Evidence map›Paper›PMID 30068487›Full record

ArticleGynecologic oncology2018

Phase I trial of selenium plus chemotherapy in gynecologic cancers.

Mihae Song, Muthu N Kumaran, Murugesan Gounder, Darlene G Gibbon, Wilberto Nieves-Neira, Ami Vaidya, Mira Hellmann, Michael P Kane, Brian Buckley, Weichung Shih and 3 more

Open access · hybridAbstract readClinical Trial, Phase I
In one paragraph

Article in Gynecologic oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
1.8field-weighted citation impact, top 16% 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

24 citing papers in PubMed, 44 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Formulation Studies with Cyclodextrins for Novel Selenium NSAID Derivatives.International journal of molecular sciences · 2024
    Article
  11. Observational
  12. [Research Advances of RAD51AP1 in Tumor Progression and Drug Resistance].Zhongguo fei ai za zhi = Chinese journal of lung cancer · 2023
    Review
  13. Article
  14. Article
  15. Review
  16. The Therapeutic Potential of Antioxidants in Chemotherapy-Induced Peripheral Neuropathy: Evidence from Preclinical and Clinical Studies.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2023
    Review
  17. Article
  18. Article
  19. Article
  20. The Role of Selenium in Pathologies: An Updated Review.Antioxidants (Basel, Switzerland) · 2022
    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

13 authors at 4 institutions in 1 country.

Mihae SongRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, United States.
Muthu N KumaranRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, United States.
Murugesan GounderRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, United States.
Darlene G GibbonRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, United States.
Wilberto Nieves-NeiraRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, United States.
Ami VaidyaRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, United States.
Mira HellmannRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, United States.
Michael P KaneRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, United States.
Brian BuckleyRutgers Environmental and Occupational Health Sciences Institute, 170 Frelinghuysen Road, Piscataway, NJ 08854, United States.
Weichung ShihRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, United States.
Paula B CaffreyDepartment of Biological Sciences, Rutgers University, 195 University Avenue, Newark, NJ 07102, United States; Department of Biological and Environmental Sciences, 250 University Avenue, California University of PA, California, PA 15419, United States.
Gerald D FrenkelDepartment of Biological Sciences, Rutgers University, 195 University Avenue, Newark, NJ 07102, United States.
Lorna Rodriguez-RodriguezRutgers Cancer Institute of New Jersey, 195 Little Albany Street, New Brunswick, NJ 08903, United States; Rutgers-Robert Wood Johnson Medical School, Department of Obstetrics, Gynecology and Reproductive Sciences, 125 Paterson Street, New Brunswick, NJ 08901, United States. Electronic address: rodriglo@cinj.rutgers.edu.
Rutgers, The State University of New Jersey · USRutgers Cancer Institute of New JerseyCalifornia University of Pennsylvania · USEnvironmental and Occupational Health Sciences Institute · US

Funding

TRANSCRIPTIONAL PROFILINGP30CA072720 · NCI · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI Chang S Chan · 1997 to 2026
$94.5M
NCI NIH HHS P30 CA072720
6 · The paper itself

Abstract

purposePreclinical studies performed in our laboratory have shown that high-dose selenium inhibits the development of carboplatin drug resistance in an ovarian cancer mouse xenograft model. Based on these data, as well as the potential serious toxicities of supranutritional doses of selenium, a phase I trial of a combination of selenium/carboplatin/paclitaxel was designed to determine the maximum tolerated dose, safety, and effects of selenium on carboplatin pharmacokinetics in the treatment of chemo-naive women with gynecologic cancers. Correlative studies were performed to identify gene targets of selenium.

methodsChemo-naïve patients with gynecologic malignancy received selenious acid IV on day 1 followed by carboplatin IV and paclitaxel IV on day 3. A standard 3 + 3 dose-escalating design was used for addition of selenium to standard dose chemotherapy. Concentrations of selenium in plasma and carboplatin in plasma ultrafiltrate were analyzed.

resultsForty-five patients were enrolled and 291 treatment cycles were administered. Selenium was administered as selenious acid to 9 cohorts of patients with selenium doses ranging from 50 μg to 5000 μg. Grade 3/4 toxicities included neutropenia (66.7%), febrile neutropenia (2.2%), pain (20.0%), infection (13.3%), neurologic (11.1%), and pulmonary adverse effects (11.1%). The maximum tolerated dose of selenium was not reached. Selenium had no effect on carboplatin pharmacokinetics. Correlative studies showed post-treatment downregulation of RAD51AP1, a protein involved in DNA repair, in both cancer cell lines and patient tumors.

conclusionOverall, the addition of selenium to carboplatin/paclitaxel chemotherapy is safe and well tolerated, and does not alter carboplatin pharmacokinetics. A 5000 μg dose of elemental selenium as selenious acid is suggested as the dose to be evaluated in a phase II trial.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCarboplatinCell Line, TumorChemotherapy-Induced Febrile NeutropeniaDNA-Binding ProteinsDown-RegulationFemaleGene ExpressionGlutathione PeroxidaseHumansInfectionsLung DiseasesMaximum Tolerated DoseCarboplatinDNA-Binding ProteinsGlutathione PeroxidasePaclitaxelRAD51AP1 protein, humanRNA-Binding ProteinsSelenious AcidSeleniumSelenoprotein PCarboplatinChemotherapyChemotherapy resistanceGynecologic cancerSelenium

Identifiers

PMID30068487
PMCPMC6154492
OpenAlexW2884271377

What OpenQuestion holds

Textmetadata
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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.