1262MO - Impact of a minimal versus CT-scan-based follow-up on patient-reported outcomes for completely resected non-small cell lung cancer (NSCLC) in phase III IFCT-0302 trial

Background

The IFCT-0302 trial was a randomized multicenter trial, which found no benefit in overall survival in adding chest CT-scan and fiberoptic bronchoscopy (optional for adenocarcinomas) to a follow-up based on physical examination and chest x-ray in resected NSCLC. We present the results of patient-reported outcomes (PROs), a secondary endpoint of the IFCT-0302 trial.

Methods

PROs consisted of Health-Related Quality of Life (HRQoL), assessed using the Short Form-12 (SF-12) questionnaire, and a penibility visual analogue scale (between 0 and 10), at randomization, every 6 months during 2 years and annually until 5 years or until disease progression or second primary cancer or death if they occurred before 5 years. Time to deterioration, used to analyze longitudinal HRQoL data, was defined as the interval between randomization and the occurrence of the first clinically relevant deterioration (5 points) compared to the HRQoL score at baseline.

Results

Between January 2005 and November 2012, 1775 patients were randomized in the IFCT-0302 trial. 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. 80.8% and 75.6% of patients completed questionnaires up to one year, respectively. There was no difference between groups in time to deterioration for the 2 dimensions of the SF-12 questionnaire: mental dimension [HR (the minimal follow-up group vs. the CT-based follow-up group): 0.92; 95%CI (0.80; 1.15); p=0.64] and physical dimension [HR: 0.87; 95%CI (0.71 ; 1.06) ; p=0.19]. Penibility was statistically greater in the CT-based follow-up group (p<0.0001), and was related to fiberoptic bronchoscopy.

Conclusions

Analysis of PROs in the IFCT-0302 trial demonstrated that adding thoracic CT-scan in the follow-up after resection of NSCLC did not influence HRQoL but penibility was increased, due to fiberoptic bronchoscopy.

Clinical trial identification

NCT00198341.

Editorial acknowledgement

Legal entity responsible for the study

IFCT.

Funding

French Health Ministry (PHRC-K), IFCT.

Disclosure

G. Eberst: Financial Interests, Personal, Advisory Board: AstraZeneca, Pfizer; Financial Interests, Personal, Speaker, Consultant, Advisor: AstraZeneca, BMS, MSD, Novartis, Pfizer, Roche. E. Giroux-Leprieur: Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, AstraZeneca, Ipsen, Janssen, Lilly, MSD, Novartis, Pfizer, Sanofi, Takeda. H. Berard: Financial Interests, Personal, Speaker, Consultant, Advisor: GSK. D. Vernerey: Financial Interests, Personal, Speaker, Consultant, Advisor: Gercor, Cure51, CellProtera SAS, Apmonia Therapeutics, Incyte, Veracyte Sas, Lysarc, Invectys, Novartis. A. Anota: Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, Ipsen, AstraZeneca, Kite Gilead. V. Westeel: Financial Interests, Personal, Speaker, Consultant, Advisor: Amgen, AstraZeneca, BMS, MSD, Roche, Sanofi, Ipsen. All other authors have declared no conflicts of interest.