AimsQuality assurance in radiotherapy (QART) is essential to ensure the scientific integrity of a clinical trial. This paper reports the findings of the retrospective QART assessment for all centres that participated in PORTEC-3; a randomised controlled trial that compared pelvic radiotherapy with concurrent chemoradiotherapy to the pelvis followed by adjuvant chemotherapy. The trial showed an overall survival benefit for the addition of the chemotherapy in the management of women with high-risk endometrial cancer.Materials and methodsClinicians were invited to upload a randomly selected case/s treated at each of the participating sites. Panel reviewers analysed the contours to certify that the target volumes and organ at risk structures were contoured according to guidelines. The results were categorised into acceptable, minor variation, major variation or unevaluable. The radiotherapy plans were dosimetrically evaluated using the well-established Trans-Tasman Radiation Oncology Group (TROG) protocol.ResultsBetween August 2010 and January 2018, data from 146 patients of 686 consecutively treated patients were retrospectively reviewed. All 16 Australia and New Zealand and 71 of 77 international centres uploaded data for evaluation. In total, 3514 dosimetric and contour variables were reviewed. Of these, 3136 variables were deemed acceptable (89.2%), with 335 minor (9.6%) and 43 major variations (1.2%). Major contour variations included the clinical target volume vaginal vault, clinical target volume parametria and differential planning target volume vault expansion.ConclusionThe results of the QART assessment confirmed high uniformity and low rates of both minor and major deviations in contouring and dosimetry in all sites. This supports the safe introduction of the PORTEC-3 treatment protocol into routine clinical practice.
BACKGROUND AND PURPOSE:To improve quality and personalization of oncology health care, decision aid tools are needed to advise physicians and patients. The aim of this work is to demonstrate the clinical relevance of a survival prediction model as a first step to multi institutional rapid learning and compare this to a clinical trial dataset. MATERIALS AND METHODS:Data extraction and mining tools were used to collect uncurated input parameters from Illawarra Cancer Care Centre's (clinical cohort) oncology information system. Prognosis categories previously established from the Maastricht Radiation Oncology (training cohort) dataset, were applied to the clinical cohort and the radiotherapy only arm of the RTOG-9111 (trial cohort). RESULTS:Data mining identified 125 laryngeal carcinoma patients, ending up with 52 patients in the clinical cohort who were eligible to be evaluated by the model to predict 2-year survival and 177 for the trial cohort. The model was able to classify patients and predict survival in the clinical cohort, but for the trial cohort it failed to do so. CONCLUSIONS:The technical infrastructure and model is able to support the prognosis prediction of laryngeal carcinoma patients in a clinical cohort. The model does not perform well for the highly selective patient population in the trial cohort.
INTRODUCTION:Protocol deviations in Randomised Controlled Trials have been found to result in a significant decrease in survival and local control. In some cases, the magnitude of the detrimental effect can be larger than the anticipated benefits of the interventions involved. The implementation of appropriate quality assurance of radiotherapy measures for clinical trials has been found to result in fewer deviations from protocol. This paper reports on a benchmarking study conducted in preparation for the PORTEC-3 trial in Australasia.METHODS:A benchmarking CT dataset was sent to each of the Australasian investigators, it was requested they contour and plan the case according to trial protocol using local treatment planning systems. These data was then sent back to Trans-Tasman Oncology Group for collation and analysis.RESULTS:Thirty three investigators from eighteen institutions across Australia and New Zealand took part in the study. The mean clinical target volume (CTV) volume was 383.4 (228.5-497.8) cm(3) and the mean dose to a reference gold standard CTV was 48.8 (46.4-50.3) Gy.CONCLUSIONS:Although there were some large differences in the contouring of the CTV and its constituent parts, these did not translate into large variations in dosimetry. Where individual investigators had deviations from the trial contouring protocol, feedback was provided. The results of this study will be used to compare with the international study QA for the PORTEC-3 trial.
This conclusion presents some closing thoughts on corporate crime discussed in the various chapters of this book. It talks about the shifting dynamics of state-corporate relations, the meaning of a vulnerable corporation, and what it means to be pragmatic and utopian. The book seeks to demonstrate that the corporation cannot be effectively reformed, not through corporate social responsibility (CSR), not through regulation, not through tinkering with structures and functions such as is the stuff of corporate governance. It is emphasized that harm and crime are not marginal but central to corporate activity, generated through corporate personhood, and the techniques and mindsets of 'externalities', the corporation's dehumanising structure of irresponsibility, and its necessarily a-moral, calculative rationality. The book also clarifies how the corporate drive for profits kills, maims and steals from people as a matter of course …
The Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM) Radiation Oncology Specialty Group (ROSG) formed a series of working groups in 2011 to develop recommendations for guidance of radiation oncology medical physics practice within the Australasian setting. These recommendations are intended to provide guidance for safe work practices and a suitable level of quality control without detailed work instructions. It is the responsibility of the medical physicist to ensure that locally available equipment and procedures are sufficiently sensitive to establish compliance to these recommendations. The recommendations are endorsed by the ROSG, and have been subject to independent expert reviews. For the Australian readers, these recommendations should be read in conjunction with the Tripartite Radiation Oncology Reform Implementation Committee Quality Working Group: Radiation Oncology Practice Standards (2011), and Radiation Oncology Practice Standards Supplementary Guide (2011). This publication presents the recommendations of the ACPSEM ROSG Total Body Electron Irradiation Working Group and has been developed in alignment with other international associations. However, these recommendations should be read in conjunction with relevant national, state or territory legislation and local requirements, which take precedence over the ACPSEM recommendations. It is hoped that the users of this and other ACPSEM recommendations will contribute to the development of future versions through the Radiation Oncology Specialty Group of the ACPSEM. This document serves as a guideline for calibration and quality assurance of equipment used for TBE in Australasia.
Chronic rhinosinusitis (CRS) is a heterogeneous disease with an uncertain pathogenesis. Group 2 innate lymphoid cells (ILC2s) represent a recently discovered cell population which has been implicated in driving Th2 inflammation in CRS; however, their relationship with clinical disease characteristics has yet to be investigated.
INTRODUCTION:Hyperthermic mitomycin (HM) is a novel treatment modality for selected patients with high-risk non-muscle invasive bladder cancer (NMIBC). We sought to determine predictors of response to this therapy.PATIENTS AND METHODS:A longitudinal, cohort study of 97 patients with high-risk NMIBC treated with ≥4 HM instillations on a prophylactic schedule was conducted. The primary outcome was time-to-progression survival; secondary outcomes were overall survival, cancer-specific survival, and adverse events. Descriptive statistics, Kaplan-Meier survival analyses, Cox proportional hazards modelling, and univariate and multivariable regression were performed.RESULTS:The presence of initial complete response (CR; no evidence of disease at first check video-cystoscopy and urine cytology) post-HM treatment was an independent predictor of good response to HM. Female patients and those without carcinoma in situ (CIS) also appeared to respond better to the intervention. The overall bladder preservation rate at a median of 27 months was 81.4%; 17/97 (17.5%) patients died during the course of the study.CONCLUSIONS:High-risk NMIBC patients can be safely treated with HM and have good oncological outcome. However, those without an initial CR have a poor prognosis and should be counselled towards adopting other treatment methodologies such as cystectomy. Female gender and lack of CIS may be good prognostic indicators for response to HM.
Aims Two HIV-1 infected patients were studied post-haematopoietic stem cell transplant (HSCT) to determine effects on the viral reservoir. Methods HIV-1 Ag/Ab was measured by chemiluminescence microparticle immunoassay (CMIA) and western blot (WB). Specific CD4+T-cell responses were measured by CD25/CD134 up-regulation. HIV-1 RNA was measured in serum and HIV-1 DNA was measured in peripheral blood mononuclear cells (PBMCs) and CD4+T-cells by PCR. CCR5 phenotype in PBMC was determined by PCR. Results Patient A and B underwent HSCT for non-Hodgkin's lymphoma and acute myeloid leukemia, respectively. Both remained on antiretroviral therapy. Patient A experienced systemic graft-versus-host disease (GVHD), whereas Patient B developed skin GVHD. Patient A was heterozygous for the CCR5Δ32 mutation and Patient B was wild-type. Following HSCT, both patients had undetectable HIV-1 RNA in plasma, and undetectable HIV-1 DNA in PBMCs and CD4+T-cells. Antigen-specific CD4+T-cell responses were absent. Pre-transplant, Ag/Abs to HIV-1 was detectable. Post-transplant, patients had low-level Ag/Abs on CMIA, but trace (Patient A) and absent (Patient B) antibody by WB. Conclusion HSCT reduced the HIV-1 reservoir size in these two patients with undetectable HIV-1 RNA in serum and DNA in PBMC/CD4+T-cells and absent antigen-specific CD4+T-cell responses. A profound reduction in Ab to HIV was demonstrated in both patients by WB. Two HIV-1 infected patients were studied post-haematopoietic stem cell transplant (HSCT) to determine effects on the viral reservoir. HIV-1 Ag/Ab was measured by chemiluminescence microparticle immunoassay (CMIA) and western blot (WB). Specific CD4+T-cell responses were measured by CD25/CD134 up-regulation. HIV-1 RNA was measured in serum and HIV-1 DNA was measured in peripheral blood mononuclear cells (PBMCs) and CD4+T-cells by PCR. CCR5 phenotype in PBMC was determined by PCR. Patient A and B underwent HSCT for non-Hodgkin's lymphoma and acute myeloid leukemia, respectively. Both remained on antiretroviral therapy. Patient A experienced systemic graft-versus-host disease (GVHD), whereas Patient B developed skin GVHD. Patient A was heterozygous for the CCR5Δ32 mutation and Patient B was wild-type. Following HSCT, both patients had undetectable HIV-1 RNA in plasma, and undetectable HIV-1 DNA in PBMCs and CD4+T-cells. Antigen-specific CD4+T-cell responses were absent. Pre-transplant, Ag/Abs to HIV-1 was detectable. Post-transplant, patients had low-level Ag/Abs on CMIA, but trace (Patient A) and absent (Patient B) antibody by WB. HSCT reduced the HIV-1 reservoir size in these two patients with undetectable HIV-1 RNA in serum and DNA in PBMC/CD4+T-cells and absent antigen-specific CD4+T-cell responses. A profound reduction in Ab to HIV was demonstrated in both patients by WB.
The Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM) Radiation Oncology Specialty Group (ROSG) formed a series of working groups in 2011 to develop position papers for guidance of radiation oncology medical physics practice within the Australasian setting. These position papers are intended to provide guidance for safe work practices and a suitable level of quality control without detailed work instructions. It is the responsibility of the medical physicist to ensure that locally available equipment and procedures are sufficiently sensitive to establish compliance to these position papers. The recommendations are endorsed by the ROSG, have been subject to independent expert reviews. For the Australian audience, these recommendations should be read in conjunction with the Tripartite Radiation Oncology Practice Standards [1, 2]. This publication presents the recommendations of the ACPSEM OPACS and OIS Working Group (OISWG) and has been developed in alignment with other international associations. However, these recommendations should be read in conjunction with relevant national, state or territory legislation and local requirements, which take precedence over the ACPSEM position papers. It is hoped that the users of this and other ACPSEM position papers will contribute to the development of future versions through the Radiation Oncology Specialty Group of the ACPSEM.