Evidence map›Paper›PMID 34185953›Full record

Trial reportAsia-Pacific journal of clinical oncology2022

Efficacy and safety of blinatumomab: Post hoc pooled analysis in Asian adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.

Yukio Kobayashi, Iekuni Oh, Toshihiro Miyamoto, Won-Sik Lee, Hiroatsu Iida, Hironobu Minami, Yoshinobu Maeda, Jun Ho Jang, Sung-Soo Yoon, Su-Peng Yeh and 4 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Asia-Pacific journal of clinical oncology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02412306 (A Phase 1b/2 Study of Blinatumomab in Japanese Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.2field-weighted citation impact, top 21% 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.

NCT02412306 phase1 / phase2completednot on this map

A Phase 1b/2 Study of Blinatumomab in Japanese Subjects With Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (ALL) (Horai Study)

TypeinterventionalSponsorAmgenRan2015 to 2019Enrolled66ConditionsRelapsed Refractory B Precursor Acute Lymphoblastic LeukemiaArmsBlinatumomab
3 · Its place in the literature

Who cites it

3 citing papers in PubMed, 6 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
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 12 institutions in 4 countries.

Yukio KobayashiNational Cancer Center Hospital, Tokyo, Japan.
Iekuni OhJichi Medical University, Tochigi, Japan.
Toshihiro MiyamotoDepartment of Medicine and Biosystemic Science, Kyushu University Graduate School of Medical Science, Fukuoka, Japan.
Won-Sik LeeDepartment of Internal Medicine, Hemato-Oncology, Busan Paik Hospital, Inje University, Busan, Korea.
Hiroatsu IidaNational Hospital Organization Nagoya Medical Center, Aichi, Japan.
Hironobu MinamiMedical Oncology/Hematology, Kobe University Graduate School of Medicine and Hospital, Kobe, Japan.
Yoshinobu MaedaOkayama University Hospital, Okayama, Japan.
Jun Ho JangDivision of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University College of Medicine, Seoul, Korea.
Sung-Soo YoonDivision of Hematology/Medical Oncology, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Su-Peng YehDivision of Hematology and Oncology, Department of Medicine, China Medical University Hospital, Taichung, Taiwan.
Qui TranAmgen Inc., Thousand Oaks, California, USA.
Joan MorrisAmgen Inc., Thousand Oaks, California, USA.ORCID https://orcid.org/0000-0002-6267-7637
Janet FranklinAmgen Inc., Thousand Oaks, California, USA.
Hitoshi KiyoiDepartment of Hematology and Oncology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Amgen (United States) · USChina Medical University · TWInje University Busan Paik Hospital · KRJichi Medical University · JPKobe University Hospital · JPKyushu University · JPNagoya University · JPNational Hospital Organization · JPOkayama University Hospital · JPSamsung Medical Center · KRSeoul National University Hospital · KRTokyo National Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundGlobal studies have demonstrated the efficacy and safety of blinatumomab-a BiTE

methodsPatients received a maximum of two cycles of induction blinatumomab for 4 weeks by continuous intravenous infusion (cycle 1/week 1: 9 μg/day; cycle 1/weeks 2-4: 28 μg/day) followed by 2 weeks of no blinatumomab (each 6-week cycle); patients received 28 μg/day blinatumomab in subsequent cycles.

resultsTwenty of 45 patients enrolled (44%) achieved complete remission with full or partial hematologic recovery compared with 44% in TOWER and 80% and 38% in phase 1b and phase 2, respectively, of Study 265. The Kaplan-Meier (KM) median overall survival was 11.9 months (95% confidence interval [CI], 9.9-17.1) and the KM median duration of relapse-free survival was 8.9 months (95% CI, 3.8-10.7). Ninety-three percent of patients had grade ≥ 3 treatment-emergent adverse events (AEs) compared with 87% in TOWER and 80% and 100% in phase 1b and phase 2, respectively, of Study 265. Five patients (11.4%) had fatal AEs.

conclusionsThe safety and efficacy of blinatumomab in Asian patients were comparable with those reported in previous global studies with no new safety signals.

Indexed as

Antibodies, BispecificAntineoplastic AgentsPrecursor B-Cell Lymphoblastic Leukemia-LymphomaPrecursor Cell Lymphoblastic Leukemia-LymphomaAdultHumansRemission InductionAntibodies, BispecificAntineoplastic Agentsblinatumomabacute lymphoblastic leukemia (ALL)Asiablinatumomabpost hoc analysisrelapsed/refractory

Identifiers

PMID34185953
PMCPMC9292847
OpenAlexW3174846611

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

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.