Congres BVPV 2019 RESPIRATOIRE ONCOLOGIE LONGKANKER … · Rookstop plannen Van der Aalst CM, van...

Preventie en Screening

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Congres BVPV 2019RESPIRATOIRE ONCOLOGIE

LONGKANKER WAAR STAAN WE?

22-05-2019

PREVENTIE EN SCREENING

1. Achtergrond Preventie

2. Longkankerscreening

3. NLST

4. NELSON

5. Hoe nu verder in de praktijk?

22-05-2019

PREVENTIE

Pneumologie voor Verpleegkundigen 2011 4

LONGKANKER

Jaar: 2012

1.824.701 nieuwe gevallen wereldwijd

Longkanker in België

www.kankerregister.org 2019

Data source: http://www.kankerregister.org

http://www.kankerregister.org/

(LUNG) Cancer screening-Belgium

Smoking facts in Belgium

http://blogs.nature.com/ofschemesandmemes/2014/09/11/the-big-issues-affecting-lung-cancer-worldwide

Sterfte per 100,000 personen

Stagnerend rookgedrag

in

Vlaanderen/België

Roken en rookstop

• Cijfers

• Opleiding

• Rookstop en CT screening

https://rookstop.vrgt.be/

Rookstop plannen

Van der Aalst CM, van den Berg KAM, Willemsen MC et al Thorax 2010;65:600-605

Baird AM for LUCE, Lung Cancer Screening: a patient’s perspective, ERS/EAPM Meeting Brussels 2019

Preventie

• Secundaire preventie

– Bij detectie van premaligne letsels

• Teriaire preventie

– Na behandeling van primaire longkanker

De Flora S et al Trends Pharmcol Sci 2016;37:120-142; Dresler C et al J Thorac Oncol 2018;13:603-605

31 MEI

WNTD

SCREENING

24

“Lung cancer screening aims to reduce lung

cancer related mortality with relatively limited

harm through early detection and treatment”

Van der Aalst CM, ten Haaf K, de Koning H. Lancet Respir Med 2016;4:749-61

LDCT lung cancer screening RCTs

Van der Aalst CM, ten Haaf K, de Koning H. Lancet Respir Med 2016;4:749-61

X

X

X

X

V

V

?

?

Total number of deaths due to lung cancer :

247 vs 309 deaths/100.000 pers.yrs (CT vs RX group)

Relative reduction in LC mortality of 20.0% or HR=0,80 ( 95%CI 0,73-0,93)

Reduction in all cause mortality of 6,7% or HR=0,93 (95% CI 0,86-0,99)

Number Needed to Screen with LDCT to prevent 1 death : 320

LDCT RCT NLST 2011

Aberle DR et al New Engl J Med 2011

LDCT LUNG CANCER SCREENING

• Benefits

• LC mortality reduction

• Reduction stages III-IV

• Harms

• False positives

• Overdiagnosis

• Overtreatment

• Radiation exposure

• Costs

• QOL

• Smoking behaviour

Janes S, De Koning H, IASLC WCLC 2016 MTE: How to implement screening?

Baldwin R, Callister MEJ. Clin Oncol 2016;28:672-681

Field J, Duffy SW, Devaraj A, Baldwin DR. Lancet Respiratory 2016;4:685-7

Yousaf-Khan U et al Thorax 2017;160:311-320

Nodule management

• NELSON nodule management plan

Heuvelmans M.A. et al, J Thorac Imaging 30, 101-107, 2015

NODULE CATEGORIZATION BASED ON SIZE AND DENSITY (NEW NODULES)

AND GROWTH RATE (EXISTING NODULES) IN THE NELSON TRIAL

OVERVIEW OF THE NELSON SCREENING PROTOCOL

NELSON : 5,5 YEARS CALCULATIONS

1st screening result

Negative

Indeterminate

Positive

Risk screen-detected lung cancer

1,0%

5,7%

48,3%

Horeweg N et al Eur Respir J 2013;42:1659-67

ERS/ESR White Paper LC Screening 2015

• Further refinements to increase quality, outcome and cost-effectiveness:

• Inclusion of risk models

• Reduction of effective radiation dose

• Computer-assisted volumetric measurements

• Assessment of comorbidities (COPD/Vascular calcifications)

• Central registry, including biobank, preferably on a European level

Kauczor H et al Eur Respir J 2015;46:28-39

34

Field JK et al Thorax 2016;71:161-70

High Risk

In

11,5% of positive responders

36

Humphrey LL et al Ann Intern Med 2013;159:411-420De Koning HJ et al Ann Intern Med 2014;160:311-320

• Lung Cancer Low-Dose CT Screening in the USA

• Percentage of eligible smokers who had low-dose CT in the past 12 months remained low and constant:

• 2010: 3,3%

• 2015: 3,9%

• Of the 6.8 million U.S. smokers eligible for low-dose CT screening, only 262,700 received it.

37

Data from the Surveillance & Health Services Research, American Cancer Society (ACS).Jemal A, Fedewa SA. Lung cancer screening with LDCT in the United States – 2010-2015. JAMA Oncol 2017early release online 2 Feb 2017

“Independent of all complicating issues such

as logistics and cost, the national

implementation of low-dose CT screening is

simply not hitting a nerve for its value as a

public health service.”

— James Mulshine, MD

Effects of volume CT lung cancer screening

Mortality results of the NELSON randomised-

controlled population-based screening trial

Harry J. de Koning, MD PhD

PI NELSON

Professor & Deputy Head

Department of Public Health

Erasmus MC, University Medical Center Rotterdam, the Netherlands

H.J. de Koning, C. van der Aalst, P.A. de Jong, E.T. Scholten, K.

Nackaerts, M. Heuvelmans, J-W. Lammers, W.P. Mali, C. Weenink, A.U.

Yousaf-Khan, N. Horeweg, S. v. ’t Westeinde, M. Prokop, J.G.J.V. Aerts,

M.A. den Bakker, E.F. Blom, F.B. Thunnissen, J. Verschakelen, R.

Vliegenthart, J.E. Walter, K. ten Haaf, H.J.M. Groen, M. Oudkerk

&

NELSON-investigatorsNEderlands-Leuvens Longkanker Screenings ONderzoek

Erasmus MC, University Medical Center Rotterdam, University Medical Center Utrecht, Spaarne Gasthuis Haarlem, University Medical Center Groningen,

University Hospital Leuven, Belgium, Maasstad Hospital Rotterdam, University Medical Center Amsterdam, Radboud University Medical Center Nijmegen

Harry J. de Koning, Erasmus MC, Public Health Rotterdam

http://www.nelsonproject.nl/nelson/main.html


NELSON - trial ISRCTN 63545820

• Randomized Controlled Trial

• Recruitment through population-based registries

• CT screening vs. no screening

• Different screening intervals

• Volume & Volume Doubling Time of nodules

• Central reading of CT images

• Expert causes of death committee &

• Follow up through national registries

Trial, initially powered (80%) for high risk males, to detect a lung cancer mortality reduction

of ≥ 25% at 10 years after randomization (individual FU)

And includes a small subgroup of women (16%)





Mailing 2- general health questionnaire- information brochure- invitation to participate- informed consent form

Mailing 1- general health questionnaire

Recruitment step 1:

Men and women aged 50-74 years derived from population registries

n=606,409

Returned questionnaires n=150,920

Completed questionnaires n=148,730

Inclusion Criteria- aged 50-74 years- smoking history >10 cig/day for >30 yrs >15 cig/day for >25yrs- smoking cessation ≤10 yearsExclusion Criteria- A moderate or poor self-reported health who were unable to climb two flights of stairs- weight ≥140 kilogram- lung cancer diagnosis (<5 years ago or ≥5 years ago but still under treatment)- current or past renal cancer, breast cancer or melanoma- CT chest examination <1 year ago

Recruitment step 2:

Eligiblesn=30,959

Initial randomization(1:1)

Eligibles who signed the informed consent

n=15,822

RANDOMISEDn=15,792

Deceased between signing informed consent and randomisation

(based on later linkages with national registries)

n=30

Control Armn=7,892

No screening

Screen Armn=7,900

CT screening in year 1,2,4 and 6.5

(2007)

J Thorac Oncol 2018;13(suppl):Abstr PL02.05


Year 1 Year 2 Year 4 Year 6.5 Year 10

Control armn=7,892

Screen armn=7,900

95.6% 92.3% 87.6% 66.8%

uptake uptakeuptake uptake

n=7,557 n=7,295 n=6,922 n=5,279

Usual care (no screening)

MORTALITY

ANALYSES

CT screening CT screening CT screening CT screening

NATIONAL LINKAGES- Statistics Netherlands/ Belgium- Dutch/ Belgium Cancer Registry- Centre for Genealogy

CAUSE OF DEATH REVIEW

Year 1 Year 2 Year 4 Year 6.5 Year 10

Control armn=7,892

Screen armn=7,900

95.6% 92.3% 87.6% 66.8%

uptake uptakeuptake uptake

n=7,557 n=7,295 n=6,922 n=5,279

Usual care (no screening)

MORTALITY

ANALYSES

CT screening CT screening CT screening CT screening

NATIONAL LINKAGES- Statistics Netherlands/ Belgium- Dutch/ Belgium Cancer Registry- Centre for Genealogy

CAUSE OF DEATH REVIEW


Yousaf-Khan et al., in preparation

J Thorac Oncol 2018;13(suppl):Abstr PL02.05

Cumulative lung cancer deaths (men only)

Cu

mu

lative

lu

ng

ca

nce

r d

ea

ths

Years since randomisation

50

100

150

200

250

01 2 3 4 5 6 107 8 9

Control arm:

214 lung cancer deaths

Screen arm:

157 lung cancer deaths


Lung cancer

mortality

rate ratio

(95% CI)

Year 8 Year 9 Year 10

MALES

0.75

P=0.015

(0.59-0.95)

0.76

P=0.012

(0.60-0.95)

0.74

P=0.003

(0.60-0.91)

FEMALES

0.39

P=0.0037

(0.18-0.78)

0.47

P=0.0069

(0.25-0.84)

0.61

P=0.0543

(0.35-1.04)


Rand: 23-12-2003 – 06-07-2006

FU: 23-12-2003 – 31-12-2015

FU 94% complete

year 10

NELSON Volume CT screening

• MALES at high risk for lung cancer have a reduced risk of dying from lung cancer of 26% in the

screen arm compared to the male control arm (95% CI 9-40%)

• In WOMEN, reductions are consistently more favourable: 39-61%

• These results are more favourable than the NLST-results & suggest gender differences

• Volume CT lung cancer screening of high risk former and current smokers results in low referral

rates (2.3%), and a very substantial reduction in lung cancer mortality (in both genders)


LUNG CANCER SCREENING-EUROPE

www.ersnet.org/the-society/news/european-respiratory-society-welcomes-the-positive-results-of-nelson-trial

Lung cancer screening-Europe

ERS Seminar 11-12 dec 2018

Lung Cancer Screening: from Trial to Practice

• Target group by age and smoking history

• Former smokers vs active smokers (others: COPD,occupation,..)

• Who selects the screening population?

• Who performs LDCT screening (Mobile CT?)

• Informed decision making: harms & benefits

• Role for GPs; patient advocacy groups

• Smoking cessation program to be offered

• Risk assessment scores/Risk models (PLCOM2012;Bach;LLPv2)

• Blood biomarkers (blood, breath, CT)

Lung cancer screening-Europe

ERS Seminar 11-12 dec 2018

Lung Cancer Screening: from Trial to Practice (2)

• Impact for radiologists:

– Training, LC prediction models; AI software; Radiomics; Central reading?

– Extrapulmonary findings

– Patient communication

• Impact for thoracic surgeons

– ESTS recommendation

– ‘Nodule Board’ (next to MOC)

• Cost-effectiveness

• Pilot study

Seijo LM et al J Thorac Oncol 2018

Brain K et al Thorax 2017

Balata H et al NHS Manchester 2018

Lung cancer screening-Belgium

www.stopdarmkanker.be/blog/darmkankerscreening-voor-vlaanderen-een-stapj/

(LUNG) Cancer screening-Belgium

https://www.ccref.org/

https://www.bevolkingsonderzoek.be/

Lung cancer screening-Flanders

• Who organizes?

• Who performs screening?

The Flemish government* itself organises population-based

screening programs but may also grant approval for high-quality

population screening programs initiated by other organisations.

The Flemish working group on Population-wide screening

programs (21 experts)** gives advice on this matter.

Without formal approval population-based screening is not allowed.

www.zorg-en-gezondheid.be/bevolkingsonderzoek

www.zorg-en-gezondheid.be/sites/default/files/atoms/files/BVO%20WG%20samenstelling%202014%20MB.pdf


Centres for ‘Kankeropsporing’ (CvKO) – field work

The Centre for ‘Kankeropsporing’ (‘screening’) is a non-profit

organisation, raised November 13, 2012. This Centre offers its

expertise to the Flemish population-based screening programs.

This non-profit organisation was created out of the Consortium of

approved regional screening centres within the Flemish Community

The Centre for ‘Kankeropsporing’ consists of 5 regional sites.

https://www.zorg-en-gezondheid.be/https://www.cvko.vlaanderen/


Population-based screening requires a population-wide approach

A well-preplanned population-based screening program is composed of

several quality-proven steps, like

1/ Every participant of the target group is well informed about the harms and

benefits? [Harms & benefits]

2/ The screening method used is well chosen and there isn’t any other approach

more useful than screening? [LDCT; smoking cessation]

3/ Is the target group (very) well-defined? [age & smoking history]

4/ Is it clear for all involved within the screening program, what the real costs are for

the screening and for the diagnosis and treatment of the disease? [Cost benefit

analysis]

5/ Does society (RIZIV) agree with the eventual total costs of screening (societal

acceptance)? [other screening programs]

6/ Are all relevant parties involved in the organisation of the screening? [CvKO]

7/ Are the screening results being adequately registered (with respect for privacy

rules), in order that the effects and the quality of the screening program may be

evaluable? [Centrale Databank/Link met Kankerregister of CT reports, FU, …]https://www.zorg-en-gezondheid.be/bevolkingsonderzoek


Population-based screening requires a population-wide approach

When the disadvantages weigh out the advantages and when the

quality of all different steps of this population-based screening cannot

be fully guaranteed, it would be better NOT to organize that particular

population-wide screening.

All these measures are often neglected or only partially covered by the

organizers of a population-wide screening program [creating Task

Force]

https://www.zorg-en-gezondheid.be/bevolkingsonderzoek


Lung Cancer Screening Task Force

- Group of interested parties* in lung cancer screening

- To submit a complete (lung cancer screening) report to the

Flemish working group on Population-based screening within the

Flemish Ministery

- Is planned for Q1 2019

- Several planned meetings, to create a full report regarding the

population-based organisation of lung cancer screening with

low-dose chest CT, using the predefined criteria

- Participants*: different parties, e.g. pneumologists, thoracic

surgeons, radiologists, members of the CvKO, epidemiologists,

health economist, …

Financing costs for LD€T screening?

• N cigarettes/day N packs/day smoked

• 1 eurocent/pack cigarettes sold, for “LC screening” ?

• In Belgium: ±625.000.000 packs sold per year (data 2010)

• Total of euros for LC screening: 6.250.000 euro per year

Documentatie map ROKEN

OIVO 2011

With the combined results of the NLST and the NELSON trial, there can no longer be any doubt about the fact that lungcancer screening saves lives. More than 220,000 people are diagnosed with lung cancer annually in the United States, andthe majority have advanced stage III or IV disease. Globally, more than 2 million cases were diagnosed in 2018, with more than 1.7 million deaths. A reduction of lung cancer mortalityby 20% to 30% would be a huge accomplishment in reducingthe global burden of lung cancer.

Nasser Altorki, MD ©Weill Cornell Medical College

ASCO Post, March 10, 2019

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