Thank you for this nice opportunity to present the results of our phase III IFCT-0302 trial comparing two follow-ups in resected non-small cell lung cancer. I have no disclosures related to this presentation.
I’ll just say that most clinical practice guidelines recommend a follow-up after resection for non-small cell lung cancer, including clinic visits with history and physical examination and chest X-rays every 6-12 months for two years and then yearly. These recommendations rely on expert opinions and a small prospective series as there was until now no randomised controlled trial to address this question.
We therefore designed with the French Thoracic Intergroup this IFCT-0302 trial. This was a randomised phase III multicentre trial comparing a minimal follow-up and a maximal follow-up. Patients were randomly assigned 1:1 in both arms. Minimal follow-up included history and clinical examination and chest X-rays. In the maximal follow-up arm patients also had regular clinic visits with chest X-rays with the addition of a thoracoabdominal CT scan and in the case of squamous cell or large cell carcinoma they also had a fibre-optic bronchoscopy. In both arms patients completed follow-up every six months during the first two postoperative years and yearly until five years.
We included 1,775 patients who had been operated on within the eight previous weeks. As you can see on this slide, there was no survival difference with regard to the primary endpoint. As you can see, three year survival rate was 77.3% in the minimal follow-up arm and 76.1% in the maximal follow-up arm. As the curves seem to diverge, the later parts of the curves seem to diverge, we performed an exploratory analysis with a landmark analysis at two years. In patients who had disease recurrence within the two postoperative years there was no survival difference with the addition of chest CT scan. In patients who did not develop recurrence at two years a CT scan seemed to lead to a significant survival benefit.
These results suggest that earlier detection of recurrence within the two postoperative years did not translate into survival benefit. However, in patients surviving with no occurrence at two years these patients have a higher risk of second primary cancer than recurrence and this second primary cancer might be more amenable to curative treatment and therefore benefit from CT scan which allows earlier detection of the second primary cancer.
In conclusion, the IFCT-0302 trial is the first large randomised trial in follow-up after surgery for non-small cell lung cancer and the first randomised trial to evaluate the interest of chest CT scan. This study showed no survival benefit to chest CT scan but maybe long-term benefit might be observed with CT scan in these patients at high risk of second primary cancers who might be candidates, just good candidates, for lung cancer screening. Our suggestion for practice is that because there is no survival difference, both follow-up protocols are acceptable. However, a CT scan every six months is probably of no value during the first two years while a yearly chest CT scan might benefit over the long term. Thank you.