Evidence map›Paper›PMID 37071252›Full record

ArticleInternational journal of clinical oncology2023

Safety and efficacy of tisagenlecleucel in patients with relapsed or refractory B-cell lymphoma: the first real-world evidence in Japan.

Hideki Goto, Toshio Kitawaki, Nobuharu Fujii, Koji Kato, Yasushi Onishi, Noriko Fukuhara, Takuji Yamauchi, Kazunori Toratani, Hiroki Kobayashi, Shota Yoshida and 7 more

Abstract read
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In one paragraph

Article in International journal of clinical oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 1 pooled it
6.2field-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

18 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
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  13. CRS and ICANS in CAR T-cell therapy for large B-cell lymphoma.Journal of clinical and experimental hematopathology : JCEH · 2025
    Review
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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

17 authors at 7 institutions in 1 country.

Hideki GotoDivision of Laboratory and Transfusion Medicine, Hokkaido University Hospital, Sapporo, Japan. hidekigt@med.hokudai.ac.jp.ORCID http://orcid.org/0000-0001-8361-9973
Toshio KitawakiDepartment of Hematology and Oncology, Kyoto University Hospital, Kyoto, Japan.
Nobuharu FujiiDivision of Transfusion, Okayama University Hospital, Okayama, Japan.
Koji KatoDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Yasushi OnishiDepartment of Hematology, Tohoku University Hospital, Sendai, Japan.
Noriko FukuharaDepartment of Hematology, Tohoku University Hospital, Sendai, Japan.
Takuji YamauchiDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Kazunori TorataniDepartment of Hematology and Oncology, Kyoto University Hospital, Kyoto, Japan.
Hiroki KobayashiDepartment of Hematology, Oncology and Respiratory Medicine, Graduate School of Medicine, Density and Pharmaceutical Sciences, Okayama University, Okayama, Japan.
Shota YoshidaDepartment of Hematology, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Masatoshi ShimoDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Sciences, Fukuoka, Japan.
Koichi OnoderaDepartment of Hematology, Tohoku University Hospital, Sendai, Japan.
Hajime SenjoDepartment of Hematology, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Masahiro OnozawaDepartment of Hematology, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Kenji HirataDepartment of Diagnostic Imaging, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Isao YokotaDepartment of Biostatistics, Faculty of Medicine, Hokkaido University, Sapporo, Japan.
Takanori TeshimaDivision of Laboratory and Transfusion Medicine, Hokkaido University Hospital, Sapporo, Japan.
Hokkaido University · JPKyushu University · JPTohoku University Hospital · JPKyoto University Hospital · JPHokkaido University Hospital · JPOkayama University · JPOkayama University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTisagenlecleucel, an autologous CD19-directed T-cell immunotherapy, can induce a durable response in adult patients with relapsed/refractory (r/r) B-cell lymphoma.

methodsTo elucidate the outcome of chimeric antigen receptor (CAR) T-cell therapy in Japanese, we retrospectively analyzed the outcomes of 89 patients who received tisagenlecleucel for r/r diffuse large B-cell lymphoma (n = 71) or transformed follicular lymphoma (n = 18).

resultsWith a median follow-up of 6.6-months, 65 (73.0%) patients achieved a clinical response. The overall survival (OS) and event-free survival (EFS) rates at 12 months were 67.0% and 46.3%, respectively. Overall, 80 patients (89.9%) had cytokine release syndrome (CRS), and 6 patients (6.7%) had a grade ≥ 3 event. ICANS occurred in 5 patients (5.6%); only 1 patient had grade 4 ICANS. Representative infectious events of any grade were cytomegalovirus viremia, bacteremia and sepsis. The most common other adverse events were ALT elevation, AST elevation, diarrhea, edema, and creatinine elevation. No treatment-related mortality was observed. A Sub-analysis showed that a high metabolic tumor volume (MTV; ≥ 80 ml) and stable disease /progressive disease before tisagenlecleucel infusion were both significantly associated with a poor EFS and OS in a multivariate analysis (P < 0.05). Notably, the combination of these 2 factors efficiently stratified the prognosis of these patients (HR 6.87 [95% CI 2.4-19.65; P < 0.05] into a high-risk group).

conclusionWe report the first real-world data on tisagenlecleucel for r/r B-cell lymphoma in Japan. Tisagenlecleucel is feasible and effective, even in late line treatment. In addition, our results support a new algorithm for predicting the outcomes of tisagenlecleucel.

Indexed as

Lymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinAdultHumansJapanNeoplasm Recurrence, LocalReceptors, Antigen, T-CellRetrospective StudiesReceptors, Antigen, T-CelltisagenlecleucelAlgorithmCAR-TLymphomaMetabolic tumor volumeTisagenlecleucel

Identifiers

PMID37071252
OpenAlexW4366236985

What OpenQuestion holds

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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.