• Title/Summary/Keyword: Response criteria

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Optimized Image-Based Surrogate Endpoints in Targeted Therapies for Glioblastoma: A Systematic Review and Meta-Analysis of Phase III Randomized Controlled Trials

  • Chong Hyun Suh;Ho Sung Kim;Seung Chai Jung;Choong Gon Choi;Sang Joon Kim;Kyung Won Kim
    • Korean Journal of Radiology
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    • v.21 no.4
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    • pp.471-482
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    • 2020
  • Objective: We aimed to determine the optimized image-based surrogate endpoints (IBSEs) in targeted therapies for glioblastoma through a systematic review and meta-analysis of phase III randomized controlled trials (RCTs). Materials and Methods: A systematic search of OVID-MEDLINE and EMBASE for phase III RCTs on glioblastoma was performed in December 2017. Data on overall survival (OS) and IBSEs, including progression-free survival (PFS), 6-month PFS (6moPFS), 12-month PFS (12moPFS), median PFS, and objective response rate (ORR) were extracted. Weighted linear regression analysis for the hazard ratio for OS and the hazard ratios or odds ratios for IBSEs was performed. The associations between IBSEs and OS were evaluated. Subgroup analyses according to disease stage (newly diagnosed glioblastoma versus recurrent glioblastoma), types of test treatment, and types of response assessment criteria were performed. Results: Twenty-three phase III RCTs published between 2000 and 2017, including 8387 patients, met the inclusion criteria. OS showed strong correlations with PFS (standardized β coefficient [R] = 0.719), 6moPFS (R = 0.647), and 12moPFS (R = 0.638). OS showed no correlations with median PFS and ORR. In subgroup analysis according to types of therapies, PFS showed the highest correlations with OS in targeted therapies for cell cycle pathways (R = 0.913) and growth factor receptors and their downstream pathways (R = 0.962). 12moPFS showed the highest correlation with OS in antiangiogenic therapy (R = 0.821). The response assessment in neuro-oncology criteria provided higher correlation coefficients between OS and IBSEs than the Macdonald criteria. Conclusion: Overall, PFS is an optimized IBSE in targeted therapies for glioblastoma; however, 12moPFS is optimal in antiangiogenic therapy.

Economic Second-Order Modeling Using Modified Notz Design (수정된 Notz계획을 이용한 2차모형의 경제적 추정)

  • Yun, Tae-Hong;Byun, Jai-Hyun
    • Journal of Korean Society for Quality Management
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    • v.40 no.4
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    • pp.431-440
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    • 2012
  • Purpose: In this paper we propose modified Notz designs which are useful to experimenters who want to adopt the sequential experimentation strategy and to estimate second-order regression model with as few experimental points as possible. Methods: We first present the design matrices and design points in two or three dimensional spaces for such small sized second-order designs as small composite, hybrid, and Notz designs. Modified Notz designs are proposed and compared with some response surface designs in terms of the total number of experimental points, the estimation capability criteria such as D- and A-optimality. Results: When sequential experimentation is necessary, the modified Notz designs are recommendable. Conclusion: The result of this paper will be beneficial to experimenters who need to do experiments more efficiently, especially for those who want to reduce the time of experimentation as much as possible to develop cutting-edge products.

A Study on the Verification of Dynamic Properities on the basis of Vibration Criteria of Isolation Pad (제진대(Isolation Pad)의 진동허용규제치에 기준한 동특성(動特性) 규명에 관한 연구)

  • 백재호;이홍기;서항석
    • Proceedings of the Korean Society for Noise and Vibration Engineering Conference
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    • 2001.05a
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    • pp.869-874
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    • 2001
  • In order that precision equipment using high precision industrial operate normally. vibration criteria of expected area that equipment be set up is micrometer level. that method is a trust design for apply to in field, when there attend to quantifiable method. Hence, semi -empirical method that using on the basis of experimental data about undefined information (properities of vibration source, dynamic properities of structure, etc.,) for prediction of vibration response make the use of dynamic structure design of semiconductor & TFT-LCD in the inside and outside country. Like this, for doing an optimal design of dynamic about structure, it is best important to get trust data that apply to semi-empirical method that is method of prediction vibration level. In this paper, on the basis of experimental data which was offered by a manufacturing company Of precisin equipment that plan to set up in semiconductor factory, we predicted vibration response on expected area that equipment be set up.

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Vibration-based damage alarming criteria for wind turbine towers

  • Nguyen, Cong-Uy;Huynh, Thanh-Canh;Dang, Ngoc-Loi;Kim, Jeong-Tae
    • Structural Monitoring and Maintenance
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    • v.4 no.3
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    • pp.221-236
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    • 2017
  • In this study, the feasibility of vibration-based damage alarming algorithms are numerically evaluated for wind turbine tower structures which are subjected to harmonic force excitation. Firstly, the algorithm of vibration-based damage alarming for the wind turbine tower (WTT) is visited. The natural frequency change, modal assurance criterion (MAC) and frequency-response-ratio assurance criterion (FRRAC) are utilized to recognize changes in dynamic characteristics due to a structural damage. Secondly, a finite element model based on a real wind turbine tower is established in a structural analysis program, Midas FEA. The harmonic force is applied at the rotor level as presence of excitation. Several structural damage scenarios are numerically simulated in segmental joints of the wind turbine model. Finally, the natural frequency change, MAC and FRRAC algorithm are employed to identify the structural damage occurred in the finite element model. The results show that these criteria could be used as promising damage existence indicators for the damage alarming in wind turbine supporting structures.

Multi-level approach for parametric roll analysis

  • Kim, Tae-Young;Kim, Yong-Hwan
    • International Journal of Naval Architecture and Ocean Engineering
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    • v.3 no.1
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    • pp.53-64
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    • 2011
  • The present study considers multi-level approach for the analysis of parametric roll phenomena. Three kinds of computation method, GM variation, impulse response function (IRF), and Rankine panel method, are applied for the multi-level approach. IRF and Rankine panel method are based on the weakly nonlinear formulation which includes nonlinear Froude-Krylov and restoring forces. In the computation result of parametric roll occurrence test in regular waves, IRF and Rankine panel method show similar tendency. Although the GM variation approach predicts the occurrence of parametric roll at twice roll natural frequency, its frequency criteria shows a little difference. Nonlinear roll motion in bichromatic wave is also considered in this study. To prove the unstable roll motion in bichromatic waves, theoretical and numerical approaches are applied. The occurrence of parametric roll is theoretically examined by introducing the quasi-periodic Mathieu equation. Instability criteria are well predicted from stability analysis in theoretical approach. From the Fourier analysis, it has been verified that difference-frequency effects create the unstable roll motion. The occurrence of unstable roll motion in bichromatic wave is also observed in the experiment.

INTEGRITY ANALYSIS OF AN UPPER GUIDE STRUCTURE FLANGE

  • LEE, KI-HYOUNG;KANG, SUNG-SIK;JHUNG, MYUNG JO
    • Nuclear Engineering and Technology
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    • v.47 no.6
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    • pp.766-775
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    • 2015
  • The integrity assessment of reactor vessel internals should be conducted in the design process to secure the safety of nuclear power plants. Various loads such as self-weight, seismic load, flow-induced load, and preload are applied to the internals. Therefore, the American Society of Mechanical Engineers (ASME) Code, Section III, defines the stress limit for reactor vessel internals. The present study focused on structural response analyses of the upper guide structure upper flange. The distributions of the stress intensity in the flange body were analyzed under various design load cases during normal operation. The allowable stress intensities along the expected sections of stress concentration were derived from the results of the finite element analysis for evaluating the structural integrity of the flange design. Furthermore, seismic analyses of the upper flange were performed to identify dynamic behavior with respect to the seismic and impact input. The mode superposition and full transient methods were used to perform time-history analyses, and the displacement at the lower end of the flange was obtained. The effect of the damping ratio on the response of the flange was also evaluated, and the acceleration was obtained. The results of elastic and seismic analyses in this study will be used as basic information to judge whether a flange design meets the acceptance criteria.

A Brief Review of the Legal Definition of Chemical Accident under the Current Chemical Substances Control Act (화학물질관리법상 화학사고 정의에 관한 소고)

  • Jihoon Park;Seon-Oh Park;Hyojin Park;Hye-Ok Kwon
    • Journal of Environmental Health Sciences
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    • v.49 no.4
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    • pp.179-182
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    • 2023
  • The Chemical Substances Control Act has been legislated to counter the risks posed by chemical substances to public health and the environment, but a number of small- and large-scaled incidents related to hazardous chemicals continue to occur every year. The Korean Ministry of Environment takes legal responsibility for prevention, preparedness, and response to nationwide chemical accidents under the Chemical Substances Control Act. The determination of chemical accidents that occur during hazardous chemical handling processes is based on the Article 2 (Definitions) of the law and the administrative criteria for judgement of chemical accidents. However, there are certain ambiguities in the scientific basis for determining chemical accidents under the current regulations. Whether or not a chemical accident has a direct influence on penalties and administrative measures for a workplace where an accident occurred, it is necessary to find reasonable criteria for determining chemical accident based on legal and scientific evidence.

Treatment outcome of hepatic re-irradiation in patients with hepatocellular carcinoma

  • Seol, Seung Won;Yu, Jeong Il;Park, Hee Chul;Lim, Do Hoon;Oh, Dongryul;Noh, Jae Myoung;Cho, Won Kyung;Paik, Seung Woon
    • Radiation Oncology Journal
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    • v.33 no.4
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    • pp.276-283
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    • 2015
  • Purpose: We evaluated the efficacy and toxicity of repeated high dose 3-dimensional conformal radiation therapy (3D-CRT) for patients with unresectable hepatocellular carcinoma. Materials and Methods: Between 1998 and 2011, 45 patients received hepatic re-irradiation with high dose 3D-CRT in Samsung Medical Center. After excluding two ineligible patients, 43 patients were retrospectively reviewed. RT was delivered with palliative or salvage intent, and equivalent dose of 2 Gy fractions for ${\alpha}/{\beta}=10Gy$ ranged from $31.25Gy_{10}$ to $93.75Gy_{10}$ (median, $44Gy_{10}$). Tumor response and toxicity were evaluated based on the modified Response Evaluation Criteria in Solid Tumors criteria and the Common Terminology Criteria for Adverse Events (CTCAE) ver. 4.0. Results: The median follow-up duration was 11.2 months (range, 4.1 to 58.3 months). An objective tumor response rate was 62.8%. The tumor response rates were 81.0% and 45.5% in patients receiving ${\geq}45Gy_{10}$ and $<45Gy_{10}$, respectively (p = 0.016). The median overall survival (OS) of all patients was 11.2 months. The OS was significantly affected by the Child-Pugh class as 14.2 months vs. 6.1 months (Child-Pugh A vs. B, p < 0.001), and modified Union for International Cancer Control (UICC) T stage as 15.6 months vs. 8.3 months (T1-3 vs. T4, p = 0.004), respectively. Grade III toxicities were developed in two patients, both of whom received ${\geq}50Gy_{10}$. Conclusion: Hepatic re-irradiation may be an effective and tolerable treatment for patients who are not eligible for further local treatment modalities, especially in patients with Child-Pugh A and T1-3.

Comparison of CT Volumetry and RECIST to Predict the Treatment Response and Overall Survival in Gastric Cancer Liver Metastases (위암 간전이 환자의 반응평가와 생존율 예측을 위한 종양 부피 측정과 RECIST 기준의 비교 연구)

  • Sung Hyun Yu;Seung Joon Choi;HeeYeon Noh;In seon Lee;So Hyun Park; Se Jong Kim
    • Journal of the Korean Society of Radiology
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    • v.82 no.4
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    • pp.876-888
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    • 2021
  • Purpose The aim of this study was to compare the diameter and volume of liver metastases on CT images in relation to overall survival and tumor response in patients with gastric cancer liver metastases (GCLM) treated with chemotherapy. Materials and Methods We recruited 43 patients with GCLM who underwent chemotherapy as a first-line treatment. We performed a three-dimensional quantification of the metastases for each patient. An independent survival analysis using the Response Evaluation Criteria in Solid Tumors (RECIST) was performed and compared to volumetric measurements. Overall survival was evaluated using Kaplan-Meier analysis and compared using Cox proportional hazard ratios following univariate analyses. Results When patients were classified as responders or non-responders based on volumetric criteria, the median overall survival was 23.6 months [95% confidence interval (CI), 8.63-38.57] and 7.6 months (95% CI, 3.78-11.42), respectively (p = 0.039). The volumetric analysis and RECIST of the non-progressing and progressing groups showed similar results based on the Kaplan-Meier method (p = 0.006) and the Cox proportional hazard model (p = 0.008). Conclusion Volumetric assessment of liver metastases could be an alternative predictor of overall survival for patients with GCLM treated with chemotherapy.

Outcome of Single Agent Generic Gemcitabine in Platinum-Resistant Ovarian Cancer, Fallopian Tube Cancer and Primary Peritoneal Adenocarcinoma

  • Suprasert, Prapaporn;Cheewakriangkrai, Chalong;Manopunya, Manatsawee
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.2
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    • pp.517-520
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    • 2012
  • Single original gemcitabine is commonly used as salvage treatment in platinum-resistant ovarian cancer, fallopian tube cancer and primary peritoneal adenocarcinoma (PPA) with a satisfactory outcome. However, efficacy data fro this regimen are limited. We therefore conducted a retrospective study to evaluate the outcome of patients who received single-agent generic gemcitabine (GEMITA) after development of clinical platinum resistance. The study period was between May 2008 and December 2010. Gemcitabine was administered intravenously in two different schedules: 1,000 $mg/m^2$ on day 1,8, and 15 every 28 days; and on days 1 and 8 every 21 days with the same dosage. Administration was until disease progression was noted. The response rate was evaluated using the Gynecologic Cancer Intergroup (GCIG) criteria while toxicity was evaluated according to WHO criteria. Sixty-six patients met the inclusion criteria in the study period. Two-thirds of them received gemcitabine as the second and third line regimen. The overall response rate was 12.1%. The median progression free survival and overall survival was 2 and 10 months, respectively. With the total 550 courses of chemotherapy,the patients developed grades 3 and 4 hematologic toxicity as follows: anemia, 1.5%; leukopenia, 13.7%; neutropenia, 27.3%; and thrombocytopenia, 3.0%. In conclusion, single agent generic gemcitabine revealed a modest efficacy in patients with platinum-resistant ovarian cancer, fallopian tube cancer and PPA without serious toxicity.