Evidence map›Paper›PMID 33829292›Full record

ArticleCancer chemotherapy and pharmacology2021

Phase I study of tamibarotene monotherapy in pediatric and young adult patients with recurrent/refractory solid tumors.

Chika Nitani, Junichi Hara, Hiroshi Kawamoto, Tomoaki Taguchi, Toshimi Kimura, Kenichi Yoshimura, Akinobu Hamada, Shigehisa Kitano, Naoko Hattori, Toshikazu Ushijima and 4 more

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

Article in Cancer chemotherapy and pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.5field-weighted citation impact, top 32% 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

4 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Review
  3. Review
  4. 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 6 institutions in 1 country.

Chika NitaniDepartment of Pediatric Hematology and Oncology, Osaka City General Hospital, 2-13-22 Miyakojima-hondori, Miyakojima-ku, Osaka, 534-0021, Japan. c-tanaka@med.osakacity-hp.or.jp.ORCID 0000-0002-1488-1326
Junichi HaraDepartment of Pediatric Hematology and Oncology, Osaka City General Hospital, 2-13-22 Miyakojima-hondori, Miyakojima-ku, Osaka, 534-0021, Japan.
Hiroshi KawamotoDepartment of Pediatric Oncology, National Cancer Center Hospital, Tokyo, Japan.
Tomoaki TaguchiDepartment of Pediatric Surgery, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Toshimi KimuraDepartment of Pharmacy, Tokyo Women's Medical University Hospital, Tokyo, Japan.
Kenichi YoshimuraCenter for Integrated Medical Research, Hiroshima University Hospital, Hiroshima, Japan.
Akinobu HamadaDivision of Molecular Pharmacology, National Cancer Center Research Institute, Tokyo, Japan.
Shigehisa KitanoDepartment of Experimental Therapeutics, National Cancer Center Hospital, Tokyo, Japan.
Naoko HattoriDivision of Epigenomics, National Cancer Center Research Institute, Tokyo, Japan.
Toshikazu UshijimaDivision of Epigenomics, National Cancer Center Research Institute, Tokyo, Japan.
Hiromi OnoClinical Research Support Office, National Cancer Center Hospital East, Chiba, Japan.
Masako NakamotoClinical Research Support Office, National Cancer Center Hospital East, Chiba, Japan.
Tsukiko HiguchiClinical Research Support Office, National Cancer Center Hospital East, Chiba, Japan.
Akihiro SatoClinical Research Support Office, National Cancer Center Hospital East, Chiba, Japan.
National Cancer Center Hospital East · JPOsaka City General Hospital · JPHiroshima University Hospital · JPKyushu University · JPTokyo National Hospital · JPTokyo Women's Medical University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTamibarotene is a synthetic retinoid that inhibits proliferation and induces differentiation of malignant cells by binding to the retinoic acid receptor α/β. Previous in vitro studies have shown that some pediatric solid tumors with retinoic acid receptors differentiate in response to retinoic acid. We conducted a phase I dose-escalation study to determine the recommended dose of tamibarotene for further study in pediatric and young adult patients with recurrent/refractory solid tumors.

methodsPediatric and young adult patients with recurrent/refractory solid tumors were administered tamibarotene at 4, 6, 8, 10, and 12 mg/m

resultsTwenty-two patients (median age 8 years) were enrolled in this study. No dose-limiting toxicity (DLT) was encountered, and tamibarotene was generally well tolerated. Two patients experienced severe adverse events (AEs), leading to discontinuation of the treatment. One grade 4 venous thrombosis and one grade 2 erythema multiforme were observed, which promptly resolved after tamibarotene discontinuance. The grade 4 venous thrombosis was a severe AE but not DLT because it occurred after the evaluation period. Pharmacokinetic analyses showed a dose-dependent increase in the maximum drug concentration (C

conclusionsThe recommended dose for phase II study of tamibarotene in pediatric and young adult patients with refractory solid tumors is 12 mg/m

Indexed as

AdolescentAdultAntineoplastic AgentsBenzoatesChildChild, PreschoolDose-Response Relationship, DrugFemaleHumansMaleMaximum Tolerated DoseNeoplasmsTetrahydronaphthalenesYoung AdultAntineoplastic AgentsBenzoatestamibaroteneTetrahydronaphthalenesDose-limiting toxicityPediatric and young adult solid tumorsPharmacokineticsRetinoic acidTamibarotene

Identifiers

PMID33829292
OpenAlexW3147684453

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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.