Radiochemotherapy with or without cetuximab for unresectable esophageal cancer: final results of a randomized phase 2 trial (LEOPARD-2).
Definitive treatment
EGFR antibody
Efficacy
Esophageal cancer
Feasibility
Journal
Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al]
ISSN: 1439-099X
Titre abrégé: Strahlenther Onkol
Pays: Germany
ID NLM: 8603469
Informations de publication
Date de publication:
Sep 2020
Sep 2020
Historique:
received:
09
04
2020
accepted:
23
05
2020
pubmed:
14
6
2020
medline:
15
12
2020
entrez:
14
6
2020
Statut:
ppublish
Résumé
To investigate the efficacy and toxicity of cetuximab when added to radiochemotherapy for unresectable esophageal cancer. This randomized phase 2 trial (clinicaltrials.gov, identifier NCT01787006) compared radiochemotherapy plus cetuximab (arm A) to radiochemotherapy (arm B) for unresectable esophageal cancer. Primary objective was 2‑year overall survival (OS). Arm A was considered insufficiently active if 2‑year OS was ≤40% (null hypothesis = H Two-year OS was 71% in arm A (95% CI: 55-87%) vs. 53% in arm B (95% CI: 36-71%); H Given the limitations of this trial, radiochemotherapy plus cetuximab was feasible. There was a trend towards improved PFS and MFS. Larger studies are required to better define the role of cetuximab for unresectable esophageal cancer.
Identifiants
pubmed: 32533228
doi: 10.1007/s00066-020-01646-4
pii: 10.1007/s00066-020-01646-4
pmc: PMC7449950
doi:
Substances chimiques
Antineoplastic Agents, Immunological
0
Cetuximab
PQX0D8J21J
Banques de données
ClinicalTrials.gov
['NCT01787006']
Types de publication
Clinical Trial, Phase II
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
795-804Références
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