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Milena Sant, MD EPAAC WP9 leader

Workshop for a. EUROPEAN HIGH RESOLUTION STUDY 6th November 2012 Malpensa airport , Milano. Study proposal frame. Milena Sant, MD EPAAC WP9 leader. Descriptive Studies and Health Planning Unit Istituto Nazionale Tumori, Milano, Italy. EPAAC WP9 Objectives

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Milena Sant, MD EPAAC WP9 leader

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  1. Workshop for a EUROPEAN HIGH RESOLUTION STUDY 6th November 2012 Malpensa airport , Milano Study proposalframe Milena Sant, MD EPAAC WP9 leader Descriptive Studies and Health Planning Unit Istituto Nazionale Tumori, Milano, Italy

  2. EPAAC WP9 Objectives • To map the main sources of cancer data in Europe and to identify the priority topics to be supported by the Partnership • To unify under a common website cancer burden indicators (incidence, mortality, survival, patterns of care and prevalence) provided by existing European activities • To individuate indicators of cancer costs and socioeconomic status to be used in population based studies • To develop a standardised approach for the collection of data on survivorship using population based cancer registries • To develop an inventory of statistical methods to analyse population based cancer data

  3. AIMS of the High-Resolution studies • To help understanding the reasons of differences in survival highlighted by the EUROCARE main analyses • To describe and compare patterns of cancer care between countries and regions • To study adherence to standard cancer care • To investigate the dissemination of innovative treatments in current clinical practice • To use updated tumour classifications, also aking use of biomolecular markers • To investigate the influence of comorbidity and metabolic factors on the prognosis of cancer patients By collecting more detailed clinical information than in the usual registry activity

  4. FURTHER AIMS of the High-Resolution studies • Update life status and clinical follow-up of the patients included in past High resolution studies time of recurrences and disease free interval • To investigate the feasibility of studying survivorship

  5. Past EUROCARE high resolution studies Italian EUROCARE-5 HR study, cases 2003-2005, follow-up end 2007 (breast, colorectal, lung, melanoma, lymphoprolipherative)

  6. EUROCARE HIGH RESOLUTION PUBLICATIONS Ten-year survival and risk of relapse for testicular cancer: a EUROCARE high resolution study Eur J Cancer 2007;43(3):585-92. What reasons lie behind long term survival differences for gastric cancer within Europe? Eur J Cancer. 2010 Apr;46(6):1086-92. Operative mortality after gastric cancer resection and long term survival differences across Europe. Br J Surg 2010 Feb;97(2):235-9. Differences in stage and therapy for breast cancer across Europe IntJCancer 2001; 93:894-90. Stage at diagnosis is a key explanation of differences in breast cancer survival across Europe IntJC 2003; 106: 416-422. Breast Carcinoma Survival in Europe and the United States: A Population-Based StudyCancer 2004; 100/4: 715-722. Prognostic Value of Morphology and Hormone Receptor Status In Breast Cancer – A Population-Based Study. BJC 2004 4;91(7):1263-8.

  7. Variation in “standard care” for breast cancer across Europe: a High Resolution study.Eur J Cancer. 2010 Jun;46(9):1528-36. Salad vegetables dietary pattern protects against HER2 positive breast cancer : a prospective Italian study.Int J Cancer 2007 15;121(4):911-4. Do pre-diagnostic drinking habits influence breast cancer survival? Tumori 2011;97(2):142-8 Understanding variation in survival for colorectal cancer in Europe: a EUROCARE high resolution study. Gut 2000;47:533-8. Comparison of regional patterns of care and survival for cancers of breast and colorectum in Europe.IARC Technical Publication No. 37, IARC Press Lyon 2003. Survival differences between European and US patients with colorectal cancer: role of stage at diagnosis and surgery. Gut 2005; 54: 268-273.

  8. Patterns of care for European colorectal cancer patients diagnosed 1996-98: a EUROCARE high Resolution study. Acta Oncol. 2010 Aug;49(6):776-83. Late outcomes of colorectal cancer treatment: a FECS –EUROCARE study.J Cancer Surviv. 2007 Dec;1(4):247-54. Prostate cancer treatment in Europe at the end of 1990s.Acta Oncol. 2009;48(6):867-73. Regional inequalities in cancer care persist in Italy and can influence survival.Cancer Epidemiol. 2012 Jul 5. Breast cancer survival in the US and Europe: A CONCORD high-resolution study. Int J Cancer. 2012 Jul 20.

  9. CRITICAL points of the EUROCARE High Resolution studies • Long time interval between data collection, quality checks, statistical analyses and publication of results • Thus published papers describe the past not the current situation • Very expensive to carry out • Representativeness with respect to incidence series • Number of cases and statistical power, robustness of results • Long-term survival difficult to estimate (re-update life status /recurrences, linkage with basic EUROCARE database not possible/not allowed)

  10. Strengths and achievements Registries proved able to collect HR data allowing generalized (population-based) conclusions: Variation in stage at diagnosis explained most survival variations for breast, colorectal and stomach cancer; treatment was a major survival determinant for testicular cancer

  11. Strengths and achievements • Presently many registries collect and analyze high resolution data • There is growing interest in investigating the effectiveness of new diagnostic and therapeutic procedures: HR studies can help • Interest in Outcomes research -- collaboration with: OECI, Alleanza Contro il Cancro, EuroCan Platform, EPAAC WP8on research • interest to link population and clinical data

  12. IS IT NOW THE TIME TO LAUNCH AN UPDATED EUROPEAN HIGH RESOLUTION STUDY?

  13. General study design and organization proposal Data management similar to EUROCARE- Survival • Uniform study protocol • Centralised data base, uniform quality checks • Same data access and publication rules, adapted to the HR Working group Cases included in the HR study: Sample of incident cancer cases for which the relevant HR data could be collected either Retrospectively or prospectively

  14. Prospective data collection: Advantages: Collection of clinical data could became part of the usual registry procedure, with no need to recuperate clinical documents that are archived elsewhere • Disavantages • Heavily dependent on the local registries procedures used for completing their files • Appropriate methods should be studied in order to ensure appropriate sampling and representativeness • Difficult to check data completeness • Need of long time interval to study survival

  15. Retrospective data collection • Advantages • It ensures representativeness with respect to incidence series (and population) • Allows inspecting and collecting the whole available clinical information and checking its completeness • Follow-up for life status available from EUROCARE-Surv  speed analyses • Disavantages • More expensive than prospective data collection • High proportion of missing data (?)

  16. Retrospectve data collection: • Randomly sampling an appropriate number of cases from the EUROCARE survival database (centralized) • From the latest available year of incidence, in most registries 2007 or later • Send record tracks to the relevant cancer registry for collection of HR clinical & Follow-up variables • Centralised data checking for format and variable consistency • Invalid /defective records back to the registries for appropiate corrections Linking HR and survival individual records helps speed analyses and reduces time lag between call for data and availability of results

  17. HR record structure & organisation Eurocare-5 record: Patient identification variables Date life status follow-up Specific High Resolution variables High resolution record Transmission to the central repository Quality Checks adherence to protocol, consistency,completeness EU High Resolution Data Base To CRs for Revisions and corrections NO OK

  18. Specific HR variables common for all cancers • Clinical characteristics, diagnosis • Way of diagnosis: screening, symptomatic/asymptomatic • Clinical and pathological TNM stage at diagnosis (or other cancer specific classifications) • Diagnostic examinations • Type of nodal examination (sentinel, lymphadenectomy) • Total/ metastatic N. lymph-nodes • Tumour morphology, grading • Molecular biomarkers (cancer- specific)

  19. Specific HR variables common for all cancers Treatment & Follow-up • Surgery, chemo, radio, target , hormonal • Type of treatment (adjuvant, neoadjuvant) • Tumour stage after neo-adjuvant treatment • Type of relapse • Date relapse • Cause of death Comorbidity • Presence of other diseases • Metabolic variables (BMI, glycaemia)

  20. Cancers where experience on HR studies exists • Most frequent cancers, represent public health issue, increasing incidence and survival • Mass screening in course in many countries • remarkable differences in care and survival across and within countries • New treatments available • Existence of guidelines or protocols for diagnosis and treament Breast Colorectal Lung • Frequent cancer, no overtime survival increase • Uniformely poor prognosis, but strongly dependent on stage and surgery

  21. Cancers where experience on HR studies exists Stomach • Incidence decreasing, but still highly frequent cancer • Poor prognosis • Differences in survival largely explained by subsite and stage • Most frequest cancer in men, incidence and survival increasing • Large differences in survival across countries • PSA diffusion and opportunistic screening impairs interpretation Prostate

  22. Cancers where experience on HR studies exists Skin melanoma • Unfrequent cancer, but incidence increasing in most EU countries • Large differences in survival across countries • Relatively favourable prognosis • Differences in survival largely explained by subsite and stage • Screening campaigns in course in some countries /opportunistic screeing • New treatments available/ under evaluation

  23. Cancers where experience on HR studies exists • Changing diagnostic criteria and classifications need accurate disease definition • new effective treatments available • Increase in survival, but mostly in wealthy countries • Long term prognosis still to be investigated • Outcomes depend on availability and access to good care Haematological malignancies

  24. Cancers where experience on HR studies exists Testis • Unfrequent cancer, but incidence increasing in most EU countries • Prognosis good in most countries, low survival largely depends on inadequate treatment • Outcomes reflect well the effectiveness of health systems • Death sentinel events (avoidable deaths)

  25. Other Cancer sites to be investigated Cervix uteri Ovary

  26. Orientative time plan Early 2013. Preparation and circulation of study protocol March – July 2013. Data collection by CRs March – October 2013. Centralised data check & corrections Within end 2013 – Preliminary data analyses Incidence 2007, Follow-up 2011–2012 first results early 2014

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