Screening for Lung Cancer Danske og internationale erfaringer DM Arena Lungekreft 11 Februar 2016

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1 Screening for Lung Cancer Danske og internationale erfaringer DM Arena Lungekreft 11 Februar 2016 HASEEM ASHRAF UDDANNELSESANSVARLIG OVERLÆGE, PhD. THORAX RADIOLOGISK AFDELING. AKERSHUS UNIVERSITETS HOSPITAL, NORWAY Dias 1 DANISH LUNG CANCER SCREENING TRIAL GENTOFTE UNIVERSITTETS HOSPITAL,DANMARK

2 PhD thesis Mortality of most commen Cancers. n (x1000) year Survival Lung 173, ,000 5% Colon 47,500 94,700 50% Breast 43, ,300 75% Prostate Dias 2 37, , Cancer Facts and Figures, American Cancer Society Death 80% New cases

3 Enhedens navn Baggrund Hyppigst forekommende kreftformer (antall tilfeller) 2013 Prostatakreft: Brystkreft: 3 220* Lungekreft: Tykktarmskreft: Føflekkreft: Flest dødsfall etter kreftform Lungekreft: Tykktarmskreft: Prostatakreft: Bukspyttkjertelkreft: Brystkreft: 637 Dias 3

4 Relativ overlevelse, begge kjønn % Total 1-års Total 2-års Total 5-års Dias 4

5 Oct. 26, 2006 Dias 5

6 Cumulative Numbers of Lung Cancers and of Deaths from Lung Cancer Trial arm C T C X R N Engl J Med 2011; 365: Screen detected lung cancer Dias 6 Lung cancer deaths

7 NCI Conclusions There were 247 deaths from lung cancer per 100,000 person-years in the low-dose CT group and 309 deaths per 100,000 personyears in the radiography group, representing a relative reduction in mortality from lung cancer with low-dose CT screening of 20.0% (95% CI, 6.8 to 26.7; P=0.004). The rate of death from any cause was reduced in the low-dose CT group, as compared with the radiography group, by 6.7% (95% CI, 1.2 to 13.6; P=0.02). Dias 7

8 Igangværende randomiserede CT screenings studier i verden o USA (53.000) AFSLUTTET!! o Holland (16.000) AFSLUTTET!! o Italien (3.000) AFSLUTTET!! o Danmark (4.000) AFSLUTTET!! o Tyskland (4.000) Frankrig (afslag) England (afslag) Norge (afslag) Dias 8

9 DLCST historie 17.3 mio kr fra Indenrigs- og Sundhedsministeriet fra Godkendt af Etisk Komite (2003), Data Tilsynet (2005). Tæt samarbejde med NELSON i Holland- Belgien Inklusions periode : October 1, 2004 march 31, 2006: Total: 4104 personer. Dias 9

10 PhD thesis 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 Dias 10 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

11 PhD thesis: Lung cancer screening with low dose CT Danish Lung Cancer Screening Trial (DLCST) Eligibility Randomized controlled trial Trial funded by Ministery of Health and Prevention Recruitment through media: Free of charge news papers and internet, mainly from greater Copenhagen area Inclusion period : October 1, 2004 march 31, 2006 Screening concluded March 31, 2010 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 Dias 11 Exclusion criteria Bodyweight over 130 kg. Former lung cancer, breastcancer, hypernephroma, malignant melanoma. Treated for other cancer <5 yrs Treated for pulmonary TB <2 yrs Symptoms of lung cancer; haemoptysis, chest pains, weight loss > 6 kg Dyspnea at rest CT scan within the last year

12 PhD thesis DLCST Classification of nodules (Prevalence screen.) Category Diameter Benign Growth > Actions signs 25 % mm Yes No CT (1 yr) 2 < 5 mm No No CT (1 yr) mm No No CT (3mth) 4 >15 mm No No Ref. Pulmon. 5 All sizes No YES Ref. Pulmon. Dias 12

13 PhD thesis DLCST baseline Results (J.Thorac. Oncol. 2009;4; ) Detection rate of Lung cancer: 17/2052 = 0.83 % False positive rate: 7.8 % 10/17 = 59 % in stage 1 (DK: 18 %) 11/17 = 65 % resection rate, (DK : 16 %) 8/11 = 73 % VATS procedures (DK: 12 % ) 2 VATS wedge resections for benign disease (1 FP) 1 death from pneumonia and heart attack 32 days after open lobectomy (65 year old male, 12 mm adenocarcinoma). Dias 13

14 Baseline characteristics of the DLCST study participants Screening Control p-value group N= 2,052 group N= 2,052 Age (Years) Mean ± SD 57.9± ± Sex, male N (%) 1147 (56) 1120 (55) Current smokers N (%) 1545 (75.3) 1579 (76.9) Pack-years Mean±SD > 30 pack-years: N (%) > 35 pack-years: N (%) 36.4± (62.3) 929(45.3) 35.9± (60.4) 865(42.2) Lung function, %pred FEV 1 : mean±sd FEV 1 /FVC : mean±sd FEV 1 /FVC < 0.7 : N (%) 93.5± ± (43.6) 94.3± ± (41.7) Unfortunate scewed randomisation more participants with > 35 pack years and lower lung function in screened group,and a higher general Dias 14 mortality risk.

15 DLCST complete cohort Lung cancer deaths: CT group: 39 Control group: 38 All deaths: CT group: 165 Control group: 163 Wille M et al. Results of the randomized Danish Lung Cancer Screening Trial with focus on high-risk profiling. AJRCCM 2015 accept for publ. Dias 15

16 23% As seen in NLST Results of the Randomized Danish Lung Cancer ScreeningTrial with Focus on High-risk Profiling. Wille MM, Dirksen A, Ashraf H. Am J Respir Crit Care Med Oct 20. Dias 16

17 Smoking habits in The Danish Lung Cancer Screening Trial CT group Control group p value Quitters 11.9% (174/1462) 11.8% (165/1395) 0.95 Re-starters 10.0% (47/469) 10.5% (44/419) 0.81 Ashraf H. et al. Thorax 2009;64; Dias 17

18 Enhedens navn Ashraf et al Thorax 2014 Dias 18

19 EUCT trials overview Screening sites NELSON (16.000) DLCST (4.000) LUSI (4.000) DANTE (2.400) ITALUNG ( MILD (4.000) Females 16% 45% 34% 0% 35% 32% Age (SD) 59 (6) 57 (5) 65 (5) 61 (4) 59 (6) 59 (6) Pack-yrs 42 (19) 36 (13) 36 (18) 47 (25) 43 (18) 43 Nodule evaluation Screening completed Baseline detection Incidence detection 3D 2D and 3D 2D and 3D 2D 2D 2D and 3D No Yes No Yes Yes No 0.9% 0.8% 1.0% 2.2% 1.5% 0.8% 0.5% 0.6% 0.5% 0.5% 0.4% 0.5% Dias 19

20 DLCST COST analysis CT-screening group (EUR 1342, IQR ) Enhedens navn Control group (EUR 1190, IQR ) (p<0.0001). When the cost of the CT-screening programme was excluded, there was no longer a statistically significant difference between groups. CONCLUSION: Higher for the true-positive and false-positive groups than for the control group. This increase was outweighed by the larger true-negative group showing no significant differences in costs compared with the control group. Dias 20

21 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 Data pooling with NELSON desirable. Dias 21

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24 Tak for opmærksomheden! Dias 24