Durvalumab after definitive chemoradiotherapy in locally advanced unresectable Non-small cell lung cancer (NSCLC): Real-world data on survival and safety from the German expanded-access program (EAP)
Menée en Allemagne dans un contexte de vie réelle à partir de données portant sur 126 patients atteints d'un cancer du poumon non à petites cellules de stade localement avancé et non résécable, cette étude évalue l'efficacité, du point de vue de la survie sans progression et de la survie globale, et la toxicité du durvalumab en traitement de consolidation après une chimioradiothérapie
Résumé en anglais
Background : Following the PACIFIC trial, durvalumab has been approved by the European MedicinesAgency (EMA) for consolidation of locally advanced PD-L1-positive NSCLC after chemoradiotherapy(CRT). Patients were treated with durvalumab in the EAP from 22.11.2017 to 15.10.2018allowing analysis of its efficacy and safety.
Methods : Data from 56 centres were analysed for adverse events (AE), progression-free survival(PFS), overall survival (OS).
Results : 126 patients actually received at least 1 cycle durvalumab. Compared to the PACIFICtrial, the EAP population had more advanced stage and included “oligometastatic” stageIV patients and patients with autoimmune disease. PFS (20.1 months) and OS (not reached)were similar in the EAP and the PACIFIC trial. 42.9% completed 12 months of durvalumabwithout deaths during FU. Stage IV patients (n = 7) had encouraging OS (not reachedat 27 months). Autoimmune disease did not affect survival. PFS and OS were similarin PD-L1-negative patients (n = 32) and PD-L1-positive patients (n = 79).
Conclusions : Survival in the EAP was comparable to the PACIFIC trial. Selected stage IV patientsand patients with autoimmune disease may benefit from durvalumab consolidation andshould be included in future immuno-oncological trials. PD-L1 did not predict survivalchallenging the exclusion of PD-L1-negative patients from durvalumab consolidation.In summary, durvalumab consolidation is safe and effective in a European real-worldsetting.
