TENERGY: multicenter phase II study of Atezolizumab monotherapy following definitive Chemoradiotherapy with 5-FU plus Cisplatin in patients with unresectable locally advanced esophageal squamous cell carcinoma.
Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Chemoradiotherapy
/ mortality
Cisplatin
/ administration & dosage
Esophageal Neoplasms
/ pathology
Esophageal Squamous Cell Carcinoma
/ pathology
Female
Fluorouracil
/ administration & dosage
Follow-Up Studies
Humans
Male
Middle Aged
Neoadjuvant Therapy
/ mortality
Prognosis
Survival Rate
Young Adult
Atezolizumab
Chemoradiotherapy
Esophageal squamous cell carcinoma
Unresectable locally advanced
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
20 Apr 2020
20 Apr 2020
Historique:
received:
10
01
2020
accepted:
05
03
2020
entrez:
22
4
2020
pubmed:
22
4
2020
medline:
13
1
2021
Statut:
epublish
Résumé
The standard treatment for patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC) is definitive chemoradiotherapy (CRT) using 5-FU plus cisplatin. However, complete response (CR) rates are low at 11-25%, resulting in 9-10 months of median overall survival (OS). An improved therapeutic efficacy by combining immunotherapy with radiation has been reported in patients with locally advanced non-small cell lung cancer. The results using ESCC cell lines suggest sequential treatment with anti-PD-L1 agents soon after completion of CRT is the most effective combination. TENERGY trial is a multicenter, phase II, proof-of-concept study to assess the efficacy and safety of atezolizumab following definitive CRT in patients with locally advanced ESCC. The main inclusion criteria are unresectable locally advanced ESCC without distant metastasis, completion of 60 Gy of radiation plus two concomitant cycles of chemotherapy (cisplatin 70 mg/m The synergistic efficacies of the sequential combination of CRT and atezolizumab should improve the CR rate, resulting in survival improvement for patients with unresectable locally advanced ESCC. Because CRT is a standard treatment option for patients with early stage to locally advanced ESCC, the sequential combination of CRT and atezolizumab has the potential to change the standard ESCC treatments. UMIN000034373, 10/04/2018 and EPOC1802.
Sections du résumé
BACKGROUND
BACKGROUND
The standard treatment for patients with unresectable locally advanced esophageal squamous cell carcinoma (ESCC) is definitive chemoradiotherapy (CRT) using 5-FU plus cisplatin. However, complete response (CR) rates are low at 11-25%, resulting in 9-10 months of median overall survival (OS). An improved therapeutic efficacy by combining immunotherapy with radiation has been reported in patients with locally advanced non-small cell lung cancer. The results using ESCC cell lines suggest sequential treatment with anti-PD-L1 agents soon after completion of CRT is the most effective combination.
METHODS
METHODS
TENERGY trial is a multicenter, phase II, proof-of-concept study to assess the efficacy and safety of atezolizumab following definitive CRT in patients with locally advanced ESCC. The main inclusion criteria are unresectable locally advanced ESCC without distant metastasis, completion of 60 Gy of radiation plus two concomitant cycles of chemotherapy (cisplatin 70 mg/m
DISCUSSION
CONCLUSIONS
The synergistic efficacies of the sequential combination of CRT and atezolizumab should improve the CR rate, resulting in survival improvement for patients with unresectable locally advanced ESCC. Because CRT is a standard treatment option for patients with early stage to locally advanced ESCC, the sequential combination of CRT and atezolizumab has the potential to change the standard ESCC treatments.
TRIAL REGISTRATION
BACKGROUND
UMIN000034373, 10/04/2018 and EPOC1802.
Identifiants
pubmed: 32312286
doi: 10.1186/s12885-020-06716-5
pii: 10.1186/s12885-020-06716-5
pmc: PMC7168951
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
atezolizumab
52CMI0WC3Y
Cisplatin
Q20Q21Q62J
Fluorouracil
U3P01618RT
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
336Subventions
Organisme : Japan Agency for Medical Research and Development
ID : 18ck0106420h0001
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