• Title/Summary/Keyword: Cox regression hazard model

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Exploratory Analysis of Patients With Gastric/Gastroesophageal Junction Adenocarcinoma With or Without Liver Metastasis From the Phase 3 RAINBOW Study

  • Takatsugu Ogata;Yukiya Narita;Zev A. Wainberg;Eric Van Cutsem;Kensei Yamaguchi;Yongzhe Piao;Yumin Zhao;Patrick M. Peterson;Sameera R. Wijayawardana;Paolo Abada;Anindya Chatterjee;Kei Muro
    • Journal of Gastric Cancer
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    • v.23 no.2
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    • pp.289-302
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    • 2023
  • Purpose: Liver metastasis (LM) is reported in approximately 40% of patients with advanced/metastatic gastric/gastroesophageal junction adenocarcinoma (metastatic esophagogastric adenocarcinoma; mGEA) and is associated with a worse prognosis. This post-hoc analysis from the RAINBOW trial reported the efficacy, safety, and biomarker outcomes of ramucirumab and paclitaxel combination treatment (RAM+PAC) in patients with (LM+) and without (LM-) LM at baseline. Materials and Methods: Patients (n=665) were randomly assigned on a 1:1 basis to receive either RAM+PAC (LM+: 150, LM-: 180) or placebo and paclitaxel (PL+PAC) (LM+: 138, LM-: 197). The overall survival (OS) and progression-free survival (PFS) were evaluated using stratified Kaplan-Meier and Cox regression models. The correlation of dichotomized biomarkers (VEGF-C, D; VEGFR-1,2) with efficacy in the LM+ versus LM- subgroups was analyzed using the Cox regression model with reported interaction P-values. Results: The presence of LM was associated with earlier progression than those without LM, particularly in patients receiving PL+PAC (hazard ratio [HR], 1.68). RAM+PAC treatment improved OS and PFS irrespective of LM status but showed greater improvement in LM+ than that in LM- (OS HR, 0.71 [LM+] vs. 0.88 [LM-]; PFS HR, 0.47 [LM+] vs. 0.76 [LM-]). Treatment-emergent adverse events were similar between patients with and without LM. No predictive relationship was observed between biomarker levels (VEGF-C, D; VEGFR-1,2) and efficacy outcome (OS, PFS) (all interaction P-values >0.05). Conclusions: RAM provided a significant benefit, irrespective of LM status; however, its effect was numerically stronger in patients with LM. Therefore, RAM+PAC is a clinically meaningful therapeutic option for patients with mGEA and LM.

Relationship between Delirium and Clinical Prognosis among Older Patients underwent Femur Fracture Surgery (대퇴부골절 후 수술환자의 섬망과 임상예후와의 관계)

  • Shim, Jae-Lan;Hwang, Seon-Young
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.2
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    • pp.649-656
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    • 2016
  • This study was a retrospective examination to identify the association of postoperative delirium of the prognosis on following femur fracture surgery in elderly patients. Data was collected from the medical records of elderly patients (aged 65 years or older), who underwent femur fracture surgery from July 2010 to January 2014, following on 3-years in one university hospital. A total of 68 patients were involved. There were 31 cases (45.6%) with delirium and 37 cases (54.4%) without delirium. The participant's average age was 80.8 (patients with delirium), and 81.8 (delirium without patients) years of age, respectively, and most of them were female. There was no significant difference between the two groups. Taking five or more medications, serum creatinine level, and the total medical costs were significantly different in the delirium group and non-delirium group. In addition, the proportional hazard model of Cox to determine the predictors for the major clinical outcome occurring after surgery revealed delirium, five or more multi-drug use, and an experience of transfusion to be significant predictors. In conclusion, postoperative delirium in the elderly undergoing femur fracture surgery can have a negative clinical outcome in patients and caregivers. Therefore, a preoperative evaluation and management of the risk factors will be necessary.

Prediction of Life Expectancy for Terminally Ill Cancer Patients Based on Clinical Parameters (말기 암 환자에서 임상변수를 이용한 생존 기간 예측)

  • Yeom, Chang-Hwan;Choi, Youn-Seon;Hong, Young-Seon;Park, Yong-Gyu;Lee, Hye-Ree
    • Journal of Hospice and Palliative Care
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    • v.5 no.2
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    • pp.111-124
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    • 2002
  • Purpose : Although the average life expectancy has increased due to advances in medicine, mortality due to cancer is on an increasing trend. Consequently, the number of terminally ill cancer patients is also on the rise. Predicting the survival period is an important issue in the treatment of terminally ill cancer patients since the choice of treatment would vary significantly by the patents, their families, and physicians according to the expected survival. Therefore, we investigated the prognostic factors for increased mortality risk in terminally ill cancer patients to help treat these patients by predicting the survival period. Methods : We investigated 31 clinical parameters in 157 terminally ill cancer patients admitted to in the Department of Family Medicine, National Health Insurance Corporation Ilsan Hospital between July 1, 2000 and August 31, 2001. We confirmed the patients' survival as of October 31, 2001 based on medical records and personal data. The survival rates and median survival times were estimated by the Kaplan-Meier method and Log-rank test was used to compare the differences between the survival rates according to each clinical parameter. Cox's proportional hazard model was used to determine the most predictive subset from the prognostic factors among many clinical parameters which affect the risk of death. We predicted the mean, median, the first quartile value and third quartile value of the expected lifetimes by Weibull proportional hazard regression model. Results : Out of 157 patients, 79 were male (50.3%). The mean age was $65.1{\pm}13.0$ years in males and was $64.3{\pm}13.7$ years in females. The most prevalent cancer was gastric cancer (36 patients, 22.9%), followed by lung cancer (27, 17.2%), and cervical cancer (20, 12.7%). The survival time decreased with to the following factors; mental change, anorexia, hypotension, poor performance status, leukocytosis, neutrophilia, elevated serum creatinine level, hypoalbuminemia, hyperbilirubinemia, elevated SGPT, prolonged prothrombin time (PT), prolonged activated partial thromboplastin time (aPTT), hyponatremia, and hyperkalemia. Among these factors, poor performance status, neutrophilia, prolonged PT and aPTT were significant prognostic factors of death risk in these patients according to the results of Cox's proportional hazard model. We predicted that the median life expectancy was 3.0 days when all of the above 4 factors were present, $5.7{\sim}8.2$ days when 3 of these 4 factors were present, $11.4{\sim}20.0$ days when 2 of the 4 were present, and $27.9{\sim}40.0$ when 1 of the 4 was present, and 77 days when none of these 4 factors were present. Conclusions : In terminally ill cancer patients, we found that the prognostic factors related to reduced survival time were poor performance status, neutrophilia, prolonged PT and prolonged am. The four prognostic factors enabled the prediction of life expectancy in terminally ill cancer patients.

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Survey of the use of statistical methods in Journal of the Korean Association of Oral and Maxillofacial Surgeons

  • Choi, Yong-Geun
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.44 no.1
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    • pp.25-28
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    • 2018
  • Objectives: This study aimed to describe recent patterns in the types of statistical test used in original articles that were published in Journal of the Korean Association of Oral and Maxillofacial Surgeons. Materials and Methods: Thirty-six original articles published in the Journal in 2015 and 2016 were ascertained. The type of statistical test was identified by one researcher. Descriptive statistics, such as frequency, rank, and proportion, were calculated. Graphical statistics, such as a histogram, were constructed to reveal the overall utilization pattern of statistical test types. Results: Twenty-two types of statistical test were used. Statistical test type was not reported in four original articles and classified as unclear in 5%. The four most frequently used statistical tests constituted 47% of the total tests and these were the chi-square test, Student's t-test, Fisher's exact test, and Mann-Whitney test in descending order. Regression models, such as the Cox proportional hazard model and multiple logistic regression to adjust for potential confounding variables, were used in only 6% of the studies. Normality tests, including the Kolmogorov-Smirnov test, Levene test, Shapiro-Wilk test, and $Scheff{\acute{e}}^{\prime}s$ test, were used diversely but in only 10% of the studies. Conclusion: A total of 22 statistical tests were identified, with four tests occupying almost half of the results. Adoption of a nonparametric test is recommended when the status of normality is vague. Adjustment for confounding variables should be pursued using a multiple regression model when the number of potential confounding variables is numerous.

Risk Factors Related to Development of Delirium in Hospice Patients (호스피스 병동의 암환자에서 섬망 발생 위험 요인)

  • Ko, Hae Jin;Youn, Chang Ho;Chung, Seung Eun;Kim, A Sol;Kim, Hyo Min
    • Journal of Hospice and Palliative Care
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    • v.17 no.3
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    • pp.170-178
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    • 2014
  • Purpose: Delirium is a common and serious neuropsychiatric complication among terminally ill cancer patients. We investigated risk factors related to the development of delirium among hospice care patients. Methods: Between May 2011 and September 2012, we included patients who were mentally alert and had no psychiatric disease or drug addiction at the hospice ward of two local hospitals. Among them, participants who had been diagnosed with delirium by two doctors according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders-4th edition) criteria were grouped as Delirium Group. We analyzed results of psychometric and other laboratory tests performed at the time of patient's admission - psychometric tests included cognitive function (mini-mental status examination, MMSE), depression (Beck Depression Inventory, BDI), anxiety, and insomnia (Insomnia Severity Index, ISI). Logistic regression analysis was used to compare delirium and the related factors. Cox's proportional hazard model was performed using significant factors of logistic regression analysis. Results: Of the 96 patients who met the inclusion criteria, 41 (42.7%) developed delirium. According to the logistic regression analysis, primary cancer site, cognitive impairment (MMSE < 24), depression ($BDI{\geq}16$), and insomnia ($ISI{\geq}15$) were significant factors related to delirium. Among the four factors, depression (OR 5.130; 95% CI, 2.009~13.097) and cognitive impairment (OR 5.130; 95% CI, 2.009~13.097) were found significant using Cox's proportional hazard model. Conclusion: The development of delirium was significantly related to depression and cognitive impairment among patients receiving hospice care. It is necessary to carefully monitor depression and cognitive function in hospice care.

Impact of Off-Hour Hospital Presentation on Mortality in Different Subtypes of Acute Stroke in Korea : National Emergency Department Information System Data

  • Kim, Taikwan;Jwa, Cheolsu
    • Journal of Korean Neurosurgical Society
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    • v.64 no.1
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    • pp.51-59
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    • 2021
  • Objective : Several studies have reported inconsistent findings among countries on whether off-hour hospital presentation is associated with worse outcome in patients with acute stroke. However, its association is yet not clear and has not been thoroughly studied in Korea. We assessed nationwide administrative data to verify off-hour effect in different subtypes of acute stroke in Korea. Methods : We respectively analyzed the nationwide administrative data of National Emergency Department Information System in Korea; 7144 of ischemic stroke (IS), 2424 of intracerebral hemorrhage (ICH), and 1482 of subarachnoid hemorrhage (SAH), respectively. "Off-hour hospital presentation" was defined as weekends, holidays, and any times except 8:00 AM to 6:00 PM on weekdays. The primary outcome measure was in-hospital mortality in different subtypes of acute stroke. We adjusted for covariates to influence the primary outcome using binary logistic regression model and Cox's proportional hazard model. Results : In subjects with IS, off-hour hospital presentation was associated with unfavorable outcome (24.6% off hours vs. 20.9% working hours, p<0.001) and in-hospital mortality (5.3% off hours vs. 3.9% working hours, p=0.004), even after adjustment for compounding variables (hazard ratio [HR], 1.244; 95% confidence interval [CI], 1.106-1.400; HR, 1.402; 95% CI, 1.124-1.747, respectively). Off-hours had significantly more elderly ≥65 years (35.4% off hours vs. 32.1% working hours, p=0.029) and significantly more frequent intensive care unit admission (32.5% off hours vs. 29.9% working hours, p=0.017) than working hours. However, off-hour hospital presentation was not related to poor short-term outcome in subjects with ICH and SAH. Conclusion : This study indicates that off-hour hospital presentation may lead to poor short-term morbidity and mortality in patients with IS, but not in patients with ICH and SAH in Korea. Excessive death seems to be ascribed to old age or the higher severity of medical conditions apart from that of stroke during off hours.

Prognostic Value of Serum Ferritin in Terminally Ill Cancer Patients (말기암환자에서 예후인자로서 혈청 Ferritin의 유용성)

  • Lee, Soo Hee;Choi, Youn Seon;Hwang, In Cheol;Yeom, Chang Hwan;Lee, June Yeong
    • Journal of Hospice and Palliative Care
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    • v.18 no.1
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    • pp.51-59
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    • 2015
  • Purpose: Predicting life expectancy of terminally ill cancer patients is very important. In many studies, ferritin is detected at higher levels in the sera of cancer patients, and higher ferritin level correlates with aggressiveness of disease and poor outcomes of patients. This study evaluated a prognostic role of serum ferritin levels in terminally ill cancer patients. Methods: This study enrolled 65 terminally ill cancer patients from March through June 2012. We assessed routine laboratory findings including serum ferritin levels as well as demographic and clinical characteristics of the patients. To examine the association between serum ferritin levels and patient's characteristics, we used Spearman's correlation analysis, Wilcoxon's rank sum test or Kruskal-Wallis test, as appropriately. For multivariate analysis, Cox's proportional hazard regression model was used to evaluate significance of serum ferritin levels as a prognostic factor. Results: A negative correlation between serum ferritin levels and survival time was found. After adjusting for sex, age, performance status, creatinine levels and white blood cell counts, serum ferritin levels were significantly associated with survival time. Conclusion: Even at the very end of life of terminal cancer patients, serum ferritin levels were an independent prognostic factor for survival.

Prognostic Value of Leptin in Terminally Ill Cancer Patients (말기암환자의 여명 예측 요인, 혈중 렙틴 농도의 효과)

  • Hong, Ji-Hyun;Lee, So-Jin;Kwak, Sang-Mi;Choi, Youn-Seon;Lee, June-Yeong
    • Journal of Hospice and Palliative Care
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    • v.15 no.2
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    • pp.99-107
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    • 2012
  • Purpose: Most terminally ill cancer patients die from cancer anorexia-cachexia syndrome. This study evaluated a prognostic role of plasma leptin levels in terminally ill cancer patients. Methods: This study enrolled 69 terminally ill cancer patients who were aged above 20 years old from July 2009 to July 2010. For univariate analysis, an association between leptin levels and patient's characteristics or other variables was examined using Spearman's correlation analysis, Wilcoxon's rank-sum test or Kruskal-Wallis test, as appropriately. For multivariable analysis, Cox's proportional hazard regression model was used to evaluate a clinical significance of plasma leptin levels as a prognostic factor and to determine factors which affect the risk of death in terminally ill cancer patients. Results: A statistically significant positive correlation between plasma leptin levels and survival time was found. Univariate Cox's proportional hazard regression analyses also showed a moderately significant association between plasma leptin levels and survival time. However, after adjusting variables for sex, white blood cell counts, total bilirubin, AST, ALT, albumin and CRP levels, plasma leptin levels were not significantly associated with survival time. Conclusion: No significant association was found between plasma leptin levels and survival time in terminally ill cancer patients. However, this study suggested a prognostic value of plasma leptin levels in gastrointestinal cancer patients.

No-Touch vs. Conventional Radiofrequency Ablation Using Twin Internally Cooled Wet Electrodes for Small Hepatocellular Carcinomas: A Randomized Prospective Comparative Study

  • Yun Seok Suh;Jae Won Choi;Jeong Hee Yoon;Dong Ho Lee;Yoon Jun Kim;Jeong Hoon Lee;Su Jong Yu;Eun Ju Cho;Jung Hwan Yoon;Jeong Min Lee
    • Korean Journal of Radiology
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    • v.22 no.12
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    • pp.1974-1984
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    • 2021
  • Objective: This study aimed to compare the efficacy between no-touch (NT) radiofrequency ablation (RFA) and conventional RFA using twin internally cooled wet (TICW) electrodes in the bipolar mode for the treatment of small hepatocellular carcinomas (HCC). Materials and Methods: In this single-center, two-arm, parallel-group, prospective randomized controlled study, we performed a 1:1 random allocation of eligible patients with HCCs to receive NT-RFA or conventional RFA between October 2016 and September 2018. The primary endpoint was the cumulative local tumor progression (LTP) rate after RFA. Secondary endpoints included technical conversion rates of NT-RFA, intrahepatic distance recurrence, extrahepatic metastasis, technical parameters, technical efficacy, and rates of complications. Cumulative LTP rates were analyzed using Kaplan-Meier analysis and the Cox proportional hazard regression model. Considering conversion cases from NT-RFA to conventional RFA, intention-to-treat and as-treated analyses were performed. Results: Enrolled patients were randomly assigned to the NT-RFA group (37 patients with 38 HCCs) or the conventional RFA group (36 patients with 38 HCCs). Among the NT-RFA group patients, conversion to conventional RFA occurred in four patients (10.8%, 4/37). According to intention-to-treat analysis, both 1- and 3-year cumulative LTP rates were 5.6%, in the NT-RFA group, and they were 11.8% and 21.3%, respectively, in the conventional RFA group (p = 0.073, log-rank). In the as-treated analysis, LTP rates at 1 year and 3 years were 0% and 0%, respectively, in the NT-RFA group sand 15.6% and 24.5%, respectively, in the conventional RFA group (p = 0.004, log-rank). In as-treated analysis using multivariable Cox regression analysis, RFA type was the only significant predictive factor for LTP (hazard ratio = 0.061 with conventional RFA as the reference, 95% confidence interval = 0.000-0.497; p = 0.004). There were no significant differences in the procedure characteristics between the two groups. No procedure-related deaths or major complications were observed. Conclusion: NT-RFA using TICW electrodes in bipolar mode demonstrated significantly lower cumulative LTP rates than conventional RFA for small HCCs, which warrants a larger study for further confirmation.

Associations of Serum Lipid Profiles with Incidence of Ischemic Heart Diseases in Korean Adults: Retrospective Cohort Study (우리나라 성인에서 혈청 지질성분비가 허혈성 심장질환 발생에 미치는 위험도 평가: 코호트 연구)

  • Shin, Sook-Hee;Lee, Tae-Yong
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.13 no.5
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    • pp.2219-2231
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    • 2012
  • This study conducted to investigate incidence rate and association of serum lipid profiles with incidence of ischemic heart disease. Study subjects consisted of 417,642 adults aged 30 years and over, who underwent physical examination and responded to questionnaire from health examination center of 19 university general hospitals. Hazard ratio of risk factor for ischemic heart disease (IHD) were calculated by Cox's proportional hazard regression model adjusted for ages, BMI and lifestyle (drinking, smoking and exercising). For TC/HDL ratio, hazard ratio of IHD in male increased from 1.21 times to 1.84 times increase with TC/HDL ratio, and that in female also increased from 1.26 times to 1.86 times. For TG/HDL ratio, hazard ratio of IHD in male increased from 1.17 times to 1.49 times increase with TG/HDL ratio, and that in female also increased from 1.42 times to 1.97 times. For LDL/HDL ratio, hazard ratio of IHD in male increased from 1.26 times to 1.82 times increase with LDL/HDL ratio, and that in female also increased from 1.26 times to 1.68 times. In conclusion serum lipid indexes are the significant risk factors for cardiovascular diseases. The higher the concentration of TC, LDL and TG is, the lower the concentration of HDL is, hazard ratio for IHD increased. Ratio of TC/HDL, TG/HDL and LDL/HDL were also verified to be significant risk factors for IHD.