Publication: 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: Difference between revisions
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| Title | 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 |
| Topic | Selenium |
| Author | Karp, DD, Lee, SJ, Keller, SM, Wright, GS, Aisner, S, Belinsky, SA, Johnson, DH, Johnston, MR, Goodman, G, Clamon, G, Okawara, G, Marks, R, Frechette, E, McCaskill-Stevens, W, Lippman, SM, Ruckdeschel, J, Khuri, FR |
| Year | 2012 |
| Journal | Journal of clinical oncology: official journal of the American Society of Clinical Oncology |
| DOI | https://doi.org/10.1200/JCO.2013.49.2173 |
Author's Abstract The abstract and the information and conclusions contained therein were written by the authors of the publication.
| 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. |
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