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

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