{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T19:50:13Z","timestamp":1791575413722,"version":"4.3.4"},"reference-count":35,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"33","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2013,11,20]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> 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\u2013small-cell lung cancer (NSCLC) receiving selenium supplementation. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Patients with completely resected stage I NSCLC were randomly assigned to take selenized yeast 200 \u03bcg 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> 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 \u2265 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Selenium was safe but conferred no benefit over placebo in the prevention of SPT in patients with resected NSCLC. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2013.49.2173","type":"journal-article","created":{"date-parts":[[2013,9,4]],"date-time":"2013-09-04T04:50:25Z","timestamp":1378270225000},"page":"4179-4187","source":"Crossref","is-referenced-by-count":107,"title":["Randomized, Double-Blind, Placebo-Controlled, Phase III Chemoprevention Trial of Selenium Supplementation in Patients With Resected Stage I Non\u2013Small-Cell Lung Cancer: ECOG 5597"],"prefix":"10.1200","volume":"31","author":[{"given":"Daniel D.","family":"Karp","sequence":"first","affiliation":[{"name":"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..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandra J.","family":"Lee","sequence":"additional","affiliation":[{"name":"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..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven M.","family":"Keller","sequence":"additional","affiliation":[{"name":"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..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gail Shaw","family":"Wright","sequence":"additional","affiliation":[{"name":"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. 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