Korean Real-world Data on Unresectable Stage III Non-Small Cell Lung Cancer (NSCLC) Patients Treated with Durvalumab after Chemoradiotherapy: PACIFIC-KR
Mené en Corée entre 2018 et 2020 sur 157 patients atteints d'un cancer du poumon non à petites cellules de stade III non résécable (durée médiane de suivi : 19,1 mois), cet essai multicentrique évalue l'efficacité, du point de vue de la survie médiane sans progression, et la sécurité d'un traitement de consolidation par durvalumab après une chimioradiothérapie
Résumé en anglais
Introduction: This study aimed to investigate real-world evidence for efficacy and safety of durvalumab consolidation (DC) after chemoradiotherapy (CRT) in patients with unresectable stage III non-small cell lung cancer (NSCLC).
Methods: Patients with stage III NSCLC who started DC after CRT between September 2018 and December 2020 and were treated at five tertiary hospitals in Korea were included. The primary endpoint was real-world progression-free survival (rwPFS). Secondary endpoints were overall survival (OS), objective response rate (ORR), and adverse events including radiation pneumonitis (RP) and immune-related adverse events (irAEs).
Results: A total of 157 patients were enrolled. At the median follow-up of 19.1 months, median rwPFS of DC was 25.9 months (95% CI: 16.5−35.4), and the 1-, 2-, and 3-year rwPFS rates were 59.4%, 51.8%, and 43.5%, respectively. The median OS were not mature, and ORR of DC was 51.0%. High PD-L1 expression (≥50%) and development of RP requiring steroid treatment were significantly associated with longer and shorter rwPFS, respectively. RP, RP requiring steroid treatment, and irAEs developed in 57 (36.3%), 42 (26.8%), and 53 (33.8%) patients, respectively. Among peripheral blood cell counts at the initiation of DC, a high derived monocyte-to-lymphocyte ratio (dMLR) was the most significant risk factor for the development of RP requiring steroid treatment and irAEs.
Conclusions: Compared with the outcome of the PACIFIC trial, this real-world data demonstrated favorable survival benefits of DC after CRT in patients with unresectable stage III NSCLC. Blood-based biomarkers could predict higher-grade RP and irAEs before the initiation of DC.