Impact of CT scan-based vs. minimal follow-up on patient-reported outcomes after surgery for non-small cell lung cancer in IFCT-0302 phase III trial.

PURPOSE: The randomized IFCT-0302 trial compared chest CT-scan to chest X-ray for surveillance follow-up in resected NSCLC. Chest CT-scan enabled the detection of more cases of early recurrence and second primary lung cancer, which were more amenable to curative-intent treatment but did not result in improved survival. After surgery for NSCLC, guidelines recommend a follow-up with chest CT-scan. Therefore, the impact of follow-up on patient health-related quality of life (HRQoL) needs to be considered. We present the results of patient-reported outcomes (PROs) of the IFCT-0302 trial. PATIENTS AND METHODS: Patients were randomly assigned to the CT-based follow-up group or to the minimal follow-up arm (clinic visits and chest x-rays). HRQoL were a prespecified secondary analysis of the IFCT-0302 trial. Procedures, including HRQoL assessed using the Short Form-12 (SF-12) questionnaire were repeated at randomization, every 6 months for 2 years and annually until 5 years. Time to deterioration (TTD) was used for longitudinal data. RESULTS: A total of 1775 patients were randomized. At baseline, 756 of the 888 patients (85.1%) in the minimal follow-up group had at least one HRQoL score available, and 747 of 887 (84.2%) in the CT-based follow-up group. There were no differences between groups in the TTD for the two dimensions of the SF-12 questionnaire: mental dimension [HR (CT-based follow-up group vs. minimal follow-up group): 0.97; 95% CI, 0.82-1.15; p = 0.74] and physical dimension [HR (CT-based follow-up group vs. minimal follow-up group): 1.13; 95% CI, 0.92-1.38; p = 0.24)]. CONCLUSIONS: No impact in HRQoL was demonstrated adding thoracic CT scans in the follow-up after resection of NSCLC.