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J Clin Oncol. 2013 Nov 20;31(33):4179-87. doi: 10.1200/JCO.2013.49.2173. Epub 2013 Sep 3.

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.

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1
Daniel 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.

Abstract

PURPOSE:

Selenium 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 METHODS:

Patients 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.

RESULTS:

The 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.

CONCLUSION:

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

PMID:
24002495
PMCID:
PMC3821010
DOI:
10.1200/JCO.2013.49.2173
[Indexed for MEDLINE]
Free PMC Article

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