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: This study examined the long-term outcomes of undifferentiated-type early gastric cancer (UD EGC) with positive horizontal margins (HMs) after endoscopic resection (ER) and compared them between additional surgery and nonsurgical management. Methods: From 2005 to 2015, a total of 1,124 patients with UD EGC underwent ER at 18 tertiary hospitals in Korea. Of them, 92 patients with positive HMs as the only noncurative factor (n=25) or with both positive HMs and tumor size >2 cm (n=67) were included. These patients underwent additional surgery (n=40), underwent additional endoscopic treatment (n=6), or were followed up without further treatment (n=46). Results: No lymph node (LN) metastasis was found in patients who underwent additional surgery. During a median follow-up of 57.7 months (interquartile range, 27.6 to 68.8 months), no LN or distant metastases or gastric cancer-related deaths occurred in the overall cohort. At baseline, the residual cancer rate was 57.8% (26/45) after additional surgery or ER. The 5-year local recurrence rate was 33.6% among patients who were followed up without additional treatment. The 5-year overall survival rates were 95.0% and 87.8% after additional surgery and nonsurgical management (endoscopic treatment or close follow-up), respectively (log-rank p=0.224). In the multivariate Cox regression analysis, nonsurgical management was not associated with an increased risk of mortality. Conclusions UD EGC with positive HMs after ER may have favorable long-term outcomes and a very low risk of LN metastasis. Nonsurgical management may be suggested as an alternative, particularly for patients with old age or chronic illness.

Background/Aims: This study examined the long-term outcomes of undifferentiated-type early gastric cancer (UD EGC) with positive horizontal margins (HMs) after endoscopic resection (ER) and compared them between additional surgery and nonsurgical management. Methods: From 2005 to 2015, a total of 1,124 patients with UD EGC underwent ER at 18 tertiary hospitals in Korea. Of them, 92 patients with positive HMs as the only noncurative factor (n=25) or with both positive HMs and tumor size >2 cm (n=67) were included. These patients underwent additional surgery (n=40), underwent additional endoscopic treatment (n=6), or were followed up without further treatment (n=46). Results: No lymph node (LN) metastasis was found in patients who underwent additional surgery. During a median follow-up of 57.7 months (interquartile range, 27.6 to 68.8 months), no LN or distant metastases or gastric cancer-related deaths occurred in the overall cohort. At baseline, the residual cancer rate was 57.8% (26/45) after additional surgery or ER. The 5-year local recurrence rate was 33.6% among patients who were followed up without additional treatment. The 5-year overall survival rates were 95.0% and 87.8% after additional surgery and nonsurgical management (endoscopic treatment or close follow-up), respectively (log-rank p=0.224). In the multivariate Cox regression analysis, nonsurgical management was not associated with an increased risk of mortality. Conclusions UD EGC with positive HMs after ER may have favorable long-term outcomes and a very low risk of LN metastasis. Nonsurgical management may be suggested as an alternative, particularly for patients with old age or chronic illness.

Background: The median-to-ulnar comparison test (MUCT), and increasingly, ultrasonography (US) are considered as complementary to and more sensitive than median nerve conduction study (NCS) in diagnosing carpal tunnel syndrome (CTS). Methods: In consecutive patients with hand paresthesia compatible with CTS but with normal median NCS, we additionally performed the MUCT and analyzed whether it yielded better diagnostic sensitivity. Results: In total, 163 hands of clinically diagnosed CTS patients were examined with routine NCS. The MUCT and US were performed in 81 hands and 31 hands, respectively. While median NCS was diagnostic in 85 (52.1%) hands, MUCT failed to demonstrate superior sensitivity over median NCS in the other hands and US revealed related abnormalities better than both routine NCS (p=0.006) and MUCT (p=0.002). Conclusions The MUCT offered no additional diagnostic benefit. On the other hand, sonographic examination had higher sensitivity for the diagnosis of CTS when applying several diagnostic criteria. Thus, US could be the screening test for diagnosing CTS prior to NCS with higher sensitivity than MUCT. However, further studies are needed to define the appropriate diagnostic criteria for US.

Background: The median-to-ulnar comparison test (MUCT), and increasingly, ultrasonography (US) are considered as complementary to and more sensitive than median nerve conduction study (NCS) in diagnosing carpal tunnel syndrome (CTS). Methods: In consecutive patients with hand paresthesia compatible with CTS but with normal median NCS, we additionally performed the MUCT and analyzed whether it yielded better diagnostic sensitivity. Results: In total, 163 hands of clinically diagnosed CTS patients were examined with routine NCS. The MUCT and US were performed in 81 hands and 31 hands, respectively. While median NCS was diagnostic in 85 (52.1%) hands, MUCT failed to demonstrate superior sensitivity over median NCS in the other hands and US revealed related abnormalities better than both routine NCS (p=0.006) and MUCT (p=0.002). Conclusions The MUCT offered no additional diagnostic benefit. On the other hand, sonographic examination had higher sensitivity for the diagnosis of CTS when applying several diagnostic criteria. Thus, US could be the screening test for diagnosing CTS prior to NCS with higher sensitivity than MUCT. However, further studies are needed to define the appropriate diagnostic criteria for US.

BACKGROUND AND OBJECTIVES: The Musical Background Questionnaire (MBQ) has been developed to assess formal musical training and listening enjoyment. The aims of this study were to translate MBQ into Korean with subsequent linguistic validation and to evaluate the effectiveness of the Korean version of MBQ (K-MBQ).SUBJECTS AND METHOD: Between 2013 and 2014, a panel affiliated with the questionnaire committee of the Korean Audiological Society reconciled the first draft K-MBQ translated by a bilingual person. A separate bilingual translator, who had never seen the original MBQ, translated the draft K-MBQ back into English, and subsequently, the panel reviewed its equivalence to the original one. K-MBQ was administered to 29 adults (M:F=15:14; aged 21 to 76 years) for cognitive debriefing. Pure tone and speech audiometry were performed in all participants. RESULTS: The translation of K-MBQ was completed through a multi-step process of forward translation, reconciliation, reverse translation, cognitive debriefing and proofreading. Thirteen (45%) of 29 subjects reported formal musical training, and 16 participants (55%) judged themselves as having no musical education and background. No significant correlation was found between musical background and hearing level, whereas self-perceived quality of music and self-perception of music elements quantified by K-MBQ were associated with hearing ability in terms of pure-tone and speech audiometry. CONCLUSION K-MBQ was translated and linguistically validated. The use of this questionnaire can provide further evaluation of musical background in patients with hearing loss or cochlear implant users.

PURPOSE: Emerging evidence indicates that runt-related transcription factor 3 (RUNX3) is an important tumor suppressor gene in several cancer types, including colorectal cancer (CRC). However, the clinical significance of RUNX3 inactivation in CRC remains unclear. The aim of this study was to examine the correlation between clinicopathologic factors and RUNX3 hypermethylation/expression in CRC. METHODS: Sixty-two CRC patients who were treated at the Soonchunhyang University College of Medicine were recruited in this study. The hypermethylation of CpG islands in the RUNX3 promoter and the expression of RUNX3 mRNA were identified by methylation-specific polymerase chain reaction (PCR) and reverse transcriptase-PCR, respectively. The expression of RUNX3 was determined by immunohistochemical staining. RESULTS: Of the 62 CRC tissue samples, 20 (32.3%) presented hypermethylated RUNX3 promoters. Aberrant RUNX3 hypermethylation was found to be associated with vascular (P = 0.006) and lymphatic (P = 0.002) invasion. Hypermethylation of RUNX3 was associated with poor survival outcomes (P = 0.038). However, expression of RUNX3 was not a prognostic factor (P = 0.363). CONCLUSION: Hypermethylation of RUNX3 may be a predictor of a poor prognosis in CRC.
Colorectal Neoplasms ; Core Binding Factor Alpha 3 Subunit ; CpG Islands ; Epigenomics ; Genes, Tumor Suppressor ; Humans ; Immunohistochemistry ; Methylation ; Polymerase Chain Reaction ; Prognosis ; RNA, Messenger ; Transcription Factor 3

Correction of funding statement in ACKNOWLEDGEMENTS section.