Evidence map›Paper›PMID 18540943›Full record

Trial reportBritish journal of haematology2008

Phase 2, single-arm trial to evaluate the effectiveness of darbepoetin alfa for correcting anaemia in patients with myelodysplastic syndromes.

Janice Gabrilove, Ronald Paquette, Roger M Lyons, Chaudhry Mushtaq, Mikkael A Sekeres, Dianne Tomita, Lyndah Dreiling

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

Trial report in British journal of haematology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00095264 (A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome), which is not on this map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
3.9field-weighted citation impact, top 6% 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.

NCT00095264 phase2completednot on this map

A Study of Darbepoetin Alfa in Anemic Subjects With Low Risk Myelodysplastic Syndrome

TypeinterventionalSponsorAmgenRan2004Enrolled209ConditionsMyelodysplastic SyndromesArmsDarbepoetin Alfa
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 80 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Trial
  4. Trial
  5. Trial
  6. Updates in low/intermediate-risk MDS.Hematology. American Society of Hematology. Education Program · 2025
    Review
  7. Review
  8. Review
  9. Treatment of Anemia in Lower-Risk Myelodysplastic Syndrome.Current treatment options in oncology · 2024
    Review
  10. Next-generation therapy for lower-risk MDS.Hematology. American Society of Hematology. Education Program · 2023
    Article
  11. Article
  12. The Clinical Efficacy of Epoetin Alfa and Darbepoetin Alfa in Patients with Low-Risk or Intermediate-1-Risk Myelodysplastic Syndrome: Retrospective Multi-center Real-Life Study.Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion · 2022
    Article
  13. Article
  14. Review
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Review
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

7 authors at 5 institutions in 1 country.

Janice GabriloveDepartment of Medicine, Mt Sinai School of Medicine, New York, NY 10029, USA. janice.gabrilove@mssm.edu
Ronald Paquette
Roger M Lyons
Chaudhry Mushtaq
Mikkael A Sekeres
Dianne Tomita
Lyndah Dreiling
Amgen (United States) · USCleveland Clinic · USMount Sinai Hospital · USSouth Carolina Oncology Associates · USUCLA Health · US

Funding

Therapeutic Strategies in Disorders of HematopoiesisK24CA100287 · NCI · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI GABRILOVE, JANICE L · 2003 to 2007
$679k
NCI NIH HHS 5K24CA100287-04
6 · The paper itself

Abstract

Patients with myelodysplastic syndromes (MDS) often develop anaemia resulting in frequent transfusions and fatigue. Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) approved for treating chemotherapy-induced anaemia. This single-arm, phase 2 study examined the efficacy of darbepoetin alfa 500 microg every 3 weeks (Q3W) for treating anaemia in low-risk MDS patients (after 6 weeks, poor responders received darbepoetin alfa 500 microg every 2 weeks). The primary end-point was the incidence of erythroid responses (International Working Group criteria) after 13 weeks of therapy. Secondary end-points included the incidence of erythroid responses at weeks 28 and 55, [or weeks 27 and 53 for dose escalations to every two weeks (Q2W)], and safety parameters. Analyses were stratified by the patient's previous ESA therapy status [ESA-naïve (n = 144) vs. prior ESA-treated (n = 62)]. After 13 weeks of therapy, 49% of ESA-naïve patients and 26% of prior ESA-treated patients achieved a major erythroid response. After 53/55 weeks, 59% of ESA-naïve patients and 34% of prior ESA-treated patients achieved a major erythroid response; 82% of ESA-naïve patients and 55% of prior ESA-treated patients achieved target haemoglobin of 110 g/l. Thromboembolic or related adverse events occurred in 2% of patients; no pulmonary embolisms were reported. In conclusion, darbepoetin alfa, 500 microg Q3W appeared well tolerated and increased haemoglobin levels in low-risk MDS patients.

Indexed as

AgedAged, 80 and overAnemiaBlood TransfusionDarbepoetin alfaDisease ProgressionDrug Administration ScheduleErythropoiesisErythropoietinFatigueFemaleHematinicsHemoglobinsHumansKaplan-Meier EstimateMaleDarbepoetin alfaErythropoietinHematinicsHemoglobins

Identifiers

PMID18540943
PMCPMC2654479
OpenAlexW1986544757

What OpenQuestion holds

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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.