Evidence map›Paper›PMID 28267244›Full record

Trial reportCancer science2017

Multicenter phase II study of nivolumab in Japanese patients with relapsed or refractory classical Hodgkin lymphoma.

Dai Maruyama, Kiyohiko Hatake, Tomohiro Kinoshita, Noriko Fukuhara, Ilseung Choi, Masafumi Taniwaki, Kiyoshi Ando, Yasuhito Terui, Yusuke Higuchi, Yasushi Onishi and 4 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer science, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed, 8 pooled it
–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

35 citing papers in PubMed, 8 syntheses or guidelines pooled it.

  1. Pooled it
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  4. Efficacy of nivolumab as checkpoint inhibitor drug on survival rate of patients with relapsed/refractory classical Hodgkin lymphoma: a meta-analysis of prospective clinical study.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2019
    Pooled it
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  17. Engaging the Innate and Adaptive Antitumor Immune Response in Lymphoma.International journal of molecular sciences · 2021
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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.

Dai MaruyamaDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.ORCID http://orcid.org/0000-0003-0654-6920
Kiyohiko HatakeDepartment of Hematology and Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Tomohiro KinoshitaDepartment of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan.
Noriko FukuharaDepartment of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Ilseung ChoiDepartment of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Masafumi TaniwakiDepartment of Hematology and Oncology, University Hospital, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Kiyoshi AndoDepartment of Hematology and Oncology, Tokai University, Isehara, Japan.
Yasuhito TeruiDepartment of Hematology and Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, Japan.
Yusuke HiguchiDepartment of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan.
Yasushi OnishiDepartment of Hematology and Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Yasunobu AbeDepartment of Hematology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Tsutomu KobayashiDepartment of Hematology and Oncology, University Hospital, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Yukari ShirasugiDepartment of Hematology and Oncology, Tokai University, Isehara, Japan.
Kensei TobinaiDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Overexpression of programmed death-1 (PD-1) ligands contributes to an immunosuppressive microenvironment. Nivolumab is a PD-1-blocking antibody that inhibits the PD-1 pathway and showed good efficacy in several types of malignancy. This phase II study examined the efficacy and safety of nivolumab in 17 Japanese patients with refractory/relapsed classical Hodgkin lymphoma previously treated with brentuximab vedotin. Sixteen patients were included in efficacy analyses and 17 in safety analyses. The primary endpoint was the centrally assessed objective response rate (ORR). The study was commenced in March 2015. We report data obtained at a cutoff of 16 March 2016, at which time 11 patients were still receiving nivolumab. The median (range) duration of treatment and follow-up were 7.0 (1.4-10.6) months and 9.8 (6.0-11.1) months, respectively. All 17 patients had previously received brentuximab vedotin. The ORR was 81.3% (95% confidence interval [CI]: 54.4-96.0%; 13/16 patients), with complete remission and partial remission in 4 and 9 patients, respectively. The overall survival (OS) and progression-free survival (PFS) rates at 6 months were 100 and 60.0% (95% CI: 31.8-79.7%), respectively; the median OS and PFS were not reached. The most common adverse events (AE) were pyrexia (41.2%), pruritus (35.3%), rash (35.3%) and hypothyroidism (29.4%). Four patients (23.5%) experienced grade 3 or 4 AE, but most AE were of grade 1 or 2. In conclusion, nivolumab is a potentially effective and tolerable treatment option for Japanese patients with relapsed/refractory classical Hodgkin lymphoma previously treated with brentuximab vedotin.

Indexed as

AdultAgedAged, 80 and overAntibodies, MonoclonalAsian PeopleBrentuximab VedotinDisease-Free SurvivalFemaleHodgkin DiseaseHumansImmunoconjugatesMaleMiddle AgedNeoplasm Recurrence, LocalNivolumabProgrammed Cell Death 1 ReceptorAntibodies, MonoclonalBrentuximab VedotinImmunoconjugatesNivolumabProgrammed Cell Death 1 ReceptorHodgkin lymphomaimmunotherapyJapanesenivolumabprogrammed death-1

Identifiers

PMID28267244
PMCPMC5448600

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.