Evidence map›Paper›PMID 32776097›Full record

Trial reportJapanese journal of clinical oncology2020

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

Dai Maruyama, Yasuhito Terui, Kazuhito Yamamoto, Noriko Fukuhara, Ilseung Choi, Junya Kuroda, Kiyoshi Ando, Akira Hattori, Kensei Tobinai

Open access · hybridAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Japanese journal of clinical oncology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed
2.0field-weighted citation impact, top 13% 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

12 citing papers in PubMed, 20 citations in OpenAlex.

  1. Article
  2. Article
  3. Review
  4. Observational
  5. Article
  6. Review
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  9. Review
  10. Engaging the Innate and Adaptive Antitumor Immune Response in Lymphoma.International journal of molecular sciences · 2021
    Review
  11. Review
  12. Review
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

9 authors at 8 institutions in 1 country.

Dai MaruyamaDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.
Yasuhito TeruiDepartment of Hematology and Oncology, Cancer Institute Hospital of JFCR, Tokyo, Japan.
Kazuhito YamamotoDepartment of Hematology and Cell Therapy, Aichi Cancer Center, Nagoya, Japan.
Noriko FukuharaDepartment of Hematology/Rheumatology, Tohoku University Graduate School of Medicine, Sendai, Japan.
Ilseung ChoiDepartment of Hematology, NHO Kyushu Cancer Center, Fukuoka, Japan.
Junya KurodaDivision of Hematology and Oncology, Department of Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Kiyoshi AndoDepartment of Hematology and Oncology, Tokai University, Isehara, Japan.
Akira HattoriMedical Affairs, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Kensei TobinaiDepartment of Hematology, National Cancer Center Hospital, Tokyo, Japan.
Tokyo National Hospital · JPAichi Cancer Center · JPKyoto Prefectural University of Medicine · JPNational Hospital Organization Kyushu Cancer Center · JPOno Pharmaceutical (Japan) · JPThe Cancer Institute Hospital · JPTohoku University · JPTokai University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMany patients with classical Hodgkin lymphoma show increased programmed death-1 ligand expression in Reed-Sternberg cells. We report the final results of a phase II study of nivolumab, an anti-programmed death-1 monoclonal antibody, in Japanese patients with relapsed or refractory classical Hodgkin lymphoma.

methodsJapanese patients with previously treated classical Hodgkin lymphoma (aged ≥ 20 years) were administered nivolumab (3 mg/kg on Day 1 of 14-day cycles) until progressive disease, an unacceptable adverse event, or another clinically relevant reason. Treatment could continue beyond progressive disease at the investigator's discretion in selected patients.

resultsSeventeen patients (median age: 63.0 years) were enrolled. The median follow-up was 38.8 months. One patient with non-Hodgkin lymphoma was excluded from efficacy analyses. The centrally assessed overall response rate in 16 classical Hodgkin lymphoma patients was 87.5% (95% confidence interval = 61.7-98.4%) and the disease control rate was 93.8% (95% confidence interval = 69.8-99.8%). The median (95% confidence interval) duration of response and progression-free survival were 8.5 (2.4-12.6) and 11.7 (1.8-42.3) months, respectively. The 3-year overall survival rate was 80.4% (95% confidence interval = 50.6-93.2%). Nivolumab was continued beyond progressive disease in seven patients; six were alive at the data cut-off. Adverse drug reactions occurred in all 17 patients with grades 3-4 adverse drug reactions in eight patients and no grade 5 adverse drug reactions. Pulmonary toxicities occurred in five patients; four of these occurred ≥17 months after starting nivolumab.

conclusionNivolumab is effective and tolerable in Japanese relapsed or refractory classical Hodgkin lymphoma patients. Continued monitoring may be necessary to detect late-onset pulmonary toxicities. CLINICAL

trial registrationJapicCTI-142755 (Japan Pharmaceutical Information Center).

Indexed as

Asian PeopleAdultAgedAged, 80 and overFemaleHodgkin DiseaseHumansJapanMaleMiddle AgedNeoplasm Recurrence, LocalNivolumabProgression-Free SurvivalTreatment OutcomeNivolumabdisease progressionHodgkin lymphomainterstitial lung diseasenivolumabsurvival

Identifiers

PMID32776097
PMCPMC7579338
OpenAlexW3048800525

What OpenQuestion holds

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LicenceCC BY
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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.