Purpose: Patients who have undergone gastrectomy have unique symptoms that are not appropriately assessed using currently available tools. This study developed and validated a symptom-focused quality of life (QoL) questionnaire for patients who have received gastrectomy for gastric cancer. Materials and Methods Based on a literature review, patient interviews, and expert consultation by the KOrean QUality of life in Stomach cancer patients Study group (KOQUSS), the initial item pool was developed. Two large-scale developmental studies were then sequentially conducted for exploratory factor analyses for content validity and item reduction. The final item pool was validated in a separate cohort of patients and assessed for internal consistency, test-retest reliability, construct validity, and clinical validity. Results The initial questionnaire consisted of 46-items in 12 domains. Data from 465 patients at 11 institutions, followed by 499 patients at 13 institutions, were used to conduct item reduction and exploratory factor analyses. The final questionnaire (KOQUSS-40) comprised 40 items within 11 domains. Validation of KOQUSS-40 was conducted on 413 patients from 12 hospitals. KOQUSS-40 was found to have good model fit. The mean summary score of the KOQUSS-40 was correlated with the EORTC QLQ-C30 and STO22 (correlation coefficients, 0.821 and 0.778, respectively). The KOQUSS-40 score was also correlated with clinical factors, and had acceptable internal consistency (> 0.7). Test-retest reliability was greater than 0.8. Conclusion The KOQUSS-40 can be used to assess QoL of gastric cancer patients after gastrectomy and allows for a robust comparison of surgical techniques in clinical trials.

Purpose: Patients who have undergone gastrectomy have unique symptoms that are not appropriately assessed using currently available tools. This study developed and validated a symptom-focused quality of life (QoL) questionnaire for patients who have received gastrectomy for gastric cancer. Materials and Methods Based on a literature review, patient interviews, and expert consultation by the KOrean QUality of life in Stomach cancer patients Study group (KOQUSS), the initial item pool was developed. Two large-scale developmental studies were then sequentially conducted for exploratory factor analyses for content validity and item reduction. The final item pool was validated in a separate cohort of patients and assessed for internal consistency, test-retest reliability, construct validity, and clinical validity. Results The initial questionnaire consisted of 46-items in 12 domains. Data from 465 patients at 11 institutions, followed by 499 patients at 13 institutions, were used to conduct item reduction and exploratory factor analyses. The final questionnaire (KOQUSS-40) comprised 40 items within 11 domains. Validation of KOQUSS-40 was conducted on 413 patients from 12 hospitals. KOQUSS-40 was found to have good model fit. The mean summary score of the KOQUSS-40 was correlated with the EORTC QLQ-C30 and STO22 (correlation coefficients, 0.821 and 0.778, respectively). The KOQUSS-40 score was also correlated with clinical factors, and had acceptable internal consistency (> 0.7). Test-retest reliability was greater than 0.8. Conclusion The KOQUSS-40 can be used to assess QoL of gastric cancer patients after gastrectomy and allows for a robust comparison of surgical techniques in clinical trials.

Purpose: To compare long-term disease-free survival (DFS) between patients receiving tegafur/gimeracil/oteracil (S-1) or capecitabine plus oxaliplatin (CAPOX) adjuvant chemotherapy (AC) for gastric cancer (GC). Materials and Methods: This retrospective multicenter observational study enrolled 983 patients who underwent curative gastrectomy with consecutive AC with S-1 or CAPOX for stage II or III GC at 27 hospitals in Korea between February 2012 and December 2013. We conducted propensity score matching to reduce selection bias. Long-term oncologic outcomes, including DFS rate over 5 years (over-5yr DFS), were analyzed postoperatively. Results: The median and longest follow-up period were 59.0 and 87.6 months, respectively. DFS rate did not differ between patients who received S-1 and CAPOX for pathologic stage II (P=0.677) and stage III (P=0.899) GC. Moreover, hazard ratio (HR) for recurrence did not differ significantly between S-1 and CAPOX (reference) in stage II (HR, 1.846; 95% confidence interval [CI], 0.693–4.919; P=0.220) and stage III (HR, 0.942; 95% CI, 0.664–1.337; P=0.738) GC. After adjustment for significance in multivariate analysis, pT (4 vs. 1) (HR, 11.667; 95% CI, 1.595–85.351; P=0.016), pN stage (0 vs. 3) (HR, 2.788; 95% CI, 1.502–5.174; P=0.001), and completion of planned chemotherapy (HR, 2.213; 95% CI, 1.618–3.028; P<0.001) were determined as independent prognostic factors for DFS. Conclusions S-1 and CAPOX AC regimens did not show significant difference in over-5yr DFS after curative gastrectomy in patients with stage II or III GC. The pT, pN stage, and completion of planned chemotherapy were prognostic factors for GC recurrence.

PURPOSE: Allergen-specific immunotherapy (AIT) is known to be the only therapeutic modality to alter the natural course of allergic diseases. However, at least 3 years of treatment is recommended for achieving long-term disease modifying effect. This study aimed to investigate factors associated with immunotherapy non-adherence in real practice. MATERIALS AND METHODS: We retrospectively reviewed medical records of patients who were diagnosed with allergic rhinitis, asthma, or atopic dermatitis, and received AIT to common allergens such as house dust mite and/or pollens from January 2007 to August 2014. In this study, non-adherence was defined as not completing 3 years of AIT. RESULTS: Among 1162 patients enrolled, 228 (19.6%) failed to complete 3 years of AIT. In multivariate analysis, age less than 20 years [odds ratio (OR) 3.11, 95% confidence interval (CI) 1.70–5.69] and 20 to 40 years (OR 2.01, 95% CI 1.17–3.43), cluster build-up (OR 1.78, 95% CI 1.05–3.02) and ultra-rush build-up schedules (OR 5.46, 95% CI 2.40–12.43), and absence of visit to other departments in the same hospital (OR 1.87, 95% CI 1.05–3.32) were independently associated with immunotherapy non-adherence. Disease duration of 5–10 years was negatively associated with non-adherence compared to shorter disease duration of less than 5 years (OR 0.61, 95% CI 0.40–0.94). Although male sex and commercial product of AIT, Tyrosine S®, compared to Novo-Helisen® were non-adherent factors in univariate analysis, no statistical significances were identified in multivariate analysis. CONCLUSION: Various factors are associated with immunotherapy adherence affecting the utility of immunotherapy. Clinicians should be aware of factors associated with adherence to maximize the utility of allergen-specific subcutaneous immunotherapy.
Allergens ; Appointments and Schedules ; Asthma ; Dermatitis, Atopic ; Humans ; Immunotherapy ; Male ; Medical Records ; Multivariate Analysis ; Pollen ; Pyroglyphidae ; Retrospective Studies ; Rhinitis, Allergic ; Tyrosine

PURPOSE: Frequent changes in chronic urticaria (CU) activity over time can cause psychological stress, which also serves as a trigger of CU. To measure the control status of CU, the Urticaria Control Test (UCT) was developed in Germany. This study aimed to investigate the validity, reliability and responsiveness to changes in CU for the Korean version of the UCT (K-UCT) and its relation with salivary cortisol and cortisone levels. METHODS: Linguistic adaptation of the UCT into Korean was conducted. A total of 96 CU patients were enrolled, and 80 of them completed the study. The K-UCT and other outcome scores for CU were measured and repeated after 4 weeks of treatment. Control status was classified by physicians into well-controlled, partly-controlled, and uncontrolled CU. Salivary cortisol and cortisone were measured by liquid chromatography-tandem mass spectrometry. RESULTS: Excellent internal consistency and intra-class reliability were obtained. Strong correlations between the K-UCT and disease severity, reflected in the Urticaria Activity Score (UAS)/global assessment of urticaria control by physicians/patient assessment of symptom severity/CU-specific quality of life were noted. K-UCT scores ≥12 were found to be optimal for determining well-controlled CU (sensitivity, 75.0%; specificity, 758%; area under the curve, 0.824). Perceived stress scale scores were significantly correlated with the UAS and the K-UCT. Salivary cortisone levels were significantly correlated with K-UCT (r = 0.308, P = 0.009) and differed significantly according to control status determined by a K-UCT ≥12. CONCLUSIONS: This study demonstrated that the K-UCT can be a valid instrument with which to gauge CU control status in Korean patients. Further studies are needed to validate salivary cortisone as a biomarker for CU control.
Cortisone* ; Germany ; Humans ; Hydrocortisone ; Korea ; Linguistics ; Mass Spectrometry ; Quality of Life ; Sensitivity and Specificity ; Stress, Psychological ; Urticaria*

PURPOSE: Omalizumab, an anti-immunoglobulin E (IgE) monoclonal antibody, has proved to be effective for the treatment of severe asthma. However, there is no direct evidence of effectiveness of omalizumab in Korean patients with severe asthma. We sought to evaluate the real-world effectiveness of omalizumab in Korean adult patients suffering from severe asthma and to identify predictors of favorable response. METHODS: A retrospective analysis of electrical medical records was performed on severe allergic asthmatic patients with omalizumab treatment group (OT group) for more than 6 months between March 2008 and February 2016. Propensity score matching was applied to define the standardized treatment control group (STC group) treated without omalizumab. Asthma-related outcomes were compared between the 2 groups, and analyzed before and after omalizumab use in the OT group. Responders to treatment were defined as patients showing >50% reduction in asthma exacerbations and/or systemic steroid requirement during the outcome period. RESULTS: One hundred twenty-four patients with severe asthma (62 in the OT group; 62 in the STC group) were enrolled in the study. Proportion of patients having the reduction of asthma exacerbation (53.2% vs 35.5%, P=0.015) and the rate of responders (67.7% vs 41.9%, P=0.007) were significantly higher in the OT group than in the STC group. Significant reductions were noted in asthma exacerbation (P=0.006), hospitalization (P=0.009), hospitalization days (P=0.006), systemic corticosteroid requirements (P=0.027), and sputum eosinophil count (P=0.031) in OT group compared with STC group. There were no significant differences in changes of forced expiratory volume in the 1 second (FEV1) levels between the 2 groups. No predictors of responders were found for omalizumab treatment. CONCLUSIONS: Omalizumab can reduce exacerbations/hospitalization/systemic steroid burst in Korean adult patients with severe asthma.
Adult ; Asthma* ; Eosinophils ; Forced Expiratory Volume ; Hospitalization ; Humans ; Korea* ; Medical Records ; Omalizumab* ; Propensity Score ; Retrospective Studies ; Sputum

PURPOSE: House dust mites (HDM) are major allergens that cause allergic rhinitis (AR). Allergen-specific subcutaneous immunotherapy (SCIT) has been shown to be clinically beneficial in many clinical trials. Such trials, however, are not reflective of all patient populations. The aim of this study was to describe the efficacy and safety of SCIT in routine clinical practice in Korean adults with AR sensitized to HDM. METHODS: We reviewed medical records of 304 patients with AR treated at an allergy clinic of a tertiary hospital using SCIT with aluminum hydroxide-adsorbed allergen extract targeting HDM alone or with pollens for at least 1 year from 2000 to 2012. Patients with asthma were excluded. Rates of remission, defined as no further requirement of maintenance medication, over time were determined by means of life tables and extension of survival analysis. Specific immunoglobulin E (IgE) levels to HDM were categorized into 6 classes. RESULTS: The mean time until achieving remission was 4.9±0.1 years, and the cumulative incidence of remission from AR was 76.6%. Severe AR (odds ratio [OR], 0.40; 95% confidence interval [CI], 0.23-0.69; P=0.001), specific IgE levels to HDM ≥17.5 kU/L (OR, 1.85; 95% CI, 1.01-3.37; P=0.045), and duration of immunotherapy ≥3 years (OR, 7.37; 95% CI, 3.50-15.51; P<0.001) were identified as significant predictors of clinical remission during SCIT for patients with AR sensitized to HDM. Overall, 73 patients (24.0%) experienced adverse reactions to SCIT, and only 1 case of anaphylaxis (0.3%) developed. CONCLUSIONS: SCIT with HDM was found to be effective and safe for patients with AR. Specific IgE levels to HDM and a duration of SCIT ≥3 years may be predictors of clinical responses to SCIT in AR patients.
Adult ; Allergens ; Aluminum ; Anaphylaxis ; Asthma ; Desensitization, Immunologic ; Dust ; Humans ; Hypersensitivity ; Immunoglobulin E ; Immunoglobulins ; Immunotherapy ; Incidence ; Life Tables ; Medical Records ; Pollen ; Pyroglyphidae ; Retrospective Studies ; Rhinitis, Allergic ; Tertiary Care Centers

PURPOSE: This study aims to determine the efficacy and safety of house dust mite (HDM)-sublingual immunotherapy (SLIT) in elderly patients with AR. METHODS: A total of 45 patients aged ≥ 60 years with HDM-induced AR who had ≥ 3 A/H ratio on skin prick test and/or ≥ 0.35 IU/L to both Dermatophagoides farinae and Dermatophagoides pteronyssinus by ImmunoCAP were enrolled in 4 university hospitals. To evaluate additional effects of HDM-SLIT, they were randomized to the SLIT-treated group (n = 30) or control group (n = 15). Rhinoconjunctivitis total symptom score (RTSS), rhinoscopy score, Korean rhinoconjunctivitis quality of life questionnaire, rhinitis control assessment test, asthma control test scores, and adverse reactions, were assessed at the first visit (V1) and after 1 year of treatment (V5); for immunological evaluation, serum levels of HDM-specific immunoglobulin A/IgE/IgG1/IgG4 antibodies and basophil response to HDMs were compared between V1 and V5 in both groups. RESULTS: There were no significant differences in demographics, RTSS, skin reactivity to HDMs, or serum total/specific IgE levels to HDMs (P < 0.05, respectively) between the 2 groups. Nasal symptom score and RTSS decreased significantly at year 1 in the 2 groups (P < 0.05). There were no significant differences in percent decrease in nasal symptom score and RTSS at year 1 between the 2 groups (P < 0.05); however, rhinoscopic nasal symptom score decreased significantly in the SLIT-treated group (P < 0.05). Immunological studies showed that serum specific IgA levels (not specific IgE/IgG) and CD203c expression on basophils decreased significantly at V5 in the SLIT-treated group (P = 0.011 and P = 0.001, respectively), not in the control group. The control group required more medications compared to the treatment group, but there were no differences in adverse reactions. CONCLUSIONS: It is suggested that HDM-SLIT for 1 year could induce symptom improvement and may induce immunomodulation in elderly rhinitis patients.
Aged* ; Antibodies ; Asthma ; Basophils ; Demography ; Dermatophagoides farinae ; Dermatophagoides pteronyssinus ; Dust* ; Hospitals, University ; Humans ; Immunoglobulin A ; Immunoglobulin E ; Immunoglobulins ; Immunomodulation ; Immunotherapy ; Pyroglyphidae* ; Quality of Life ; Rhinitis* ; Rhinitis, Allergic ; Skin ; Sublingual Immunotherapy*

PURPOSE: Toluene diisocyanate (TDI) is a leading cause of occupational asthma (OA). Periostin is a matricellular protein implicated in type 2 immunity-driven asthma. Its pathogenic role in TDI-OA has not been completely elucidated. The present study was performed to investigate the role of periostin in TDI-OA. MATERIALS AND METHODS: Serum periostin levels were measured in subjects with TDI-OA, asymptomatic TDI-exposure controls (AECs), non-occupational asthmatics (NAs), and unexposed normal controls (NCs). To understand the mechanism by which TDI induces periostin production, primary small airway epithelial cells (SAECs) were cultured under stimulation of TDI and neutrophils from asthmatic patients. RESULTS: Fifty-three subjects with TDI-OA, 71 AECs, 67 NAs, and 83 NCs were enrolled. Serum periostin levels were significantly higher in TDI-OA subjects than in AECs (p=0.001), NAs (p < 0.001), and NCs (p < 0.001). In TDI-exposed subjects (TDI-OA and AEC), the PC20 methacholine levels were significantly lower in subjects with a higher periostin level than in those with a lower periostin level. TDI exposure did not increase periostin production directly by SAECs; however, periostin production increased significantly after co-culture with TDI and neutrophils, which was suppressed by an antioxidant. In addition, increased release of TGF-β1 was noted from SAECs when exposed to TDI and neutrophils, which was also suppressed by an antioxidant. CONCLUSION: These results suggest that an increased periostin level may contribute to the progression of airway inflammation to remodeling in TDI-exposed workers. A high serum periostin level is a potential serologic marker of the phenotype of TDI-OA.
Asthma ; Asthma, Occupational* ; Coculture Techniques ; Epithelial Cells ; Humans ; Inflammation ; Methacholine Chloride ; Neutrophils ; Phenotype ; Reactive Oxygen Species ; Toluene 2,4-Diisocyanate ; Toluene*

BACKGROUND/AIMS: Chronic urticaria (CU) is a common skin disorder characterized by wheals and pruritus lasting more than 6 weeks. Due to its long duration and changeable symptoms, the quality of life (QOL) of patients with CU can be impaired substantially. We evaluated the CU-QOL, a previously validated CU-specific QOL measure, and investigated factors influencing QOL in chronic spontaneous urticaria (CSU) patients. METHODS: A hospital-based cross-sectional study was performed on 390 adult patients diagnosed with CSU from March 2009 to December 2012 at the Allergy and Clinical Immunology Clinic at Ajou University Hospital. The CU-QOL questionnaire, urticaria activity score (UAS), combined angioedema, and serum total immunoglobulin E (IgE) levels were investigated. RESULTS: The average CU-QOL score obtained from the questionnaire was 70.6 (of 100 points). The CU-QOL scores correlated significantly with the UAS, particularly with the 15-point UAS (UAS-15; coefficient –0.532, p < 0.01) rather than the 6-point UAS (–0.502, p < 0.01). The patients presenting with angioedema and urticaria had poorer scores in the urticaria symptom domain than those with urticaria alone (37.4 vs. 46.9, p = 0.004). Log-transformed serum total IgE levels correlated significantly with CU-QOL (–0.131, p < 0.05). Multivariate regression models indicated that severe CU (UAS-15 score ≥ 13), log (total IgE), and the presence of angioedema were significant predictors of impaired CU-QOL (< 85 points). CONCLUSIONS CU has a substantial negative impact on QOL. The assessment of UAS-15, total IgE, and the presence of angioedema can be useful to predict QOL of the patients with CSU.