Evidence map›Paper›PMID 33792128›Full record

Trial reportCancer science2021

Phase II study of E7777 in Japanese patients with relapsed/refractory peripheral and cutaneous T-cell lymphoma.

Hidetsugu Kawai, Kiyoshi Ando, Dai Maruyama, Kazuhito Yamamoto, Eiji Kiyohara, Yasuhito Terui, Noriko Fukuhara, Tomomitsu Miyagaki, Yoshiki Tokura, Mamiko Sakata-Yanagimoto and 11 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
6.8field-weighted citation impact, top 3% of its field
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

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
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  5. Trial
  6. Review
  7. Article
  8. Novel agents and therapeutic advances in T cell lymphoma.International journal of hematology · 2026
    Review
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  11. Article
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  16. Systemic capillary leak syndrome.Nature reviews. Disease primers · 2024
    Review
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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

21 authors at 16 institutions in 2 countries.

Hidetsugu KawaiDepartment of Hematology and Oncology, Tokai University School of Medicine, Isehara, Japan.
Kiyoshi AndoDepartment of Hematology and Oncology, Tokai University School of Medicine, Isehara, Japan.
Dai MaruyamaDepartment of Hematology, National Cancer Center Hospital, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0003-0654-6920
Kazuhito YamamotoDepartment of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan.ORCID https://orcid.org/0000-0002-8588-8955
Eiji KiyoharaDepartment of Dermatology, Osaka University Hospital, Osaka, Japan.
Yasuhito TeruiDepartment of Hematology Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan.
Noriko FukuharaDepartment of Hematology and Rheumatology, Tohoku University Hospital, Sendai, Japan.
Tomomitsu MiyagakiDepartment of Dermatology, The University of Tokyo Hospital, Tokyo, Japan.
Yoshiki TokuraDepartment of Dermatology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
Mamiko Sakata-YanagimotoDepartment of Hematology, University of Tsukuba Hospital, Tsukuba, Japan.
Tadahiko IgarashiDepartment of Hematology, Gunma Cancer Center, Ota, Japan.
Junya KurodaDivision of Hematology and Oncology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Jiro FujitaDepartment of Dermatology, Osaka University Hospital, Osaka, Japan.
Toshiki UchidaDepartment of Hematology and Oncology, Japanese Red Cross Nagoya Daini Hospital, Nagoya, Japan.
Takayuki IshikawaDepartment of Hematology, Kobe City Medical Center General Hospital, Kobe, Japan.
Kentaro YonekuraDepartment of Dermatology, Imamura General Hospital, Kagoshima, Japan.
Koji KatoDepartment of Hematology and Oncology, Kyushu University Hospital, Fukuoka, Japan.ORCID https://orcid.org/0000-0002-5815-4585
Tadashi NakanishiEisai Co., Ltd., Tokyo, Japan.
Kenya NakaiEisai Co., Ltd., Tokyo, Japan.
Risa MatsunagaEisai Co., Ltd., Tokyo, Japan.
Kensei TobinaiDepartment of Hematology, National Cancer Center Hospital, National Cancer Center Hospital, Tokyo, Japan.
Eisai (Japan) · JPNational Cancer Center · USOsaka University Hospital · JPTokai University · JPAichi Cancer Center · JPGunma Children's Medical Center · JPHamamatsu University School of Medicine · JPImamura Hospital · JPJapanese Red Cross Nagoya Daini Hospital · JPKobe City Medical Center General Hospital · JPKyoto Prefectural University of Medicine · JPKyushu University Hospital · JPThe Cancer Institute Hospital · JPTohoku University Hospital · JPUniversity of Tokyo Hospital · JPUniversity of Tsukuba Hospital · JP

Funding

Eisai Co., Ltd
6 · The paper itself

Abstract

E7777 is a recombinant cytotoxic fusion protein composed of the diphtheria toxin fragments A and B and human interleukin-2. It shares an amino acid sequence with denileukin diftitox, but has improved purity and an increased percentage of active monomer. We undertook a multicenter, single-arm phase II study of E7777 in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) to evaluate its efficacy, safety, pharmacokinetics, and immunogenicity. A total of 37 patients were enrolled, of which 17 and 19 patients had PTCL and CTCL, respectively, and one patient with another type of lymphoma (extranodal natural killer/T-cell lymphoma, nasal type), diagnosed by the Central Pathological Diagnosis Committee. Among the 36 patients with PTCL and CTCL, objective response rate based on the independent review was 36% (41% and 31%, respectively). The median progression-free survival was 3.1 months (2.1 months in PTCL and 4.2 months in CTCL). The common adverse events (AEs) observed were increased aspartate aminotransferase (AST) / alanine aminotransferase (ALT), hypoalbuminemia, lymphopenia, and pyrexia. Our results indicated that a 9 µg/kg/d dose of E7777 shows efficacy and a manageable safety profile in Japanese patients with relapsed or refractory PTCL and CTCL, with clinical activity observed across the range of CD25 expression. The common AEs were manageable, but increase in ALT / AST, hypoalbuminemia, and capillary leak syndrome should be carefully managed during the treatment.

Indexed as

Administration, IntravenousBinding SitesDiphtheria ToxinDrug Administration ScheduleFemaleHumansInterleukin-2JapanLymphoma, T-Cell, CutaneousLymphoma, T-Cell, PeripheralMaleNeoplasm Recurrence, LocalRecombinant Fusion ProteinsSurvival AnalysisTreatment OutcomeDiphtheria ToxinE7777 fusion proteinIL2 protein, humanInterleukin-2Recombinant Fusion ProteinsCD25cutaneous T-cell lymphomaE7777interleukin-2peripheral T-cell lymphoma

Identifiers

PMID33792128
PMCPMC8177793
OpenAlexW3140244252

What OpenQuestion holds

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LicenceCC BY-NC
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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.