Evidence map›Paper›PMID 32639651›Full record

Trial reportCancer science2020

A multicenter, open-label, phase II study of tirabrutinib (ONO/GS-4059) in patients with Waldenström's macroglobulinemia.

Naohiro Sekiguchi, Shinya Rai, Wataru Munakata, Kenshi Suzuki, Hiroshi Handa, Hirohiko Shibayama, Tomoyuki Endo, Yasuhito Terui, Noriko Iwaki, Noriko Fukuhara and 5 more

Erratum issuedAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 45 papers.

0numbers the graph read from it
0cells of the map it votes in
45citing papers in PubMed
–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

45 citing papers in PubMed.

  1. Trial
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  13. Bruton's Tyrosine Kinase Inhibitors: Recent Updates.International journal of molecular sciences · 2024
    Review
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Naohiro SekiguchiDepartment of Hematology, National Hospital Organization Disaster Medical Center, Tachikawa, Japan.ORCID https://orcid.org/0000-0001-9860-8257
Shinya RaiDepartment of Hematology and Rheumatology, Faculty of Medicine, Kindai University, Osakasayama, Japan.
Wataru MunakataDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.
Kenshi SuzukiDepartment of Hematology, Japanese Red Cross Medical Center, Tokyo, Japan.
Hiroshi HandaDepartment of Hematology, Gunma University Graduate School of Medicine, Maebashi, Japan.
Hirohiko ShibayamaDepartment of Hematology and Oncology, Osaka University Graduate School of Medicine, Suita, Japan.
Tomoyuki EndoDepartment of Hematology, Hokkaido University Hospital, Sapporo, Japan.
Yasuhito TeruiDepartment of Hematology Oncology, The Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Noriko IwakiDepartment of Hematology, Kanazawa University Hospital, Kanazawa, Japan.
Noriko FukuharaDepartment of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Hiro TatetsuDepartment of Hematology, Kumamoto University Hospital, Kumamoto, Japan.
Shinsuke IidaDepartment of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.ORCID https://orcid.org/0000-0002-4951-960X
Takayuki IshikawaDepartment of Hematology, Kobe City Medical Center General Hospital, Kobe, Japan.
Ryota ShiibashiDepartment of Clinical Development, Ono Pharmaceutical Co., LTD., Osaka, Japan.
Koji IzutsuDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.

Funding

Ono Pharmaceutical
6 · The paper itself

Abstract

Tirabrutinib is a second-generation Bruton's tyrosine kinase inhibitor with greater selectivity than ibrutinib. Here, we conducted a multicenter, phase II study of tirabrutinib in patients with treatment-naïve (Cohort A) or with relapsed/refractory (Cohort B) Waldenström's macroglobulinemia (WM). Patients were treated with tirabrutinib 480 mg once daily. The primary endpoint was major response rate (MRR; ≥ partial response). Secondary endpoints included overall response rate (ORR; ≥ minor response), time to major response (TTMR), progression-free survival (PFS), overall survival (OS), and safety. In total, 27 patients (18 in Cohort A; 9 in Cohort B) were enrolled. The median age was 71 y, and the median serum immunoglobulin M level was 3600 mg/dL. Among the patients, 96.2% had the MYD88

Indexed as

AgedAged, 80 and overBiomarkersFemaleGenotypeHumansImidazolesMaleMiddle AgedMutationMyeloid Differentiation Factor 88Neoplasm GradingProtein Kinase InhibitorsPyrimidinesReceptors, CXCR4Treatment OutcomeBiomarkersCXCR4 protein, humanImidazolesMYD88 protein, humanMyeloid Differentiation Factor 88Protein Kinase InhibitorsPyrimidinesReceptors, CXCR4tirabrutinibB-cell malignancyBTK inhibitorJapanesetirabrutinibWaldenström’s macroglobulinemia

Identifiers

PMID32639651
PMCPMC7469793

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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.