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Describing Patterns of Care in Pancreatic Cancer – a Population-Based Study Running Title: Population-Based Pancreatic Cancer Patterns of Care

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Describing Patterns of Care in Pancreatic Cancer – a Population-Based Study Running Title: Population-Based Pancreatic Cancer Patterns of Care THIS IS A PRE-PRINT VERSION OF AN ARTICLE PUBLISHED IN FINAL FORM IN PANCREAS 2015; 44 (8) 1259-65. Title: Describing Patterns of Care in Pancreatic Cancer – a population-based study Running Title: Population-based Pancreatic Cancer Patterns of Care Elizabeth A. Burmeister, MSc Population Health, QIMR Berghofer Medical Research Institute and the University of Queensland, Brisbane, Australia Dianne L. O’Connell, PhD Cancer Research Division, Cancer Council NSW and theUniversity of Newcastle, New South Wales, Australia Vanessa L. Beesley, PhD Population Health, QIMR Berghofer Medical Research Institute, Brisbane, Australia David Goldstein, FRACP Department of Medical Oncology, Prince of Wales Hospital and the University of New South Wales, New South Wales, Australia Helen M. Gooden, MPh Sydney Nursing School, University of Sydney, New South Wales,, Australia Monika Janda, PhD Queensland University of Technology, Brisbane, Australia Susan J. Jordan, PhD Population Health, QIMR Berghofer Medical Research Institute, Brisbane, Australia Neil D. Merrett, FRACS School of Medicine, University of Western Sydney, New South Wales,, Australia Madeleine E. Payne, BSc Population Health, QIMR Berghofer Medical Research Institute, Brisbane, AustraliaDavid Wyld, FRACP Department of Medical Oncology, Royal Brisbane and Women’s Hospital, Brisbane, Australia Rachel E. Neale, PhD Population Health, QIMR Berghofer Medical Research Institute, Brisbane, Australia for The Pancreatic Cancer Patterns of Care Study Group Corresponding author: Elizabeth Burmeister QIMR Berghofer Medical Research Institute 300 Herston Road Herston Queensland Australia 4029 Ph: + 61 7 38453547 Fax: + 61 7 38453502 Email: [email protected] This study was funded by a National Health and Medical Research Council (NHMRC) (Australia) project grant (#613654). RE Neale is funded by a senior research fellowship, SJ Jordan by a career development fellowship and E Burmeister by a doctoral scholarship, all from the NHMRC. 1 Abstract Objectives: Despite pancreatic cancer being the 5th highest cause of cancer death in developed regions there is a paucity of population-based management details for patients with pancreatic cancer. The objective of this study was to reflect on current practice and outcomes to facilitate future improvement. Methods: A comprehensive population-based patterns-of-care study in two Australian states was conducted. Patients diagnosed with pancreatic adenocarcinoma between July 2009 and June 2011 were identified by cancer registries, and detailed clinical data were collected from medical records. Results: Data were collected for 1863 patients, 96% of those eligible. The majority resided in major cities, their median age was 72 years and 54% were men. Over half the cases (58%) had metastatic disease at diagnosis. Resection was attempted for 20% of patients but only completed in 15%. The uptake of adjuvant chemotherapy (76%) and the proportion alive at one-year (22%) were higher than reported in previous population-based reports. Of those with no complete surgical resection, 43% received palliative chemotherapy. Conclusion: This population-based overview of the management of patients with pancreatic cancer suggests that, despite evidence that the proportion surviving and the use of adjuvant chemotherapy has increased, there may still be under-utilisation of cancer-directed therapies. Introduction Pancreatic cancer is the 14th most common type of cancer diagnosed in the developed world.1 It has a median survival of 6 months and an overall five-year survival of less than 5%. Consequently it is the 5th most common cause of cancer death in developed regions,1 and current projections suggest that it will be the second leading cause of cancer death within 10 years.2, 3 Surgery offers the only possibility for cure, but the majority of patients present with metastatic or locally advanced disease which precludes curative resection. Co-morbidities and performance status in an older patient cohort may also influence the decision to withhold a radical surgical resection. Those patients who undergo an oncologically complete resection have five-year survival of approximately 15 to 20% compared with less than 5% for the 80% of patients who are inoperable.4 Chemotherapy and radiotherapy are treatment options in neo-adjuvant, adjuvant or palliative settings, but these modalities offer minimal benefit in terms of survival.5-7 Best practice recommendations for management of pancreatic cancer were compiled by a group of experts at the World Congress on Gastrointestinal Cancer in 2006 (Barcelona 2006),8 with additional recommendations for management of metastatic cancer made in 2012.9 The United 2 States National Comprehensive Cancer Network (NCCN) has also published clinical practice guidelines for pancreatic cancer.10 Despite these publications it is apparent that there is considerable variation in the quality of management and care of patients with pancreatic cancer.11-13 There have been few attempts to describe management of pancreatic cancer at a population level, but evidence from the limited population-based studies that have been conducted in Australia (2011), Europe (2009) and the USA (2007) suggest that multimodality therapies are underutilised and that this may be related to patient and/or health-service characteristics.14,15,16 Data reflecting the current status of the variability in the management of patients with pancreatic cancer and the factors associated with the choice of different treatments is required. This will support changes in clinical practice and policy needed to optimise the care of all patients with this disease. We have therefore carried out a population-based study in two Australian states where over 50% of Australians reside. In this report we describe the methods and patient cohort and provide a broad overview of care. Materials and Methods Patient identification and data from Cancer Registries Eligible patients were those who were aged 18 years or older, notified to the Queensland (QLD) Cancer Registry between 1 July 2009 and 30 June 2011 or to the New South Wales (NSW) Cancer Registry (Cancer Institute NSW) between 1 July 2009 and 31st December 2010 with a diagnosis of pancreatic ductal adenocarcinoma (ICD-10 code C25). From the cancer registries we obtained the patients’ sex, age at diagnosis, date of initial diagnosis, name and address of the treating clinician at the time of the initial diagnosis, and the hospital where the diagnosis was made (if applicable). Where available we also obtained the date of death. The cancer registries also provided the statistical local area (SLA (QLD)) or local government area (LGA (NSW)) for the patients’ residential locations. We used these to allocate patients to a level of socioeconomic status using the Socio-Economic Indexes for Areas (SEIFA) 201117 and geographical location based on the Accessibility/Remoteness Index of Australia (ARIA+) 2011.18 The Index of Relative Socio-economic Disadvantage (IRSD) (SEIFA 2011) is a general index of disadvantage which uses data including income, home-ownership and occupation, captured in the five-yearly census, to rank areas in Australia according to relative socioeconomic advantage and disadvantage. We categorised patients according to their IRSD score by using the quintile cut- points for the state-specific population distributions. ARIA+ is derived from measures of road distances between populated localities and service centres. Areas are categorised as major cities, 3 inner regional, outer regional, remote or very remote. Due to the small population in remote and very remote areas these were grouped with outer regional areas. Ethical review: We obtained approval to access medical records without patient consent under the QLD Public Health Act and under the guidelines of the NSW Privacy Act. Ethics approval was obtained from the QIMR Berghofer Medical Research Institute, the Royal Brisbane and Women’s Hospital (on behalf of all public hospitals in QLD) and by the NSW Population and Health Services Research Ethics Committee. Additional ethics approvals and individual site-specific approvals were obtained for each public hospital and private hospital as required. All data collected for review was de- identified at source. Clinical Data Collection: Research nurses accessed medical records for each patient, commencing with the record from the facility where the diagnosis was made if possible. The nurses used a standardised case report form (CRF) to abstract very detailed data about patient management from the medical record. Discharge summaries and correspondence were checked for evidence of referral to other centres for further management, and medical records at these centres were also reviewed. Information about initial presentation and investigations: We captured information about initial symptoms, investigations and disease stage according to the International Union Against Cancer (UICC 6th Edition) tumour node metastasis classification system.19 The tumour (T), node (N) and metastatic (M) status used to stage the disease was obtained from pathology reports on resection or, for those with no resection or missing TNM data, from initial investigations including imaging. We also classified patients according to the treating clinician’s assessment of whether the tumour was resectable or not. Initial Eastern Cooperative Oncology Group (ECOG) performance status and co-morbidities, such as cardiovascular disease, respiratory disease, renal impairment,
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