Chest CT plus X-ray versus chest X-ray for follow-up of completely resected non-small cell lung cancer (IFCT-0302): a multicentre, open-label, randomized, phase 3 trial

0

Background

Even after resection of early-stage non-small cell lung cancer (NSCLC), patients have a high risk of developing a recurrence and a second primary lung cancer. Our aim was to assess the effectiveness of a follow-up approach including clinic visits, chest x-rays, chest CT scans, and fiberoptic bronchoscopy versus clinic visits and chest x-rays after surgery for NSCLC. resectable.

Methods

In this multicenter, open-label, randomized phase 3 trial (IFCT-0302), patients aged 18 years or older and after complete resection of pathological NSCLC from stage I to IIIA according to the sixth edition of the TNM classification were recruited. within 8 weeks of resection from 122 hospitals and tertiary centers in France. Patients were randomly assigned (1:1) to either CT-based follow-up (clinical visits, chest X-rays, thoraco-abdominal CT scans, and fiberoptic bronchoscopy for non-adenocarcinoma histology) or minimal follow-up (visits and chest radiographs) after surgery for NSCLC, by means of a computer-generated sequence using the minimization method. The procedures were repeated every 6 months for the first 2 years and annually for up to 5 years. The primary endpoint was overall survival analyzed in the intent-to-treat population. Secondary endpoints, also analyzed in the intent-to-treat population, included disease-free survival. This trial is registered with ClinicalTrials.gov, NCT00198341and is active, but does not register.

Results

Between January 3, 2005 and November 30, 2012, 1775 patients were recruited and randomized to a follow-up group (888 patients in the minimal follow-up group; 887 patients in the CT-based follow-up group). Median overall survival was not significantly different between follow-up groups (8 5 years [95% CI 7·4–9·6] in the minimal follow-up group
versus 10 3 years [8·1–not reached] in the CT-based follow-up group; adjusted hazard ratio
[HR] 0 95, 95% CI 0 83–1 10; log-rank p=0 49). Disease-free survival was not significantly different between follow-up groups (median not reached [95% CI not estimable–not estimable]
in the minimal follow-up group versus 4 9 [4·3–not reached] in the CT-based follow-up group; Adjusted HR 1 14, 95% CI 0 99–1 30; log-rank p=0 063). Recurrence was detected in 246 (27.7%) of 888 patients in the minimal follow-up group and in 289 (32.6%) of 887 patients in the CT follow-up group. A second primary lung cancer was diagnosed in 27 (3.0%) patients in the minimal follow-up group and 40 patients (4.5%) in the CT-based follow-up group. No serious adverse events related to the trial procedures were reported.

Interpretation

Adding chest CT scans during follow-up, which included clinic visits and chest x-rays after surgery, did not lead to longer survival in patients with NSCLC. However, it allowed the detection of more cases of early recurrence and second primary lung cancer, which are more amenable to treatment with curative intent, supporting the use of CT-based follow-up, especially in countries where lung cancer screening is already in place. , as well as other support measures.

Funding

Ministry of Health, National Cancer Institute, Weisbrem-Benenson Foundation, La Ligue Nationale Contre Le Cancer and Lilly Oncology.

Translation

For the French translation of the summary, see the Additional Documents section.

Share.

Comments are closed.