Neoadjuvant durvalumab plus radiation versus durvalumab alone in stages I-III non-small cell lung cancer: survival outcomes and molecular correlates of a randomized phase II trial.
Journal
Nature communications
ISSN: 2041-1723
Titre abrégé: Nat Commun
Pays: England
ID NLM: 101528555
Informations de publication
Date de publication:
19 Dec 2023
19 Dec 2023
Historique:
received:
23
08
2023
accepted:
04
12
2023
medline:
20
12
2023
pubmed:
20
12
2023
entrez:
19
12
2023
Statut:
epublish
Résumé
We previously reported the results of a randomized phase II trial (NCT02904954) in patients with early-stage non-small cell lung cancer (NSCLC) who were treated with either two preoperative cycles of the anti-PD-L1 antibody durvalumab alone or combined with immunomodulatory doses of stereotactic radiation (DRT). The trial met its primary endpoint of major pathological response, which was significantly higher following DRT with no new safety signals. Here, we report on the prespecified secondary endpoint of disease-free survival (DFS) regardless of treatment assignment and the prespecified exploratory analysis of DFS in each arm of the trial. DFS at 2 and 3 years across patients in both arms of the trial were 73% (95% CI: 62.1-84.5) and 65% (95% CI: 52.5-76.9) respectively. For the exploratory endpoint of DFS in each arm of the trial, three-year DFS was 63% (95% CI: 46.0-80.4) in the durvalumab monotherapy arm compared to 67% (95% CI: 49.6-83.4) in the dual therapy arm. In addition, we report post hoc exploratory analysis of progression-free survival as well as molecular correlates of response and recurrence through high-plex immunophenotyping of sequentially collected peripheral blood and gene expression profiles from resected tumors in both treatment arms. Together, our results contribute to the evolving landscape of neoadjuvant treatment regimens for NSCLC and identify easily measurable potential biomarkers of response and recurrence.
Identifiants
pubmed: 38114518
doi: 10.1038/s41467-023-44195-x
pii: 10.1038/s41467-023-44195-x
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
8435Subventions
Organisme : U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI)
ID : 5UH3CA244697
Organisme : U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI)
ID : CA271545-01A1
Organisme : U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI)
ID : CA258829
Organisme : U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI)
ID : CA280414
Organisme : U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI)
ID : CA266446
Organisme : U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI)
ID : CA274506
Organisme : U.S. Department of Defense (United States Department of Defense)
ID : W81XWH2110309
Informations de copyright
© 2023. The Author(s).
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