Evidence map›Paper›PMID 33472913›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2021

Phase I Trial of DNA Methyltransferase Inhibitor Guadecitabine Combined with Cisplatin and Gemcitabine for Solid Malignancies Including Urothelial Carcinoma (SPIRE).

Simon J Crabb, Sarah Danson, James W F Catto, Syed Hussain, Danna Chan, Denise Dunkley, Nichola Downs, Ellice Marwood, Laura Day, Geoff Saunders and 9 more

Open access · bronzeAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
5.6field-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

18 citing papers in PubMed, 24 citations in OpenAlex.

  1. Review
  2. Review
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Article
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

19 authors at 8 institutions in 2 countries.

Simon J CrabbSouthampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom. S.J.Crabb@southampton.ac.uk.ORCID 0000-0003-3521-9064
Sarah DansonSheffield Experimental Cancer Medicine Centre, Weston Park Hospital, University of Sheffield, Sheffield, England, United Kingdom.ORCID 0000-0002-3593-2890
James W F CattoAcademic Urology Unit, University of Sheffield, Sheffield, England, United Kingdom.
Syed HussainSheffield Experimental Cancer Medicine Centre, Weston Park Hospital, University of Sheffield, Sheffield, England, United Kingdom.
Danna ChanAstex Pharmaceuticals, Inc., Pleasanton, California.
Denise DunkleySouthampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.
Nichola DownsSouthampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.
Ellice MarwoodSouthampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.
Laura DaySouthampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.
Geoff SaundersSouthampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.
Michelle LightSouthampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.
Amy WhiteheadSouthampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.
Deborah EllisSouthampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.ORCID 0000-0001-5888-8768
Naveed SarwarDepartment of Oncology, Charing Cross Hospital, London, England, United Kingdom.
Deborah EntingDepartment of Oncology, Guy's and St Thomas' NHS Foundation Trust, London, England, United Kingdom.
Alison BirtleLancashire Teaching Hospitals NHS Foundation Trust, Preston, England, United Kingdom.ORCID 0000-0002-2621-0909
Bernadette JohnsonThe Institute of Cancer Research, Sutton, England, United Kingdom.
Robert HuddartThe Institute of Cancer Research, Sutton, England, United Kingdom.ORCID 0000-0003-3604-1990
Gareth GriffithsSouthampton Clinical Trials Unit, University of Southampton, Southampton, England, United Kingdom.
University Hospital Southampton NHS Foundation Trust · GBInstitute of Cancer Research · GBWeston Park Cancer Centre · GBCharing Cross Hospital · GBGuy's and St Thomas' NHS Foundation Trust · GBLancashire Teaching Hospitals NHS Foundation Trust · GBPlex Pharmaceuticals (United States) · USUniversity of Sheffield · GB

Funding

Cancer Research UK 19903Cancer Research UK 25352Cancer Research UK A19903Department of Health NIHR300047
6 · The paper itself

Abstract

purposePreclinical data indicate that DNA methyltransferase inhibition will circumvent cisplatin resistance in various cancers. PATIENT AND

methodsSPIRE comprised a dose-escalation phase for incurable metastatic solid cancers, followed by a randomized dose expansion phase for neoadjuvant treatment of T2-4a N0 M0 bladder urothelial carcinoma. The primary objective was a recommended phase II dose (RP2D) for guadecitabine combined with gemcitabine and cisplatin. Treatment comprised 21-day gemcitabine and cisplatin cycles (cisplatin 70 mg/m

resultsWithin the escalation phase, dose-limiting toxicities related predominantly to myelosuppression requiring G-CSF prophylaxis from cohort 2 (guadecitabine 20 mg/m

conclusionsThe guadecitabine RP2D was 20 mg/m

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsAzacitidineCarcinoma, Transitional CellCisplatinDeoxycytidineFemaleGemcitabineGranulocyte Colony-Stimulating FactorHumansMaleMiddle AgedUrinary Bladder NeoplasmsAzacitidineCisplatinDeoxycytidineGemcitabineGranulocyte Colony-Stimulating Factorguadecitabine

Identifiers

PMID33472913
PMCPMC7611191
OpenAlexW3121980208

What OpenQuestion holds

Textmetadata
LicenceTDM
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.