Evidence map›Paper›PMID 22816487›Full record

Trial reportCancer science2012

Phase I/II study of decitabine in patients with myelodysplastic syndrome: a multi-center study in Japan.

Yasuhiro Oki, Yutaka Kondo, Kazuhito Yamamoto, Michinori Ogura, Masanobu Kasai, Yukio Kobayashi, Takashi Watanabe, Naokuni Uike, Kazuma Ohyashiki, Shin-ichiro Okamoto and 7 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer science, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00796003 (A Phase I/II Clinical Study of JNJ-30979754), which is not on this map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
3.1field-weighted citation impact, top 8% 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.

NCT00796003 phase1completednot on this map

A Phase I/II Clinical Study of JNJ-30979754 (Decitabine) in Patients With Myelodysplastic Syndrome

TypeinterventionalSponsorJanssen Pharmaceutical K.K.Ran2008 to 2010Enrolled39ConditionsMyelodysplastic SyndromeArmsJNJ-30979754 15 mg/m2, JNJ-30979754 20 mg/m2
3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 41 citations in OpenAlex.

  1. Trial
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  4. Review
  5. Article
  6. Article
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  8. Article
  9. Azacitidine-induced hyperglycaemia.BMJ case reports · 2019
    Article
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  16. 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 12 institutions in 1 country.

Yasuhiro OkiDepartment of Hematology and Cell Therapy, Aichi Cancer Center Hospital, Nagoya, Japan. yoki@mdanderson.org
Yutaka Kondo
Kazuhito Yamamoto
Michinori Ogura
Masanobu Kasai
Yukio Kobayashi
Takashi Watanabe
Naokuni Uike
Kazuma Ohyashiki
Shin-ichiro Okamoto
Kazunori Ohnishi
Akihiro Tomita
Yasushi Miyazaki
Kaoru Tohyama
Harumi Y Mukai
Tomomitsu Hotta
Masao Tomonaga
Aichi Cancer Center · JPJapanese Red Cross Nagoya Daini Hospital · JPTokyo National Hospital · JPHamamatsu University School of Medicine · JPJapanese Red Cross Society, Japan · JPKawasaki Medical School Hospital · JPKeio University · JPNagasaki University Hospital · JPNagoya University · JPNational Hospital Organization · JPNational Hospital Organization Kyushu Cancer Center · JPTokyo Medical University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The management of myelodysplastic syndrome (MDS) remains challenging. We performed a phase I/II study to evaluate the safety and efficacy of decitabine in patients with MDS in Japan. Patients with MDS with red cell transfusion dependence or 5-30% blasts in marrow and with an International Prognostic Scoring System score of intermediate-1 or higher were eligible. Patients received intravenous decitabine at 15 or 20 mg/m(2) daily for 5 days every 4 weeks. A total of 37 patients were enrolled. Three patients received 15 mg/m(2) and experienced no dose limiting toxicity during the first cycle. Thirty-four patients received 20 mg/m(2) . Grade 3 or greater non-hematologic toxicities included cerebral infarction (n = 1), subdural hematoma (n = 1), elevated blood glucose (n = 1), and pulmonary hypertension (n = 1). At 20 mg/m(2) , complete response, partial response, and hematologic improvement were observed in 7 (20.6%), 2 (5.9%), and 7 (20.6%) patients, respectively. Complete cytogenetic response was observed in 30% of evaluable 20 patients. The median number of cycles to clinical response was 4 (range 4-8), and duration of remission was 474+ days (range 294-598+). The 2-year rate of acute myeloid leukemia-free survival was 52%. Correlative studies revealed hypomethylation in multiple genes in peripheral blood cells after treatment. Hypomethylation was generally more profound in CD15 + peripheral blood cells, which reflects myeloid cells, than in peripheral blood mononuclear cells. In summary, decitabine was safe and demonstrated efficacy in Japanese patients with high-risk MDS. This trial was registered at ClinicalTrials.gov (NCT00796003).

Indexed as

AgedAntimetabolites, AntineoplasticAzacitidineDecitabineDose-Response Relationship, DrugFemaleHumansJapanMaleMiddle AgedMyelodysplastic SyndromesTreatment OutcomeAntimetabolites, AntineoplasticAzacitidineDecitabine

Identifiers

PMID22816487
PMCPMC7659334
OpenAlexW2049658944

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.