PMID- 35141799
OWN - NLM
STAT- MEDLINE
DCOM- 20220309
LR  - 20220309
IS  - 1432-1750 (Electronic)
IS  - 0341-2040 (Linking)
VI  - 200
IP  - 1
DP  - 2022 Feb
TI  - 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.
PG  - 95-105
LID - 10.1007/s00408-022-00511-8 [doi]
AB  - PURPOSE: 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). METHODS: 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. RESULTS: 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. CONCLUSION: 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.
CI  - (c) 2022. The Author(s), under exclusive licence to Springer Science+Business 
      Media, LLC, part of Springer Nature.
FAU - Avrillon, Virginie
AU  - Avrillon V
AUID- ORCID: 0000-0002-5508-557X
AD  - Centre Leon Berard, Lyon, France. Virginie.avrillon@lyon.unicancer.fr.
FAU - Daniel, Catherine
AU  - Daniel C
AD  - Institut Curie, Paris, France.
FAU - Boisselier, Pierre
AU  - Boisselier P
AD  - Institut du Cancer de Montpellier, Montpellier, France.
FAU - Le Pechoux, Cecile
AU  - Le Pechoux C
AD  - Institut Gustave Roussy, Villejuif, France.
FAU - Chouaid, Christos
AU  - Chouaid C
AD  - Centre Hospitalier Intercommunal de Creteil, Creteil, France.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220209
PL  - United States
TA  - Lung
JT  - Lung
JID - 7701875
RN  - 0 (Antibodies, Monoclonal)
RN  - 28X28X9OKV (durvalumab)
SB  - IM
MH  - Aged
MH  - Antibodies, Monoclonal/adverse effects
MH  - *Carcinoma, Non-Small-Cell Lung
MH  - Chemoradiotherapy/adverse effects
MH  - Humans
MH  - *Lung Neoplasms
MH  - Male
MH  - Middle Aged
OTO - NOTNLM
OT  - Concurrent chemoradiotherapy
OT  - Durvalumab consolidation
OT  - Real-life data
OT  - Safety
OT  - Stage III non-small cell lung cancer
EDAT- 2022/02/11 06:00
MHDA- 2022/03/11 06:00
CRDT- 2022/02/10 05:41
PHST- 2021/07/02 00:00 [received]
PHST- 2022/01/06 00:00 [accepted]
PHST- 2022/02/11 06:00 [pubmed]
PHST- 2022/03/11 06:00 [medline]
PHST- 2022/02/10 05:41 [entrez]
AID - 10.1007/s00408-022-00511-8 [pii]
AID - 10.1007/s00408-022-00511-8 [doi]
PST - ppublish
SO  - Lung. 2022 Feb;200(1):95-105. doi: 10.1007/s00408-022-00511-8. Epub 2022 Feb 9.