Evidence map›Paper›PMID 28597329›Full record

Trial reportInternational journal of hematology2017

Safety and efficacy of mogamulizumab in patients with adult T-cell leukemia-lymphoma in Japan: interim results of postmarketing all-case surveillance.

Kenji Ishitsuka, Satoshi Yurimoto, Kouichi Kawamura, Yukie Tsuji, Manabu Iwabuchi, Takeshi Takahashi, Kensei Tobinai

Abstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 11% 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

17 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

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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

7 authors at 3 institutions in 1 country.

Kenji IshitsukaDivision of Hematology and Immunology, Center for Chronic Viral Diseases, Graduate School of Medical and Dental Sciences, Kagoshima University, Kagoshima, Japan. kenji-i@m.kufm.kagoshima-u.ac.jp.
Satoshi YurimotoMedical Affairs, Kyowa Hakko Kirin Co., Ltd., Tokyo, Japan.
Kouichi KawamuraMedical Affairs, Kyowa Hakko Kirin Co., Ltd., Tokyo, Japan.
Yukie TsujiPharmacovigilance and Quality Assurance Division, Kyowa Hakko Kirin Co., Ltd., Tokyo, Japan.
Manabu IwabuchiPharmacovigilance and Quality Assurance Division, Kyowa Hakko Kirin Co., Ltd., Tokyo, Japan.
Takeshi TakahashiMedical Affairs, Kyowa Hakko Kirin Co., Ltd., Tokyo, Japan.
Kensei TobinaiDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.
Kyowa Kirin (Japan) · JPKagoshima University · JPTokyo National Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

We present the interim results of a postmarketing all-case surveillance study in patients with C-C chemokine receptor 4 (CCR4)-positive, relapsed or refractory adult T-cell leukemia-lymphoma (ATL) treated with the anti-CCR4 monoclonal antibody mogamulizumab since its 2012 launch in Japan. The safety and efficacy analysis populations comprised 484 and 442 patients, respectively. The ATL subtype was acute in 58.9% and lymphoma in 34.2% of patients. All patients were scheduled to receive intravenous infusions of mogamulizumab (1.0 mg/kg) once weekly for eight weeks, alone or in combination with other modalities. Adverse drug reactions (ADRs) were reported in 74.0% of patients, of which 35.7% were serious and 6.2% were fatal. The priority survey items of infusion-related reaction, skin disorder, infection, immune disorder, and tumor lysis syndrome were reported in 29.3, 34.3, 22.1, 3.5, and 2.5% of patients, respectively. Graft-versus-host disease was reported in 25/42 patients who received mogamulizumab before allogeneic hematopoietic stem cell transplantation. The best overall response rate was 57.7% overall, 57.5% in patients treated with mogamulizumab alone, and 58.2% in patients treated with combination therapy. This surveillance indicates that mogamulizumab shows acceptable tolerability in practice; however, because of the risk of serious/fatal ADRs, patients administered mogamulizumab should be carefully monitored.

Indexed as

Product Surveillance, PostmarketingAdultAgedAntibodies, Monoclonal, HumanizedFemaleHumansJapanLeukemia-Lymphoma, Adult T-CellMaleMiddle AgedAntibodies, Monoclonal, HumanizedmogamulizumabATLMogamulizumabPostmarketing surveillance

Identifiers

PMID28597329
OpenAlexW2624145351

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.