Search

This randomized trial of fractionation after breast reconstruction (FABREC) sought to compare quality-of-life (QOL) and clinical outcomes of hypofractionated (HF) vs. conventionally-fractionated (CF) postmastectomy radiation therapy (PMRT) in the setting of immediate prosthetic reconstruction. Between 3/2018 and 11/2021, 400 patients at 18 centers with Stage 0-III breast cancer and immediate placement of tissue expander (TE) or implant (I) after mastectomy were randomized 1:1 to HF or CF photon PMRT. Respective doses in the two arms were 42.56 Gy/16 fractions to the chest wall (CW), with or without axillary/supraclavicular lymph node (LN) radiation (39.9 Gy/15 fractions) and 50 Gy in 25 fractions to CW (46-50 Gy to axillary LNs). A boost was not permitted; bolus was used at physician discretion. CW toxicity was defined as any grade ≥3 adverse event (CTCAE) after PMRT initiation. Patients were censored at study withdrawal or at diagnosis of distant recurrence. Participants completed QOL instruments (FACT-B, BREAST-Q, Lymph-ICF) at baseline, 6, 12 and 18-months from PMRT initiation. Questions regarding financial burden were included with the 6-month survey. Primary endpoint of the study was improvement in the Physical Well-Being (PWB) domain of FACT-B at 6 months with pre-specified stratification by age (younger than 45 vs. 45 years or older). QOL scores were compared using Student's t-test. Median follow-up for the 385 patients analyzed was 31.8 months (range, 6.9-54.4); median age was 47.0 years (range, 23-79). Preoperative chemotherapy was used in 67.8% and preoperative endocrine therapy (ET) in 21.5% of the cohort. There were 16 distant (8 in each arm), and 2 local-regional (1 in each arm) recurrences. CW toxicity occurred in 35 patients (19 HF, 16 CF, p=0.58) at medians of 3.4 and 4.8 months after RT initiation in the HF and CF arms, respectively (p=0.82). Post-operative infection before RT (HR=3.31, p=0.03), irradiation of TE vs I (HR=7.74, p=0.046), preoperative endocrine therapy (HR=3.45, p=0.0007) and number of LNs removed (HR=1.06/node, p=0.02) were significant for developing CW toxicity on multivariate analysis, while fractionation was not (HF HR=1.19, p=0.63). There was no significant difference in overall change in PWB scores at 6 months between the two treatment arms (p=0.71) or separately in younger (p=0.15) and older cohorts (p=0.27). However, HF patients younger than 45 were less bothered by side-effects of treatment (p=0.045) and nausea (p=0.02) vs. CF patients younger than 45. Among patients who took unpaid time off from work during treatment (n=51), those receiving HF required fewer hours off than those receiving CF (73.7 vs. 125.8, p=0.046). Physical well-being and overall toxicity profile of HF PMRT were comparable between HF and CF PMRT. HF was associated with better 6-month QOL in some domains among younger patients. Our early results support the use of HF PMRT in the setting of TE- or implant-based breast reconstruction. [ABSTRACT FROM AUTHOR]

BACKGROUND: Anemia augments the already high rates of fatal and major nonfatal cardiovascular and renal events in individuals with type 2 diabetes. In 2004, we initiated the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT). This report presents the baseline characteristics and therapies of TREAT participants and subgroups defined by the presence or absence of overt proteinuria and history of cardiovascular disease. The design of TREAT and baseline characteristics also are compared with 2 recent trials of nondialysis patients with chronic kidney disease (CKD) in which treatment with another erythropoiesis-stimulating agent targeting greater hemoglobin levels had either a neutral or adverse effect on clinical outcomes. STUDY DESIGN: Randomized trial. SETTING & PARTICIPANTS: 4,044 participants with type 2 diabetes, CKD (defined as estimated glomerular filtration rate of 20 to 60 mL/min/1.73 m(2)), and anemia (hemoglobin < or = 11 g/dL) from 24 countries. INTERVENTION: Darbepoetin alfa to attempt to increase hemoglobin levels to 13 g/dL compared with placebo. OUTCOMES: TREAT is an event-driven design to continue until approximately 1,203 patients experience a primary event: the composite end point of death or cardiovascular morbidity (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia). The composite end point of death or need for long-term renal replacement therapy also is a primary end point. CONCLUSIONS: With several-fold more patient-years and a placebo arm, TREAT will provide a robust estimate of the safety and efficacy of darbepoetin alfa and generate prospective data regarding the risks of major cardiovascular and renal events in a contemporarily managed cohort of patients with type 2 diabetes, CKD, and anemia. Copyright © 2009 National Kidney Foundation, Inc. [ABSTRACT FROM AUTHOR]

Abstract: The development of low decontaminated mixed oxide (MOX) fuel, which contains minor actinoides (MA) and fission products (FP), is in progress to established Advanced Fast Reactor (FR) Fuel Cycle system. This paper describes the study on the sintering characteristics and the physical properties of MOX fuel containing Am, Np, and simulated FP. MOX powder containing Am, Np and simulated FP were sintered at high temperature in various oxygen partial pressure. From the result of ceramography, it is found that the grain growth rate of the pellets sintered in high oxygen partial pressure is high. From the result of EPMA analysis (Pu, Am, Ln) oxide was observed in the pellets. The melting points of the pellets with oxygen to metal (O/M) ratio of 1.95 are higher than those with O/M ratio of 1.98. This tendency is similar to that of MOX fuel containing about 30% Pu. [Copyright &y& Elsevier]

Rock mass characterization is required for many applications in rock engineering practice including excavation design, support design, stope design, amongst others. For these purposes, it is necessary to obtain design input parameters such as deformation moduli and strength parameters for numerical modeling. Although such parameters can ultimately be determined from in situ tests, at the preliminary design stage, where access to underground is limited, the practical way to obtain these parameters is to apply a rock mass classification system to characterize the rock mass and estimate the rock mass properties. Over the years, many classification systems, such as RQD, Rock Mass Rating, Q and Geological Strength Index (GSI) systems, have been developed. Amongst them, the Q system is widely used for rock support system design and the GSI system is used for estimating design parameters. The GSI system is the only rock mass classification system that is directly linked to engineering parameters such as Mohr–Coulomb, Hoek–Brown strength parameters or rock mass modulus. However, the application of the existing GSI system is hindered by the facts that the use of the system is to some extent subjective and requires long-term experience.In the present study, a quantitative approach to assist in the use of the GSI system is presented. It employs the block volume and a joint condition factor as quantitative characterization factors. The approach is built on the linkage between descriptive geological terms and measurable field parameters such as joint spacing and joint roughness. The newly developed approach adds quantitative means to facilitate use of the system, especially by inexperienced engineers.The GSI system is applied to characterize the jointed rock masses at two underground powerhouse cavern sites in Japan. GSI values are obtained from block volume and joint condition factor, which in turn are determined from site construction documents and field mapping data. Based on GSI values and intact rock strength properties, equivalent Mohr–Coulomb strength parameters and elastic modulus of the jointed rock mass are calculated and compared to in situ test results. The point estimate method is implemented to approximate the mean and variance of the mechanical properties of the jointed rock masses. It is seen that both the means and variances of strength and deformation parameters predicted from the GSI system are in good agreement with field test data. [Copyright &y& Elsevier]

Aim: To determine the diagnostic accuracy of computed tomography (CT)-guided percutaneous cutting needle biopsy (PCNB) for thymic tumours in accordance with the World Health Organization (WHO) classification. Material and methods: We retrospectively analysed a consecutive series of 138 cases in which CT-guided PCNB had been performed for an anterior mediastinal tumour. Its sensitivity and specificity for thymic epithelial tumours were evaluated, and the concordance between the histopathological diagnosis according to the WHO classification of thymic tumours based on PCNB and the diagnosis is based on the surgical specimens was assessed by Kappa statistic. Results: The diagnostic sensitivity and specificity of CT-guided PCNB for thymic tumours were 93.3 and 100%, respectively. The overall concordance between the diagnosis according to the WHO classification established by PCNB specimen and by the surgical specimen was 79.4% (weighted kappa=0.79). Conclusion: CT-guided PCNB is a reliable method of diagnosing thymic tumours, and there was good concordance for the WHO classification between the diagnosis based on CT-guided PCNB specimen and that based on the surgical specimen. [Copyright &y& Elsevier]