Quality assurance of axillary radiotherapy in the EORTC AMAROS trial 10981/22023: the dummy run

Purpose: To assess and if needed improve the compliance of participating institutions to the radiotherapy guidelines of the EORTC AMAROS trial 10981/22023 comparing axillary radiotherapy to axillary surgery in sentinel node positive patients with early stage breast cancer. Materials and methods: A transverse contour and a frontal view radiograph of the axillary region of a 'dummy' patient were sent to all institutions intending to participate in the trial with the request to produce a radiotherapy treatment plan according to the protocol guidelines. Additional information on dose prescription, the treatment technique and field matching with breast fields and internal mammary lymph node fields was requested in a questionnaire. Results: Eighteen institutions have performed the dummy run. At first assessment, the dose was not specified according to the protocol in seven cases, while two institutions did not comply with the dose prescription of 50 Gy in 25 fractions. Dose heterogeneity was over 20% in 10 institutions, caused by the use of a two-field technique in eight cases. Ten institutions did not apply special techniques to obtain non-overlapping match planes. In 10 cases, one or more field borders or blocks were positioned incorrectly. Following recommendations from the quality assurance committee given to the participating institutions on an individual basis, 10 institutions adapted their technique. Thereafter, 16 institutions could be accepted for trial participation. Conclusions: A number of potential protocol deviations were found at first assessment. Since recommendations led to a large number of adaptations by the participants, a considerable improvement in protocol compliance and inter-institutional consistency was achieved. (C) 2003 Elsevier Ireland Ltd. All rights reserve

Is contrast enhancement required to visualize a known breast tumor in a pre-operative CT scan?

AbstractBackground and purposeA pre-operative CT scan with contrast enhancement (CE) has recently been proposed to improve tumorbed delineation in breast conserving therapy. However, it is not clear whether CE is required for visualization of a known breast tumor. The main aims of this study were to compare the sensitivity of a CE-CT scan with a native CT scan (i.e. without CE) and to identify characteristics predictive for the requirement of CE.Patients and methodsBoth a CE-CT and a native CT were made in 58 breast cancer patients (age 37–75yr), prior to breast conserving surgery. Visibility of the tumor on CT was scored by three observers (clearly visible/doubtful/not visible). Age, tumor size, palpable tumor yes/no, histology, and visibility on mammography were analyzed with respect to the visibility of the tumor on the native CT.ResultsThe sensitivity for tumor detection was better for CE-CT (95%) than for native CT (83%) (p<0.001). Only mammographic visibility scores appeared to be significantly correlated with the visibility of the tumor on the native CT (p=0.013).ConclusionIn most patients CE is not required to visualize a known breast tumor. Mammographic visibility is a good parameter to decide on the use of CE

Set-up verification and 2-dimensional electronic portal imaging device dosimetry during breath hold compared with free breathing in breast cancer radiation therapy

Purpose: To compare set-up and 2-dimensional (2D) electronic portal imaging device (EPID) dosimetry data of breast cancer patients treated during voluntary moderately deep inspiration breath hold (vmDIBH) and free breathing (FB). Methods and materials: Set-up data were analyzed for 29 and 51 consecutively treated patients, irradiated during FB and vmDIBH, respectively. Of the 51 vmDIBH patients, the first 25 had undergone an extra trained computed tomography (CT) scan and used an additional "breathing stick" (vmDIBH_trained). The last 26 patients did not use the breathing stick and did not undergo a trained CT (vmDIBH_untrained). The delivered 2D transit dose was measured with EPID in 15 FB and 28 vmDIBH patients and compared with a 2D predicted dose by calculating global gamma values ?? using 5% and 5 mm as dose difference and distance-to-agreement criteria, respectively. Measurements with a percentage of pixels with an absolute gamma value > 1 (|??| > 1) greater than 10% were classified as deviating. Results: Only small, sub-millimeter differences were seen in the set-up data between the different patient groups. The mean of means, systematic error, and random error ranged from - 0.6 mm to 3.3 mm. The percentage of pixels with |??| > 1 for all patients was 9.8% (2-25.8). No statistically significant differences were observed between the patient groups. In total, 38% of the gamma images were classified as deviating: 43.6% in vmDIBH_untrained patients compared with 38.0% in vmDIBH_trained patients and 33.3% in FB patients (P >.05). Conclusion: Both set-up and 2D EPID dosimetry data indicate that reproducibility of radiation therapy for patients treated during FB and vmDIBH is similar. Small but not significant differences in 2D EPID dosimetry were observed. Further investigation with 3-dimensional EPID dosimetry is recommended to investigate the clinical relevance of deviant gamma images

Effects of alirocumab on cardiovascular and metabolic outcomes after acute coronary syndrome in patients with or without diabetes: a prespecified analysis of the ODYSSEY OUTCOMES randomised controlled trial

Background After acute coronary syndrome, diabetes conveys an excess risk of ischaemic cardiovascular events. A reduction in mean LDL cholesterol to 1.4-1.8 mmol/L with ezetimibe or statins reduces cardiovascular events in patients with an acute coronary syndrome and diabetes. However, the efficacy and safety of further reduction in LDL cholesterol with an inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9) after acute coronary syndrome is unknown. We aimed to explore this issue in a prespecified analysis of the ODYSSEY OUTCOMES trial of the PCSK9 inhibitor alirocumab, assessing its effects on cardiovascular outcomes by baseline glycaemic status, while also assessing its effects on glycaemic measures including risk of new-onset diabetes