Evidence map›Paper›PMID 26179770›Full record

Trial reportCancer science2015

A phase II study of bortezomib in patients with relapsed or refractory aggressive adult T-cell leukemia/lymphoma.

Kenji Ishitsuka, Atae Utsunomiya, Hiroo Katsuya, Shogo Takeuchi, Yoshifusa Takatsuka, Michihiro Hidaka, Tatsunori Sakai, Makoto Yoshimitsu, Takashi Ishida, Kazuo Tamura

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

Trial report in Cancer science, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed
2.2field-weighted citation impact, top 12% 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

19 citing papers in PubMed, 31 citations in OpenAlex.

  1. MogamulizumabHaematologica · 2019
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  8. Genetic Landscape of Peripheral T-Cell Lymphoma.Life (Basel, Switzerland) · 2022
    Review
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  10. Review
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  12. Article
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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

10 authors at 5 institutions in 1 country.

Kenji IshitsukaDivision of Oncology, Hematology and Infectious Diseases, Fukuoka University, Fukuoka, Japan.
Atae UtsunomiyaDepartment of Hematology, Imamura Bun-in Hospital, Kagoshima, Japan.
Hiroo KatsuyaDivision of Oncology, Hematology and Infectious Diseases, Fukuoka University, Fukuoka, Japan.
Shogo TakeuchiDepartment of Hematology, Imamura Bun-in Hospital, Kagoshima, Japan.
Yoshifusa TakatsukaDepartment of Hematology, Imamura Bun-in Hospital, Kagoshima, Japan.
Michihiro HidakaDepartment of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
Tatsunori SakaiDepartment of Hematology, National Hospital Organization Kumamoto Medical Center, Kumamoto, Japan.
Makoto YoshimitsuDivision of Hematology and Immunology, Center for Chronic Viral Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Takashi IshidaDepartment of Hematology and Oncology, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Kazuo TamuraDivision of Oncology, Hematology and Infectious Diseases, Fukuoka University, Fukuoka, Japan.
Fukuoka University Hospital · JPImamura Hospital · JPKumamoto Medical Center · JPKagoshima University · JPNagoya City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Adult T-cell leukemia/lymphoma (ATL) is a malignancy of peripheral T-lymphocytes with a poor prognosis. This multicenter, two-stage, single-arm, phase II study assessed the efficacy and safety of bortezomib in patients with relapsed/refractory ATL who received at least one regimen of chemotherapy. The primary endpoint was the best overall response rate (ORR), and secondary endpoints included safety, the best response by lesions, and progression-free survival (PFS). Fifteen patients were enrolled in the first stage of this study. One partial remission (PR) and five stable disease (SD) were observed as the best overall responses, and ORR was 6.7% (95% confidence interval (C.I.) 0.17-31.95%). Responses according to disease sites were one complete remission (CR) in peripheral blood, two PR in measurable targeted lesions, and two PR in skin lesions. Progression-free survival (PFS) was 38 (95% CI; 18-106) days. All patients developed ≥1 adverse events (AEs), and 80% of patients had ≥1 grade 3/4 AEs; however, no new safety findings were obtained. Although these results fulfilled the planned settings to proceed to the second stage, the coordinating committee decided to terminate this study because single agent activity did not appear to be very promising for this cohort of patients.

Indexed as

AgedAntineoplastic AgentsBortezomibDisease-Free SurvivalFemaleHumansLeukemia-Lymphoma, Adult T-CellMaleMiddle AgedRemission InductionAntineoplastic AgentsBortezomibAdult T-cell leukemia/lymphomabortezomibnuclear factor-κBproteasome inhibitorsalvage treatment

Identifiers

PMID26179770
PMCPMC4582992
OpenAlexW1909862186

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.