• The Korean Journal of Applied Statistics
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• v.9 no.2
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• pp.95-108
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• 1996

There are many clinical trials where a large portion of the patients are cured of disease. In such a case, one might be more interested in testing the differences in cure rates rather than other types of differences in failure distribution. For ethical and economic reasons, clinical trials must be repeatedly monitored for evidence of treatment benefit or harm. In this article, we examined by simulation the properties of nonparametric group sequential methods for comparing the cure rates between two treatment groups during the trial in a wide range of alternatives, censoring rates and cure rates.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.6
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• pp.2669-2673
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• 2012

Purpose: Pancreatic carcinoma is one of the most malignant tumors of the alimentary system, with relatively high incidence rates. The purpose of this study was to assess the efficacy and safety of two regimens for advanced pancreatic carcinoma: continuous transarterial infusion versus systemic venous chemotherapy with gemcitabine and 5-fluorouracil. Methods: Of the 48 patients with advanced pancreatic carcinoma receiving chemotherapy with gemcitabine and 5-fluorouracil, 24 received the selective transarterial infusion, and 24 the systemic chemotherapy. For the continuous transarterial infusion group (experimental group), all patients received gemcitabine 1000 mg/$m^2$, given by 30-minute transarterial infusion, on day 1 of a 4-week cycle for 2 cycles, and a dose of 600 mg/$m^2$ 5-fluorouracil was infused on days 1~5 of a 4-week cycle for 2 cycles. For the systemic venous group (control group), gemcitabine and 5-fluorouracil were infused through a peripheral vein, a dose of 1000 mg/$m^2$ gemcitabine being administrated over 30 min on days 1 and 8 of a 4-week cycle for 2 cycles, and a dose of 600 mg/$m^2$ 5-fluorouracil was infused on days 1~5 of a 4-week cycle for 2 cycles. The effectiveness and safety were evaluated after 2 cyclesaccording to WHO criteria. Results:The objective effective rate in transarterial group was 33.3% versus 25% in the systemic group, the difference not being significant (P=0.626). Clinical benefit rates(CBR) in the transarterial and systemic groups were 83.3% and 58.3%, respectively (P=0.014). The means and medians for survival time in transarterial group were higher than those of the systemic group (P < 0.005). at the same time, the adverse effects did not significantly differ between the two groups (P > 0.05). Conclusion: Continuous transarterial infusion chemotherapy with gemcitabine and 5-fluorouracil could improve clinical benefit rate and survival time of patients with advanced pancreatic carcinoma, compared with systemic venous chemotherapy. Since adverse effects were limited in the transarterial group, the regimen of continuous transarterial infusion chemotherapy can be used more extensively in clinical practice. A CT and MRI conventional sequence can be used for efficacy evaluation after chemotherapy in pancreatic carcinoma.

• Korean Journal of Clinical Pharmacy
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• v.22 no.2
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• pp.113-122
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• 2012

ACC/AHA/SCAI Guideline recommends for administration dual antiplatelet therapy after drug-eluting stent (DES) to prevent restenosis and stent thrombosis in patients with percutaneous coronary intervention (PCI). Recently triple antiplatelet therapy including cilostazol is known to reduce restenosis and stent thrombosis significantly after DES implantation. However, there is lack of data providing the efficacy of triple antiplatelet therapy. The purpose of this study is to evaluate the clinical effects of the triple therapy after DES implantation compared with the dual therapy. This retrospective study collected data from medical charts of 251 patients who received DES implantation between Jul 2006 and Jun 2008. They received either dual antiplatelet therapy (N = 154 clopidogrel and aspirin; Dual group) or triple antiplatelet therapy (N = 97 cliostazol, clopidogrel and aspirin; Triple group). Major adverse cardiac event rates (MACE, included total death, myocardial infarction, target lesion revascularization) at 12 months, 24 months, stent thrombosis, rates of bleeding complications and adverse drug reactions were compared between these two groups. Compared with the dual group, the triple group had a similar incidence of the MACE rates at 24months (12.3% vs. 12.4%, p = 0.99). There is no difference in overall stent thrombosis between two groups (Dual group 2.6% vs. Triple group 4.1%, p = 0.5). Subgroup analysis showed that diabetic patients got more benefit in reducing MACE rates but, there is no statistical difference. Bleeding complications and adverse drug effects were not different significantly. As compared with dual antiplatelet therapy, triple antiplatelet therapy did not reduce the 12-months, 24-months MACE rates and stent thrombosis. Bleeding complications and adverse drug effects were not different.

• Korean Journal of Clinical Pharmacy
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• v.24 no.2
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• pp.126-134
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• 2014

Purpose: This study was aimed to examine the financial effect of 2-tiered copayment system on annual expenditure of pharmacy benefit in the National Health Insurance (NHI) of Korea, focusing on oral antidiabetic medications. Methods: 284 oral antidiabetic products with 14 different active single ingredients listed in the National Formulary of NHI (August 2009) were assigned to tier 1 or tier 2 according to the selected criteria. 10 different combinations of coinsurance rates were selected to estimate the changes in drug expenditure cost of NHI. Results: The annual drug cost was estimated based on the drug price per unit listed in the National Formulary and the used amount of products in 2009 from the IMS Health data of Korea. In the combinations of coinsurance rate of 20% for tier 1 and 40% for tier 2, the total annual drug cost was estimated to be reduced by 1.3% in the case of no change of generic and original drug consumptions, and to be reduced by 4.3% in the case of 10% increased generic drug consumptions. Conclusion: The tiered copayment system with optimal coinsurance rates appears to be a potential strategy to reduce the financial burden of NHI in Korea by promoting the use of generic products.

• Korean Journal of Clinical Oncology
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• v.14 no.2
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• pp.116-119
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• 2018

Purpose: This study assessed the effect of chemotherapy over stage II colon cancer in terms of presence of high-risk factors. Methods: Data were retrospectively reviewed for 364 patients with stage II colon cancer who underwent curative surgery between January 2007 and December 2012. High-risk factors of stage II colon cancer were examined, and the overall survival (OS) rates were analyzed. Survival benefit of adjuvant chemotherapy was also analyzed. Results: One hundred and fifteen cases had exclusively single high-risk factor and 194 cases were negative for high-risk factors. Postoperative chemotherapy was performed in 262 of 364 patients (72.0%). The 5-year OS was 79.4% and 86.6% for patients without adjuvant chemotherapy and those with chemotherapy, respectively. The 5-year OS was 88.2% and 83.3% for patients having exclusively single high-risk factor with adjuvant chemotherapy and those without chemotherapy, respectively. Conclusion: Adjuvant chemotherapy for patients with stage II colon cancer having exclusively single high-risk factor could be omitted, weighing up the survival benefit and side effect of chemotherapy.

• Clinical and Experimental Pediatrics
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• v.55 no.4
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• pp.115-120
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• 2012

Although high-dose chemotherapy and autologous stem cell transplantation (HDCT/autoSCT) have improved the prognosis for patients with high-risk neuroblastoma (NB), event-free survival rates remain in the range of 30 to 40%, which is unsatisfactory. To further improve outcomes, several clinical trials, including tandem HDCT/autoSCT, high-dose $^{131}I$-metaiodobenzylguanidine treatment, and immunotherapy with NB specific antibody, have been undertaken and pilot studies have reported encouraging results. Nonetheless, about half of high-risk NB patients still experience treatment failure and have no realistic chance for cure with conventional treatment options alone after relapse. Therefore, a new modality of treatment is warranted for these patients. In recent years, several groups of investigators have examined the feasibility and effectiveness of reduced-intensity allogeneic stem cell transplantation (RI alloSCT) for the treatment of relapsed/progressed NB. Although a graft-versus-tumor effect has not yet been convincingly demonstrated in the setting of relapsed NB, the strategy of employing RI alloSCT has provided hope that treatment-related mortality will be reduced and a therapeutic benefit will emerge. However, alloSCT for NB is still investigational and there remain many issues to be elucidated in many areas. At present, alloSCT is reserved for specific clinical trials testing the immunomodulatory effect against NB.

• Clinical and Experimental Reproductive Medicine
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• v.48 no.3
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• pp.203-210
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• 2021

We performed a systematic review and meta-analysis to evaluate whether intralipid administration improved the outcomes of in vitro fertilization. Online databases (PubMed, Cochrane Library, Medline, and Embase) were searched until March 2020. Only randomized controlled trials (RCTs) that assessed the role of intralipid administration during in vitro fertilization were considered. We analyzed the rates of clinical pregnancy and live birth as primary outcomes. Secondary outcomes included the rates of chemical pregnancy, ongoing pregnancy, and missed abortion. We reviewed and assessed the eligibility of 180 studies. Five RCTs including 840 patients (3 RCTs: women with repeated implantation failure, 1 RCT: women with recurrent spontaneous abortion, 1 RCT: women who had experienced implantation failure more than once) met the selection criteria. When compared with the control group, intralipid administration significantly improved the clinical pregnancy rate (risk ratio [RR], 1.48; 95% confidence interval [CI], 1.23-1.79), ongoing pregnancy rate (RR, 1.82; 95% CI, 1.31-2.53), and live birth rate (RR, 1.85; 95% CI, 1.44-2.38). However, intralipid administration had no beneficial effect on the miscarriage rate (RR, 0.75; 95% CI, 0.48-1.17). A funnel plot analysis revealed no publication bias. Our findings suggest that intralipid administration may benefit women undergoing in vitro fertilization, especially those who have experienced repeated implantation failure or recurrent spontaneous abortion. However, larger, well-designed studies are needed to confirm these findings.

• Asian Pacific Journal of Cancer Prevention
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• v.14 no.3
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• pp.1981-1984
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• 2013

Objective: The optimal duration of adjuvant trastuzumab treatment in patients with HER2-positive breast cancer is not known. The aim of this study was to evaluate the efficacy of 6 months of adjuvant trastuzumab treatment in patients with stage II or III HER2-positive breast cancer. Methods: The records of patients with HER2-positive stage II or III breast cancer who were admitted to the Breast Center of Taipei Medical University Hospital and Yuan's General Hospital between 2000 and 2008 were reviewed. All patients received adjuvant trastuzumab at an initial dose of 4 mg/kg followed by a maintenance dose of 2 mg/kg/week for 22 weeks in combination with chemotherapy. Results: A total of 51 patients were included with a mean age of 46.9 years. Approximately 55% of the patients had stage III disease. The mean follow-up time from initiation of treatment was 45.2 months (range, 0.9 to 85 months). During follow-up, 46 patients (90.2%) did not experience tumor recurrence. The mean estimated disease free survival was 80.2 months. The estimated 1-, 2-, 5-, and 7-year survival rates were 97.9%, 93.1%, 93.1%, and 93.1%, respectively. The most common adverse effects were gastrointestinal symptoms (21.6%), chills (17.6%), dizziness (9.8%), and bone pain (7.8%). No cardiac or hematologic adverse events occurred. Conclusion: Adjuvant therapy with trastuzumab for 6 months resulted in a clinical benefit in patients with HER2-positive breast cancer.

• Journal of Korean Foot and Ankle Society
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• v.26 no.3
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• pp.111-117
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• 2022

Despite the lack of evidence-based standard guidelines to select the best surgical treatment option for end-stage ankle osteoarthritis, the rate of total ankle arthroplasty (TAA) is increasing rapidly relative to ankle arthrodesis (AA) with the development of implant designs and surgical techniques. Physicians and patients would benefit from a more comprehensive understanding of the differences in postoperative pain relief, functional improvement, the rates of complication or reoperation, and restoration of gait ability and sports activity. This paper overviews the current consensus on indications and contraindications for TAA and provides a literature review on a comparison of the clinical and functional results between TAA and AA.

• Journal of Korean Neurosurgical Society
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• v.30 no.sup2
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• pp.266-272
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• 2001

Objectives : Chemotherapy remains part of the treatment triad that includes surgery and radiotherapy for the management of glioblastomas, but disappointing results of chemotherapy have raised the suggestion that chemotherapy should perhaps be abandoned. In order to determine the chemotherapy effect given in addition to radiotherapy, we performed a randomized clinical study of irradiation alone and combination of irradiation with chemotherapy in the treatment of glioblastomas. Methods : From 1991 to 1999, 204 consecutive patients suffering from supratentorial glioblastomas were treated in our hospital. We compared the survival rates/times of these patients according to the treatment modalities[group I-67 patients treated by surgery with radiotherapy and adjuvant chemotherapy(ACNU, paclitaxel, tamoxifen, and others) ; group II-106 by surgery with radiotherapy ; and group III-31 by surgery only]. Results : The overall median survival time was 12 months, with overall survival rates at 1 and 2 year of 46.7% and 16.6%, respectively. On univariate analysis, median survival and 1- and 2-year survival rates were statistically improved by the use of chemotherapy ; group I-15 months, 75.7%, and 25.9%, group II-11 months, 39.3%, and 15.4%, and group III-3 months, 9.7%, and 6.5%, respectively(p=0.0001). But, on multivariate analysis considering compounding variables, survival was independently associated only with radiotherapy(p=0.0112). Conclusion : These results suggest that the addition of chemotherapy to radiotherapy does not affect the overall survival in glioblastomas. Mainly long-survivor glioblastoma patients might benefit by adjuvant chemotherapy, which probably means patients with initial favorable prognostic factors(young age, minimal residual tumors, good performance status). It is necessary to continue to search for an effective chemotherapy regimen to prolong survival of patients with glioblastomas.