Evidence map›Paper›PMID 32312286›Full record

Trial reportBMC cancer2020

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.

Hideaki Bando, Daisuke Kotani, Takahiro Tsushima, Hiroki Hara, Shigenori Kadowaki, Ken Kato, Keisho Chin, Kensei Yamaguchi, Shun-Ichiro Kageyama, Hidehiro Hojo and 8 more

Abstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in BMC cancer, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 39 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
39citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

39 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors.

Hideaki BandoDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Daisuke KotaniDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Takahiro TsushimaDivision of Gastrointestinal Oncology Shizuoka Cancer Center, Shizuoka, Japan.
Hiroki HaraDepartment of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
Shigenori KadowakiDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.
Ken KatoDepartment of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.
Keisho ChinDepartment of Gastroenterological Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Kensei YamaguchiDepartment of Gastroenterological Medicine, Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Shun-Ichiro KageyamaDivision of Radiation Oncology and Particle Therapy, National Cancer Center Hospital East, Kashiwa, Japan.
Hidehiro HojoDivision of Radiation Oncology and Particle Therapy, National Cancer Center Hospital East, Kashiwa, Japan.
Masaki NakamuraDivision of Radiation Oncology and Particle Therapy, National Cancer Center Hospital East, Kashiwa, Japan.
Hidenobu TachibanaDivision of Radiation Oncology and Particle Therapy, National Cancer Center Hospital East, Kashiwa, Japan.
Masashi WakabayashiClinical Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan.
Miki FukutaniClinical Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan.
Yosuke TogashiDivision of Cancer Immunology, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center Hospital East, Kashiwa, Japan.
Nozomu FuseClinical Research Support Office, National Cancer Center Hospital East, Kashiwa, Japan.
Hiroyoshi NishikawaDivision of Cancer Immunology, Exploratory Oncology Research and Clinical Trial Center, National Cancer Center Hospital East, Kashiwa, Japan.
Takashi KojimaDepartment of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan. takojima@east.ncc.go.jp.

Funding

Japan Agency for Medical Research and Development 18ck0106420h0001
6 · The paper itself

Abstract

backgroundThe 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.

methodsTENERGY 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: 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 registrationUMIN000034373, 10/04/2018 and EPOC1802.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsChemoradiotherapyCisplatinEsophageal NeoplasmsEsophageal Squamous Cell CarcinomaFemaleFluorouracilFollow-Up StudiesHumansMaleMiddle AgedNeoadjuvant TherapyAntibodies, Monoclonal, HumanizedatezolizumabCisplatinFluorouracilAtezolizumabChemoradiotherapyEsophageal squamous cell carcinomaUnresectable locally advanced

Identifiers

PMID32312286
PMCPMC7168951

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.