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Barton R.,Queens Center for Oncology and Haematology | English A.,East Riding of Yorkshire PCT | Nabb S.,University of Hull | Rigby A.S.,University of Hull | Johnson M.J.,University of Hull
Lung Cancer | Year: 2010

Background: Breathlessness remains a refractory symptom in malignant lung disease. Breathing training is an effective, non-pharmacological intervention but it is unclear how this should be delivered. This feasibility study aimed to assess recruitment and retention, best end point and variability of breathlessness scores in order to calculate sample size for a future study. Method: This was a single centre, randomised controlled non-blinded parallel group feasibility study. Eligible participants (breathless patients with intrathoracic malignancy) received three breathlessness management training sessions or a single session only. Follow-up was for eight weeks and endpoints were: numerical rating scales (NRS) of breathlessness severity; breathlessness distress; HADS questionnaire; coping (BriefCOPE and our NRS coping question); EQ-5D and EQ-VAS. Results: 22 patients were randomised over 12 months; 55% of expected recruitment from pilot data. Screening logs indicated this resulted, in part, from excluding patients who were receiving or who had recently received chemotherapy or radiotherapy. There was 40% drop-out by week four. The most useful NRS scores for breathlessness severity were for " worst" and " average" over past 24. h. From the variability data for " worst breathlessness" , a sample size of 270 should allow detection of a 30% improvement in area under the curve in the three-session group compared with single-session, (90% power; p=0.05, two-tailed; 2:1 randomisation single:three sessions) allowing 50% drop out at four weeks. Conclusions: The follow-on study will test the hypothesis that three sessions of training improve breathlessness better than a single session. It will include patients undergoing palliative anti-cancer therapy. Stratification by centre will allow for differences in rates of chemotherapy or radiotherapy and variations in breathlessness service configuration. © 2010 Elsevier Ireland Ltd. Source

Dhadda A.S.,Queens Center for Oncology and Haematology | Bessell E.M.,University of Nottingham | Scholefield J.,University of Nottingham | Dickinson P.,University of Nottingham | Zaitoun A.M.,University of Nottingham
Clinical Oncology | Year: 2014

Aims: The pathology of tumours after chemo/radiotherapy for locally advanced rectal cancer can be difficult to interpret. The ypTNM staging does not accurately predict outcomes. Therefore, we developed a new prognostic index for this purpose. Materials and methods: The Nottingham Rectal Cancer Prognostic Index (NRPI) is based on a study of 158 patients with locally advanced rectal cancer treated with preoperative chemo/radiotherapy at Nottingham University Hospital between April 2001 and December 2008. Patients were treated with radiotherapy to a dose of 50 Gy in 25 fractions over 5 weeks with/without concurrent capecitabine chemotherapy. Surgery was carried out after an interval of 6-10 weeks. Factors found to be significant on univariate analysis to predict for disease-free (DFS) and overall survival were further explored in multivariate analysis. The significant factors (Mandard tumour regression grade, perineural invasion, circumferential resection margin status and nodal status) were weighted to establish a score for the index. The median follow-up was 40 months (range 3-90 months). Results: On survival analysis, four distinct prognostic groups were found: Score 0 = excellent prognosis, 1-3 = good prognosis, 4-8 = moderate prognosis, 9-14 = poor prognosis. The NRPI significantly predicted both DFS and overall survival (P < 0.0001). DFS at 5 years was 95, 63, 25 and 0% for the four groups. On multivariate analysis the NRPI was found to be the strongest predictor of DFS including nodal and circumferential resection margin status (P < 0.0001). It was a stronger predictor of overall survival than the American Joint Committee on Cancer/Dukes staging (P < 0.0001). Conclusions: The NRPI allocates patients into distinct prognostic categories. This seems to be a much stronger predictive factor than the American Joint Committee on Cancer/Dukes staging. This requires further validation, but seems to be a useful clinical index for future studies. © 2014 The Royal College of Radiologists. Source

Smith A.,University of York | Howell D.,University of York | Patmore R.,Queens Center for Oncology and Haematology | Jack A.,St Jamess Hospital | Roman E.,University of York
British Journal of Cancer | Year: 2011

Background: Ascertainment of cases and disease classification is an acknowledged problem for epidemiological research into haematological malignancies.Methods: The Haematological Malignancy Research Network comprises an ongoing population-based patient cohort. All diagnoses (paediatric and adult) across two UK Cancer Networks (population 3.6 million, 2000 diagnoses annually, socio-demographically representative of the UK) are made by an integrated haematopathology laboratory. Diagnostics, prognostics, and treatment are recorded to clinical trial standards, and socio-demographic measures are routinely obtained. Results: A total of 10 729 haematological malignancies (myeloid2706, lymphoid8023) were diagnosed over the 5 years, that is, from 2004 to 2009. Descriptive data (age, sex, and deprivation), sex-specific age-standardised (European population) rates, and estimated UK frequencies are presented for 24 sub-types. The age of patients ranged from 4 weeks to 99 years (median 70.6 years), and the male rate was more than double the female rate for several myeloid and lymphoid sub-types, this difference being evident in both children and adults. No relationship with deprivation was detected.Conclusion: Accurate population-based data on haematological malignancies can be collected to the standard required to deliver reproducible results that can be extrapolated to national populations. Our analyses emphasise the importance of gender and age as disease determinants, and suggest that aetiological investigations that focus on socio-economic factors are unlikely to be rewarding. © 2011 Cancer Research UK All rights reserved. Source

Al Sa'D M.,University of Manchester | Graham J.,University of Manchester | Liney G.P.,Queens Center for Oncology and Haematology | Moore C.J.,Christie Medical Physics and Engineering
Physics in Medicine and Biology | Year: 2013

Comparison of dose distributions using the 3D gamma method is anticipated to provide better indicators for the quality assurance process than the 2.5D (stacked 2D slice-by-slice) gamma calculation, especially for advanced radiotherapy technologies. This study compares the accuracy of the 3D and 2.5D gamma calculation methods. 3D and 2.5D gamma calculations were carried out on four reference/evaluation 3D dose sample pairs. A number of analysis methods were used, including average gamma and gamma volume histograms. We introduce the concept of gamma-angle histograms. Noise sensitivity tests were also performed using two different noise models. The advantage of the 3D gamma method showed up as a higher proportion of points passing the tolerance criteria of 3% dose difference and 3 mm distance-to-agreement (DTA), with considerably lower average gamma values, a lower influence of the DTA criterion, and a higher noise tolerance. The 3D gamma approach is more reliable than the 2.5D approach in terms of providing comprehensive quantitative results, which are needed in quality assurance procedures for advanced radiotherapy methods. © 2013 Institute of Physics and Engineering in Medicine. Source

Langley R.E.,MRC Clinical Trials Unit | Stephens R.J.,MRC Clinical Trials Unit | Nankivell M.,MRC Clinical Trials Unit | Pugh C.,MRC Clinical Trials Unit | And 8 more authors.
Clinical Oncology | Year: 2013

Aims: Over 30% of patients with non-small cell lung cancer (NSCLC) develop brain metastases. If inoperable, optimal supportive care (OSC), including steroids, and whole brain radiotherapy (WBRT) are generally considered to be standard care, although there is no randomised evidence demonstrating that the addition of WBRT to OSC improves survival or quality of life. Materials and methods: QUARTZ is a randomised, non-inferiority, phase III trial comparing OSC + WBRT versus OSC in patients with inoperable brain metastases from NSCLC. The primary outcome measure is quality-adjusted life years (QALYs). QUARTZ was threatened with both loss of funding and early closure due to poor accrual. A lack of preliminary randomised data supporting the trial's hypotheses was thought to underlie the poor accrual, so, with no knowledge of the data, the independent trial steering committee agreed to the unusual step of releasing interim data. Results: Between March 2007 and April 2010, 151 (of the planned 534) patients were randomised (75 OSC + WBRT, 76 OSC). Participants' baseline demographics included median age 67 years (interquartile range 62-73), 60% male, 50% with a Karnofsky performance status <70; steroid usage was similar in the two groups; 64/75 (85%) received WBRT (20 Gy in five fractions). Median survival was: OSC + WBRT 49 days (95% confidence interval 39-61), OSC 51 days (95% confidence interval 27-57) - hazard ratio 1.11 (95% confidence interval 0.80-1.53) in favour of WBRT. Quality of life assessed using EQ-5D showed no evidence of a difference. The estimated mean QALYs was: OSC + WBRT 31 days and OSC 30 days, difference -1 day (95% confidence interval -12.0 to +13.2 days). Conclusion: These interim data indicate no early evidence of detriment to quality of life, overall survival or QALYs for patients allocated to OSC alone. They provide key information for discussing the trial with patients and strengthen the argument for continuing QUARTZ to definitively answer this important clinical question. © 2012 The Royal College of Radiologists. Source

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