First-Line Osimertinib in Patients with EGFR-Mutant Advanced Non-Small Cell Lung Cancer: Outcome and Safety in the Real World: FLOWER Study
Menée dans un contexte de vie réelle auprès de 126 patients atteints d'un cancer du poumon non à petites cellules de stade avancé et présentant une mutation EGFR, cette étude prospective évalue l'efficacité, du point de vue du taux de réponse globale, de la survie sans progression et de la survie globale, et la toxicité de l'osimertinib en traitement de première ligne
Background : Osimertinib became the standard treatment for patients with untreated EGFR-mutant advanced non-small-cell lung cancer (aNSCLC) following results reported in the phase III randomized FLAURA trial. Due to strict exclusion criteria, patient populations included in pivotal trials are only partially representative of real-world patients. Methods : We designed an observational, prospective, multicenter study enrolling patients with EGFR-mutant aNSCLC receiving first-line osimertinib to evaluate effectiveness, safety, and progression patterns in the real-world. Results : At data cut-off, 126 Caucasian patients from 9 oncology centers were included. At diagnosis, 16 patients (12.7%) had a performance status (PS) ≥2 and 38 (30.2%) had brain metastases. Overall response rate (ORR) was 73%, disease control rate (DCR) 96.0%. After a median follow-up of 12.3 months, median time-to-treatment discontinuation (mTTD) was 25.3 months, median progression-free-survival (mPFS) was 18.9 months and median overall survival (mOS) was not reached (NR). 110 patients (87%) experienced adverse events (AEs), 42 (33%) of grade 3–4, with venous thromboembolism (VTE) as the most common (n = 10, 7.9%). No difference in rates of VTE was reported according to age, PS, comorbidity, and tumor load. We observed longer mTTD in patients without symptoms (NR vs. 18.8 months) and with <3 metastatic sites at diagnosis (NR vs. 21.4 months). Patients without brain metastases experienced longer mPFS (NR vs. 13.3 months). No difference in survival outcome was observed according to age, comorbidity, and type of EGFR-mutation. Isolated progression and progression in <3 sites were associated with longer TTD. Conclusion Osimertinib confirmed effectiveness and safety in the real world, although thromboembolism was more frequent than previously reported.