Purpose: This single-arm phase II trial investigate the efficacy and safety of S-1 plus oxaliplatin (SOX) in patients with metastatic breast cancer. Materials and Methods: Patients with metastatic breast cancer previously treated with anthracyclines and taxanes were enrolled. Patients received S-1 (40-60 mg depending on patient’s body surface area, twice a day, day 1-14) and oxaliplatin (130 mg/m2, day 1) in 3 weeks cycle until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) according to Response Evaluation Criteria in Solid Tumor 1.1. Secondary endpoints included time-to-progression (TTP), duration-of-response (DoR), overall survival (OS), and adverse events. Results: A total of 87 patients were enrolled from 11 institutions in Korea. Hormone receptor was positive in 54 (62.1%) patients and six (6.9%) had human epidermal growth factor receptor 2–positive disease. Forty-eight patients (85.1%) had visceral metastasis and 74 (55.2%) had more than three sites of metastases. The ORR of SOX regimen was 38.5% (95% confidence interval [CI], 26.9 to 50.0) with a median TTP of 6.0 months (95% CI, 5.1 to 6.9). Median DoR and OS were 10.3 months (95% CI, 5.5 to 15.1) and 19.4 (95% CI, not estimated) months, respectively. Grade 3 or 4 neutropenia was reported in 28 patients (32.1%) and thrombocytopenia was observed in 23 patients (26.6%). Conclusion This phase II study showed that SOX regimen is a reasonable option in metastatic breast cancer previously treated with anthracyclines and taxanes.

Objective: To compare the changes in blood urea nitrogen/creatinine (BUN/Cr) ratio, a dehydration status indicator, among patients with mild dysphagia depending on the addition of fluid thickeners. Methods: A total of 81 patients who underwent serial dietary trials of the videofluoroscopic swallowing study (VFSS) and displayed penetration signs with a penetration-aspiration scale of 4 or less during the liquid trials were enrolled and classified into two groups according to the dietary instructions from the VFSS results. Group A comprised patients who were permitted to freely consume water with a regular diet. Group B comprised patients allowed to take a regular diet but with the addition of a fluid thickener while ingesting water. To analyze whether the patients of each group were dehydrated, we calculated the serum BUN/Cr ratio using blood tests, which were performed within 1 week of the VFSS test date and 1 month later. Results: There were 4 cases of suspected pneumonia within 1 month after the VFSS test, with no significant differences between the two groups. The BUN/Cr ratio of the 1-month follow-up blood test when compared to the initial blood test showed a significant decrease in Group A (P=0.022) compared with Group B (P=0.033). Conclusion Patients with mild dysphagia who consumed water freely showed a decrease in the BUN/Cr ratio compared to those who added fluid thickeners to their drinking water.

Background/Aims: Daratumumab has shown an encouraging antitumor effect in patients with multiple myeloma (MM), and was known to alter the immune properties by off-targeting immunosuppressive cells. Here, we aimed to evaluate the change in absolute lymphocyte count (ALC) as a surrogate marker for predicting survival outcomes of patients treated with daratumumab. Methods: Between 2018 and 2021, the medical records of patients with relapsed/refractory MM (RRMM) treated with daratumumab monotherapy at 10 centers in South Korea were reviewed. We collected the ALC data at pre-infusion (D0), day 2 after the first infusion (D2), and prior to the third cycle of daratumumab therapy (D56). Results: Fifty patients who were administered at least two cycles of daratumumab were included. Overall response rate was 54.0% after two cycles of daratumumab treatment. On D2, almost all patients experienced a marked reduction in ALC. However, an increase in ALC on D56 (ALCD56) was observed in patients with non-progressive disease, whereas failure of ALC recovery was noted in those with progressive disease. Patients with ALCD56 > 700/μL (n = 39, 78.0%) had prolonged progression- free survival (PFS) and overall survival (OS) than those with ALCD56 ≤ 700/μL (median PFS: 5.8 months vs. 2.6 months, p = 0.025; median OS: 24.1 months vs. 6.1 months, p = 0.004). In addition, ALCD56 >700/μL was a significant favorable prognostic factor for PFS (hazard ratio [HR], 0.22; p = 0.003) and OS (HR, 0.23; p = 0.012). Conclusions Increase in ALC during daratumumab treatment was significantly associated with prolonged survival outcomes in patients with RRMM. The ALC value can predict clinical outcomes in patients treated with daratumumab.

Objective: To investigate the relationship between the torque onset angle (TOA) of the isokinetic test for knee extensors in the paretic side and walking related balance in subacute stroke patients. Methods: We retrospectively reviewed patients with first-ever strokes who have had at least two isokinetic tests within 6 months of onset. 102 patients satisfied the inclusion criteria. The characteristics of walking related balance were measured with the Berg Balance Scale sub-score (sBBS), Timed Up and Go test (TUG), 10-m Walk Test (10MWT) and Functional Independence Measure sub-score (sFIM). The second isokinetic test values of the knee extensor such as peak torque, peak torque to weight ratio, hamstring/quadriceps ratio, TOA, torque stop angle, torque at 30 degrees, and peak torque asymmetry ratio between paretic and non-paretic limb were also taken into account. Pearson’s correlation, simple regression and multiple regression analysis were used to analyze the correlation between TOA and walking related balance. Results: TOA of the knee extensor of the paretic limb showed significant correlations with BBS, sBBS, TUG, 10MWT, and sFIM according to Pearson’s correlation analysis. TOA also had moderate to good correlations with walking related balance parameters in partial correlation analysis. In multiple regression analysis, TOA of the paretic knee extensor was significantly associated with walking related balance parameters. Conclusion This study demonstrated that TOA of the paretic knee extensor is a predictable parameter of walking related balance. Moreover, we suggest that the ability to recruit muscle quickly is important in walking related balance.

Dysphagia is a common problem in children with a tracheostomy tube. Such children are at risk of malnutrition, developmental problems, increased medical complications, and pose an increased burden on their caregivers. Therefore, proper evaluation and dysphagia rehabilitation are necessary for children with a tracheostomy tube.Also, as many such children experience serious complications, it is necessary to consider decannulation as early as possible, soon after the indication for tracheostomy placement is resolved. Decannulation should be performed safely as per the appropriate protocol.

The present study examined cortical cerebral microinfarcts (CMIs) on a 3T magnetic resonance imaging and investigated the impact of CMIs on the comprehensive functional outcomes during the post-stroke rehabilitation period. Patients with acute phase of firstever ischemic stroke were retrospectively recruited (n = 62) and divided into 2 groups with and without CMIs. Clinical parameters including age, sex, stroke lesion laterality, location, the National Institutes of Health Stroke Scale score, as well as history of hypertension, dyslipidemia, diabetes mellitus, and smoking were obtained. Functional outcomes were assessed twice at baseline and one month later with the Korean version of the MiniMental State Examination, the Berg balance scale (BBS), and the functional independence measure. Partial correlation and multiple linear regression analyses were used to examine the relationship between the presence of CMIs and the change in functional outcomes. At least one CMI was reported in 27 patients, who were older (p = 0.043). The presence of CMIs was significantly associated with functional impairment in all 3 functional outcomes, after controlling for confounding factors (p < 0.05). CMIs might contribute to poor functional outcomes during the post-stroke rehabilitation period. These results suggest that CMIs should be considered when establishing rehabilitation treatment strategies or making a prognosis.

Background/Aims: The prospective Crohn’s Disease Clinical Network and Cohort Study is a nationwide multicenter cohort study of patients with Crohn’s disease (CD) in Korea, aiming to prospectively investigate the clinical features and long-term prognosis associated with CD. Methods: Patients diagnosed with CD between January 2009 and September 2019 were prospectively enrolled. They were divided into two cohorts according to the year of diagnosis: cohort 1 (diagnosed between 2009 and 2011) versus cohort 2 (between 2012 and 2019). Results: A total of 1,175 patients were included, and the median follow-up duration was 68 months (interquartile range, 39.0 to 91.0 months). The treatment-free durations for thiopurines (p<0.001) and anti-tumor necrosis factor agents (p=0.018) of cohort 2 were shorter than those of cohort 1. Among 887 patients with B1 behavior at diagnosis, 149 patients (16.8%) progressed to either B2 or B3 behavior during follow-up. Early use of thiopurine was associated with a reduced risk of behavioral progression (adjusted hazard ratio [aHR], 0.69; 95% confidence interval [CI], 0.50 to 0.90), and family history of inflammatory bowel disease was associated with an increased risk of behavioral progression (aHR, 2.29; 95% CI, 1.16 to 4.50). One hundred forty-one patients (12.0%) underwent intestinal resection, and the intestinal resection-free survival time was significantly longer in cohort 2 than in cohort 1 (p=0.003). The early use of thiopurines (aHR, 0.35;95% CI, 0.23 to 0.51) was independently associated with a reduced risk of intestinal resection. Conclusions The prognosis of CD in Korea appears to have improved over time, as evidenced by the decreasing intestinal resection rate. Early use of thiopurines was associated with an improved prognosis represented by a reduced risk of intestinal resection.

Background/Aims: This study assessed the efficacy and safety of adalimumab (ADA) and explored predictors of response in Korean patients with ulcerative colitis (UC). Methods: A prospective, observational, multicenter study was conducted over 56 weeks in adult patients with moderately to severely active UC who received ADA. Clinical response, remission, and mucosal healing were assessed using the Mayo score. Results: A total of 146 patients were enrolled from 17 academic hospitals. Clinical response rates were 52.1% and 37.7% and clinical remission rates were 24.0% and 22.0% at weeks 8 and 56, respectively. Mucosal healing rates were 39.0% and 30.1% at weeks 8 and 56, respectively. Prior use of anti-tumor necrosis factor-α (anti-TNF-α) did not affect clinical and endoscopic responses. The ADA drug level was significantly higher in patients with better outcomes at week 8 (P<0.05). In patients with lower endoscopic activity, higher body mass index, and higher serum albumin levels at baseline, the clinical response rate was higher at week 8. In patients with lower Mayo scores and C-reactive protein levels, clinical responses, and mucosal healing at week 8, the clinical response rate was higher at week 56. Serious adverse drug reactions were identified in 2.8% of patients. Conclusions ADA is effective and safe for induction and maintenance in Korean patients with UC, regardless of prior anti-TNF-α therapy. The ADA drug level is associated with the efficacy of induction therapy. Patients with better short-term outcomes were predictive of those with an improved long-term response.

Background/Aims: Little is known about the clinical course of hepatitis B virus (HBV)-infected patients undergoing anti-tumor necrosis factor α (TNF-α) therapy for inflammatory bowel disease (IBD). We aimed to investigate the clinical course of HBV infection and IBD and to analyze liver dysfunction risks in patients undergoing anti-TNF-α therapy. Methods: This retrospective multinational study involved multiple centers in Korea, China, Tai-wan, and Japan. We enrolled IBD patients with chronic or resolved HBV infection, who received anti-TNF-α therapy. The patients’ medical records were reviewed, and data were collected using a web-based case report form. Results: Overall, 191 patients (77 ulcerative colitis and 114 Crohn’s disease) were included, 28.3% of whom received prophylactic antivirals. During a median follow-up duration of 32.4 months, 7.3% of patients experienced liver dysfunction due to HBV reactivation. Among patients with chronic HBV infection, the proportion experiencing liver dysfunction was significantly higher in the non-prophylaxis group (26% vs 8%, p=0.02). Liver dysfunction occurred in one patient with resolved HBV infection. Antiviral prophylaxis was independently associated with an 84% reduction in liver dysfunction risk in patients with chronic HBV infection (odds ratio, 0.16; 95% confidence interval, 0.04 to 0.66; p=0.01). The clinical course of IBD was not associated with liver dysfunction or the administration of antiviral prophylaxis. Conclusions Liver dysfunction due to HBV reactivation can occur in HBV-infected IBD patients treated with anti-TNF-α agents. Careful monitoring is needed in these patients, and antivirals should be administered, especially to those with chronic HBV infection.