Evidence map›Paper›PMID 22729159›Full record

Trial reportCancer chemotherapy and pharmacology2012

Phase I/II trial of non-cytotoxic suramin in combination with weekly paclitaxel in metastatic breast cancer treated with prior taxanes.

Maryam B Lustberg, Shubham Pant, Amy S Ruppert, Tong Shen, Yong Wei, Ling Chen, Lisa Brenner, Donna Shiels, Rhonda R Jensen, Michael Berger and 6 more

Open access · greenAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2012. 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
1.5field-weighted citation impact, top 18% 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, 27 citations in OpenAlex.

  1. Spinal P2XPurinergic signalling · 2026
    Article
  2. Article
  3. Review
  4. The Role of Ceramide and Sphingolipid Metabolism in Cancer Therapeutics.Journal of oncology research and therapy · 2024
    Article
  5. Metabolomics and EMT Markers of Breast Cancer: A Crosstalk and Future Perspective.Pathophysiology : the official journal of the International Society for Pathophysiology · 2022
    Review
  6. Review
  7. Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
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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

16 authors at 2 institutions in 1 country.

Maryam B LustbergDivision of Medical Oncology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, B421 Starling-Loving Hall, 320 West 10th Avenue, Columbus, OH 43210-1240, USA. maryam.lustberg@osumc.edu
Shubham Pant
Amy S Ruppert
Tong Shen
Yong Wei
Ling Chen
Lisa Brenner
Donna Shiels
Rhonda R Jensen
Michael Berger
Ewa Mrozek
Bhuvaneswari Ramaswamy
Michael Grever
Jessie L Au
M Guillaume Wientjes
Charles L Shapiro
The Ohio State University · USThe Ohio State University Wexner Medical Center · US

Funding

Translational Therapeutics Research Program (TT)P30CA016058 · NCI · OHIO STATE UNIVERSITY · PI Tasleem J Padamsee · 1985 to 2026
$132.3M
Translational Training Grant in Experimental TherapeuticsK12CA133250 · NCI · OHIO STATE UNIVERSITY · PI WILLIAM E. CARSON, Rosa Lapalombella · 2008 to 2026
$15.0M
The Ohio State University Center for Clinical and Translational Science (UL1)UL1TR000090 · NCATS · OHIO STATE UNIVERSITY · PI JACKSON, REBECCA D · 2012 to 2013
$7.9M
NCATS NIH HHS UL1 TR000090NCI NIH HHS 3 P30 CA016058-33S2NCI NIH HHS K12 CA133250NCI NIH HHS P30 CA016058
6 · The paper itself

Abstract

purposeSuramin, a polysulfonated naphthylurea, inhibits the actions of polypeptide growth factors including acidic and basic fibroblast growth factors (aFGF and bFGF), which confer broad spectrum chemotherapy resistance. We hypothesized that suramin at non-cytotoxic doses in combination with weekly paclitaxel would be well tolerated and demonstrate anti-tumor activity.

methodsWomen with metastatic breast cancer who had been previously treated with a taxane in the adjuvant or metastatic setting were eligible. The primary objective of the phase I was to determine the dose of intravenous (IV) weekly suramin that resulted in plasma concentrations between 10 and 50 umol/l over 8-48 h (or the target range) in combination with IV 80 mg/m(2) of weekly paclitaxel. The primary objective of the phase II trial was to determine the anti-tumor activity of the dosing regimen defined in phase I. Therapy was continued until disease progression or development of unacceptable toxicity.

resultsThirty-one patients were enrolled (9: phase I; 22: phase II). In phase I, no dose-limiting toxicities were observed. Pharmacokinetics during the first cycle showed suramin concentrations within the target range for 21 of 24 weekly treatments (88 %). In phase II, the objective response rate (ORR) was 23 % (95 % CI 8-45 %), the median progression-free survival was 3.4 months (95 % CI 2.1-4.9 months), and the median overall survival was 11.2 months (95 % CI 6.6-16.0 months).

conclusionsNon-cytotoxic doses of suramin in combination with weekly paclitaxel were well tolerated. The efficacy was below the pre-specified criteria required to justify further investigation.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFatigueFemaleFibroblast Growth Factor 2HumansLeukopeniaMiddle AgedNauseaNeoplasm MetastasisPaclitaxelFibroblast Growth Factor 2PaclitaxelSuraminTaxoids

Identifiers

PMID22729159
PMCPMC3466596
OpenAlexW2004232421

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.