• Progress in Medical Physics
• /
• v.33 no.3
• /
• pp.25-35
• /
• 2022

Purpose: Planning for radiotherapy relies on implicit estimation of the probability of tumor control and the probability of complications in adjacent normal tissues for a given dose distribution. Methods: The aim of this pilot study was to reconstruct dose-volume histograms (DVHs) from text files generated by the Eclipse treatment planning system developed by Varian Medical Systems and to verify the integrity and accuracy of the dose statistics. Results: We further compared dose statistics for intensity-modulated radiotherapy of the head and neck between the Eclipse software and software developed in-house. The dose statistics data obtained from the Python software were consistent, with deviations from the Eclipse treatment planning system found to be within acceptable limits. Conclusions: The in-house software was able to provide indices of hotness and coldness for treatment planning and store statistical data generated by the software in Oracle databases. We believe the findings of this pilot study may lead to more accurate evaluations in planning for radiotherapy.

• Communications for Statistical Applications and Methods
• /
• v.29 no.3
• /
• pp.287-299
• /
• 2022

In radiation epidemiology, the excess relative risk (ERR) model is used to determine the dose-response relationship. In general, the dose-response relationship for the ERR model is assumed to be linear, linear-quadratic, linear-threshold, quadratic, and so on. However, since none of these functions dominate other functions for expressing the dose-response relationship, a Bayesian semiparametric method using splines has recently been proposed. Thus, we improve the Bayesian semiparametric method for the selection of the tuning parameters for splines as the number and location of knots using a Bayesian knot selection method. Equally spaced knots cannot capture the characteristic of radiation exposed dose distribution which is highly skewed in general. Therefore, we propose a nonparametric Bayesian knot selection method based on a Dirichlet process mixture model. Inference of the spline coefficients after obtaining the number and location of knots is performed in the Bayesian framework. We apply this approach to the life span study cohort data from the radiation effects research foundation in Japan, and the results illustrate that the proposed method provides competitive curve estimates for the dose-response curve and relatively stable credible intervals for the curve.

• The Korean Journal of Applied Statistics
• /
• v.26 no.3
• /
• pp.453-470
• /
• 2013

In this paper, we consider a Bayesian analysis of the dose-effect relationship of cadmium to evaluate a benchmark dose(BMD). For this purpose, two dose-response curves commonly used in the toxicity study are fitted based on Bayesian methods to the data collected from the scientific literature on cadmium toxicity. Specifically, Bayesian meta-analysis and hierarchical modeling build an overall dose-effect relationship that use a piecewise linear model and Hill model, where the inter-study heterogeneity and inter-individual variability of dose and effect such as gender, age and ethnicity are accounted. Estimation of the unknown parameters is made by using a Markov chain Monte Carlo algorithm based user-friendly software WinBUGS. Benchmark dose estimates are evaluated for various cut-offs and compared with different tested subpopulations with with gender, age and ethnicity based on these two Bayesian hierarchical models.

• Journal of the Korean Data and Information Science Society
• /
• v.25 no.5
• /
• pp.987-998
• /
• 2014

The primary purpose of this paper is to derive a benchmark dose lower limit (BMDL) of lead for the attention deficit/hyperactive disorder (ADHD) based on a longitudinal cohort data set which is referred to as CHEER data set. The CHEER data were recently recruited from the Ministry of Environment of S. Korea to investigate the effect of environment on children's health We first confirm the correlation of ADHD with the blood lead level using a linear mixed effect model. We report from the longitudinal characteristic of CHEER data that ADHD scores tend to have "regression to the mean". A dose-response curve of blood lead level with ADHD being the end point is derived and from this dose-response curve a few BMDLs are derived based on corresponding assumptions on the benchmark region.

• The Korean Journal of Applied Statistics
• /
• v.22 no.5
• /
• pp.1033-1046
• /
• 2009

In new drug development studies or clinical trials, zero-dose control is needed in general to determine the lowest dose level for a new drug which can act with our bodies. When the lowest dose level compared with zero-dose control has significant difference in effect, it is referred as minimum effective dose(MED). We propose, in this paper, parametric sequential test using updated control to identify the minimum effective dose(MED) level. Monte Carlo Simulation is adapted to examine the power and experimental significance levels of the proposed method with other methods.

• The Korean Journal of Applied Statistics
• /
• v.25 no.3
• /
• pp.389-401
• /
• 2012

This paper derives a benchmark dose(BMD) and its 95% lower confidence limit(BMDL) using a semi-parametric regression model for small lead based changes in attention-deficit hyperactivity disorder(ADHD) scores in the first wave of the Children's Health and Environment Research(CHEER) survey data, which have been regularly collected in South Korea since 2005. Ha et al. (2009) showed that the appearance of ADHD symptoms had a borderline trend of increasing with the blood lead concentration. Butdz-J${\o}$rgensen (EFSA, 2010a) derived the BMDL of lead corresponding to a benchmark region of 1 full intelligent quotient (IQ) score using the raw data in Lanphear et al. (2005, EHP). European Food Safety Authority (EFSA, 2010b) determined the BMDL of $1.2{\mu}g/dl$ as a reference point for the characterization of lead when assessing the risk of the intellectual deficit measured by IQ scores. Kim et al. (2011) indicated that an even lower BMDL could be obtained based on the ADHD score; however, the BMDLs depended heavily upon the model assumptions. We show in this paper that a semi-parametric approach resolves the model dependence of BMDLs.

• The Korean Journal of Applied Statistics
• /
• v.33 no.2
• /
• pp.137-145
• /
• 2020

Phase I clinical trials (Dose Finding Studies) are the first step in administering new drugs developed through animal experiments or in vitro experiments to humans. An important area of interest in designing Phase I clinical trials is determining the dose that provides the greatest efficacy and acceptable safe dose to the patient. In this paper, we propose a method to determine the maximum tolerated dose considering efficacy and safety using Biased coin design and stopping rule. The proposed method is compared with existing methods through simulation.

• The Korean Journal of Applied Statistics
• /
• v.27 no.1
• /
• pp.13-20
• /
• 2014

Phase I Clinical Trials estimate a Maximum Tolerated Dose(MTD). In this paper, an MTD estimation method applied stopping rule is proposed for Phase I Clinical Trials. The suggested MTD estimation method is compared to the Continual Reassessment Method(CRM) method using a Monte Carlo simulation study.

• Journal of Korean Society for Quality Management
• /
• v.39 no.2
• /
• pp.329-336
• /
• 2011

The purpose of Phase I clinical trial is to identify the maximum tolerated dose with specific toxicity rate. The standard TER design does not guarantee the pre-specified toxicity rate. It depends on the dose-toxicity curves. Therefore it is necessary to check the expected toxicity rate of various dose-toxicity curves before we conduct clinical trials. We developed TERAplusB library to help this situation, especially in cancer research. This package will help design the cancer clinical trial. We can compare the expected toxicity rates, the expected number of patients, and the expected times calculated with various dose-toxicity curves. This process will help find the best clinical trial design of the proposed drug.

• Radiation Oncology Journal
• /
• v.32 no.2
• /
• pp.57-62
• /
• 2014

Purpose: To evaluate association between equivalent dose in 2 Gy (EQD2) to rectal point dose and gastrointestinal toxicity from whole pelvic radiotherapy (WPRT) and intracavitary brachytherapy (ICBT) in cervical cancer patients who were evaluated by rectosigmoidoscopy in Faculty of Medicine, Chiang Mai University. Materials and Methods: Retrospective study was designed for the patients with locally advanced cervical cancer, treated by radical radiotherapy from 2004 to 2009 and were evaluated by rectosigmoidoscopy. The cumulative doses of WPRT and ICBT to the maximally rectal point were calculated to the EQD2 and evaluated the association of toxicities. Results: Thirty-nine patients were evaluated for late rectal toxicity. The mean cumulative dose in term of EQD2 to rectum was 64.2 Gy. Grade 1 toxicities were the most common findings. According to endoscopic exam, the most common toxicities were congested mucosa (36 patients) and telangiectasia (32 patients). In evaluation between rectal dose in EQD2 and toxicities, no association of cumulative rectal dose to rectal toxicity, except the association of cumulative rectal dose in EQD2 >65 Gy to late effects of normal tissue (LENT-SOMA) scale ${\geq}$ grade 2 (p = 0.022; odds ratio, 5.312; 95% confidence interval, 1.269-22.244). Conclusion: The cumulative rectal dose in EQD2 >65 Gy have association with ${\geq}$ grade 2 LENT-SOMA scale.