Research: KARP and COLLEAGUES,

Listed in Issue 244

Abstract

KARP and COLLEAGUES,  (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 conducted a double-blind, placebo-controlled trial to determine the potential chemopreventive benefit of selenium in lung cancer.

Background

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 tumours (SPTs) in patients with resected non-small-cell lung cancer (NSCLC) receiving selenium supplementation.

Methodology

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 favour 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.

References

Karp DD(1), 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. 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. J Clin Oncol. 31(33):4179-87. Nov 20 2013. doi: 10.1200/JCO.2013.49.2173. Epub Sep 3 2013.

Comment

This well-designed double-blind, placebo-controlled trial study to assess whether selenium supplements prevented second primary tumours (SPTs) in lung cancer patients showed no benefit compared with placebo. One of the requirements of recruitment to the trial was no excessive vitamin intake, so it is unknown whether selenium in addition to other chemopreventive supplements might have had an improved outcome.

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