Clinical trialLung cancer

Reduced Lung-Cancer Mortality with Volume CT Screening in a Randomized Trial

N Engl J Med · 202013,195 men (primary analysis) and 2594 women (subgroup analysis)

de Koning HJ, van der Aalst CM, de Jong PA, Scholten ET, Nackaerts K, Heuvelmans MA, et al. N Engl J Med. 2020. 382:503-513

Study type: Clinical trial
Study name: NELSON
Design: Population-based randomised trial in the Netherlands and Belgium; low-dose volume CT versus no screening (Netherlands Trial Register: NL580)
Sample size: 13,195 men (primary analysis) and 2594 women (subgroup analysis)
Source: N Engl J Med · 2020

In plain words

This European study showed that low-dose CT scans of the lungs in current and former smokers lowered the risk of dying from lung cancer in men by about a quarter, even when compared with “no screening”. Measuring the volume of lung nodules meant that fewer people were referred for further tests because of suspicious findings.

Key results

0.76

Cumulative rate ratio for lung cancer death at 10 years (men)

95% CI 0.61–0.94; P=0.01

2.50 vs 3.30

Lung cancer deaths per 1000 person-years (men)

Screening vs control

0.67

Mortality rate ratio at 10 years (women)

95% CI 0.38–1.14; 0.41 to 0.52 in years 7 to 9

2.1%

Referral rate for a suspicious nodule

9.2% had at least one additional CT scan (initially indeterminate result)

5.58 vs 4.91

10-year lung cancer incidence (men, per 1000 person-years)

Screening vs control; mean adherence to screening 90.0%

Treatment arms and regimens

1Volume CT screening

Low-dose CT at baseline (T0), year 1, year 3 and year 5.5; nodules assessed by volume and volume-doubling time.

2Control

No screening.

Source of the regimen details: Abstract of the paper (screening schedule; no drug)

Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.

Study population

Men and women aged 50 to 74 years who were current or former smokers at high risk of lung cancer (exact smoking criteria in the full text).

Endpoints

Primary outcome: lung cancer mortality in men with at least 10 years of follow-up (to 31 December 2015). Other outcomes: lung cancer incidence, referral rate and nodule management.

Safety and side effects

With the volume-based approach to nodule assessment, the referral rate for suspicious findings was low (2.1%), and 9.2% of screened participants needed at least one additional CT scan. Details of invasive procedures are in the full text.

Clinical significance and place in guidelines

NELSON was the most important European confirmation of the NLST findings and showed that volumetric nodule assessment reduces false positives. This study was the basis for European support of organised lung cancer screening programmes and underpinned the 2021 USPSTF recommendation (together with NLST and modelling).

Limitations

The primary analysis was in men only, and the number of women was too small for a firm conclusion (the confidence interval crosses 1); screening intervals were irregular; no reduction in all-cause mortality was reported, and recruitment was based on a population questionnaire.

Original article (DOI)PubMed

This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.