Journal of the National Cancer Institute, Vol. 93, No. 8, 571, April 18, 2001 © 2001 Oxford University Press MEMORANDUM FOR: Science Writers and Editors on the Journal Press List Isotretinoin, a Vitamin A Derivative, Does Not Prevent Secondary Primary Tumors in Non-Small-Cell Lung Cancer April 12, 2000 (EMBARGOED FOR RELEASE 4 P.M. EDT April 17) Katherine Arnold, Deputy News Editor, Dan Eckstein, (301) 986-1891, ext. 112 A major clinical trial reports that isotretinoin, a vitamin A derivative, does not prevent secondary primary tumors in patients with stage I non-small-cell lung cancer. In previous trials, isotretinoin prevented secondary primary cancers associated with head and neck cancers. As patients with non-small-cell lung cancer have a high rate of second primary tumors (SPTs), a clinical trial was conducted to see if isotretinoin would prevent SPTs in lung cancer patients. Scott Lippman, M.D., at The University of Texas M. D. Anderson Cancer Center, with co-investigators at many institutions, present the results of their study in the April 18 issue of the Journal of the National Cancer Institute. The study involved 1166 patients who had been surgically treated for non-small-cell lung cancer and who were disease free when they entered the study. The study population had a median age of 65 years and was predominantly male (57%) and white (92%). The two arms were well balanced with respect to these demographic characteristics and three stratification factors—histology, tumor stage, and smoking status. Patients were randomly assigned to receive either 30 mg of isotretinoin or a placebo, to be taken orally once a day for 3 years. All patients underwent a variety of tests during the study, including chest x-rays, to determine if new SPTs had developed. The median follow-up time for living patients was 3.5 years. Detailed data analyses found no statistically significant differences between the isotretinoin and placebo groups with respect to the time to SPTs, recurrences, or mortality. Secondary multivariate and subset analyses suggested that isotretinoin was harmful in current smokers and beneficial in never smokers. Statistically significant treatment-related toxic effects associated with isotretinoin included lip and skin dryness, conjunctivitis, and joint pain. At the end of 3 years, 40% of the treatment group and 25% of the placebo group were not taking their pills as instructed. The authors conclude that, although no completed randomized chemoprevention trial has shown a benefit in active smokers, their trial’s secondary finding of a potential benefit in never and former smokers supports future chemoprevention studies in this setting. Contact: Jane Brust, The University of Texas M. D. Anderson Cancer Center, Houston, (713) 792-0655; fax: (713) 794-4418; jbrust@mail.mdanderson.org. ____________________________ Lippman SM, Lee JJ, Karp DD, Vokes EE, Benner SE, Goodman GE, et al. Randomized phase III intergroup trial of isotretinoin to prevent second primary tumors in stage I non-small-cell lung cancer. J Natl Cancer Inst 2001:93:605–18. Note: This memo to reporters is from the Journal staff and is not an official release of the National Cancer Institute (NCI) or Oxford University Press (OUP) nor does it reflect NCI or OUP policy. In addition, unless otherwise stated, all articles and items published in the Journal reflect the individual views of the authors and not necessarily the official points of view held by NCI, any other component of the U.S. government, OUP, or the organizations with which the authors are affiliated. Neither NCI nor any other component of the U.S. government nor OUP assumes any responsibility for the completeness of the articles or other items or the accuracy of the conclusions reached therein. Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.