Induction chemotherapy followed by definitive chemoradiotherapy versus chemoradiotherapy alone in esophageal squamous cell carcinoma: a randomized phase II trial.
Aged
Antineoplastic Combined Chemotherapy Protocols
/ adverse effects
Chemoradiotherapy
/ adverse effects
Cisplatin
/ therapeutic use
Disease-Free Survival
Docetaxel
/ therapeutic use
Esophageal Neoplasms
/ pathology
Esophageal Squamous Cell Carcinoma
/ pathology
Female
Humans
Induction Chemotherapy
/ adverse effects
Male
Middle Aged
Prospective Studies
Survival Rate
Treatment Outcome
Journal
Nature communications
ISSN: 2041-1723
Titre abrégé: Nat Commun
Pays: England
ID NLM: 101528555
Informations de publication
Date de publication:
29 06 2021
29 06 2021
Historique:
received:
30
11
2020
accepted:
11
06
2021
entrez:
30
6
2021
pubmed:
1
7
2021
medline:
23
7
2021
Statut:
epublish
Résumé
This randomized phase II trial aims to compare the efficacy and safety of induction chemotherapy followed by definitive chemoradiotherapy (CRT) versus CRT alone in patients with esophageal squamous cell carcinoma (ESCC) unsuitable for surgery (N = 110). The primary outcome was overall response rate (ORR), whereas the secondary outcome was overall survival. This trial did not meet pre-specified endpoints. The ORR was 74.5% in the induction chemotherapy group versus 61.8% in the CRT alone group (P = 0.152). The 3-year overall survival rate was 41.8% in the induction chemotherapy group and 38.1% in the CRT alone group (P = 0.584; hazard ratio, 0.88; 95% CI, 0.54-1.41). Grade 3-5 adverse events were similar. Patients who responded to induction chemotherapy had improved survival in the post-hoc analysis. These results demonstrate no improvement in response rate or survival with the addition of induction chemotherapy to CRT in unselected patients with ESCC. Trial number: NCT02403531.
Identifiants
pubmed: 34188053
doi: 10.1038/s41467-021-24288-1
pii: 10.1038/s41467-021-24288-1
pmc: PMC8242031
doi:
Substances chimiques
Docetaxel
15H5577CQD
Cisplatin
Q20Q21Q62J
Banques de données
ClinicalTrials.gov
['NCT02403531']
Types de publication
Clinical Trial, Phase II
Comparative Study
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
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