Objective
Avoidance of organs at risk has become possible with advances in image‐guided volumetric‐modulated arc therapy (VMAT) techniques. This study was designed to evaluate the safety and ...feasibility of stereotactic ablative radiotherapy (SABR) for early stage glottic cancer. This report presents the preliminary result of the first and second dose level.
Methods
Fraction size was increased from 3.5 gray (Gy) (total dose 59.5 Gy) to 9 Gy (total dose 45 Gy). Dose‐limiting toxicities were defined as grade 3 or higher treatment‐related toxicities. Voice outcome was assessed with electroglottography, and quality of life (QoL) was measured with the Head and Neck Cancer Inventory (HNCI).
Results
Seven patients received 59.5 Gy at 3.5 Gy per fraction as the first dose level, and five patients received 55 Gy at 5 Gy per fraction as the second dose level. None of the patients developed grade 3+ toxicity throughout a median follow‐up of 17.5 months (range, 1.7–30.6 months). One patient in the second dose level recurred in the primary site at 4 months after radiotherapy (RT) and received total laryngectomy. The rest of participants were disease‐free at locoregional and distant sites. Jitter, shimmer, mean phonation time, and noise‐to‐harmony ratio did not change significantly at 6 months after RT. HNCI scores between pretreatment and posttreatment were not significantly different (P = 0.221).
Conclusion
This study revealed acceptable toxicity, voice outcome, and QoL in patients treated with hypofractionated VMAT of 3.5 Gy and 5 Gy per fraction. This phase I study is currently ongoing with a dose of 55 Gy in 11 fractions and 45 Gy in five fractions.
Level of Evidence
2b. Laryngoscope, 2560–2565, 2018
Although optimal medical therapy (OMT) after coronary revascularization is advocated for intensive secondary prevention, its criteria and effect on long-term outcomes are uncertain. Using data from ...the ASAN-Multivessel (Asan Medical Center-Multivessel Revascularization) registry, we identified 8,311 patients who underwent coronary artery bypass grafting (CABG) (n = 3,115) or percutaneous coronary intervention (PCI) (n = 5,196). OMT was defined as the combination of minimum of 3 medications in 4 drug classes (antiplatelet drugs, statins, β blockers, and angiotensin-converting enzyme inhibitors or angiotensin receptor blockers). Two primary outcomes were all-cause mortality and serious composite outcome of death, spontaneous myocardial infarction, or stroke at 10 years. Of 8,311 patients, 4,321 (52.0%) followed OMT. In the 3,397 propensity-score-matched cohort, OMT status compared with non-OMT status was significantly associated with a lower risk of all-cause mortality (10.7% vs 18.7%; hazard ratio HR 0.55, 95% confidence interval CI 0.47 to 0.65) and serious composite outcome (14.5% vs 22.5%, HR 0.635, 95% CI 0.55 to 0.73) at 10 years. The association on 10-year mortality was more prominent in the PCI group (HR 0.45, 95% CI 0.36 to 0.56) than in the CABG group (HR 0.72, 95% CI 0.58 to 0.90) with a significant interaction (p = 0.001). Overall findings were consistent using different OMT criteria (all 4 types of medications). In conclusion, OMT significantly lowered the risks of mortality and major cardiovascular events at 10 years in patients with multivessel revascularization. The OMT impact on mortality was more remarkable in the PCI group than in the CABG group. This work was registered at http://ClinicalTrials.gov (Identifier: NCT02039752).
Effective treatment options for patients with metastatic breast cancer resistant to anthracyclines and taxanes are limited. Ixabepilone has single-agent activity in these patients and has ...demonstrated synergy with capecitabine in this setting. This study was designed to compare ixabepilone plus capecitabine versus capecitabine alone in anthracycline-pretreated or -resistant and taxane-resistant locally advanced or metastatic breast cancer.
Seven hundred fifty-two patients were randomly assigned to ixabepilone 40 mg/m(2) intravenously on day 1 of a 21-day cycle plus capecitabine 2,000 mg/m(2) orally on days 1 through 14 of a 21-day cycle, or capecitabine alone 2,500 mg/m(2) on the same schedule, in this international phase III study. The primary end point was progression-free survival evaluated by blinded independent review.
Ixabepilone plus capecitabine prolonged progression-free survival relative to capecitabine (median, 5.8 v 4.2 months), with a 25% reduction in the estimated risk of disease progression (hazard ratio, 0.75; 95% CI, 0.64 to 0.88; P = .0003). Objective response rate was also increased (35% v 14%; P < .0001). Grade 3/4 treatment-related sensory neuropathy (21% v 0%), fatigue (9% v 3%), and neutropenia (68% v 11%) were more frequent with combination therapy, as was the rate of death as a result of toxicity (3% v 1%, with patients with liver dysfunction >/= grade 2 liver function tests at greater risk). Capecitabine-related toxicities were similar for both treatment groups.
Ixabepilone plus capecitabine demonstrates superior efficacy to capecitabine alone in patients with metastatic breast cancer pretreated or resistant to anthracyclines and resistant to taxanes.
Background
The multicohort, phase II, nonrandomized KEYNOTE-059 study evaluated pembrolizumab ± chemotherapy in advanced gastric/gastroesophageal junction cancer. Results from cohorts 2 and 3, ...evaluating first-line therapy, are presented.
Methods
Patients ≥ 18 years old had previously untreated recurrent or metastatic gastric/gastroesophageal junction adenocarcinoma. Cohort 3 (monotherapy) had programmed death receptor 1 combined positive score ≥ 1. Cohort 2 (combination therapy) received pembrolizumab 200 mg on day 1, cisplatin 80 mg/m
2
on day 1 (up to 6 cycles), and 5-fluorouracil 800 mg/m
2
on days 1–5 of each 3-week cycle (or capecitabine 1000 mg/m
2
twice daily in Japan). Primary end points were safety (combination therapy) and objective response rate per Response Evaluation Criteria in Solid Tumors version 1.1 by central review, and safety (monotherapy).
Results
In the combination therapy and monotherapy cohorts, 25 and 31 patients were enrolled; median follow-up was 13.8 months (range 1.8–24.1) and 17.5 months (range 1.7–20.7), respectively. In the combination therapy cohort, grade 3/4 treatment-related adverse events occurred in 19 patients (76.0%); none were fatal. In the monotherapy cohort, grade 3–5 treatment-related adverse events occurred in seven patients (22.6%); one death was attributed to a treatment-related adverse event (pneumonitis). The objective response rate was 60.0% 95% confidence interval (CI), 38.7–78.9 (combination therapy) and 25.8% (95% CI 11.9–44.6) (monotherapy).
Conclusions
Pembrolizumab demonstrated antitumor activity and was well tolerated as monotherapy and in combination with chemotherapy in patients with previously untreated advanced gastric/gastroesophageal junction adenocarcinoma.
Clinical Trial
ClinicalTrials.gov
NCT02335411
The aim of this study was to investigate the prevalence and prognostic significance of psychological distress in gastric cancer patients.
The study population included 229 gastric cancer patients ...visiting Yonsei Cancer Center between November 2009 and March 2011. The distress was measured by available tools including the Modified Distress Thermometer (MDT), Hospital Anxiety and Depression Scale (HADS), and Center for Epidemiologic Studies-Depression Scale (CES-D). Patients with psychological distress were defined as those who scored above the cut-off values in both the MDT and either one of the HADS or CES-D.
The median age of patients was 56 (range, 20 to 86) and 97 (42.4%) patients were with stage IV disease status at enrollment. The overall prevalence of psychological distress was 33.6% (95% CI: 27.5-39.8%) in 229 gastric cancer patients. In multiple logistic regression analysis, lower education level (odds ratio OR 2.39; 95% confidence interval CI 1.11-5.17, P = 0.026) and higher disease stage (OR 2.72; 95% CI 1.47-5.03, P = 0.001) were associated with psychological distress. In stage I-III disease, patients with psychological distress had worse disease-free survival (DFS) (5-year DFS rate: 60% vs 76%, P = 0.49) compared with those without psychological distress. In stage IV disease (n = 97), patients with psychological distress showed poorer overall survival than those without psychological distress (median OS (Overall Survival): 12.2 vs. 13.8 months, P = 0.019).
Psychological distress is common in patients with all stages of gastric cancer and is associated with worse outcomes.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
This study aimed to develop a convolutional neural network (CNN) using the EfficientNet algorithm for the automated classification of acute appendicitis, acute diverticulitis, and normal appendix and ...to evaluate its diagnostic performance. We retrospectively enrolled 715 patients who underwent contrast-enhanced abdominopelvic computed tomography (CT). Of these, 246 patients had acute appendicitis, 254 had acute diverticulitis, and 215 had normal appendix. Training, validation, and test data were obtained from 4,078 CT images (1,959 acute appendicitis, 823 acute diverticulitis, and 1,296 normal appendix cases) using both single and serial (RGB red, green, blue) image methods. We augmented the training dataset to avoid training disturbances caused by unbalanced CT datasets. For classification of the normal appendix, the RGB serial image method showed a slightly higher sensitivity (89.66 vs. 87.89%; p = 0.244), accuracy (93.62% vs. 92.35%), and specificity (95.47% vs. 94.43%) than did the single image method. For the classification of acute diverticulitis, the RGB serial image method also yielded a slightly higher sensitivity (83.35 vs. 80.44%; p = 0.019), accuracy (93.48% vs. 92.15%), and specificity (96.04% vs. 95.12%) than the single image method. Moreover, the mean areas under the receiver operating characteristic curve (AUCs) were significantly higher for acute appendicitis (0.951 vs. 0.937; p < 0.0001), acute diverticulitis (0.972 vs. 0.963; p = 0.0025), and normal appendix (0.979 vs. 0.972; p = 0.0101) with the RGB serial image method than those obtained by the single method for each condition. Thus, acute appendicitis, acute diverticulitis, and normal appendix could be accurately distinguished on CT images by our model, particularly when using the RGB serial image method.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
► The effects of retorting temperature on the shale oil yield and properties. ► Boiling point distribution analysis was carried out. ► The retorting temperature had great effects on shale oil ...quality. ► Shale oil had less low-boiling point oil fraction and high-boiling point oil fraction. ► Heavy oil fractions were produced initially and light oil fractions came out later.
The effects of retorting temperature of oil shale on the yield and properties of shale oil produced were studied in a batch reactor. US western oil shale was retorted at the temperatures of 400, 450, and 500°C. During the retorting process, shale oil samples were collected at different time periods and their distillation characteristics were analyzed. The yield of shale oil was increased with increasing reaction temperature, but the ratio of oil/gas was reduced in the retorting at 500°C. This implies that there exists an optimal retorting temperature for the maximum yield of liquid oil. It is noticeable that the boiling point of shale oil was lowest when the retorting was carried out at 450°C and the shale oils obtained in the retorting at 400 and 500°C showed similar boiling point distributions. In the analysis of shale oil collected at different time periods, high boiling point oils were produced initially, and later low boiling point oils were produced.
Long-term comparative outcomes after percutaneous coronary intervention (PCI) with everolimus-eluting stents and coronary artery bypass grafting (CABG) are limited in patients with multivessel ...coronary artery disease.
This prospective, multicenter, randomized controlled trial was conducted in 27 international heart centers and was designed to randomly assign 1776 patients with angiographic multivessel coronary artery disease to receive PCI with everolimus-eluting stents or CABG. After inclusion of 880 patients (438 in the PCI group and 442 in the CABG group) between July 2008 and September 2013, the study was terminated early because of slow enrollment. The primary end point was the composite of death from any cause, myocardial infarction, or target vessel revascularization.
During a median follow-up of 11.8 years (interquartile range, 10.6-12.5 years; maximum, 13.7 years), the primary end point occurred in 151 patients (34.5%) in the PCI group and 134 patients (30.3%) in the CABG group (hazard ratio HR, 1.18 95% CI, 0.88-1.56;
=0.26). No significant differences were seen in the occurrence of a safety composite of death, myocardial infarction, or stroke between groups (28.8% and 27.1%; HR, 1.07 95% CI, 0.75-1.53;
=0.70), as well as the occurrence of death from any cause (20.5% and 19.9%; HR, 1.04 95% CI, 0.65-1.67;
=0.86). However, spontaneous myocardial infarction (7.1% and 3.8%; HR, 1.86 95% CI, 1.06-3.27;
=0.031) and any repeat revascularization (22.6% and 12.7%; HR, 1.92 95% CI, 1.58-2.32;
<0.001) were more frequent after PCI than after CABG.
In patients with multivessel coronary artery disease, there were no significant differences between PCI and CABG in the incidence of major adverse cardiac events, the safety composite end point, and all-cause mortality during the extended follow-up.
URL: https://www.
gov; Unique identifiers: NCT05125367 and NCT00997828.
This study sought to compare long-term outcomes of early surgery with a conventional treatment strategy in asymptomatic patients with severe mitral regurgitation (MR).
The timing of surgery in ...asymptomatic severe MR remains controversial.
From 1996 to 2009, 610 consecutive asymptomatic patients (364 men, 50 ± 14 years of age) with severe degenerative MR and preserved left ventricular function were evaluated prospectively. Early surgery was performed on 235 patients, and the conventional treatment strategy was chosen for 375 patients. We compared overall mortality, cardiac mortality, and cardiac events (operative mortality, cardiac mortality, repeat surgery, and urgent admission due to heart failure) between the 2 treatment strategies in the propensity score-matched cohort.
For the 207 propensity score-matched pairs, early surgery had a lower risk of cardiac mortality (hazard ratio HR: 0.109; 95% confidence interval CI: 0.014 to 0.836; p = 0.033) and cardiac events (HR: 0.216; 95% CI: 0.083 to 0.558; p = 0.002) than conventional treatment. On Cox proportional hazard model analysis, the risk of cardiac events was significantly lower in the early surgery group than in the conventional treatment group in patients aged 50 years of age and older (HR: 0.221; 95% CI: 0.086 to 0.567; p = 0.002), but not significantly different in those younger than 50 years of age (p = 0.20).
Compared with conservative management, early surgery is associated with significant long-term reductions of cardiac mortality and cardiac events in asymptomatic severe MR. These benefits were evident among patients age 50 years of age and older.
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