A prospective randomized trial comparing hypofractionation with conventional fractionation radiotherapy for T1-2 glottic squamous cell carcinomas: Results of a Korean Radiation Oncology Group (KROG-0201) study
Moon S.H.,Research Institute and Hospital |
Cho K.H.,Research Institute and Hospital |
Chung E.J.,Ilsan Hospital |
Lee C.G.,Yonsei University |
And 7 more authors.
Radiotherapy and Oncology | Year: 2014
Background and purpose To prospectively investigate the effect of radiotherapy fraction size on clinical outcomes in early glottic carcinoma Methods and materials Patients with T1-2 glottic carcinoma were eligible for the protocol. Although 282 patients were required, the study was closed prematurely due to poor accrual with only 156 patients. Of these, 82 patients were allocated to conventional fractionation (CONV) arm (66 Gy/33 fractions for T1 and 70 Gy/35 fractions for T2), with 74 patients to hypofractionation (HYPO) arm (63 Gy/28 fractions for T1 and 67.5 Gy/30 fractions for T2) the primary objective was local progression-free survival (LPFS). Results With a median follow-up of 67 months (range, 2-122 months), the 5-year LPFS was 77.8% for CONV arm and 88.5% for HYPO arm (HR 1.55, p = 0.213). No significant difference was observed in the toxicity profile between the two arms. In a subgroup exploratory analysis for T1a disease, the 5-year LPFS trended positively in HYPO arm (76.7% vs. 93.0%, HR 3.65, p = 0.056). Conclusions Given that HYPO is at least not inferior to CONV with a similar toxicity profile, the hypofractionation scheme used in this study can be offered to patients with T1-2 glottic carcinoma with potential advantages in terms of local control and a shortened overall treatment time. © 2013 Elsevier Ireland Ltd. All rights reserved.
PubMed | Soonchunhyang University, Seoul National University, Wonju Severance Christian Hospital, Kyung Hee University and 4 more.
Type: Journal Article | Journal: American journal of kidney diseases : the official journal of the National Kidney Foundation | Year: 2016
Renal infarction is a rare condition resulting from an acute disruption of renal blood flow, and the cause and outcome of renal infarction are not well established.Case series.438 patients with renal infarction in January 1993 to December 2013 at 9 hospitals in Korea were included. Renal infarction was defined by radiologic findings that included single or multiple wedge-shaped parenchymal perfusion defects in the kidney.Causes of renal infarction included cardiogenic (n=244 [55.7%]), renal artery injury (n=33 [7.5%]), hypercoagulable (n=29 [6.6%]), and idiopathic (n=132 [30.1%]) factors.We used recurrence, acute kidney injury (AKI; defined as creatinine level increase 0.3mg/dL within 48 hours or an increase to 150% of baseline level within 7 days during the sentinel hospitalization), new-onset estimated glomerular filtration rate (eGFR)<60mL/min/1.73m(2) (for >3 months after renal infarction in the absence of a history of decreased eGFR), end-stage renal disease (ESRD; receiving hemodialysis or peritoneal dialysis because of irreversible kidney damage), and mortality as outcome metrics.Treatment included urokinase (n=19), heparin (n=342), warfarin (n=330), and antiplatelet agents (n=157). 5% of patients died during the initial hospitalization. During the median 20.0 (range, 1-223) months of follow-up, 2.8% of patients had recurrent infarction, 20.1% of patients developed AKI, 10.9% of patients developed new-onset eGFR<60mL/min/1.73m(2), and 2.1% of patients progressed to ESRD.This was a retrospective study; it cannot clearly determine the specific causal mechanism for certain patients or provide information about the causes of mortality. 16 patients were excluded from the prognostic analysis.Cardiogenic origins were the most important causes of renal infarction. Despite aggressive treatment, renal infarction can lead to AKI, new-onset eGFR<60mL/min/1.73m(2), ESRD, and death.
PubMed | Korea Research Institute of Standards and Science, Korea University, Hallym University, Catholic University of Korea and 8 more.
Type: Journal Article | Journal: Cardiovascular therapeutics | Year: 2016
It is still unclear which layer (intima or media) is mainly involved in increased carotid intima-media thickness (CIMT) by aging and also unclear regarding CIMT value suggesting high cardiovascular risk, although 75th percentile value of CIMT is known as a high risk in asymptomatic adults. We sought to find the changes of carotid intima thickness (CIT) and carotid media thickness (CMT) by aging and the 75th percentile value of CIMT in asymptomatic Korean adults.This is an observational cohort study. Carotid ultrasound findings (n=2204 from 12 hospitals) were prospectively collected. The carotid images were sent to Korea Research Institute of Standards and Science for analysis using specialized software which can measure intima and media wall also.Mean age was 58.113.5years old (52% of men). Pearsons correlation coefficient between age and right CIMT (r=.489, P<.001) and right CMT (r=.482, P<.001) was higher than that between age and right CIT (r=.284, P<.001). Mean right CIMT in male and female was 0.6960.163 and 0.6860.167mm (P=.180), and the 75 percentile value was 0.778 and 0.771mm, respectively. Mean right CIT was 0.3110.069 and 0.3030.064mm (P=.009), and mean right CMT was 0.3910.124 and 0.3880.131mm (P=.694) in male and female, respectively. Left carotid ultrasound findings showed similar to the right one.An increased CIMT by aging was mainly due to increased CMT rather than CIT in asymptomatic adults. The 75th percentile values of right CIMT were 0.778 and 0.771mm in asymptomatic Korean male and female adults, respectively.
PubMed | Ajou University, Dong - A University, Biometric Research Branch, Chonnam National University and 10 more.
Type: | Journal: Cancer research and treatment : official journal of Korean Cancer Association | Year: 2017
To evaluate the impact of post-mastectomy radiotherapy (PMRT) on loco-regional recurrence-free survival (LRRFS), disease-free survival (DFS) and overall survival (OS) in pT1-2N1 patients treated with taxane-based chemotherapy.We retrospectively reviewed the medical data of pathological N1 patients who were treated with MRM (modified radical mastectomy) and adjuvant taxane-based chemotherapy in 12 hospitals between January 2006 and December 2010.We identified 714 consecutive patients. The median follow-up duration was 69 months (range, 1-114 months) and the 5-yr LRRFS, DFS, and OS rates were 97%, 94% and 98%, respectively, in patients who received PMRT(PMRT(+)). The corresponding figures were 96%, 90% and 96%, respectively, in patients who did not receive PMRT(PMRT(-)). PMRT had no significant impact on survival. Upon multivariable analysis, only the histological grade (HG) was statistically significant as a prognostic factor for LRRFS and DFS. In a subgroup analysis of HG 3 patients, PMRT(+) showed better DFS (P=0.081).PMRT had no significant impact on LRRFS, DFS or OS in pT1-2N1 patients treated with taxane-based chemotherapy. PMRT showed a marginal benefit for DFS in HG 3 patients. Randomized studies are needed to confirm the benefit of PMRT in high risk patients, such as those with HG 3.
Prognostic Impact of Elective Supraclavicular Nodal Irradiation for Patients with N1 Breast Cancer after Lumpectomy and Anthracycline plus Taxane-based Chemotherapy (KROG 1418): A Multicenter Case-Controlled Study
PubMed | Ajou University, Dong - A University, Chonnam National University, Hallym University and 9 more.
Type: | Journal: Cancer research and treatment : official journal of Korean Cancer Association | Year: 2017
This study was conducted to evaluate the impact of supraclavicular lymph node radiotherapy (SCNRT) on N1 breast cancer patients receiving post-lumpectomy whole-breast irradiation (WBI) and anthracycline plus taxane-based (AT) chemotherapy.We performed a case-control analysis to compare the outcomes of WBI and WBI plus SCNRT (WBI+SCNRT). Among 1,147 patients with N1 breast cancer who received post-lumpectomy radiotherapy and AT-based chemotherapy in 12 hospitals, 542 were selected after propensity score matching. Patterns of failure, disease-free survival (DFS), distant metastasis-free survival (DMFS), and treatment-related toxicity were compared between groups.A total of 41 (7.6%) patients were found to have recurrence. SCN failure was detected in three patients, two in WBI and one in WBI+SCNRT. All SCN failures were found simultaneously with distant metastasis. There was no significant difference in patterns of failure or survival between groups. The 5-year DFS and DMFS for patients with WBI and WBI+SCNRT were 94.4% vs. 92.6% (p=0.50) and 95.1% vs. 94.5% (p=0.99), respectively. The rates of lymphedema and radiation pneumonitis were significantly higher in the WBI+SCNRT than in the WBI.We did not find a benefit of SCNRT for N1 breast cancer patients receiving AT-based chemotherapy.
PubMed | Korea University, Eulji University, Catholic University of Daegu, Daegu Fatima Hospital and 10 more.
Type: Journal Article | Journal: American journal of infection control | Year: 2016
Postexposure prophylaxis for occupational exposure to hepatitis B virus (HBV) plays an important role in the prevention of HBV infections in health care workers (HCWs). We examined data concerning the acceptable duration between occupational exposure and administration of a hepatitis B immunoglobulin (HBIG) injection in an occupational clinical setting.A retrospective analysis was conducted with data from 143 cases of HCWs exposed to HBV in 15 secondary and tertiary teaching hospitals between January 2005 and June 2013. Data were taken from the infection control records of each hospital.Active vaccination after HBV exposure was started in 119 cases (83.2%) and postvaccination testing for hepatitis B antibody showed positive seroconversion in 93% of cases. In 98 cases (68.5%), HBIG was administered within 24hours after HBV exposure; however, 45 HCWs (31.5%) received an HBIG injection more than 24hours postexposure and 2 among the 45 received an injection after 7days. Although 31.5% received an HBIG injection more than 24hours postexposure, no cases of seroconversion to hepatitis b antibody positivity occurred.For susceptible HCWs, HBIG administered between 24hours and 7days postexposure may be as effective as administration within 24hours in preventing occupational HBV infection.
A Randomized, Double-Blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of Fimasartan/Amlodipine Combined Therapy Versus Fimasartan Monotherapy in Patients With Essential Hypertension Unresponsive to Fimasartan Monotherapy
PubMed | Dong - A University, Korea University, University of Ulsan, Catholic University of Korea and 16 more.
Type: | Journal: Clinical therapeutics | Year: 2016
The goal of this study was to evaluate whether the blood pressure-lowering efficacy of fimasartan/amlodipine combination therapy was superior to that of fimasartan monotherapy after 8 weeks of treatment in patients with hypertension who had failed to respond adequately to fimasartan monotherapy.This trial was a randomized, double-blind, multicenter, Phase III clinical study. Patients who failed to respond after 4 weeks of treatment with 60 mg daily of fimasartan (sitting systolic blood pressure [SiSBP]) 140 mm Hg) were randomized to receive either daily fimasartan 60 mg or fimasartan/amlodipine 60 mg/10 mg. The primary efficacy end point was the change in SiSBP from baseline to week 8. Secondary end points included the change in SiSBP from baseline to week 4, the changes in sitting diastolic blood pressure from baseline to weeks 4 and 8, and the response rate (SiSBP <140 mm Hg or decrease in SiSBP 20 mm Hg) or control rate (SiSBP <140 mm Hg) at week 8. Treatment-emergent adverse events were also assessed.Of 143 patients randomized to treatment, 137 patients who had available efficacy data were analyzed. The mean age of patients was 59.1 (8.9) years, and 100 (73.0%) were male. Baseline SiSBP and sitting diastolic blood pressure were 150.6 (9.2) mm Hg and 91.7 (8.6) mm Hg, respectively. In the fimasartan/amlodipine combination group, a greater reduction in SiSBP from baseline to week 8 was observed compared with the fimasartan group (7.8 [13.3] mm Hg in the fimasartan group vs 20.5 [14.6] mm Hg in the fimasartan/amlodipine group; P < 0.0001). This reduction was observed after 4 weeks. The mean SiSBP changes from baseline to week 4 were 8.1 (15.8) mm Hg in the fimasartan group and 20.1 (14.7) mm Hg in the fimasartan/amlodipine group (P < 0.0001). At week 8, the response rate was significantly higher in the fimasartan/amlodipine (82.1%) group than in the fimasartan (32.9%) group (P < 0.0001). The control rate at week 8 was also higher in the fimasartan/amlodipine (79.1%) group than in the fimasartan (31.4%) group (P < 0.0001). Adverse drug reactions were observed in 9 patients (6.3%), with no significant differences between treatment groups. There were no serious adverse events associated with the study drugs.Fimasartan/amlodipine combination therapy exhibited superior efficacy in reducing blood pressure, with no increase in adverse drug reactions, compared with fimasartan monotherapy. ClinicalTrials.gov identifier: NCT02152306.
PubMed | Yonsei University, Daedong Hospital, Wonju Severance Christian Hospital and Konyang University
Type: Journal Article | Journal: Yonsei medical journal | Year: 2016
To examine the usefulness of various receptor tyrosine kinase expressions as prognostic markers and therapeutic targets in muscle invasive urothelial cancer (UC) patients.We retrospectively analyzed the data of 98 patients with muscle invasive UC who underwent radical cystectomy between 2005 and 2010 in Yonsei Cancer Center. Using formalin fixed paraffin embedded tissues of primary tumors, immunohistochemical staining was done for human epidermal growth factor receptor 2 (HER2), fibroblast growth factor receptor 1 (FGFR1), and fibroblast growth factor receptor 3 (FGFR3).There were 41 (41.8%), 44 (44.9%), and 14 (14.2%) patients who have over-expressed HER2, FGFR1, and FGFR3, respectively. In univariate analysis, significantly shorter median time to recurrence (TTR) (12.9 months vs. 49.0 months; p=0.008) and overall survival (OS) (22.3 months vs. 52.7 months; p=0.006) was found in patients with FGFR1 overexpression. By contrast, there was no difference in TTR or OS according to the HER2 and FGFR3 expression status. FGFR1 remained as a significant prognostic factor for OS with hazard ratio of 2.23 (95% confidence interval: 1.27-3.90, p=0.006) in multivariate analysis.Our result showed that FGFR1 expression, but not FGFR3, is an adverse prognostic factor in muscle invasive UC patients after radical cystectomy. FGFR1 might be feasible for prognosis prediction and a potential therapeutic target after thorough validation in muscle invasive UC.