Background: Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests. Methods The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.

Background: Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests. Methods The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.

Background: Bulky or multiple lymph node (LN) metastases are associated with poor prognosis in cervical cancer, and the size or number of LN metastases is not yet reflected in the staging system and therapeutic strategy. Although the therapeutic effects of surgical resection of bulky LNs before standard treatment have been reported in several retrospective studies, wellplanned randomized clinical studies are lacking. Therefore, the aim of the Korean Gynecologic Oncology Group (KGOG) 1047/DEBULK trial is to investigate whether the debulking surgery of bulky or multiple LNs prior to concurrent chemoradiation therapy (CCRT) improves the survival rate of patients with cervical cancer IIICr diagnosed by imaging tests. Methods The KGOG 1047/DEBULK trial is a phase III, multicenter, randomized clinical trial involving patients with bulky or multiple LN metastases in cervical cancer IIICr. This study will include patients with a short-axis diameter of a pelvic or para-aortic LN ≥2 cm or ≥3 LNs with a short-axis diameter ≥1 cm and for whom CCRT is planned. The treatment arms will be randomly allocated in a 1:1 ratio to either receive CCRT (control arm) or undergo surgical debulking of bulky or multiple LNs before CCRT (experimental arm). CCRT consists of extended-field external beam radiotherapy/pelvic radiotherapy, brachytherapy and LN boost, and weekly chemotherapy with cisplatin (40 mg/m 2 ), 4–6 times administered intravenously.The primary endpoint will be 3-year progression-free survival rate. The secondary endpoints will be 3-year overall survival rate, treatment-related complications, and accuracy of radiological diagnosis of bulky or multiple LNs.

Background: Nilotinib is a tyrosine kinase inhibitor approved by the Ministry of Food and Drug Safety for frontline and 2nd line treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). This study aimed to confirm the safety and efficacy of nilotinib in routine clinical practice within South Korea. Methods: An open-label, multicenter, single-arm, 12-week observational post-marketing surveillance (PMS) study was conducted on 669 Korean adult patients with Ph + CML from December 24, 2010, to December 23, 2016. The patients received nilotinib treatment in routine clinical practice settings. Safety was evaluated by all types of adverse events (AEs) during the study period, and efficacy was evaluated by the complete hematological response (CHR) and cytogenetic response. Results: During the study period, AEs occurred in 61.3% (410 patients, 973 events), adverse drug reactions (ADRs) in 40.5% (271/669 patients, 559 events), serious AEs in 4.5% (30 patients, 37 events), and serious ADRs in 0.7% (5 patients, 8 events). Furthermore, unexpected AEs occurred at a rate of 6.9% (46 patients, 55 events) and unexpected ADRs at 1.2% (8 patients, 8 events). As for the efficacy results, CHR was achieved in 89.5% (442/494 patients), and minor cytogenetic response or major cytogenetic response was achieved in 85.8% (139/162 patients). Conclusion This PMS study shows consistent results in terms of safety and efficacy compared with previous studies. Nilotinib was well tolerated and efficacious in adult Korean patients with Ph + CML in routine clinical practice settings.

Background/Aims: We evaluated the feasibility and long-term efficacy of the combination of cytarabine, idarubicin, and all-trans retinoic acid (ATRA) for treating patients with newly diagnosed acute promyelocytic leukemia (APL). Methods: We included 87 patients with newly diagnosed acute myeloid leukemia and a t(15;17) or promyelocytic leukemia/retinoic acid receptor alpha (PML-RARα) mutation. Patients received 12 mg/m2/day idarubicin intravenously for 3 days and 100 mg/m2/day cytarabine for 7 days, plus 45 mg/m2/day ATRA. Clinical outcomes included complete remission (CR), relapse-free survival (RFS), overall survival (OS), and the secondary malignancy incidence during a 20-year follow-up. Results: The CR, 10-year RFS, and 10-year OS rates were 89.7%, 94.1%, and 73.8%, respectively, for all patients. The 10-year OS rate was 100% for patients that achieved CR. Subjects were classified according to the white blood cell (WBC) count in peripheral blood at diagnosis (low-risk, WBC < 10,000/mm3; high-risk, WBC ≥ 10,000/mm3). The low-risk group had significantly higher RFS and OS rates than the high-risk group, but the outcomes were not superior to the current standard treatment (arsenic trioxide plus ATRA). Toxicities were similar to those observed with anthracycline plus ATRA, and higher than those observed with arsenic trioxide plus ATRA. The secondary malignancy incidence after APL treatment was 2.7%, among the 75 patients that achieved CR, and 5.0% among the 40 patients that survived more than 5 years after the APL diagnosis. Conclusions Adding cytarabine to anthracycline plus ATRA was not inferior to anthracycline plus ATRA alone, but it was not comparable to arsenic trioxide plus ATRA. The probability of secondary malignancy was low.

BACKGROUND/AIMS: There have been no nationwide studies to investigate the trends in incidence and 5-year survival rates of intra- and extrahepatic bile duct cancers and gall-bladder cancer. Therefore, our study aimed to describe the incidence and 5-year survival rates of biliary tract cancers by subsites in South Korea. METHODS: A total of 86,134 patients with biliary tract cancers were selected from the National Health Information Database. Age-standardized incidence rates and annual percentage changes were calculated. Life-table methods and log-rank tests were used to determine the differences in survival rates. Cox-proportional hazard models were used to estimate the hazard ratio of the patients with biliary tract cancers. RESULTS: The incidence rate of intra-hepatic bile duct cancer decreased by 1.3% annually from 8.8 per 100,000 in 2006 to 7.8 per 100,000 in 2015. Extrahepatic bile duct cancer also showed a decreasing trend by 2.2% per year from 8.7 per 100,000 in 2006 to 6.7 per 100,000 in 2015. Gallbladder cancer showed the greatest decline, with an annual percentage change of 2.8% from 6.3 per 100,000 to 5.2 per 100,000 during the same period. The 5-year survival rates were 30.0% in gallbladder cancer, 27.8% in extrahepatic bile duct cancer, and 15.9% in intra-hepatic bile duct cancer. CONCLUSIONS: The overall incidence rates of intrahepatic and extrahepatic bile duct cancer and gallbladder cancer decreased from 2006 to 2015. Among biliary tract cancers, intrahepatic bile duct cancers exhibited the highest incidence rate and the worst survival rate.
Bile Duct Neoplasms ; Bile Ducts, Extrahepatic ; Bile Ducts, Intrahepatic ; Biliary Tract Neoplasms* ; Biliary Tract* ; Cholangiocarcinoma ; Gallbladder Neoplasms ; Humans ; Incidence* ; Korea* ; Proportional Hazards Models ; Survival Rate

PURPOSE: To identify the differential MRI findings between myxoid tumors and benign peripheral nerve sheath tumors (BPNSTs) in the musculoskeletal system. MATERIALS AND METHODS: The study participants included a total of 35 consecutive patients who underwent MRI between September 2011 and December 2013. The patients were pathologically diagnosed with myxoid tumors (22 patients) or BPNSTs (13 patients). Evaluation was done by two radiologists, based on the following characteristics: size, margin, degree of signal intensity (SI) on T2-weighted images (T2WI), homogeneity of SI on T2WI, enhancement pattern, enhancement homogeneity, presence of cystic portion, internal fat component, presence of fat split sign, presence of target sign, presence of continuation with adjacent neurovascular bundle, and presence of surrounding halo. RESULTS: Large size, high SI on T2WI, heterogeneous enhancement, and internal fat component were commonly observed in myxoid tumors, while homogenous enhancement, fat split sign, target sign were common in BPNSTs. The differences were statistically significant (P < 0.05). Other findings, such as margin, homogeneity of SI on T2WI, enhancement pattern (peripheral or solid), internal cystic portion, continuation with neurovascular bundle, and surrounding halo, did not show significant difference between myxoid tumors and BPNSTs (P > 0.05). CONCLUSION: In the differential diagnosis of myxoid tumors and BPNSTs involving the musculoskeletal system, several MRI findings such as degree of SI on T2WI, enhancement homogeneity, internal fat component, fat split sign, and target sign, may be helpful in establishing the diagnosis.
Diagnosis ; Diagnosis, Differential ; Humans ; Magnetic Resonance Imaging* ; Musculoskeletal System* ; Nerve Sheath Neoplasms* ; Peripheral Nerves*

BACKGROUND/AIMS: Adenoma detection rate (ADR) is widely used as an index of colonoscopy quality management. Although advanced adenomas can be found less frequently than non-advanced adenomas, advanced adenomas have a higher clinical significance during screening for colorectal cancer. The aim of this study was to investigate the correlation between advanced and non-advanced ADR among colonoscopists. METHODS: This study is an observational study of a cohort of patients undergoing screening colonoscopy between 2009 and 2010. We collected the data on patients' characteristics and colonoscopic findings. The detection rates of adenoma and advanced adenoma were calculated. Logistic regression was used to determine the effects of variables on advanced adenoma detection, and spearman's rank-order correlation was used to evaluate the relationship between advanced ADR and ADR. RESULTS: A total of 561 patients underwent screening colonoscopy by 18 experienced colonoscopists. Most colonoscopists had adequate (>20%) ADRs. Logistic regression showed that increased patient age (OR 1.07 per 1 year increase, 95% CI 1.009-1.133, p=0.023) and male gender (OR 1.860, 95% CI 0.764-4.529, p=0.171) were associated with advanced ADR. When colonoscopists were divided into two groups on the basis of advanced ADR of 5%, ADR was also significantly higher in the group having higher level of advanced ADR. However, there was no correlation between advanced ADR and ADR among colonoscopists as an individual. CONCLUSIONS: Colonoscopists' advanced ADRs were independent of their ADRs, indicating that advanced ADR could be quite low even among colonoscopists with acceptable ADRs. Thus, there seems to be a limitation in using ADR as an adequate index of colonoscopy quality management.
Adenoma/*diagnosis ; Adult ; Aged ; Cohort Studies ; Colonoscopy ; Colorectal Neoplasms/*diagnosis ; Early Detection of Cancer ; Female ; Humans ; Logistic Models ; Male ; Middle Aged ; Neoplasm Staging ; Odds Ratio

BACKGROUND: Scabies is an old and common contagious skin disease. The incidence of scabies has decreased through the economic growth of Korea. However, recent outbreaks in medical facilities have created a suspicion that the infection of scabies is an emerging public health problem. OBJECTIVE: We evaluated the epidemiological and clinical aspects of patients diagnosed with scabies in Korea. This prospective study follows the retrospective study already performed by the same authors in 2011. METHODS: A multicenter, prospective study of scabies was performed at 25 hospitals in Korea. We included 914 patients who were diagnosed with scabies. Microscopic examination revealed scabies mites or eggs, or clinical improvement after treatment. Patients were asked to provide information on scabies, especially regarding the contact source, and the physicians examined them. RESULTS: Of the participants, 432 patients were men and 482 were women. Patients aged younger than 10 years and 60~69 years were the most common groups. Scabies more commonly affected patients during the fall and winter. Of the patients, 68.0% were thought to be infected at their homes, followed by nursing homes or hospitals (25.7%), and 31.6% through contact with other patients or, occasionally, staff members, including caregivers. CONCLUSION: We confirmed that scabies is an emerging threat in institutions, especially medical facilities. In addition, we suggest that public and in-hospital education is essential to minimize the problems associated with scabies.
Caregivers ; Disease Outbreaks ; Economic Development ; Education ; Eggs ; Epidemiologic Studies* ; Epidemiology ; Female ; Humans ; Incidence ; Korea ; Male ; Mites ; Nursing Homes ; Ovum ; Prospective Studies* ; Public Health ; Scabies* ; Skin Diseases

BACKGROUND: Scabies is one of the common skin diseases observed in developing countries. The incidence of scabies has decreased dramatically since the late 1980s in Korea. However, recent outbreaks in nursing homes or hospitals have been raising public health concerns. OBJECTIVE: We intended to evaluate the epidemiological and clinical aspects of patients diagnosed with scabies in Korea. In particular, we tried to investigate the changing trend of contact sources in our society. METHODS: A multi-center cross sectional study was performed at 25 hospitals in Korea. We included 1,539 patients who were diagnosed with scabies. These patients showed scabies mites or eggs under microscopic examination, or clinical improvement after treatment. Their medical records with information of contact sources were reviewed. RESULTS: Six hundred and ninety-three patients were males and 826 were females. Patients' age from 70 to 79 was the most common followed by patients below 10 years of age. More patients were found in the fall and winter months. 66.7% of patients were thought to be infected at their homes which were situated next to nursing homes or hospitals (23.1%). Place of infection could not be verified in 39.3% of patients. 25.8% of patients were suggested to be infected through contact with medical staff or patients from hospitals or nursing homes. CONCLUSION: We confirmed that the contact sources of scabies are changing in our society; nursing homes and hospitals are emerging sources of infection. The majority of patients are old or very young who are vulnerable to many diseases. Therefore, dermatologists should pay attention to new contact sources and appropriate care of patients.
Developing Countries ; Disease Outbreaks ; Eggs ; Female ; Humans ; Hypogonadism ; Incidence ; Korea ; Male ; Medical Records ; Medical Staff ; Mites ; Mitochondrial Diseases ; Nursing Homes ; Ophthalmoplegia ; Ovum ; Public Health ; Retrospective Studies ; Scabies ; Skin Diseases