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Cullen J.,University of Manchester | Saleem A.,University of Manchester | Swindell R.,Medical Statistics | Burt P.,Christie Hospital NHS Foundation Trust | Moore C.,North Technologies
Biomedical Signal Processing and Control | Year: 2010

As cancer therapy becomes more effective, allowing patients to live longer, the long-term morbidity of treatment assumes greater significance. Trastuzumab (Herceptin ®), a monoclonal antibody that targets the epidermal growth factor, has proven efficacy in breast cancer patients but is also known to be cardiotoxic. Left ventricular ejection fraction (LVEF), a measure of cardiac function, is commonly used to evaluate patients receiving trastuzumab by Multiple Gated Acquisition (MUGA) isotope scans. In this paper, we have assessed the utility of previously published ventricular synchrony parameters in patients undergoing trastuzumab therapy. In addition, we apply Approximate Entropy (ApEn) to MUGA images, as a new measure of cardiac dysfunction and have evaluated its utility in the same patients. A significant change in LVEF (p = 0.015) and ApEn (p = 0.020) but not ventricular synchrony measures were observed over the course of treatment in these patients. The results suggest that ApEn provides a useful measure of cardiac function and synchrony. © 2009 Elsevier Ltd. All rights reserved.

Farnell D.J.J.,University of Manchester | Mandall P.,Clinical Oncology | Anandadas C.,Clinical Oncology | Routledge J.,Clinical Oncology | And 7 more authors.
Radiotherapy and Oncology | Year: 2010

Purpose: To improve a questionnaire used to collect patient-reported outcomes from patients with early stage prostate cancer treated with brachytherapy. A secondary aim was to adapt the Late Effects of Normal Tissue (LENT) subjective toxicity questionnaire for use to collect Common Terminology Criteria for Adverse Events (CTCAE) data, the current preferred platform for assessing radiation toxicity. Materials and methods: Three hundred and seventy-seven patients were treated with permanent iodine-125 seed implant brachytherapy for early prostate cancer. Toxicity data were collected before and at nine time points post-treatment (0-36 months). Compliance rates for patients completing individual items and item-subsection correlation coefficients were calculated. A factor analysis was carried out to analyse responses to the questionnaire and identify less informative questions, which could be removed. Cronbach's α coefficient was used to measure reliability. Results: Two thousand one hundred and eighty-eight questionnaires were analysed. There was poor compliance for questions specifically relating to operations and bowel medication. We found that the division of the questionnaire into subsections based on anatomical site was reasonable and that certain items could be safely removed. The high mean value for Cronbach's α across all questionnaires (0.752; 95% CI: 0.726-0.779) indicated that the questionnaire was reliable. Fifteen of the 44 questions were removed from the original questionnaires. Questions on urinary incontinence severity, management of urinary and bowel incontinence, effects of reduced flow of urine and the effects of symptoms on activity of daily living and change in sexual function were required to adapt the LENT subjective questionnaire for use to collect CTCAE data. Conclusions: A questionnaire, validated over 6 years to collect LENT subjective data were adapted and is a reliable approach for collecting CTCAE data after prostate brachytherapy. © 2010 Elsevier Ireland Ltd. All rights reserved.

Grassi P.,Medical Oncology Unit 1 | Verzoni E.,Medical Oncology Unit 1 | Mariani L.,Medical Statistics | De Braud F.,Medical Oncology Unit 1 | And 3 more authors.
Clinical Genitourinary Cancer | Year: 2013

Background: Pancreatic metastasis accounts for 2% to 11% of all mRCC cases. The prognostic value of pancreatic metastases in the era of TTs is unclear. We evaluated outcomes in a cohort of mRCC patients with pancreatic metastases (PmRCC) who were treated with TTs. Patients and Methods: We retrospectively reviewed the records of 354 mRCC patients treated at our institute between January 2005 and June 2012. Differences in terms of OS between this unselected cohort of mRCC patients and a subgroup of patients with PmRCC were investigated. Kaplan-Meier and log-rank test methods were used to evaluate OS. Results: In total, 24 PmRCC (7%) patients were identified, and were compared with a cohort of 330 mRCC patients with metastasis at other sites. Pancreatic metastases were synchronous in 3 patients, and they were metachronous in 11 patients. Surgical resection of pancreatic metastases was performed in 2 (8%) patients. At a maximum follow-up of 89 months (median, 51 months), median OS was 39 months in PmRCC patients, vs. 23 months in the mRCC patient group (P =.0004). Conclusion: Among mRCC patients treated with TTs, the presence of pancreatic metastasis seems to be associated with a longer survival than the presence of metastasis at other sites. © 2013 Elsevier Inc. All rights reserved.

Iversen L.,Primary Care | Hannaford P.C.,Primary Care | Lee A.J.,Medical Statistics | Fielding S.,University of Aberdeen
British Journal of General Practice | Year: 2010

Background Although many individuals have multiple lifestyle risk factors, tew studies have investigated the impact of lifestyle risk factor combinations among women. Aim To investigate the relationship between individual and combinations of lifestyle risk factors in middle-aged women with subsequent mortality, and to estimate the associated population attributable risks. Design of study Prospective cohort study. Setting Royal College of General Practitioners' (RCGP) Oral Contraception Study, UK. Method In 1994-1995, women remaining under follow-up in the RCGP Oral Contraception Study were sent a lifestyle survey, from which modifiable risk factors were identified: pack-years smoked, physical inactivity, never drinking versus consuming at least 7 units of alcohol weekly, and being underweight, overweight, or obese. The cohort was followed to December 2006 or death. Population attributable risks were calculated. Results Of 10 059 women studied, 896 died. Pack-years smoked (11-20 years: adjusted hazard ratio [HR] = 1.82, 95% confidence interval [Cl] = 1.46 to 2.27; >20 years: adjusted HR = 2.34, 95% Cl = 2.00 to 2.74); never drinking alcohol (adjusted HR = 1.66, 95% Cl = 1.34 to 2.05); being underweight (adjusted = HR 1.66, 95% Cl = 1.03 to 2.68); and physical inactivity (<15 hours/week: adjusted HR = 1.73, 95% Cl = 1.46 to 2.04) were significantly associated with mortality compared with their respective reference group. Women with multiple lifestyle risk factors had higher mortality risks than those reporting one factor. The population attributable risk of the combination of smoking, physical inactivity, body mass index outside normal range, and alcohol (never drinking or excess intake) was 59% (95% Cl = 31 % to 78%). Conclusion Assuming a causal relationship between lifestyle and mortality, avoidance of four lifestyle risk factors would have prevented 60% of the deaths. The importance of avoiding smoking and undertaking physical inactivity during midlife should continue to be emphasised. © British Journal of General Practice 2010.

Martinez-Lozano Sinues P.,National Research Council Italy | Martinez-Lozano Sinues P.,ETH Zurich | Landoni E.,University of Milan | Miceli R.,Medical Statistics | And 6 more authors.
Journal of Breath Research | Year: 2015

Breath analysis represents a new frontier in medical diagnosis and a powerful tool for cancer biomarker discovery due to the recent development of analytical platforms for the detection and identification of human exhaled volatile compounds. Statistical and bioinformatic tools may represent an effective complement to the technical and instrumental enhancements needed to fully exploit clinical applications of breath analysis. Our exploratory study in a cohort of 14 breast cancer patients and 11 healthy volunteers used secondary electrospray ionization-mass spectrometry (SESI-MS) to detect a cancer-related volatile profile. SESI-MS full-scan spectra were acquired in a range of 40-350 mass-to-charge ratio (m/z), converted to matrix data and analyzed using a procedure integrating data pre-processing for quality control, and a two-step class prediction based on machine-learning techniques, including a robust feature selection, and a classifier development with internal validation. MS spectra from exhaled breath showed an individual-specific breath profile and high reciprocal homogeneity among samples, with strong agreement among technical replicates, suggesting a robust responsiveness of SESI-MS. Supervised analysis of breath data identified a support vector machine (SVM) model including 8 features corresponding to m/z 106, 126, 147, 78, 148, 52, 128, 315 and able to discriminate exhaled breath from breast cancer patients from that of healthy individuals, with sensitivity and specificity above 0.9. Our data highlight the significance of SESI-MS as an analytical technique for clinical studies of breath analysis and provide evidence that our noninvasive strategy detects volatile signatures that may support existing technologies to diagnose breast cancer. © 2015 IOP Publishing Ltd.

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