Evidence map›Paper›PMID 24002495›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Randomized, double-blind, placebo-controlled, phase III chemoprevention trial of selenium supplementation in patients with resected stage I non-small-cell lung cancer: ECOG 5597.

Daniel D Karp, Sandra J Lee, Steven M Keller, Gail Shaw Wright, Seena Aisner, Steven Alan Belinsky, David H Johnson, Michael R Johnston, Gary Goodman, Gerald Clamon and 7 more

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

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 62 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 8 pooled it
8.8field-weighted citation impact, top 1% 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

62 citing papers in PubMed, 8 syntheses or guidelines pooled it, 129 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Selenium for preventing cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
  5. Pooled it
  6. Selenium for preventing cancer.The Cochrane database of systematic reviews · 2014
    Pooled it
  7. Guideline
  8. Pooled it
  9. Methyl selenocysteine: single-dose pharmacokinetics in men.Cancer prevention research (Philadelphia, Pa.) · 2011
    Trial
  10. Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Review
  17. Article
  18. Review
  19. Article
  20. Review

2 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 4 institutions in 2 countries.

Daniel D KarpDaniel D. Karp, The University of Texas MD Anderson Cancer Center, Houston; David H. Johnson, University of Texas Southwestern, Dallas, TX; Sandra J. Lee, Dana-Farber Cancer Institute, Boston, MA; Steven M. Keller, Montefiore Medical Center, Bronx, NY; Gail Shaw Wright, Florida Cancer Specialists, New Port Richey, FL; Seena Aisner, University of Medicine and Dentistry of New Jersey/New Jersey Medical School Cancer Institute of New Jersey, Newark, NJ; Steven Alan Belinsky, Lovelace Respiratory Research Institute, Albuquerque, NM; Gary Goodman, Swedish Medical Center Cancer Institute; Gary Goodman, Fred Hutchinson Cancer Research Center, Seattle, WA; Gerald Clamon, University of Iowa, Iowa City, IA; Randolph Marks, Mayo Clinic, Rochester, MN; Worta McCaskill-Stevens, National Cancer Institute, Rockville, MD; Scott M. Lippman, University of California San Diego Cancer Center, San Diego, CA; John Ruckdeschel, Intermountain Healthcare, Salt Lake City, UT; Fadlo R. Khuri, Emory University, Atlanta, GA; Michael R. Johnston, Dalhousie University, Halifax, Nova Scotia; Michael R. Johnston, National Cancer Institute of Canada Clinical Trials Group, Kingston; Gordon Okawara, McMaster University, Hamilton, Ontario; and Eric Frechette, Hopital Laval, Quebec City, Quebec, Canada.
Sandra J Lee
Steven M Keller
Gail Shaw Wright
Seena Aisner
Steven Alan Belinsky
David H Johnson
Michael R Johnston
Gary Goodman
Gerald Clamon
Gordon Okawara
Randolph Marks
Eric Frechette
Worta McCaskill-Stevens
Scott M Lippman
John Ruckdeschel
Fadlo R Khuri
Mayo Clinic · USMcMaster University · CANational Institutes of Health · USUniversité Laval · CA

Funding

Tumor Evolution and Metastasis ProgramP30CA016672 · NCI · UNIVERSITY OF TX MD ANDERSON CAN CTR · PI Fabien Delerue · 1985 to 2026
$290.8M
CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
RTOG Foreign AccrualU10CA021661 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI CURRAN, WALTER J. · 1985 to 2013
$150.3M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
Foreign Accrual - ECOGU10CA037403 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2014
$34.6M
RTOG Foreign AccrualsU10CA037422 · NCI · AMERICAN COLLEGE OF RADIOLOGY · PI BRUNER, DEBORAH WATKINS · 1985 to 2013
$30.4M
ECOG Specimen BankingU24CA114737 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI COMIS, ROBERT L · 2005 to 2014
$9.3M
ONCOLOGYU10CA049957 · NCI · VANDERBILT UNIVERSITY · PI BERLIN, JORDAN D · 1989 to 2013
$5.4M
SOUTHWEST ONCOLOGY GROUPU10CA020319 · NCI · SWEDISH MEDICAL CENTER, FIRST HILL · PI GOODMAN, GARY E · 1985 to 2013
$5.1M
Participation in the Eastern Cooperative Oncology GroupU10CA107868 · NCI · UNIV OF MED/DENT NJ-R W JOHNSON MED SCH · PI AISNER, JOSEPH · 2004 to 2013
$2.3M
NCI NIH HHS CA037403NCI NIH HHS CA107868NCI NIH HHS CA14958NCI NIH HHS CA20319NCI NIH HHS CA21661NCI NIH HHS CA25224NCI NIH HHS CA31946NCI NIH HHS CA33601NCI NIH HHS CA37422NCI NIH HHS CA49957NCI NIH HHS CA73590NCI NIH HHS CA80775NCI NIH HHS N01 CA032102NCI NIH HHS P30 CA016672NCI NIH HHS U10 CA014958NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA021661NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA037403NCI NIH HHS U10 CA037422NCI NIH HHS U10 CA049957NCI NIH HHS U10 CA073590NCI NIH HHS U10 CA080775NCI NIH HHS U10 CA107868NCI NIH HHS U24 CA114737
6 · The paper itself

Abstract

purposeSelenium has been reported to have chemopreventive benefits in lung cancer. We conducted a double-blind, placebo-controlled trial to evaluate the incidence of second primary tumors (SPTs) in patients with resected non-small-cell lung cancer (NSCLC) receiving selenium supplementation. PATIENTS AND

methodsPatients with completely resected stage I NSCLC were randomly assigned to take selenized yeast 200 μg versus placebo daily for 48 months. Participation was 6 to 36 months postoperatively and required a negative mediastinal node biopsy, no excessive vitamin intake, normal liver function, negative chest x-ray, and no other evidence of recurrence.

resultsThe first interim analysis in October 2009, with 46% of the projected end points accumulated, showed a trend in favor of the placebo group with a low likelihood that the trial would become positive; thus, the study was stopped. One thousand seven hundred seventy-two participants were enrolled, with 1,561 patients randomly assigned. Analysis was updated in June 2011 with the maturation of 54% of the planned end points. Two hundred fifty-two SPTs (from 224 patients) developed, of which 98 (from 97 patients) were lung cancer (38.9%). Lung and overall SPT incidence were 1.62 and 3.54 per 100 person-years, respectively, for selenium versus 1.30 and 3.39 per 100 person-years, respectively, for placebo (P = .294). Five-year disease-free survival was 74.4% for selenium recipients versus 79.6% for placebo recipients. Grade 1 to 2 toxicity occurred in 31% of selenium recipients and 26% of placebo recipients, and grade ≥ 3 toxicity occurred in less than 2% of selenium recipients versus 3% of placebo recipients. Compliance was excellent. No increase in diabetes mellitus or skin cancer was detected.

conclusionSelenium was safe but conferred no benefit over placebo in the prevention of SPT in patients with resected NSCLC.

Indexed as

Dietary SupplementsAdultAgedAged, 80 and overAlopeciaCarcinoma, Non-Small-Cell LungChemopreventionConstipationDouble-Blind MethodFatigueFemaleHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedSelenium

Identifiers

PMID24002495
PMCPMC3821010
OpenAlexW2121667178

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.