Evidence map›Paper›PMID 12799626›Full record

Trial reportBritish journal of cancer2003

A dose- and schedule-finding study of darbepoetin alpha for the treatment of chronic anaemia of cancer.

R E Smith, N S Tchekmedyian, D Chan, L A Meza, D W Northfelt, R Patel, M Austin, A B Colowick, G Rossi, J Glaspy

2 registry-linked trialsOpen access · bronzeAbstract readClinical TrialControlled Clinical TrialMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 18 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 7 pooled it
4.9field-weighted citation impact, top 4% 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.

NCT00381836 phase2 / phase3terminatednot on this mapstarted 2006, after this paper: background citation

A Randomized, Multi-center Study to Assess the Effect of Darbepoetin Alfa (Aranesp®) for the Treatment of Anemia in Patients With Advanced Hormone Independent Prostate Cancer and Anaemia

TypeinterventionalSponsorUniversity of AarhusRan2006 to 2007Enrolled140ConditionsProstatic Neoplasms, AnemiaArmsDarbepoetin Alfa
NCT01039350 phase2terminatednot on this mapstarted 2006, after this paper: background citation

Prospective, Multicenter, Open Label and Single-arm Study of Darbepoetin Alfa for Anemia in Myelodisplastic Syndrome Patients.

TypeinterventionalSponsorFundacion para el Estudio de la Hematologia y Hemoterapia en AragonRan2006 to 2009Enrolled80ConditionsMyelodysplastic SyndromeArmsDarbepoetin alfa
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 7 syntheses or guidelines pooled it, 75 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Venous thromboembolism risk and erythropoiesis-stimulating agents for the treatment of cancer-associated anemia: a meta-analysis.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2014
    Pooled it
  4. Erythropoietin or darbepoetin for patients with cancer.The Cochrane database of systematic reviews · 2012
    Pooled it
  5. Drug therapy for the management of cancer-related fatigue.The Cochrane database of systematic reviews · 2010
    Pooled it
  6. Pooled it
  7. Pooled it
  8. Article
  9. Spanish Society of Medical Oncology consensus on the use of erythropoietic stimulating agents in anaemic cancer patients.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2009
    Article
  10. Darbepoetin alpha in the treatment of cancer chemotherapy-induced anemia.Therapeutics and clinical risk management · 2007
    Article
  11. Speed of haemoglobin response in patients with cancer: a review of the erythropoietic proteins.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2007
    Review
  12. Article
  13. The relationship between patient knowledge of hemoglobin levels and health-related quality of life.Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation · 2006
    Article
  14. Article
  15. Single-dose darbepoetin administration to anemic preterm neonates.Journal of perinatology : official journal of the California Perinatal Association · 2005
    Article
  16. Article
  17. Management of anemia in patients with cancer.Current oncology reports · 2004
    Review
  18. 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

10 authors at 6 institutions in 1 country.

R E SmithSouth Carolina Oncology Associates, 1301 Taylor, Suite 1A, Columbia, SC 29201, USA. rsmith@sconcology.net
N S Tchekmedyian
D Chan
L A Meza
D W Northfelt
R Patel
M Austin
A B Colowick
G Rossi
J Glaspy
Amgen (United States) · USMayo Clinic in Arizona · USSouth Carolina Oncology Associates · USSouthwest Women's Oncology · USUCLA Medical Center · USUniversity of California, Los Angeles · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

A multicentre study evaluated the efficacy and safety of darbepoetin alpha administered weekly (QW), every 3 weeks (Q3W), and every 4 weeks (Q4W) to anaemic patients with cancer not concurrently receiving chemotherapy or radiotherapy. The QW portion (n=102) was an open-label, sequential, dose-escalation design; cohorts received darbepoetin alpha QW by subcutaneous (s.c.) injection at 0.5, 1.0, 2.25, or 4.5 micro g kg(-1) week(-1) for 12 weeks. The 12-week placebo-controlled, double-blind Q3W (6.75 micro g kg(-1)) and Q4W (6.75 or 10.0 micro g kg(-1)) schedules (n=86), which enrolled different patients, took place after the QW schedule and were followed by a 12-week, open-label phase. Patients were evaluated for change in haemoglobin end points and red blood cell transfusions, serum darbepoetin alpha concentration, and safety. Selected domains of health-related quality of life (HRQOL) were measured. With QW dosing, at least 70% of each cohort had a haemoglobin increase from baseline of > or =2 g dl(-1) or a concentration > or =12 g dl(-1) (haematopoietic response). In the 4.5 micro g kg(-1) QW cohort, all patients achieved a haematopoietic response (100%; 95% confidence interval (CI)=100, 100). In the Q3W and Q4W schedules, all cohorts had at least 60% of patients who achieved a haematopoietic response. Darbepoetin alpha effectively increases haemoglobin concentration when given QW, Q3W, or Q4W. Less-frequent administration may benefit patients with chronic anaemia of cancer and their caregivers alike.

Indexed as

AgedAnemiaChronic DiseaseDarbepoetin alfaDrug Administration ScheduleErythropoietinFemaleHumansMaleMiddle AgedNeoplasmsTreatment OutcomeDarbepoetin alfaErythropoietin

Identifiers

PMID12799626
PMCPMC2741110
OpenAlexW2081203495

What OpenQuestion holds

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LicenceCC BY
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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.