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Milena Sant, MD EPAAC WP9 leader Descriptive Studies and Health Planning Unit Istituto Nazionale Tumori, Milano, Italy EUROPEAN HIGH RESOLUTION STUDY 6th.

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Presentation on theme: "Milena Sant, MD EPAAC WP9 leader Descriptive Studies and Health Planning Unit Istituto Nazionale Tumori, Milano, Italy EUROPEAN HIGH RESOLUTION STUDY 6th."— Presentation transcript:

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

2 EPAAC WP9 Objectives 1. To map the main sources of cancer data in Europe and to identify the priority topics to be supported by the Partnership 2. To unify under a common website cancer burden indicators (incidence, mortality, survival, patterns of care and prevalence) provided by existing European activities 3. To individuate indicators of cancer costs and socioeconomic status to be used in population based studies 4. To develop a standardised approach for the collection of data on survivorship using population based cancer registries 5. To develop an inventory of statistical methods to analyse population based cancer data

3 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 AIMS of the High-Resolution studies By collecting more detailed clinical information than in the usual registry activity

4 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 FURTHER AIMS of the High-Resolution studies

5 Past EUROCARE high resolution studies Year diagnosis Breast Colorectal Testis Stomach Prostate Italian EUROCARE-5 HR study, cases , follow-up end 2007 (breast, colorectal, lung, melanoma, lymphoprolipherative)

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

7 Variation in standard care for breast cancer across Europe: a High Resolution study. Eur J Cancer Jun;46(9): Salad vegetables dietary pattern protects against HER2 positive breast cancer : a prospective Italian study. Int J Cancer ;121(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: Comparison of regional patterns of care and survival for cancers of breast and colorectum in Europe. IARC Technical Publication No. 37, IARC Press Lyon Survival differences between European and US patients with colorectal cancer: role of stage at diagnosis and surgery. Gut 2005; 54:

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


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

14 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 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

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 Eurocare-5 record: Patient identification variables Date life status follow-up Specific High Resolution variables High resolution record HR record structure & organisation Quality Checks adherence to protocol, consistency,completeness EU High Resolution Data Base Transmission to the central repository To CRs for Revisions and corrections NOOK

18 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) Specific HR variables common for all cancers

19 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) Specific HR variables common for all cancers

20 Cancers where experience on HR studies exists Breast Colorectal 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 Lung Frequent cancer, no overtime survival increase Uniformely poor prognosis, but strongly dependent on stage and surgery

21 Prostate 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 Cancers where experience on HR studies exists

22 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 Cancers where experience on HR studies exists

23 Haematological malignancies 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 Cancers where experience on HR studies exists

24 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) Cancers where experience on HR studies exists

25 Other Cancer sites to be investigated Cervix uteri Ovary

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

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