Trial reportAdvances in therapy2015
Decitabine for Treatment of Myelodysplastic Syndromes in Chinese Patients: An Open-Label, Phase-3b Study.
Trial report in Advances in therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01751867 (An Open-label, Multi-center, Phase IIIb Study for Decitabine in Patients With Myelodysplastic Syndrome), which is not on this map. Cited by 18 papers, 2 of them syntheses that pooled 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.
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.
An Open-label, Multi-center, Phase IIIb Study for Decitabine in Patients With Myelodysplastic Syndrome (MDS)
Who cites it
18 citing papers in PubMed, 2 syntheses or guidelines pooled it, 29 citations in OpenAlex.
- Pooled it
- Pooled it
- Sintilimab plus decitabine for higher-risk treatment-naïve myelodysplastic syndromes: efficacy, safety, and biomarker analysis of a phase II, single-arm trial.Journal for immunotherapy of cancer · 2024Trial
- Effect of Chinese medicine treatment based on pattern identification on cellular immunophenotype of myelodysplastic syndrome.Chinese journal of integrative medicine · 2017Trial
- [Chinese guidelines for diagnosis and treatment of myelodysplastic neoplasms (2026)].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2026Article
- [Analysis of the association between pre- and post-treatment genetic mutation status and treatment efficacy and survival in patients with newly diagnosed myelodysplastic syndromes with excess blasts receiving hypomethylating agent therapy].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2025Article
- Recent advances on gene-related DNA methylation in cancer diagnosis, prognosis, and treatment: a clinical perspective.Clinical epigenetics · 2025Review
- [Long-term hypomethylating agents in patients with myelodysplastic syndromes: a multi-center retrospective study].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2024Article
- Decitabine in patients with myelodysplastic syndromes: A multi-center, open-label, dose comparison trial.Cancer medicine · 2023Article
- Epigenetic regulation in hematopoiesis and its implications in the targeted therapy of hematologic malignancies.Signal transduction and targeted therapy · 2023Review
- Historical expectations with DNA methyltransferase inhibitor monotherapy in MDS: when is combination therapy truly "promising"?Blood advances · 2022Article
- The use of hypomethylating agents in hematologic malignancies: treatment preferences and results.International journal of hematologic oncology · 2021Article
- Hypomethylating Chemotherapeutic Agents as Therapy for Myelodysplastic Syndromes and Prevention of Acute Myeloid Leukemia.Pharmaceuticals (Basel, Switzerland) · 2021Review
- Article
- A retrospective study comparing azacitidine with decitabine in Chinese patients with refractory anemia with excess blast based on two clinical trials in a single center.American journal of translational research · 2019Article
- [The efficacy and safety of the patients of myelodysplastic syndromes-refractory anemia with excess blasts treated with decitabine alone or CAG/HAG regimen].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2017Article
- [Analysis of the impact of decitabine treatment cycles on efficacy and safety in patients of myelodysplastic syndrome-refractory anemia with excess blasts].Zhonghua xue ye xue za zhi = Zhonghua xueyexue zazhi · 2016Article
- Epigenetic Modulation as a Therapeutic Prospect for Treatment of Autoimmune Rheumatic Diseases.Mediators of inflammation · 2016Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 13 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe objective of this study was to evaluate the efficacy and safety of decitabine in Chinese patients with myelodysplastic syndrome (MDS).
methodsPatients (≥18 years) who had a de novo or secondary MDS diagnosis according to French-American-British classification and an International Prognostic Scoring System score ≥0.5 were enrolled and randomized (1:1) to one of two decitabine regimens: 3-day treatment (3-h intravenous infusion of 15 mg/m(2) given every 8 h for three consecutive days/cycle/6 weeks) or 5-day treatment (1-h intravenous infusion of 20 mg/m(2) once daily on days 1-5/cycle/4 weeks). After a minimum of 30 patients were assigned to 3-day schedule, the remaining were assigned to the 5-day schedule. The primary efficacy endpoint was the overall response rate (ORR). Secondary outcome measures included hematologic improvement (HI), cytogenetic response rate, the time to acute myeloid leukemia (AML) progression, and overall survival (OS).
resultsIn total, 132 of 135 enrolled patients (3-day treatment, n = 36; 5-day treatment, n = 99) discontinued treatment (major reasons included patient withdrawal/lack of efficacy, n = 48; adverse events, n = 23; and disease progression, n = 22). During the study, 35 of 132 (26.5%) patients from the intent-to-treat (ITT) group achieved significant (P < 0.001) ORR [3-day group (n = 10, 29.4%), P = 0.003; 5-day group (n = 25, 25.5%), P < 0.001]. The HI rate was similar between the 3-day (47.1%) and 5-day groups (48.0%). Cytogenetic response was achieved in 20 of the 30 (66.7%) patients who had a baseline cytogenetic abnormality. Fifty-three (40.2%) AML transformations or deaths occurred and the median AML-free survival time was 23.8 months for all patients from the ITT set; 24-month OS rate was 48.9%. Adverse events of myelosuppression-related disorders (85.6%) and infections (43.2%) were commonly reported.
conclusionDecitabine treatment was efficacious in Chinese patients with MDS with its safety profile comparable to the global studies of decitabine conducted to date.
fundingXian-Janssen Pharmaceutical Ltd. China (a company of Johnson & Johnson).
trial registrationClinicalTrials.gov identifier, NCT01751867.
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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.