milena sant, md epaac wp9 leader descriptive studies and health planning unit istituto nazionale...
TRANSCRIPT
Milena Sant, MDEPAAC WP9 leader
Descriptive Studies and Health Planning UnitIstituto Nazionale Tumori, Milano, Italy
EUROPEAN HIGH RESOLUTION STUDY 6th November 2012
Malpensa airport , Milano
Workshop for a
Study proposal frame
EPAAC WP9 ObjectivesEPAAC 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
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
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
Past EUROCARE high resolution studies
Year diagnosis 1987-89 1990-92 1996-98
Breast
Colorectal
Testis
Stomach
Prostate
Italian EUROCARE-5 HR study, cases 2003-2005, follow-up end 2007(breast, colorectal, lung, melanoma, lymphoprolipherative)
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.
Ten-year survival and risk of relapse for testicular cancer: a EUROCARE high resolution study Eur J Cancer 2007;43(3):585-92.
Differences in stage and therapy for breast cancer across EuropeIntJCancer 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 Study Cancer 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.
EUROCARE HIGH RESOLUTION PUBLICATIONS
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.
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.
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)
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
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
IS IT NOW THE TIME IS IT NOW THE TIME TO LAUNCH AN UPDATED TO LAUNCH AN UPDATED
EUROPEAN HIGH RESOLUTION STUDY?EUROPEAN HIGH RESOLUTION STUDY?
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
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
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 (?)
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 Linking HR and survival individual records helps speed analyses and reduces time lag between call for data and analyses and reduces time lag between call for data and
availability of results availability of results
Eurocare-5 record:Patient identification variables
Date life status follow-up
SpecificHigh Resolution variables
High resolution record
HR record structure & organisation
Quality Checks adherence to protocol,
consistency,completeness
EU High ResolutionData Base
Transmission to the central repository
To CRs for Revisions and
correctionsNO OK
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
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
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
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
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
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
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
Other Cancer sites to be investigated
Cervix uteri
Ovary
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