Regarding the optimal follow-up after surgery for early-stage NSCLC, the ESMO guidelines recommend patient surveillance every six months for 2-3 years with visits including history, physical examination and preferably contrast-enhanced spiral chest CT at 12 and 24 months . Thereafter, annual visits including history, physical examination and chest CT should be performed to detect second primary tumours (SPCs). However, these recommendations are not based on randomised trials and therefore only have a low-to-moderate level of evidence.
The multi-centre phase III IFCT-0302 trial was the first large randomised study on follow-up after surgery for NSCLC and the first randomised trial to evaluate the interest of chest CT . It compared minimal follow-up (Min), consisting of clinical visits with history and physical examination, chest x-ray and CT scan only in case of symptoms or abnormal chest x-ray, with maximal follow-up (Max). Max included history and physical examination as well as chest x-ray, but also contrast-enhanced CT scan of the thorax and upper abdomen. Fiberoptic bronchoscopy was mandatory for squamous and large-cell carcinomas.
In both arms, patients completed follow-up every six months for two years, followed by annual visits. A total of 1,775 patients with clinical stage I, II, or IIIA and T4 N0-2 NSCLC were enrolled within eight weeks after anatomic complete resection. Overall survival was defined as the primary endpoint.
After a median follow-up of 8 years and 10 months, OS did not differ significantly between the two arms (123.6 and 99.7 months with Max and Min, respectively; HR, 0.94; p = 0.37). At eight years, 54.6 % vs. 51.7 % of patients were alive. There was a trend for a shorter disease-free survival in the Max cohort (59.2 months vs. not reached; p = 0.07), which reflects earlier detection of recurrence and SPCs by CT scan. According to an exploratory analysis, patients experiencing relapses or SPCs at 24 months achieved the same median OS with both surveillance strategies, whereas CT-based surveillance significantly improved OS in those without recurrence or SPCs at 24 months.
The authors concluded that CT scans every six months are probably of no value during the first two years after surgery, but annual chest scans might be useful in the long term. Patients at high risk for SPCs that are potentially amenable to curative treatment can experience long-term benefits.