Effectiveness and safety of electroacupuncture for poststroke patients with shoulder pain: study protocol for a double-center, randomized, patient- and assessor-blinded, sham-controlled, parallel, clinical trial.

BACKGROUND: Practitioners of complementary and alternative medicine have suggested that acupuncture could alleviate poststroke shoulder pain, based on the clinical evidence. This study protocol is aimed at showing the effectiveness and safety of electroacupuncture therapy for stroke survivors with shoulder pain. METHODS: After assessing their eligibility, 60 stroke survivors with shoulder pain will be enrolled from two traditional Korean medicine hospitals and randomly divided into either the verum or the sham electroacupuncture (EA) group with a 1:1 ratio. The participants will receive 9 sessions of EA procedures for 3 weeks. The verum EA consists of needling on 6 unilateral acupoints (LI4, LI15, TE14, SI9, SI11, and GB21) with electronic stimulation. A non-penetrating Park sham device and fake electronic stimulation will be used in the sham group on the same acupoints. Patients and outcome assessors will be blinded throughout the entire study. A visual analog scale will be used primarily for the evaluation, and pain rating scale, Fugl-Meyer assessment for upper extremity, modified Ashworth scale, manual muscle test, passive range of motion test, Korean version of a modified Barthel index, and Korean version of the Beck depression inventory will be also be measured. A blinding index will be assessed. For safety, adverse events will be recorded. Data will be statistically analyzed by two-sample t-test or Wilcoxon rank sum test for efficacy and a chi-squared test or Fisher's exact test for safety, at 5% of significance level. DISCUSSION: We expect this double-center, randomized, sham-controlled, patient- and assessor-blinded parallel trial to explore the effectiveness and safety of EA therapy, compared with sham EA, for poststroke shoulder pain. TRIAL REGISTRATION: https://clinicaltrials.gov/ct2/show/NCT03086863.

A model predicting survival of patients with recurrent or progressive hepatocellular carcinoma: the MORE score.

BACKGROUND AND AIM: Most prognostic models for hepatocellular carcinoma are based on data at the time of diagnosis. However, the disease frequently recurs or progresses after initial treatment, with changes in tumor burden and clinical status. Therefore, we developed a risk score model to predict survival of hepatocellular carcinoma patients at the time of disease recurrence or progression. METHODS: Of 1972 patients newly diagnosed with hepatocellular carcinoma at the National Cancer Center, Korea, between January 2004 and December 2009, 1301 with recurrent or progressive disease were enrolled. They were randomly classified into a development (75%, n = 976) and a validation cohort (25%, n = 325). A survival prediction method was established in the development cohort using the multivariate Cox proportional hazards model, and its performance was evaluated on the validation cohort. RESULTS: A model predicting survival of patients with recurrent or progressive hepatocellular carcinoma was developed using some known independent prognostic factors for overall survival: age, albumin, Model for End-Stage Liver Disease score, tumor burden, serum alpha-fetoprotein level, and presence of ascites. In addition, initial treatment modality and best response after initial treatment were also independent prognostic factors and were incorporated in the model. The C-statistics and χ2 statistics of this novel score for the validation cohort were 0.808 (95% CI: 0.781-0.834) and 4.408 for 3-year survival. CONCLUSIONS: A new model to predict survival of patients with recurrent or progressive hepatocellular carcinoma was developed and validated. This model may be useful for planning subsequent treatments.

A comparison of digital tomosynthesis and chest radiography in evaluating airway lesions using computed tomography as a reference.

OBJECTIVES: To compare the diagnostic performance of digital tomosynthesis (DTS) and chest radiography for detecting airway abnormalities, using computed tomography (CT) as a reference. MATERIALS AND METHODS: We evaluated 161 data sets from 149 patients (91 with and 70 without airway abnormalities) who had undergone radiography, DTS, and CT to detect airway problems. Radiographs and DTS were evaluated to localize and score the severity of the airway abnormalities, and to score the image quality using CT as a reference. Receiver operating characteristics (ROC), McNemar's test, weighted kappa, and the paired t-test were used for statistical analysis. RESULTS: The sensitivity of DTS was higher (reader 1, 93.51 %; reader 2, 94.29 %) than chest radiography (68.83 %; 71.43 %) in detecting airway lesions. The diagnostic accuracy of DTS (90.91 %; 94.70 %) was also significantly better than that of radiography (78.03 %; 82.58 %, all p < 0.05). DTS image quality was significantly better than chest radiography (1.83, 2.74; p < 0.05) in the results of both readers. The inter-observer agreement with respect to DTS findings was moderate and superior when compared to radiography findings. CONCLUSIONS: DTS is a more accurate and sensitive modality than radiography for detecting airway lesions that are easily obscured by soft tissue structures in the mediastinum. KEY POINTS: • Digital tomosynthesis offers new diagnostic options for airway lesions. • Digital tomosynthesis is more sensitive and accurate than radiography for airway lesions. • Digital tomosynthesis shows better image quality than radiography. • Assessment of lesion severity, via tomosynthesis is comparable to computed tomography.

Recurrence-associated pathways in hepatitis B virus-positive hepatocellular carcinoma.

BACKGROUND: Despite the recent identification of several prognostic gene signatures, the lack of common genes among experimental cohorts has posed a considerable challenge in uncovering the molecular basis underlying hepatocellular carcinoma (HCC) recurrence for application in clinical purposes. To overcome the limitations of individual gene-based analysis, we applied a pathway-based approach for analysis of HCC recurrence. RESULTS: By implementing a permutation-based semi-supervised principal component analysis algorithm using the optimal principal component, we selected sixty-four pathways associated with hepatitis B virus (HBV)-positive HCC recurrence (p < 0.01), from our microarray dataset composed of 142 HBV-positive HCCs. In relation to the public HBV- and public hepatitis C virus (HCV)-positive HCC datasets, we detected 46 (71.9%) and 18 (28.1%) common recurrence-associated pathways, respectively. However, overlap of recurrence-associated genes between datasets was rare, further supporting the utility of the pathway-based approach for recurrence analysis between different HCC datasets. Non-supervised clustering of the 64 recurrence-associated pathways facilitated the classification of HCC patients into high- and low-risk subgroups, based on risk of recurrence (p < 0.0001). The pathways identified were additionally successfully applied to discriminate subgroups depending on recurrence risk within the public HCC datasets. Through multivariate analysis, these recurrence-associated pathways were identified as an independent prognostic factor (p < 0.0001) along with tumor number, tumor size and Edmondson's grade. Moreover, the pathway-based approach had a clinical advantage in terms of discriminating the high-risk subgroup (N = 12) among patients (N = 26) with small HCC (<3 cm). CONCLUSIONS: Using pathway-based analysis, we successfully identified the pathways involved in recurrence of HBV-positive HCC that may be effectively used as prognostic markers.

Oncological and surgical results of laparoscopic versus open liver resection for HCC less than 5 cm: case-matched analysis.

BACKGROUND: The purpose of this study is the evaluation of the surgical and oncological results of laparoscopic liver resection (LLR) for hepatocellular carcinoma (HCC) by comparing laparoscopic and open liver resection (OLR) in the treatment of this disease. Retrospective analysis of laparoscopic and OLR for HCC (<5 cm) performed over a 4-year period was conducted. The LLR was done by a single surgeon. METHODS: The study was performed on patients who received liver resection for HCC between July 2007 and August 2011 in our institution. Propensity-based matched analyses were used to account for operative method selection biases. During the 4 years, 1,050 patients with HCC received an operation. Among them patients who never received TACE or RFA before surgery and had HCC (<5 cm) were selected for this study. RESULTS: 174 patients had OLR, and 58 patients underwent LLR. Patients who received LLR had lower operative time, transfusion rate, complication rate, and shorter hospital days. There were significant differences in hospital mortality and morbidity between the two groups. Dietary recovery was relatively fast in the group of LLR. Overall and disease-free survival rates during the 4 years were also not significantly different between the two groups. CONCLUSIONS: LLR is a developing and safe technique in a select group of patients including those with malignancies, and use of this procedure is associated with short hospital stays, a rapid return to a normal diet, full mobility, and minimal morbidity, with acceptable oncological parameters. It may be an optimal method of hepatectomy in HCC (<5 cm). Further, long-term follow-up should be acquired for adequate evaluation for survival.

Clinical outcomes of a cohort series of patients with hepatocellular carcinoma in a hepatitis B virus-endemic area.

BACKGROUND AND AIMS: To evaluate the clinical outcomes of patients with hepatocellular carcinoma (HCC) and compare the findings with that of a previous cohort. METHODS: Overall, 1972 HCC patients diagnosed and treated at the National Cancer Center, Korea between 2004 and 2009 were enrolled. The data of this cohort were compared with those of a previous cohort (2000-2003) from the same institution. RESULTS: In all (mean age, 56.4 years; 1642 men), 74.6% was hepatitis B virus (HBV) positive, 81.6% were Child-Pugh (CP) class A, and 64.4% was Barcelona Clinic Liver Cancer (BCLC) stage C. The modified Union for International Cancer Control (mUICC) stage I, II, III, IVa, and IVb was found in 8.9%, 29.6%, 24.8%, 23.1%, and 13.6% patients, respectively. The most common initial treatment was transarterial chemotherapy (58.3%), followed by resection (18.6%). The 5-year survival rate of BCLC stage 0, A, B, and C were 79.6%, 67.2%, 33.9%, and 17.1%, respectively. The performance status, BCLC stage, mUICC stage, CP class, model for end-stage liver disease score, tumor characteristics, portal vein tumor invasion, and serum alpha-fetoprotein level proved to be independent prognostic variables. Overall survival in the present cohort was better than that in the previous cohort (hazard ratio, 0.829; 95% confidence interval, 0.754-0.912), especially for advanced HCC patients with HBV-positive status. CONCLUSIONS: This cohort study provides valuable insights into the characteristics of HCC in Korean patients. Our findings may help develop clinical trials, treatment strategies, and prognosis systems for HCC patients in HBV-endemic areas.

Incidence and risk factors of 30-day early and 90-day late morbidity and mortality of radical cystectomy during a 13-year follow-up: a comparative propensity-score matched analysis of complications between neobladder and ileal conduit.

OBJECTIVE: We report on the short and late morbidity and mortality of ileal conduit and neobladder after radical cystectomy with their associated risk factors. METHODS: We retrospectively collected data on 308 non-metastatic bladder cancer patients who underwent radical cystectomy with either ileal conduit or neobladder for a curative intent from January 1999 to December 2011. Post-operative morbidity and mortality of 30-day (early) and 90-day (late) complication with their risk factors were examined in association with different types of urinary diversion. A comparative analysis using propensity-score matching was performed with matching variables of age, sex, number of underlying diseases and pathologic T and N stages, lymph node dissection, operative time and time of surgical year for comparison of the early and late morbidities between ileal conduit and neobladder. RESULTS: During the median follow-up of 46.6 months, early and late morbidities were 29.5% (n=91) and 19.8% (n=61), and complication-related mortalities were 2.2 and 6.6%, respectively. The type of urinary diversion significantly affected only the late complications (early: neobladder 57 vs. ileal conduit 47, P=0.096; late: neobladder 67 vs. ileal conduit 37, P<0.001). However, after propensity-score matching, no significant differences in early and late morbidities were observed between neobladder and ileal conduit. For risk factors of morbidity, number of removed lymph node states and hypertension were independently significant for both early and late complications (P<0.05). CONCLUSIONS: The type of urinary diversion affected only late complication, however, results of the matching analysis showed no significant differences in early and late morbidities between neobladder and ileal conduit.

Validation of the MSKCC and Heng risk criteria models for predicting survival in patients with metastatic renal cell carcinoma treated with sunitinib.

PURPOSE: To validate the Memorial Sloan-Kettering Cancer Center (MSKCC) and Heng models with metastatic renal cell carcinoma treated with sunitinib, and to investigate prognostic factors in these patients. METHODS: This study included 106 patients with metastatic renal cell carcinoma who were treated with sunitinib from April 2007 to July 2012 including 35 patients who received systemic treatment before sunitinib and 71 that were naive to systemic treatment. Patients were evaluated using the MSKCC and Heng models, and the significance of several prognostic factors were evaluated. RESULTS: The application of the MSKCC and Heng risk criteria resulted in stratification into 3 groups (favorable, intermediate, and poor risk) with distinctly different overall survival (OS) curves (P < 0.001 and P < 0.001, respectively), for the pretreated patients (P < 0.001 and P < 0.001, respectively). The Heng model had slightly better discriminatory ability (χ (2) = 30.82, Harrell's C = 0.6895) than the MSKCC model (χ (2) = 25.13, Harrell's C = 0.6532). Multivariate analysis revealed that the absence of nephrectomy and no hypertension at baseline, along with elevated C-reactive protein levels, were independent risk factors for poorer OS. CONCLUSIONS: The MSKCC and Heng model were both valid models for predicting OS. The no nephrectomy, no hypertension at baseline, and high C-reactive protein levels were independently associated with poorer OS.

Use of MDLC-DIGE and LC-MS/MS to identify serum biomarkers for complete remission in patients with acute myeloid leukemia.

The response criteria for complete remission (CR) in acute myeloid leukemia (AML) are currently based on morphology and blood cell counts. However, these criteria are insufficient to establish a diagnosis in cases with poor quality bone marrow (BM) samples demonstrating a loss of cellular morphology. We investigated whether the sera of patients contained biomarkers that indicate disease response status. First, we performed multidimensional liquid chromatography-differential gel electrophoresis (MDLC-DIGE) to generate protein profiles of two pooled, paired serum samples from patients who had achieved CR; one collected at diagnosis (PreCR) and the other collected after chemotherapy (CR). Then, with the biomarker candidates found, ELISA was carried out for individual PreCR and CR samples, and for other verification sets including nonremission (NR) patients and normal samples. We selected two proteins, complement factor H (CFH) and apolipoprotein H (ApoH), with dye (Cy) ratios showing greater than 2.0-fold differences between the pooled samples. ELISA showed that CFH and ApoH are useful for distinguishing between the recovered (CR and normal) and nonrecovered (PreCR, PreNR, and NR) states in AML (p <0.001). We successfully applied a protein profiling technology of MDLC-DIGE and LC-MS/MS to discover two biomarkers for CR which needs further validation for a clinical setting.

Tensile properties and thermal shock reliability of Sn-Ag-Cu solder joint with indium addition.

The thermal shock reliability and tensile properties of a newly developed quaternary Sn-1.2Ag-0.5Cu-0.4In (wt%) solder alloy were investigated and compared to those of ternary Sn-Ag-Cu based Pb-free solder alloys. It was revealed that the Sn-1.2Ag-0.5Cu-0.4In solder alloy shows better thermal shock reliability compared to the Sn-1.0Ag-0.5Cu and Sn-3.0Ag-0.5Cu solder alloys. The quaternary alloy has higher strength than Sn-1.0Ag-0.5Cu alloy, and higher elongation than Sn-3.0Ag-0.5Cu alloy. It was also revealed that the addition of indium promotes the formation of Ag3(Sn, In) phase in the solder joint during reflow process.

Can a Traditional Korean Manual Therapy Be a Complementary and Alternative Strategy for Cervicogenic Dizziness? A Study Protocol for a Randomized Controlled Trial.

Cervicogenic dizziness is dizziness triggered by movement or positioning of the cervical spine and is often accompanied by neck pain or stiffness. This is a prospective, pragmatic, assessor-blind, randomized controlled trial aimed at testing the efficacy and safety of adjuvant Chuna Manual Therapy (CMT) in patients with cervicogenic dizziness under usual care treatments. Fifty patients with cervicogenic dizziness will be randomly allocated to CMT or usual care (UC) groups in a 1 : 1 ratio. Extensive screening procedures, including examinations for central nervous system problems and nystagmus, will be applied to exclude other dizziness-inducing disorders. The eligible participants will receive 12 sessions of CMT plus UC or only UC over 6 weeks. CMT includes mandatory and discretionary techniques, whereas UC includes electrotherapy, thermotherapy, and patient education. The efficacy will be evaluated primarily as Dizziness Handicap Inventory score. The severity and frequency of dizziness, the level of neck pain or stiffness, and the cervical range of motion will also be evaluated. Safety will be assessed by adverse events. The data will be statistically analyzed at p < 0.05. Trial Registration. This trial was registered with Clinical Research Information Service (CRIS) in Korea, KCT0002565, on 29 November 2017, https://cris.nih.go.kr/cris/search/search_result_st01_kren.jsp?seq=9610<ype=&rtype=.

Corrigendum to "Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: Study Protocol of a Pilot Multicentered, Randomized, Parallel, Sham-Controlled Trial".

[This corrects the article DOI: 10.1155/2016/5709295.].

A Herbal Medicine, Gongjindan, in Subjects with Chronic Dizziness (GOODNESS Study): Study Protocol for a Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Clinical Trial for Effectiveness, Safety, and Cost-Effectiveness.

This study protocol aims to explore the effectiveness, safety, and cost-effectiveness of a herbal medication, Gongjindan (GJD), in patients with chronic dizziness. This will be a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, clinical trial. Seventy-eight patients diagnosed with Meniere's disease, psychogenic dizziness, or dizziness of unknown cause will be randomized and allocated to either a GJD or a placebo group in a 1 : 1 ratio. Participants will be orally given 3.75 g GJD or placebo in pill form once a day for 56 days. The primary outcome measure will be the Dizziness Handicap Inventory score. Secondary outcome measures will be as follows: severity (mean vertigo scale and visual analogue scale) and frequency of dizziness, balance function (Berg Balance Scale), fatigue (Fatigue Severity Scale) and deficiency pattern/syndrome (qi blood yin yang-deficiency questionnaire) levels, and depression (Korean version of Beck's Depression Inventory) and anxiety (State-Trait Anxiety Inventory) levels. To assess safety, adverse events, including laboratory test results, will be monitored. Further, the incremental cost-effectiveness ratio will be calculated based on quality-adjusted life years (from the EuroQoL five dimensions' questionnaire) and medical expenses. Data will be statistically analyzed at a significance level of 0.05 (two-sided). This trial is registered with ClinicalTrials.gov NCT03219515, in July 2017.

The mitochondrial hinge protein, UQCRH, is a novel prognostic factor for hepatocellular carcinoma.

Alterations in mitochondrial respiration contribute to the development and progression of cancer via abnormal biogenesis, including generation of reactive oxygen species. Ubiquinol-cytochrome c reductase hinge protein (UQCRH) consists of the cytochrome bc1 complex serving respiration in mitochondria. In the present study, we analyzed UQCRH abnormalities in hepatocellular carcinoma (HCC) and its association with clinical outcomes of patients. UQCRH expression in HCC was determined via semiquantitative and quantitative real-time reverse transcriptase polymerase chain reaction of 96 surgically resected HCC tissues positive for hepatitis B virus surface antigen. UQCRH was frequently overexpressed in HCC tissues (46.8%, based on 2.1-fold cutoff). UQCRH overexpression was observed in HCCs with larger tumor size, poorer differentiation, or vascular invasion. Kaplan-Meier analysis revealed significantly shorter overall (P = 0.005) and recurrence-free survival (P = 0.027) in patients with tumors overexpressing UQCRH. The prognostic impact of UQCRH was significant in subgroups of patients divided according to the α-fetoprotein (AFP) level. The patient subgroup with higher AFP levels (≥20 ng/mL) exhibited significant differences in 5-year overall (18.5% vs. 67.9%) and recurrence-free survival rates (11.1% vs. 46.4%) between groups with and without UQCRH overexpression. In contrast, no marked survival differences were observed between subgroups with lower AFP levels (<20 ng/mL). Multivariate analysis defined UQCRH as an independent poor prognostic factor. Conclusively, our results indicate that UQCRH overexpression is correlated with poor outcomes of HCC patients. Furthermore, in patients grouped as high risk based on elevated AFP, lack of UQCRH overexpression could be a useful indicator for clinical treatment.

Effectiveness and Safety of Electroacupuncture on Poststroke Urinary Incontinence: Study Protocol of a Pilot Multicentered, Randomized, Parallel, Sham-Controlled Trial.

This pilot multicentered, randomized, parallel, sham-controlled trial is intended to evaluate the effectiveness and safety of electroacupuncture therapy for poststroke patients with urinary incontinence. Forty stroke survivors aged >19 years will be recruited in 2 hospitals in the Republic of Korea. Patients who experienced stroke within 2 years and satisfy criteria of urinary frequencies ≥2 with either 3 to 4 points on the Patient Perception of Intensity of Urgency Scale or 13 points or more on the Korean version of the International Prostate Symptom Scale (K-IPSS) will be identified, along with other eligibility criteria. Patients will be randomly allocated to either a treatment or control group to receive 10 sessions of electroacupuncture or sham therapies, respectively. Patients and outcome assessors will be blinded. The primary outcome is the change of Total Urgency and Frequency Score between the baseline and the trial endpoint. The K-IPSS, the International Consultation on Incontinence Questionnaire for Urinary Incontinence Short Form, and the Lower Urinary Tract Symptoms Outcome Score will be evaluated for effectiveness assessment. Adverse events will be reported after every session. The Blinding Index will also be calculated. Data will be statistically analyzed with 0.05 significance levels by 2-sided testing.

A Study of Relationship of Atheroembolic Risk Factors with Postoperative Recovery in Renal Function after Partial Nephrectomy in Patients Staged T1-2 Renal Cell Carcinoma during Median 4-Year Follow-up.

PURPOSE: The objective of this study is to evaluate the relationship of atheroembolic risk factors with postoperative recovery of renal function after on-clamp partial nephrectomy (PN) with warm ischemia in patients with staged T1-2 renal cell carcinoma (RCC). MATERIALS AND METHODS: A total of 234 patients from 2004 to 2012 were included, and their clinicopathologic and operative parameters, including atheroembolic risk factors were reviewed retrospectively. Renal function, as determined by estimated glomerular filtration rate (eGFR) and measurement of serum creatinine level (Cr) at each scheduled follow-up for a median four years, was compared between the high-risk (HR) group (n=49, ≥ five risk factors) and the low-risk (LR) group (n=185, < five risk factors). RESULTS: Except for baseline renal function and number of risk factors for atheroembolism, differences in characteristics between groups were comparatively insignificant. At 3 months after the operation, Cr and eGFR differed significantly between the two groups (p < 0.05), but no differences were observed afterward. Significant deterioration from baseline in Cr and eGFR was observed in both groups at 1 month after the operation, with a greater change in the HR group (p < 0.05). From measurement to measurement, significantly faster deterioration in Cr and eGFR was observed in the HR group than in the LR group until 6 months after the operation (Cr: LR, 0.02 mg/dL and HR, 0.13 mg/dL; eGFR: LR, 1.50 mL/min/1.73 m(2) and HR, 6.38 mL/min/1.73 m(2); p < 0.05). CONCLUSION: The presence of atheroembolic risk factors may negatively influence postoperative recovery of renal function after PN in patients with localized RCC.

Clinical Characteristics of Patients with Cryptogenic Hepatocellular Carcinoma in a Hepatitis B Virus-Endemic Area.

OBJECTIVES: Chronic hepatitis B virus (HBV) infection is the most common cause of hepatocellular carcinoma (HCC) in South Korea, but a high prevalence of metabolic diseases may result in increases in the incidence of cryptogenic HCC (cHCC). We studied characteristics of the cHCC in a single-center cohort. METHODS: A cohort of 1,784 HCC patients newly diagnosed and treated at the National Cancer Center, Korea, between 2004 and 2009 was reviewed and analyzed. RESULTS: The cause of HCC was categorized as cHCC, HBV, hepatitis C virus (HCV), or alcohol. Overall, 162 (9.1%) patients of the HCC cohort had cHCC, and their mean age was 61.9 years. The median survival of cHCC patients was 24.7 months, which was the second shortest among the four groups after HBV HCC. cHCC patients had the largest tumor size (mean 7.4 cm) and the second highest proportion of poor prognostic factors such as the proportion of poorly defined tumors and extrahepatic spread in imaging studies. cHCC patients had better survival than HBV HCC patients according to multivariate analysis. Among cHCC patients, 137 (84.6%) had anti-HBc IgG antibodies, but this sub-group had different clinical features to those of HBV HCC patients. The body mass index (BMI) and hyperglycemia and hypercholesterolemia levels in cHCC patients were similar to those in HCV and alcoholic HCC patients. CONCLUSIONS: Anti-HBc IgG antibodies were present in most cHCC patients, but cHCC patients had better survival than HBV HCC patients on multivariate analysis. However, cHCC patients had a larger mean tumor size and more aggressive tumor characteristics than HCV HCC or alcoholic HCC patients did. It is hoped that this study will contribute to a better understanding of cHCC in HBV-endemic areas.

Development and Validation of a Prediction Model to Estimate Individual Risk of Pancreatic Cancer.

INTRODUCTION: There is no reliable screening tool to identify people with high risk of developing pancreatic cancer even though pancreatic cancer represents the fifth-leading cause of cancer-related death in Korea. The goal of this study was to develop an individualized risk prediction model that can be used to screen for asymptomatic pancreatic cancer in Korean men and women. MATERIALS AND METHODS: Gender-specific risk prediction models for pancreatic cancer were developed using the Cox proportional hazards model based on an 8-year follow-up of a cohort study of 1,289,933 men and 557,701 women in Korea who had biennial examinations in 1996-1997. The performance of the models was evaluated with respect to their discrimination and calibration ability based on the C-statistic and Hosmer-Lemeshow type χ2 statistic. RESULTS: A total of 1,634 (0.13%) men and 561 (0.10%) women were newly diagnosed with pancreatic cancer. Age, height, BMI, fasting glucose, urine glucose, smoking, and age at smoking initiation were included in the risk prediction model for men. Height, BMI, fasting glucose, urine glucose, smoking, and drinking habit were included in the risk prediction model for women. Smoking was the most significant risk factor for developing pancreatic cancer in both men and women. The risk prediction model exhibited good discrimination and calibration ability, and in external validation it had excellent prediction ability. CONCLUSION: Gender-specific risk prediction models for pancreatic cancer were developed and validated for the first time. The prediction models will be a useful tool for detecting high-risk individuals who may benefit from increased surveillance for pancreatic cancer.

What Is the Ideal Tumor Regression Grading System in Rectal Cancer Patients after Preoperative Chemoradiotherapy?

PURPOSE: Tumor regression grade (TRG) is predictive of therapeutic response in rectal cancer patients after chemoradiotherapy (CRT) followed by curative resection. However, various TRG systems have been suggested, with subjective categorization, resulting in interobserver variability. This study compared the prognostic validity of four different TRG systems in order to identify the most ideal TRG system. MATERIALS AND METHODS: This study included 933 patients who underwent preoperative CRT and curative resection. Primary tumors alone were graded according to the American Joint Committee on Cancer (AJCC), Dworak, and Ryan TRG systems, and both primary tumors and regional lymph nodes were graded according to a modified Dworak TRG system. The ability of each TRG system to predict recurrence-free survival (RFS) and overall survival (OS) was analyzed using chi-square and C statistics. RESULTS: All four TRG systems were significantly predictive of both RFS and OS (p < 0.001 each), however none was a better predictor of prognosis than ypStage. Among the four TRGs, the mDworak TRG system was a better predictor of RFS and OS than the AJCC, Dworak, and Ryan TRG systems, and both the chi-square and C statistics were higher for the former, although the differences were not statistically significant. The combination of ypStage and the modified Dworak TRG better predicted RFS and OS than ypStage alone. CONCLUSION: The modified Dworak TRG system for evaluation of entire tumors including regional lymph nodes is a better predictor of survival than current TRG systems for evaluation of the primary tumor alone.