Evidence map›Paper›PMID 25676423›Full record

Trial reportLeukemia2015

A randomised comparison of the novel nucleoside analogue sapacitabine with low-dose cytarabine in older patients with acute myeloid leukaemia.

A K Burnett, N Russell, R K Hills, N Panoskaltsis, A Khwaja, C Hemmaway, P Cahalin, R E Clark, D Milligan

Abstract readComparative StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Leukemia, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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

15 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Comparison of efficacy of HCAG and CAG re-induction chemotherapy in elderly low- and intermediate-risk group patients diagnosed with acute myeloid leukemia.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021
    Trial
  3. Review
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Review
  10. Article
  11. Article
  12. New drugs in acute myeloid leukemia.Annals of oncology : official journal of the European Society for Medical Oncology · 2016
    Review
  13. Review
  14. Article
  15. Acute myeloid leukemia in the older adults.Leukemia research reports · 2016
    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

9 authors.

A K BurnettDepartment of Haematology, Cardiff University School of Medicine, Cardiff, UK.
N RussellDepartment of Haematology, Nottingham University Hospital NHS Trust, Nottingham, UK.
R K HillsDepartment of Haematology, Cardiff University School of Medicine, Cardiff, UK.
N PanoskaltsisNorthwick Park Hospital, Harrow, UK.
A KhwajaUniversity College London Hospitals, 1st Floor Central, London, UK.
C HemmawayQueen's Hospital, Rom Valley Way, Romford, UK.
P CahalinBlackpool Victoria Hospital, Blackpool, UK.
R E ClarkDepartment of Haematology, Royal Liverpool University Hospital, Prescot St, Liverpool, UK.
D MilliganDepartment of Haematology, Birmingham Heartlands Hospital, Birmingham, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The development of new treatments for older patients with acute myeloid leukaemia (AML) is an active area, but has met with limited success. Sapacitabine is a novel orally administered nucleoside analogue that has shown encouraging activity in unrandomised early-stage trials. We randomised 143 untreated patients with AML or with high-risk myelodysplastic syndrome (>10% marrow blasts) between sapacitibine and low-dose ara-C (LDAC) in our 'Pick a Winner' trial design. At the planned interim analysis there was no difference between LDAC and sapacitibine in terms of remission rate (CR/CRi, 27% vs 16% hazard ratio (HR) 1.98(0.90-4.39) P=0.09), relapse-free survival (10% vs 14% at 2 years, HR 0.73(0.33-1.61) P=0.4) or overall survival (OS; 12% vs 11% at 2 years, HR 1.24(0.86-1.78) P=0.2). Sapacitibine was well tolerated, apart from more grade 3/4 diarrhoea. On the basis of these findings sapacitibine did not show sufficient evidence of benefit over LDAC for the trial to be continued.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsArabinonucleosidesCytarabineCytosineFemaleFollow-Up StudiesHumansLeukemia, Myeloid, AcuteMaleMiddle AgedNeoplasm StagingPrognosisRemission InductionSurvival RateArabinonucleosidesCytarabineCytosinesapacitabine

Identifiers

PMID25676423

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.