Evidence map›Paper›PMID 24814862›Full record

Trial reportCancer science2014

Phase I / II study of brentuximab vedotin in Japanese patients with relapsed or refractory CD30-positive Hodgkin's lymphoma or systemic anaplastic large-cell lymphoma.

Michinori Ogura, Kensei Tobinai, Kiyohiko Hatake, Kenichi Ishizawa, Naokuni Uike, Toshiki Uchida, Tatsuya Suzuki, Tomohiro Aoki, Takashi Watanabe, Dai Maruyama and 4 more

Open access · goldAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer science, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed, 2 pooled it
5.9field-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

33 citing papers in PubMed, 2 syntheses or guidelines pooled it, 54 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

14 authors at 6 institutions in 1 country.

Michinori OguraDepartment of Hematology and Oncology, Nagoya Daini Red Cross Hospital, Nagoya, Japan.
Kensei Tobinai
Kiyohiko Hatake
Kenichi Ishizawa
Naokuni Uike
Toshiki Uchida
Tatsuya Suzuki
Tomohiro Aoki
Takashi Watanabe
Dai Maruyama
Masahiro Yokoyama
Takatoshi Takubo
Hideaki Kagehara
Takafumi Matsushima
Japanese Red Cross Nagoya Daini Hospital · JPTakeda (Japan) · JPTokyo National Hospital · JPThe Cancer Institute Hospital · JPNational Hospital Organization Kyushu Cancer Center · JPTohoku University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Brentuximab vedotin is an antibody-drug conjugate that selectively delivers the antimicrotubule agent monomethyl auristatin E into CD30-expressing cells. To assess its safety, pharmacokinetics, and efficacy in Japanese patients with refractory or relapsed CD30-positive Hodgkin's lymphoma or systemic anaplastic large-cell lymphoma, we carried out a phase I/II study. Brentuximab vedotin was given i.v. on day 1 of each 21-day cycle up to 16 cycles. In the phase I part of a dose-escalation design, three patients per cohort were treated at doses of 1.2 and 1.8 mg/kg. In the phase II part, a dose of 1.8 mg/kg was given to 14 patients (nine with Hodgkin's lymphoma and five with systemic anaplastic large-cell lymphoma). The median number of treatment cycles was 16 (range, 4-16). In the phase I part, no dose-limiting toxicity event was observed. In the total population, common adverse events included lymphopenia (80%), neutropenia (65%), leukopenia (65%), and peripheral sensory neuropathy (60%). Grade 3/4 adverse events in more than two patients were lymphopenia (50%) and neutropenia (15%). The pharmacokinetic profile was similar to that observed in the previous studies in the USA. In the phase II part, six patients (67%) with Hodgkin's lymphoma achieved an objective response with 56% of complete response rate, and five patients (100%) with systemic anaplastic large-cell lymphoma achieved an objective response with 80% of complete response rate. These results show that brentuximab vedotin has an acceptable safety profile and promising antitumor activity in the Japanese population. This trial was registered in JAPIC Clinical Trials Information (JapicCTI-111650).

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsAsian PeopleBrentuximab VedotinDrug Administration ScheduleFemaleHodgkin DiseaseHumansImmunoconjugatesKi-1 AntigenLymphoma, Large-Cell, AnaplasticLymphopeniaMaleMiddle AgedAntineoplastic AgentsBrentuximab VedotinImmunoconjugatesKi-1 AntigenAnaplastic large cell lymphomabrentuximab vedotinclinical trialHodgkin's lymphomaJapanese patients

Identifiers

PMID24814862
PMCPMC4317919
OpenAlexW2046282385

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.