Evidence map›Paper›PMID 25805811›Full record

Trial reportBlood2015

Vosaroxin and vosaroxin plus low-dose Ara-C (LDAC) vs low-dose Ara-C alone in older patients with acute myeloid leukemia.

Mike Dennis, Nigel Russell, Robert K Hills, Claire Hemmaway, Nicki Panoskaltsis, Mary-Frances McMullin, Lars Kjeldsen, Helen Dignum, Ian F Thomas, Richard E Clark and 2 more

Open access · bronzeAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Blood, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 2 pooled it
6.5field-weighted citation impact, top 3% 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.

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

23 citing papers in PubMed, 2 syntheses or guidelines pooled it, 49 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Article
  7. Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Emerging therapies for acute myeloid leukemia.Journal of hematology & oncology · 2017
    Review
  14. Treatment of Relapsed/Refractory Acute Myeloid Leukemia.Current treatment options in oncology · 2017
    Review
  15. Article
  16. Review
  17. Review
  18. Review
  19. New drugs in acute myeloid leukemia.Annals of oncology : official journal of the European Society for Medical Oncology · 2016
    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

12 authors at 10 institutions in 2 countries.

Mike DennisDepartment of Haematology, Christie Hospital, Manchester, United Kingdom;
Nigel RussellDepartment of Haematology, Nottingham University Hospital National Health Service Trust, Nottingham, United Kingdom;
Robert K HillsDepartment of Haematology, Cardiff University School of Medicine, Cardiff, United Kingdom;
Claire HemmawayDepartment of Haematology, Queen's Hospital, Romford, United Kingdom;
Nicki PanoskaltsisDepartment of Haematology, Imperial College, Northwick Park Hospital Campus, London, United Kingdom;
Mary-Frances McMullinDepartment of Haematology, Belfast City Hospital, Belfast, United Kingdom;
Lars KjeldsenDepartment of Haematology, Rigshospitalet, Copenhagen, Denmark;
Helen DignumDepartment of Haematology, Queen Alexandra Hospital, Portsmouth, United Kingdom;
Ian F ThomasDepartment of Haematology, Cardiff University School of Medicine, Cardiff, United Kingdom;
Richard E ClarkDepartment of Haematology, Royal Liverpool University Hospital, Liverpool, United Kingdom; and.
Don MilliganDepartment of Haematology, Heartlands Hospital, Birmingham, United Kingdom.
Alan K BurnettDepartment of Haematology, Cardiff University School of Medicine, Cardiff, United Kingdom;
Cardiff University · GBHeartlands Hospital · GBNational Health Service · GBNorthwick Park Hospital · GBQueen Alexandra Hospital · GBQueen's Hospital · GBRigshospitalet · DKRoyal Liverpool University Hospital · GBThe Christie Hospital · GBUniversity of Ulster · GB

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 leukemia is an active area, but has met with limited success. Vosaroxin, a quinolone-derived intercalating agent has several properties that could prove beneficial. Initial clinical studies showed it to be well-tolerated in older patients with relapsed/refractory disease. In vitro data suggested synergy with cytarabine (Ara-C). To evaluate vosaroxin, we performed 2 randomized comparisons within the "Pick a Winner" program. A total of 104 patients were randomized to vosaroxin vs low-dose Ara-C (LDAC) and 104 to vosaroxin + LDAC vs LDAC. When comparing vosaroxin with LDAC, neither response rate (complete recovery [CR]/complete recovery with incomplete count recovery [CRi], 26% vs 30%; odds ratio [OR], 1.16 (0.49-2.72); P = .7) nor 12-month survival (12% vs 31%; hazard ratio [HR], 1.94 [1.26-3.00]; P = .003) showed benefit for vosaroxin. Likewise, in the vosaroxin + LDAC vs LDAC comparison, neither response rate (CR/CRi, 38% vs 34%; OR, 0.83 [0.37-1.84]; P = .6) nor survival (33% vs 37%; HR, 1.30 [0.81-2.07]; P = .3) was improved. A major reason for this lack of benefit was excess early mortality in the vosaroxin + LDAC arm, most obviously in the second month following randomization. At its first interim analysis, the Data Monitoring and Ethics Committee recommended closure of the vosaroxin-containing trial arms because a clinically relevant benefit was unlikely.

Indexed as

AgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCytarabineDose-Response Relationship, DrugFemaleFollow-Up StudiesHumansLeukemia, Myeloid, AcuteMaleMiddle AgedNaphthyridinesNeoplasm Recurrence, LocalNeoplasm StagingPrognosisProspective StudiesCytarabineNaphthyridinesThiazolesvosaroxin

Identifiers

PMID25805811
PMCPMC4536889
OpenAlexW369237374

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.