Nationwide Real-Life Safety and Treatment Exposure Data on Durvalumab After Concurrent Chemoradiotherapy in Unresectable Stage III, Locally Advanced, Non-small Cell Lung Cancer: Analysis of Patients Enrolled in the French Early Access Program.
Concurrent chemoradiotherapy
Durvalumab consolidation
Real-life data
Safety
Stage III non-small cell lung cancer
Journal
Lung
ISSN: 1432-1750
Titre abrégé: Lung
Pays: United States
ID NLM: 7701875
Informations de publication
Date de publication:
02 2022
02 2022
Historique:
received:
02
07
2021
accepted:
06
01
2022
pubmed:
11
2
2022
medline:
11
3
2022
entrez:
10
2
2022
Statut:
ppublish
Résumé
Consolidation immunotherapy with the PD-L1 inhibitor durvalumab following concurrent chemoradiotherapy (cCRT) has shown a significant survival improvement and is now a standard of care in patients with unresectable stage III or non-operable non-small cell lung cancer (NSCLC). In this early access program cohort, demographic, disease characteristics and safety data were collected for 576 patients from 188 centers, who received durvalumab 10 mg/kg intravenous infusion every 2 weeks, until disease progression or unacceptable toxicity or for a maximum of 12 months following cCRT. Durvalumab exposure data were available for 402 patients. Overall, 576 patients were included, 72.9% were men, median age 64.0 years, 52.3% had a stage IIIB disease. PD-L1 status captured in 445 (77%) patients was positive (48.1%), negative (32.6%), unknown (19.3%). At the end of cCRT, adverse events (AEs) all grade ≤ 2, were reported in 22.7% of patients, mainly esophagitis (6.3%). The main reasons of discontinuation were completion of the planned 12 months of consolidation treatment (42.1% patients), disease progression (28.6%) and adverse events (19.5%). Treatment completion was similar in PDL-1 positive and PDL-1 negative patients groups. 20.7% patients had a SAE drug reaction and 17.7% stopped treatment mainly due to SAE. ADR rate and early treatment discontinuation were higher in patients > 70 years old. Death due to AEs occurred in 7 patients, 2 had interstitial lung disease. Safety data with durvalumab consolidation after cCRT in a large cohort of patients with stage III NSCLC are reported in this real-life cohort. Consistent data were reported both in the PD-L1 positive and PD-L1 negative NSCLC patients in daily practice.
Identifiants
pubmed: 35141799
doi: 10.1007/s00408-022-00511-8
pii: 10.1007/s00408-022-00511-8
doi:
Substances chimiques
Antibodies, Monoclonal
0
durvalumab
28X28X9OKV
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
95-105Informations de copyright
© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
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