ; Colonoscopy ; Colorectal Neoplasms ; Constipation ; Diabetes Mellitus ; Diabetes Mellitus, Type 2 ; Incidence ; Logistic Models ; Retrospective Studies

No abstract available.
Colorectal Neoplasms ; Diabetes Mellitus, Type 2

We describe a 39-year-old man with spontaneous rupture of a gastric stromal tumor causing hemoperitoneum. Ultrasonography showed a large mass broadly abutting the stomach and liver. Computed tomography demonstrated a heterogeneous enhanced mass arising from the stomach and focal perforation of the tumor with hemoperitoneum; endoscopic ultrasonography showed an exophytic heterogeneous mass originating from the gastric muscle layer. Angiography revealed that the right gastric artery was the main artery supplying the tumor. A gastric stromal tumor with bloody fluid in the peritoneal cavity was seen at the laparotomy. The tumor was excised completely, and subsequent histological and immunohistochemical studies indicated that it was a gastric stromal tumor. We report a relatively rare case of gastric stromal tumor causing hemoperitoneum due to spontaneous rupture of the tumor.
Adult ; Angiography ; Arteries ; Endosonography ; Hemoperitoneum ; Humans ; Laparotomy ; Liver ; Muscles ; Peritoneal Cavity ; Rupture, Spontaneous ; Stomach

PURPOSE: As average life expectancies are prolonged, the elderly population is steadily increasing. The increasing number of elderly persons has been accompanied by cases of acute appendicitis in the elderly. In order to understand the clinical significance and to improve the treatment of elderly patients with appendicitis. we analyzed patients over 60 years of age with appendicitis. METHODS: We retrospectively reviewed the medical records of 268 patients over 60 years of age who were pathologically diagnosed with appendicitis. We analyzed the patients' clinicopathologic factors and outcomes, dividing them into 3 age groups: 60~69, 70~79, 80 and over. RESULTS: Of the 268 patients, there were 109 male and 159 female. The sex ratio was 1:1.46. The numbers of patients in each group were 169 (63.1%) in the 60-69 group, 73 (27.2%) in the 70~79 group, and 26 (9.7%) in the over 80 group. There was no difference in the leukocyte count and the time delay in surgical treatment between the groups. In the older groups, compared to the younger groups, there were more frequent paramedian and median incisions in the operation (P=0.02), a longer duration of postoperative admission (P=0.001) and starvation after the operation (P<0.001). In the pathologic findings, the gangrenous and abscess stages of appendicitis were more frequent in the older groups than in the younger groups (P<0.001). CONCLUSIONS: Early aggressive diagnostic intervention, such as ultrasound and CT, is essential in managing appendicitis in elderly patients who complain of vague abdominal pain.
Abdominal Pain ; Abscess ; Aged* ; Appendicitis* ; Female ; Humans ; Leukocyte Count ; Life Expectancy ; Male ; Medical Records ; Retrospective Studies ; Sex Ratio ; Starvation ; Ultrasonography

BACKGROUND: Necrotizing fasciitis is a life threatening severe soft tissue infection primarily involving the fascia and the subcutaneous tissue with thrombosis of the cutaneous microcirculation. The purpose of the study was to analyze the microbiological and clinical characteristics of necrotizing fasciitis in Korea and to suggest adequate antibiotic therapy. METHODS: We retrospectively reviewed medical records of three Soonchunhyang University Hospitals in Seoul, Bucheon and Cheonan. Patients admitted for skin graft or secondary treatment were excluded. Blood cultures were obtained at the time of admission and pus cultures were obtained at the time of first operative debridement. RESULTS: Twenty two patients (16 males, 6 females, 16~82 years old, median age: 59 years old) were enrolled for this study. Fourteen pateints underwent surgical treatment and 2 of them died of necrotizing fasciitis. Gram positive organisms were isolated in 13 cases and gram negative organisms were isolated in 11 cases. Third generation cephalosporin resistant gram negative organisms were isolated in 3 cases. CONCLUSIONS: This study suggest that characteristics of necrotizing fascitis in Korea were; high proportion of aged person, predominance of type 2 necrotizing fascitis and increasing tendency of third generation cephalosporin resistant gram negative bacterial infections. Consequently, initial choice of empirical antibiotics for necrotizing fasciitis should consider 3rd generation cephalosporin resistant gram negative organisms. Prompt surgical debridement and adequate antimicrobial therapy are mandatory for improved survival.
Anti-Bacterial Agents ; Cephalosporin Resistance ; Chungcheongnam-do ; Debridement ; Fascia ; Fasciitis, Necrotizing* ; Female ; Gram-Negative Bacterial Infections ; Gyeonggi-do ; Hospitals, University* ; Humans ; Korea* ; Male ; Medical Records ; Microcirculation ; Retrospective Studies ; Seoul ; Skin ; Soft Tissue Infections ; Subcutaneous Tissue ; Suppuration ; Thrombosis ; Transplants