1218P - FALCONS, a non-interventional retrospective study in resected NSCLC patients using the EPITHOR database, first analysis

Background

Immunotherapy has been introduced as adjuvant treatment and more recently in clinical trials investigating the perioperative setting in patients with early-stage non-small cell lung cancer (NSCLC). The retrospective FALCONS study aims to enhance understanding of early-stage NSCLC patients' characteristics and care pathways by complementing clinical trial evidence with real-world insights. FALCONS is based on the French national registry EPITHOR, which collects epidemiological and clinical data on thoracic surgical procedures.

Methods

FALCONS is analyzing data from patients who underwent thoracic surgery from 2016 to 2018 (Cohort A, N=9429, 27 sites), including recipients of neoadjuvant treatment (Cohort A1, n=758) and adjuvant treatment (Cohort A2, n=993). Baseline characteristics, treatment management and overall survival (OS) were analyzed in each cohort over a minimum 5-year period. A forthcoming chart review will complete the analysis (Cohort B, N=517, 11 sites).

Results

An even distribution of male/female patients and smoking habits was observed in all cohorts. Cohort A1 and A2 patients were younger than A patients. In the neoadjuvant A1 cohort, there were fewer ECOG PS 0 patients (A1, 42%; A2, 53%; A, 49%), more dyspnea score 0 (A1, 63%; A2, 59%; A, 58%), more squamous histology (A1, 31%; A2, 26%; A, 24%), more pneumonectomy surgeries (A1, 16%; A2, 11%; A, 6%) and fewer comorbidities (A1, 86%; A2, 92%; A, 90%). Stage III–IV TNM pre-surgery was more frequent in A1 (67%; A2, 32%; A, 19%) compared to post-surgery (A1, 46%; A2, 48%; A, 24%). As of 31 December 2023, the estimated 5-year OS rates were 53% in A1, 52% in A2 and 65% in A. Median OS were 65.6 (95% CI 58.2–77.6), 64.8 (95% CI 58.9–70.6) months and not reached, respectively.

Conclusions

This study confirms in a real world setting a recent meaningful improvement in survival outcomes, probably reflecting the progressive implementation in France of the regulatory requirement for multidisciplinary treatment decisions of NSCLC. Despite these encouraging results, the morbi-mortality remains high in early stages highlighting the need for new treatments for NSCLC at operable stages.

Clinical trial identification

Editorial acknowledgement

Medical writing assistance was provided by Isabelle Lawrence, Potentiel d’Action (France).

Legal entity responsible for the study

Roche.

Funding

Roche.

Disclosure

M. Wislez, M. Alifano, H. Lena: Financial Interests, Advisory Board: Roche. S. Michiels: Financial Interests, Personal, Other, DSMB member: Servier, Biophytis, Yuhan, IQVIA, Kedrion; Financial Interests, Personal, Advisory Board, Study Scientific Committee member: Roche. L. Emonnot, C. Esnault, S. Gally, L. Goncalves, C. Kuypers, V. Machuron, S. Micon, S. Saget, K. Thokagevistk: Other, Full or part-time Employment: Roche. L. Boyer: Financial Interests, Institutional, Advisory Role: Roche. P.A. Thomas: Non-Financial Interests, Institutional, Project Lead, Co-gestionnaire EPITHOR: CNP-CTCV; Financial Interests, Institutional, Trial Chair: Roche SA; Financial Interests, Institutional, Expert Testimony: Ethicon; Financial Interests, Personal, Advisory Board: AstraZeneca, MSD, Amgen. All other authors have declared no conflicts of interest.