Evidence map›Paper›PMID 39586984›Full record

Observational studyInternational journal of hematology2025

Real-world effectiveness and safety of ibrutinib in patients with chronic lymphocytic leukemia in Japan: the Orbit study.

Tsuyoshi Muta, Yosuke Masamoto, Go Yamamoto, Shingo Kurahashi, Yoshihiro Kameoka, Shuichi Ota, Eri Matsuki, Kazutaka Ozeki, Takanori Toyama, Naoki Takahashi and 13 more

Abstract readMulticenter StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in International journal of hematology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 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

2 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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

23 authors.

Tsuyoshi MutaDepartment of Transfusion Medicine Clinical Laboratory, Hiroshima Red Cross Hospital and Atomic-Bomb Survivors Hospital, Hiroshima, Japan.
Yosuke MasamotoDepartment of Cell Therapy and Transplantation Medicine, The University of Tokyo Hospital, Tokyo, Japan.
Go YamamotoDepartment of Hematology, Toranomon Hospital, Tokyo, Japan.
Shingo KurahashiDepartment of Hematology and Oncology, Toyohashi Municipal Hospital, Aichi, Japan.
Yoshihiro KameokaDepartment of Hematology, Nephrology and Rheumatology, Akita University Graduate School of Medicine and Faculty of Medicine, Akita, Japan.
Shuichi OtaDepartment of Hematology, Sapporo Hokuyu Hospital, Sapporo, Japan.
Eri MatsukiDivision of Hematology, Department of Medicine, Keio University School of Medicine, Tokyo, Japan.
Kazutaka OzekiDepartment of Hematology and Oncology, JA Aichi Konan Kosei Hospital, Aichi, Japan.
Takanori ToyamaDepartment of Internal Medicine, Miyazaki Prefectural Nobeoka Hospital, Miyazaki, Japan.
Naoki TakahashiDepartment of Hematology, International Medical Center, Saitama Medical University, Saitama, Japan.
Takahiro KumodeDepartment of Hematology and Rheumatology, Kindai University Hospital, Osaka, Japan.
Nobuyuki AotsukaDepartment of Hematology and Oncology, Japanese Red Cross Narita Hospital, Chiba, Japan.
Takuro YoshimuraDepartment of Hematology, Osaka City General Hospital, Osaka, Japan.
Hideto TamuraDepartment of Diabetes, Endocrinology and Hematology, Dokkyo Medical University Saitama Medical Center, Saitama, Japan.
Ai OmiDepartment of Medical Affairs, Janssen Pharmaceutical K.K, 3-5-2 Nishi-Kanda, Chiyoda-Ku, Tokyo, 101-0065, Japan. AOmi@ITS.JNJ.com.ORCID http://orcid.org/0000-0001-9391-5661
Kazuhiro ShibayamaStatistics & Decision Sciences Japan, Janssen Pharmaceutical K.K., Tokyo, Japan.
Aki WatanabeMedical Affairs Delivery Unit, Global Development, Janssen Pharmaceutical K.K., Tokyo, Japan.
Yasushi IsobeDepartment of Medical Oncology, Hematology and Infectious Diseases, Fukuoka University Hospital, Fukuoka, Japan.
Kensuke KojimaDepartment of Hematology, Kochi Medical School, Kochi University, Kochi, Japan.
Jun TakizawaDepartment of Hematology, Endocrinology and Metabolism, Niigata University Faculty of Medicine, Niigata, Japan.
Hirokazu NagaiHematology Department, National Hospital Organization Nagoya Medical Center, Aichi, Japan.
Junji SuzumiyaDepartment of Hematology, Koga Community Hospital, Yaizu, Japan.
Sadao AokiDepartment of Medical Technology, Faculty of Medical Technology, Niigata University of Pharmacy and Medical and Life Sciences, Niigata, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ibrutinib is a first-in-class Bruton's tyrosine kinase inhibitor that is approved for the treatment of chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in Japan based on randomized clinical trial data. The aim of the real-world, retrospective Orbit study was to describe long-term clinical outcomes and management in adults (aged ≥ 20 years) with CLL/SLL treated with ibrutinib, either as first-line (1L) treatment or for relapsed or refractory (RR) disease, in routine clinical practice in Japan between July 2018 and December 2020. A total of 246 patients were registered, and the safety and per-protocol sets included 237 and 234 patients, respectively. After a median follow-up of 35.7 months, the 36-month progression-free survival rate was 80.9% in the 1L CLL cohort and 67.2% in the RR CLL cohort, and the 36-month overall survival rates were 90.8% and 83.7%, respectively. Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥ 3 adverse events of special interest were atrial fibrillation (2.1%), infections (herpesvirus infection, fungal infection, or Pneumocystis jiroveci pneumonia; 1.7%), bleeding (3.8%), and second primary malignancy (2.5%). These findings confirm the long-term, real-world effectiveness and safety of ibrutinib for the treatment of Japanese patients with newly diagnosed or RR CLL/SLL.

Indexed as

AdenineLeukemia, Lymphocytic, Chronic, B-CellPiperidinesProtein Kinase InhibitorsAdultAgedAged, 80 and overFemaleHumansJapanMaleMiddle AgedRetrospective StudiesSurvival RateTreatment OutcomeAdenineibrutinibPiperidinesProtein Kinase InhibitorsBruton’s tyrosine kinase inhibitorChronic lymphocytic leukemiaIbrutinibJapanReal-world studySmall lymphocytic lymphoma

Identifiers

PMID39586984
PMCPMC11782388

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.