Danish Lung Cancer Screening Trial (DLCST).

Transcription

1 Danish Lung Cancer Screening Trial (DLCST). Röntgenveckan, Karlstad 11.september 2014 Jesper Holst Pedersen, MD, DMsci, Associate Professor Rigshospitalet University of Copenhagen, Denmark

2 DLCST (Danish Lung Cancer Screening Trial).. history 17.3 mio kr (2.3 mio Euro) from Danish Ministry of Health Approved by Ethics commite (2003), Data Security Board (Data tilsynet) (2005). Close collaboration with NELSON in Holland- Belgium Inclusion period : October 1, 2004 march 31, 2006: Total: 4104 persons. One Screening Center!

3 DLCST: Trial end points. Primary end point: Reduction in Lung cancer specific mortality by > 20 %, in EU collaboration Secondary end points: Psycho-social consequences of screening, especially false positive test results. Smoking habits and smoking cessation during and after CT screening for LC Value of PET in small nodules Cost-benefit of CT screening

4 Recruitment to DLCST Recruitment through media ; Only free of charge news papers in greater Copenhagen area (2.3 mio inhabitants) (Metro Express, Søndagsavisen etc). Trial funded by Ministery of Health and Prevention, free of charge persons voluntered (oct to march ) 1757 (30 %) were excluded persons (70 %) randomised at the screening clinic after signing informed consent. In CT group, CT scan performed within 4 weeks after consent. Compliance was 99.7 % (5 pers. not scanned).

5 DLCST. Inclusion Criteria: Age Years Smoker or former smoker Smoking history of > 20 pack years Former smokers quit < 10 years. Able to walk 2 flights of stairs or 36 steps up without stopping Lung function (FEV1) > 30% of predicted

6 CT equipment DLCST Dedicated Phillips multislice 16 channel spiral CTscanner Siemens lung care work station, for volume calculation of solid nodules Independant double reading, with consensus by 2 chest radiologists (>10 yrs experience) Difficult cases; referal to Utrecht (prof. M.Prokop)

7 Enhedens navn Follow Up in DLCST: ANNUAL QUESTIONAERES HOSPITAL FILES DANISH LUNG CANCER REGISTER CPR-REGISTER (VITAL STATISTICS), CAUSE OF DEATH REGISTER AUTOPSY REPORTS LOCAL CAUSE OF DEATH COMMITTEE

8 DLCST Design Prevalence year 1 Year 2 Year 3 Year 4 Year 5 Control 2052 QOL+ Smok. QOL+ Smok. QOL+ Smok. QOL+ Smok. Random QOL Smoke Question CT screen 2052 CT+QOL + Smok. CT+QOL + Smok. CT+QOL + Smok. CT+QOL + Smok. End points: Lung cancer incidence, stage, treatment, mortality. Smoking habits, quality of Life

9 DLCST Age distibution at base line (years) (Total N= 4104) CT Control CT Control

10 DLCST: Gender distribution (Total N= 4104) males females 0 control (%) CT (%) Total (%) males 27,2 27,8 55,1 females 22,8 22,1 44,9

11 DLCST: Socio-economic groupings (CT versus Control) (N= 4104) CT Control 0 Gr.1 Gr.2 Gr.3 Gr.4 Gr.5 Mis CT Control

12 DLCST. NODULE CLASSIFICATION Nodules Prevalence screening Size 2-D ( < 5mm, 5-15 mm, > 15 mm) and 3-D volume (Siemens Lung Care ) Non Calcified Nodules: solid, semi solid, non solid GGO Incidence screening Growth by linear measurement and 3-D volume (25 % increase or VDT < 400 days, days, > 600 days).

13 Nodule detection in DLCST (Saghir Z. et al. Thorax 2012; 67; )

14 Lung Cancers in DLCST after 5 annual visits. Saghir Z. et al. Thorax 2012; 67;

15 Saghir Z. et al. Thorax 2012; 67; Enhedens navn

16 Enhedens navn DLCST screen results: True and false positive test results. All positives, true and false positives False positive rate year. 1-4: 1,6 2,0 %

17 LC Treatment in DLCST

18 Treatment of screen detected non-lung cancer nodules in DLCST One patient with a lung metastasis, One patient with lymphoma 7 patients with a benign nodule (9%) underwent surgical treatment due to suspicion of malignancy. All treated by VATS Including 1 diagnostic VATS lobectomy for at central benign nodule

19 Incidental findings in the CT screened group (2052 prs). 2 abdominal aortic aneurism (+operated) 2 Kidney cancer. 1 Mamma cancer 1 benign teratoma in mediastinum (VATS)

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26 DLCST conclusions after 5 annual screening rounds (end 2010). False positive rate and recall rate much better than NLST. Especially in incidence screening rounds (< 2 %) Screening leads to more minimal invasive surgery (84 %). 75 % of LC in early stage, but no stage shift so far Health economics: Savings from the true negative group, but increased cost from false positive. But too early for cost effectiveness analysis. Negative psychological consequences only temporary Calcium scoring is feasible and a predictor of overall and Cardio Vascular death Final mortality evaluation planned in Data pooling with NELSON desirable.

27 Acknowledgements: DLCST Steering Commitee Jesper Holst Pedersen, Surgery, Chairman/PI Asger Dirksen; Phillip Tønnesen; Martin Døssing; Paul Clementsen; Niels Seersholm; Klaus Richter Larsen, Saigham Zaighir (Pulmonology) Klaus Kofoed, Thomas Rasmussen(Cardiology) John Brodersen, Hanne Thorsen, Jakob Rasmussen (Inst. Public Health, Univeristy of Copenhagen) Karen Bach; Hanne Hansen; Haseem Ashraf (Radiology) Jann Mortensen (PET Nuclear Medicine, RH ) Birgit Guldhammer Skov (Pathology)

28 Thank you for your attention.