Evidence map›Paper›PMID 33492746›Full record

ArticleCancer science2021

Phase 1 study of tazemetostat in Japanese patients with relapsed or refractory B-cell lymphoma.

Wataru Munakata, Yukari Shirasugi, Kensei Tobinai, Makoto Onizuka, Shinichi Makita, Rikio Suzuki, Dai Maruyama, Hidetsugu Kawai, Koji Izutsu, Tadashi Nakanishi and 3 more

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

Article in Cancer science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed
3.8field-weighted citation impact, top 6% 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

23 citing papers in PubMed, 30 citations in OpenAlex.

  1. Trial
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  8. Epigenetics-targeted drugs: current paradigms and future challenges.Signal transduction and targeted therapy · 2024
    Review
  9. Complete response using theInternational cancer conference journal · 2024
    Article
  10. Review
  11. Article
  12. Review
  13. Pharmacology and pharmacokinetics of tazemetostat.Cancer chemotherapy and pharmacology · 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

13 authors at 3 institutions in 1 country.

Wataru MunakataDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0002-4679-0656
Yukari ShirasugiDepartment of Hematology and Oncology, Tokai University School of Medicine, Isehara, Japan.
Kensei TobinaiDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.
Makoto OnizukaDepartment of Hematology and Oncology, Tokai University School of Medicine, Isehara, Japan.
Shinichi MakitaDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0001-6609-8088
Rikio SuzukiDepartment of Hematology and Oncology, Tokai University School of Medicine, Isehara, Japan.
Dai MaruyamaDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.ORCID https://orcid.org/0000-0003-0654-6920
Hidetsugu KawaiDepartment of Hematology and Oncology, Tokai University School of Medicine, Isehara, Japan.
Koji IzutsuDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.
Tadashi NakanishiDepartment of Clinical Development, Eisai Co., Ltd., Tokyo, Japan.
Sari ShibaClinical Pharmacology Science Department, Eisai Co., Ltd., Tokyo, Japan.
Seichiro HojoClinical Data Science Department, Eisai Co., Ltd., Tokyo, Japan.
Kiyoshi AndoDepartment of Hematology and Oncology, Tokai University School of Medicine, Isehara, Japan.
Tokai University · JPTokyo National Hospital · JPEisai (Japan) · JP

Funding

Eisai
6 · The paper itself

Abstract

backgroundTazemetostat is a selective and orally available inhibitor of enhancer of zeste homolog 2 (EZH2), a histone methyltransferase and epigenetic regulator of cellular differentiation programs. We carried out a phase I study of tazemetostat in Japanese patients with relapsed or refractory B-cell non-Hodgkin-type lymphoma (B-NHL) to evaluate its tolerability, safety, pharmacokinetics, and preliminary antitumor activity.

methodsTazemetostat was given orally at a single dose of 800 mg on the first day and 800 mg twice daily (BID: total 1600 mg/d) on following days in a 28-day/cycle manner. Tazemetostat dose-limiting toxicity (DLT) was evaluated up to the end of the first treatment cycle. Archival tumor tissues were analyzed for hotspot EZH2 mutations.

resultsAs of 15 January 2018, seven patients (four follicular lymphoma [FL] and three diffuse large B-cell lymphoma [DLBCL]) were enrolled. The median age was 73 (range, 59-85) years, and the median number of prior chemotherapy regimens was three (range, one to five). No DLT was observed (one patient was not evaluable due to early disease progression). The common treatment-related adverse events (AEs) were thrombocytopenia and dysgeusia (three patients each; 42.9%). No treatment-related serious AEs were observed. The objective response rate was 57% (4/7 patients), including responses in three of four patients with FL and one of three patients with DLBCL. An EZH2 mutation was detected in one patient with FL responding to treatment.

conclusionsTazemetostat at 800 mg BID showed an acceptable safety profile and promising antitumor activity in Japanese patients with relapsed or refractory B-NHL.

Indexed as

Administration, OralAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBenzamidesBiphenyl CompoundsDrug Administration ScheduleDrug Resistance, NeoplasmEnhancer of Zeste Homolog 2 ProteinFemaleHumansJapanLymphoma, B-CellMaleMiddle AgedMorpholinesBenzamidesBiphenyl CompoundsEnhancer of Zeste Homolog 2 ProteinEZH2 protein, humanMorpholinesPyridonestazemetostatdiffuse large B-cell lymphomaenhancer of zeste homolog 2follicular lymphomaphase I studytazemetostat

Identifiers

PMID33492746
PMCPMC7935786
OpenAlexW3124516339

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.