Evidence map›Paper›PMID 37127801›Full record

Trial reportInternational journal of hematology2023

Phase 2 study of combination chemotherapy with bortezomib in children with relapsed and refractory acute lymphoblastic leukemia.

Naoyuki Miyagawa, Hiroaki Goto, Atsushi Ogawa, Atsushi Kikuta, Yoshiyuki Kosaka, Masahiro Sekimizu, Daisuke Tomizawa, Hidemi Toyoda, Hidefumi Hiramatsu, Junichi Hara and 6 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Publisher
In one paragraph

Trial report in International journal of hematology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.9field-weighted citation impact, top 26% 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

0 citing papers in PubMed, 3 citations in OpenAlex.

No citing paper in PubMed yet.

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

16 authors at 11 institutions in 1 country.

Naoyuki MiyagawaDivision of Hematology and Oncology, Kanagawa Children's Medical Center, 2-138-4 Mutsukawa, Minami-Ku, Yokohama, Kanagawa, 232-8555, Japan. nmiyagawa@kcmc.jp.ORCID http://orcid.org/0000-0003-4400-2481
Hiroaki GotoDivision of Hematology and Oncology, Kanagawa Children's Medical Center, 2-138-4 Mutsukawa, Minami-Ku, Yokohama, Kanagawa, 232-8555, Japan.
Atsushi OgawaDepartment of Pediatrics, Niigata Cancer Center Hospital, Niigata, Japan.
Atsushi KikutaDepartment of Pediatric Oncology, Fukushima Medical University Hospital, Fukushima, Japan.
Yoshiyuki KosakaDepartment of Hematology and Oncology, Hyogo Prefectural Kobe Children's Hospital, Kobe, Japan.
Masahiro SekimizuDepartment of Pediatrics, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Daisuke TomizawaDivision of Leukemia and Lymphoma, Children's Cancer Center, National Center for Child Health and Development, Tokyo, Japan.
Hidemi ToyodaDepartment of Pediatrics, Mie University Graduate School of Medicine, Mie, Japan.
Hidefumi HiramatsuDepartment of Pediatrics, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
Junichi HaraDepartment of Pediatric Hematology/Oncology, Osaka City General Hospital, Osaka, Japan.
Shinji MochizukiDepartment of Pediatrics, Hiroshima University Hospital, Hiroshima, Japan.
Hideki NakayamaDepartment of Pediatrics, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.
Kenichi YoshimuraMedical Center for Translational and Clinical Research, Hiroshima University Hospital, Hiroshima, Japan.
Yuka Iijima-YamashitaDepartment of Advanced Diagnosis, Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Masashi SanadaDepartment of Advanced Diagnosis, Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.
Chitose OgawaDepartment of Pediatric Oncology, National Cancer Center Hospital, Tokyo, Japan.
National Hospital Organization · JPHiroshima University Hospital · JPKanagawa Children's Medical Center · JPFukushima Medical University Hospital · JPKobe Children's Hospital · JPKyoto University · JPMie University · JPNational Center For Child Health and Development · JPNational Hospital Organization Kyushu Cancer Center · JPNiigata Cancer Center Hospital · JPOsaka City General Hospital · JP

Funding

Japan Agency for Medical Research and Development 20ck0106419h0003
6 · The paper itself

Abstract

Treatment outcomes for children with relapsed and refractory acute lymphoblastic leukemia (R/R-ALL) remain poor, and the optimal induction therapy has not been determined. Bortezomib is a proteasome inhibitor that acts synergistically and additively with standard chemotherapy for ALL. We evaluated the efficacy and safety of combination chemotherapy with bortezomib in children with R/R-ALL. This single-arm, multicenter, phase 2 study was conducted in Japan between 2016 and 2020. Eligible patients were divided into two cohorts: a high-risk first-relapse cohort of untreated patients with high-risk first-relapsed ALL and an expansion cohort of patients with refractory ALL, including multiple relapses, relapse after allogeneic hematopoietic cell transplantation, and induction failure. All patients received a single course of chemotherapy as induction therapy. Sixteen patients (10 in the high-risk first-relapse cohort, six in the expansion cohort) were evaluable. The overall remission rate after induction therapy was 60% in the high-risk first-relapse cohort and 16.7% in the expansion cohort. All patients had minimal residual disease. Adverse events were acceptable except for interstitial lung disease and hypoxia in a patient in the expansion cohort, but addition of bortezomib to conventional chemotherapy did not produce obvious improvement in children with R/R-ALL.

Indexed as

Precursor Cell Lymphoblastic Leukemia-LymphomaAcute DiseaseAntineoplastic Combined Chemotherapy ProtocolsBortezomibChildHumansRecurrenceTreatment OutcomeBortezomibAcute lymphoblastic leukemiaBortezomibChildrenProteasome inhibitorRelapse and refractory

Identifiers

PMID37127801
OpenAlexW4367596732

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.