• Title/Summary/Keyword: hazard analysis

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A Randomized Phase III Study of Patients With Advanced Gastric Adenocarcinoma Without Progression After Six Cycles of XELOX (Capecitabine Plus Oxaliplatin) Followed by Capecitabine Maintenance or Clinical Observation

  • Guk Jin Lee;Hyunho Kim;Sung Shim Cho;Hyung Soon Park;Ho Jung An;In Sook Woo;Jae Ho Byun;Ji Hyung Hong;Yoon Ho Ko;Der Sheng Sun;Hye Sung Won;Jong Youl Jin;Ji Chan Park ;In-Ho Kim;Sang Young Roh;Byoung Yong Shim
    • Journal of Gastric Cancer
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    • v.23 no.2
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    • pp.315-327
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    • 2023
  • Purpose: Oxaliplatin, a component of the capecitabine plus oxaliplatin (XELOX) regimen, has a more favorable toxicity profile than cisplatin in patients with advanced gastric cancer (GC). However, oxaliplatin can induce sensory neuropathy and cumulative, dose-related toxicities. Thus, the capecitabine maintenance regimen may achieve the maximum treatment effect while reducing the cumulative neurotoxicity of oxaliplatin. This study aimed to compare the survival of patients with advanced GC between capecitabine maintenance and observation after 1st line XELOX chemotherapy. Materials and Methods: Sixty-three patients treated with six cycles of XELOX for advanced GC in six hospitals of the Catholic University of Korea were randomized 1:1 to receive capecitabine maintenance or observation. The primary endpoint was progression-free survival (PFS), analyzed using a two-sided log-rank test stratified at a 5% significance level. Results: Between 2015 and 2020, 32 and 31 patients were randomized into the maintenance and observation groups, respectively. After randomization, the median number of capecitabine maintenance cycles was 6. The PFS was significantly higher in the maintenance group than the observation group (6.3 vs. 4.1 months, P=0.010). Overall survival was not significantly different between the 2 groups (18.2 vs. 16.5 months, P=0.624). Toxicities, such as hand-foot syndrome, were reported in some maintenance group patients. Maintenance treatment was a significant factor associated with PFS in multivariate analysis (hazard ratio, 0.472; 95% confidence interval, 0.250-0.890; P=0.020). Conclusions: After 6 cycles of XELOX chemotherapy, capecitabine maintenance significantly prolonged PFS compared with observation, and toxicity was manageable. Maintenance treatment was a significant prognostic factor associated with PFS.

An Exploratory Study on Forecasting Sales Take-off Timing for Products in Multiple Markets (해외 복수 시장 진출 기업의 제품 매출 이륙 시점 예측 모형에 관한 연구)

  • Chung, Jaihak;Chung, Hokyung
    • Asia Marketing Journal
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    • v.10 no.2
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    • pp.1-29
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    • 2008
  • The objective of our study is to provide an exploratory model for forecasting sales take-off timing of a product in the context of multi-national markets. We evaluated the usefulness of key predictors such as multiple market information, product attributes, price, and sales for the forecasting of sales take-off timing by applying the suggested model to monthly sales data for PDP and LCD TV provided by a Korean electronics manufacturer. We have found some important results for global companies from the empirical analysis. Firstly, innovation coefficients obtained from sales data of a particular product in other markets can provide the most useful information on sales take-off timing of the product in a target market. However, imitation coefficients obtained from the sales data of a particular product in the target market and other markets are not useful for sales take-off timing of the product in the target market. Secondly, price and product attributes significantly influence on take-off timing. It is noteworthy that the ratio of the price of the target product to the average price of the market is more important than the price ofthe target product itself. Lastly, the cumulative sales of the product are still useful for the prediction of sales take-off timing. Our model outperformed the average model in terms of hit-rate.

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Impact of Gender Differences in Elderly Patients with Acute Myocardial Infarction (고령의 급성 심근경색증 환자에서 성별에 따른 영향)

  • Seol, Soo Young;Jeong, Myung Ho;Lee, Seung Hun;Sohn, Seok-Joon;Cho, Jae Yeong;Kim, Min Chul;Sim, Doo Sun;Hong, Young Joon;Park, Hyung Wook;Kim, Ju Han;Ahn, Youngkeun;Cho, Jeong Gwan;Park, Jong Chun
    • The Korean Journal of Medicine
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    • v.94 no.1
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    • pp.96-106
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    • 2019
  • Background/Aims: It is well known that gender differences are associated with clinical outcomes in patients with acute myocardial infarction (AMI). However, it is not clear whether gender differences affect the prognosis of elderly patients with AMI. Methods: We analyzed the incidence of in-hospital complications and mortality in the Korea Acute Myocardial Infarction Registry-National Institutes of Health from November 2011 to June 2015. This study included elderly patients (≥ 75 years) diagnosed with AMI. Results: A total of 2,953 patients were eligible for this study. Among them, 1,529 (51.8%) patients were female, and the mean age of the female group was older than that of the male group (80.7 ± 4.4 vs. 79.6 ± 4.0 years, respectively, p < 0.001). Elderly females utilized emergency medical services less frequently compared with elderly males (11.5 vs. 15.4%, respectively, p < 0.001). Elderly female AMI patients had a similar rate of in-hospital mortality compared with elderly males (7.1 vs. 8.4%, respectively, p = 0.196). The rate of major cardiac adverse events (MACEs) was lower in elderly females than males during a 12-month follow-up (hazard ratio [HR] 1.19, 95% confidence interval [CI] 1.00-1.41, p = 0.045). According to multivariate analysis, the male gender is an independent factor for predicting 1-year MACEs (HR 1.37, 95% CI 1.14-1.65, p < 0.001). Conclusions: No significant differences in peri-procedural complications or in-hospital mortality were observed between male and female elderly patients with AMI. However, elderly female patients had a more favorable prognosis than male patients during a 1-year clinical follow-up.

Postoperstive Chemoradiotherapy in Locally Advanced Rectal Cancer (국소 진행된 직장암에서 수술 후 화학방사선요법)

  • Chai, Gyu-Young;Kang, Ki-Mun;Choi, Sang-Gyeong
    • Radiation Oncology Journal
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    • v.20 no.3
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    • pp.221-227
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    • 2002
  • Purpose : To evaluate the role of postoperative chemoradiotherapy in locally advanced rectal cancer, we retrospectively analyzed the treatment results of patients treated by curative surgical resection and postoperative chemoradiotherapy. Materials and Methods : From April 1989 through December 1998, 119 patients were treated with curative surgery and postoperative chemoradiotherapy for rectal carcinoma in Gyeongsang National University Hospital. Patient age ranged from 32 to 73 years, with a median age of 56 years. Low anterior resection was peformed in 59 patients, and abdominoperineal resection in 60. Forty-three patients were AJCC stage II and 76 were stage III. Radiation was delivered with 6 MV X rays using either AP-PA two fields, AP-PA both lateral four fields, or PA both lateral three fields. Total radiation dose ranged from 40 Gy to 56 Gy. In 73 patients, bolus infusions of 5-FU $(400\;mg/m^2)$ were given during the first and fourth weeks of radiotherapy. After completion of radiotherapy, an additional four to six cycles of 5-FU were given. Oral 5-FU (Furtulone) was given for nine months in 46 patients. Results : Forty $(33.7\%)$ of the 119 patients showed treatment failure. Local failure occurred in 16 $(13.5\%)$ patients, 1 $(2.3\%)$ of 43 stage II patients and 15 $(19.7\%)$ of 76 stage III patients. Distant failure occurred in 31 $(26.1\%)$ patients, among whom 5 $(11.6\%)$ were stage II and 26 $(34.2\%)$ were stage III. Five-year actuarial survival was $56.2\%$ overall, $71.1\%$ in stage II patients and $49.1\%$ in stage III patients (p=0.0008). Five-year disease free survival was $53.3\%$ overall, $68.1\%$ in stage II and $45.8\%$ in stage III (p=0.0006). Multivariate analysis showed that T stage and N stage were significant prognostic factors for five year survival, and that T stage, N stage, and preoperative CEA value were significant prognostic factors for five year disease free survival. Bowel complication occurred in 22 patients, and was treated surgically in 15 $(12.6\%)$, and conservatively in 7 $(5.9\%)$. Conclusion : Postoperative chemoradiotherapy was confirmed to be an effective modality for local control of rectal cancer, but the distant failure rate remained high. More effective modalities should be investigated to lower the distant failure rate.

The Content and Risk Assessment of Heavy Metals in Herbal Pills (유통 환제의 유해 중금속 함량 및 위해도 평가)

  • Lee, Sung-Deuk;Lee, Young-Ki;Kim, Moo-Sang;Park, Seok-Ki;Kim, Yeon-Sun;Chae, Young-Zoo
    • Journal of Food Hygiene and Safety
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    • v.27 no.4
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    • pp.375-387
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    • 2012
  • The objective of this study is investigation of contamination levels and assessment of health risk effects of heavy metals in herbal pills. 31 Items and 93 samples were obtained for this investigation from major herbal medicine producing areas, herbal markets and on-line supermarkets from Jan to Jun in 2010. Inductively coupled plasma mass spectrometer method was conducted for the quantitative analysis of Pb, Cd and As. In addition, the mercury analyzer system was conducted for that of Hg without sample digestion. The average contents of heavy metals in samples were as follows : 0.87 mg/kg for Pb, 0.08 mg/kg for Cd, 2.87 mg/kg for As and 0.16 mg/kg for Hg, respectively. In addition, the average contents of heavy metals in different parts of plants, including cortex, fructus, herba, radix, seed, algae and others were 0.63 mg/kg, 3.94 mg/kg, 1.42 mg/kg, 1.05 mg/kg, 0.16 mg/kg, 22.31 mg/kg and 10.17 mg/kg, respectively. After the estimations of dietary exposure, the acceptable daily intake (ADI), the average daily dose (ADD), the provisional tolerable weekly intake (PTWI) and the relative hazard of heavy metals were evaluated. As the results, the relative hazards compared to PTWI in samples were below the recommended standard of JECFA as Pb 3.1%, Cd 0.9%, Hg 0.5%. Cancer risks through slope factor (SF) by Ministry of Environment Republic Korea and Environmental Protection Agency was $4.24{\times}10^{-7}$ for Pb and $3.38{\times}10^{-4}$ for As (assuming that the total arsenic content was equal to the inorganic arsenic). Based on our results, possible Pb-induced cancer risks in herbal pills according to parts used including cortex, fructus, herba, radix, seed, algae and others were $1.95{\times}10^{-7}$, $1.45{\times}10^{-6}$, $2.14{\times}10^{-7}$, $6.27{\times}10^{-7}$, $1.99{\times}10^{-8}$, $3.61{\times}10^{-7}$ and $9.64{\times}10^{-8}$, respectively. Possible As-induced cancer risks in herbal pills by parts used including cortex, fructus, herba, radix, seed, algae and others were $1.54{\times}10^{-5}$, $7.24{\times}10^{-5}$, $1.23{\times}10^{-4}$, $2.02{\times}10^{-5}$, $3.25{\times}10^{-6}$, $2.18{\times}10^{-3}$ and $5.67{\times}10^{-6}$ respectively. Taken together, these results indicate that the majority of samples except for some samples with relative high contents of heavy metals were safe.

Improvement of Certification Criteria based on Analysis of On-site Investigation of Good Agricultural Practices(GAP) for Ginseng (인삼 GAP 인증기준의 현장실천평가결과 분석에 따른 인증기준 개선방안)

  • Yoon, Deok-Hoon;Nam, Ki-Woong;Oh, Soh-Young;Kim, Ga-Bin
    • Journal of Food Hygiene and Safety
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    • v.34 no.1
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    • pp.40-51
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    • 2019
  • Ginseng has a unique production system that is different from those used for other crops. It is subject to the Ginseng Industry Act., requires a long-term cultivation period of 4-6 years, involves complicated cultivation characteristics whereby ginseng is not produced in a single location, and many ginseng farmers engage in mixed-farming. Therefore, to bring the production of Ginseng in line with GAP standards, it is necessary to better understand the on-site practices of Ginseng farmers according to established control points, and to provide a proper action plan for improving efficiency. Among ginseng farmers in Korea who applied for GAP certification, 77.6% obtained it, which is lower than the 94.1% of farmers who obtained certification for other products. 13.7% of the applicants were judged to be unsuitable during document review due to their use of unregistered pesticides and soil heavy metals. Another 8.7% of applicants failed to obtain certification due to inadequate management results. This is a considerably higher rate of failure than the 5.3% incompatibility of document inspection and 0.6% incompatibility of on-site inspection, which suggests that it is relatively more difficult to obtain GAP certification for ginseng farming than for other crops. Ginseng farmers were given an average of 2.65 points out of 10 essential control points and a total 72 control points, which was slightly lower than the 2.81 points obtained for other crops. In particular, ginseng farmers were given an average of 1.96 points in the evaluation of compliance with the safe use standards for pesticides, which was much lower than the average of 2.95 points for other crops. Therefore, it is necessary to train ginseng farmers to comply with the safe use of pesticides. In the other essential control points, the ginseng farmers were rated at an average of 2.33 points, lower than the 2.58 points given for other crops. Several other areas of compliance in which the ginseng farmers also rated low in comparison to other crops were found. These inclued record keeping over 1 year, record of pesticide use, pesticide storages, posts harvest storage management, hand washing before and after work, hygiene related to work clothing, training of workers safety and hygiene, and written plan of hazard management. Also, among the total 72 control points, there are 12 control points (10 required, 2 recommended) that do not apply to ginseng. Therefore, it is considered inappropriate to conduct an effective evaluation of the ginseng production process based on the existing certification standards. In conclusion, differentiated certification standards are needed to expand GAP certification for ginseng farmers, and it is also necessary to develop programs that can be implemented in a more systematic and field-oriented manner to provide the farmers with proper GAP management education.

The Analysis of Radiation Exposure of Hospital Radiation Workers (병원 방사선 작업 종사자의 방사선 피폭 분석 현황)

  • Jeong Tae Sik;Shin Byung Chul;Moon Chang Woo;Cho Yeong Duk;Lee Yong Hwan;Yum Ha Yong
    • Radiation Oncology Journal
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    • v.18 no.2
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    • pp.157-166
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    • 2000
  • Purpose : This investigation was peformed in order to improve the health care of radiation workers, to predict a risk, to minimize the radiation exposure hazard to them and for them to realize radiation exposure danger when they work in radiation area in hospital. Methods and Materials : The documentations checked regularly for personal radiation exposure in four university hospitals in Pusan city in Korea between January 1, 1993 and December 31, 1997 were analyzed. There were 458 persons in this documented but 111 persons who worked less then one year were excluded and only 347 persons were included in this study. Results : The average of yearly radiation exposure of 347 persons was 1.52$\pm$1.35 mSv. Though it was less than 50mSv, the limitaion of radiation in law but 125 (36%) people received higher radiation exposure than non-radiation workers. Radiation workers under 30 year old have received radiation exposure of mean 1.87$\pm$1.01 mSv/year, mean 1.22$\pm$0.69 mSv between 31 and 40 year old and mean 0.97$\pm$0.43 mSv/year over 41year old (p<0.001). Men received mean 1.67$\pm$1.54 mSv/year were higher than women who received mean 1.13$\pm$0.61 mSv/year (p<0.01). Radiation exposure in the department of nuclear modicine department in spite of low energy sources is higher than other departments that use radiations in hospital (p<0.05). And the workers who received mean 3.59$\pm$1.81 msv/year in parts of management of radiation sources and injection of sources to patient receive high radiation exposure in nuclear medicine department (p<0.01). In department of diagnostic radiology high radiation exposure is in barium enema rooms where workers received mean 3.74$\pm$1.74 mSv/year and other parts where they all use fluoroscopy such as angiography room of mean 1.17$\pm$0.35 mSv/year and upper gastrointestinal room of mean 1.74$\pm$1.34 mSv/year represented higher radiation exposure than average radiation exposure in diagnostic radiology (p<0.01). Doctors and radiation technologists received higher radiation exposure of each mean 1.75$\pm$1.17 mSv/year and mean 1.50$\pm$1.39 mSv/year than other people who work in radiation area in hospital (p<0.05). Especially young doctors and technologists have the high opportunity to receive higher radiation exposure. Conclusions : The training and education of radiation workers for radiation exposure risks are important and it is necessary to rotate worker in short period in high risk area. The hospital management has to concern health of radiation workers more and to put an effort to reduce radiation exposure as low as possible in radiation areas in hospital.

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