© 2001 by Oxford University Press
Journal of the National Cancer Institute, Vol. 93, No. 8, 605-618,
April 18, 2001
© 2001 Oxford University Press
Randomized Phase III Intergroup Trial of Isotretinoin to Prevent Second Primary Tumors in Stage I Non-Small-Cell Lung Cancer
Affiliations of authors: S. M. Lippman (Departments of Clinical Cancer Prevention and Thoracic/Head and Neck Medical Oncology), J. J. Lee, H. W. Kim (Department of Biostatistics), S. E. Benner, R. Lotan, W. K. Hong (Department of Thoracic/Head and Neck Medical Oncology), J. A. Roth (Department of Thoracic Surgery), The University of Texas M. D. Anderson Cancer Center, Houston; D. D. Karp, W. Fry, Eastern Cooperative Oncology Group, Brookline, MA; E. E. Vokes, S. L. Graziano, Cancer and Leukemia Group B, Chicago, IL; G. E. Goodman, D. R. Gandara, Southwest Oncology Group, San Antonio, TX; F. R. Khuri, G. Okawara, Radiation Therapy Oncology Group, Philadelphia, PA; R. Marks, C. L. Woodhouse, North Central Cancer Treatment Group, Rochester, MN; R. J. Winn, B. Williams, C. Perez, The University of Texas M. D. Anderson Cancer Center Community Clinical Oncology Program.
Correspondence to: Scott M. Lippman, M.D., Department of Clinical Cancer Prevention, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Blvd., Box 236, Houston, TX 77030–4095 (e-mail: slippman{at}mdanderson.org).
Background: Promising data have suggested that retinoid chemoprevention may help to control second primary tumors (SPTs), recurrence, and mortality of stage I non-small-cell lung cancer (NSCLC) patients. Methods: We carried out a National Cancer Institute (NCI) Intergroup phase III trial (NCI #I91–0001) with 1166 patients with pathologic stage I NSCLC (6 weeks to 3 years from definitive resection and no prior radiotherapy or chemotherapy). Patients were randomly assigned to receive a placebo or the retinoid isotretinoin (30 mg/day) for 3 years in a double-blind fashion. Patients were stratified at randomization by tumor stage, histology, and smoking status. The primary endpoint (time to SPT) and the secondary endpoints (times to recurrence and death) were analyzed by log-rank test and the Cox proportional hazards model. All statistical tests were two-sided. Results: After a median follow-up of 3.5 years, there were no statistically significant differences between the placebo and isotretinoin arms with respect to the time to SPTs, recurrences, or mortality. The unadjusted hazard ratio (HR) of isotretinoin versus placebo was 1.08 (95% confidence interval [CI] = 0.78 to 1.49) for SPTs, 0.99 (95% CI = 0.76 to 1.29) for recurrence, and 1.07 (95% CI = 0.84 to 1.35) for mortality. Multivariate analyses showed that the rate of SPTs was not affected by any stratification factor. Rate of recurrence was affected by tumor stage (HR for T2 versus T1 = 1.77 [95% CI = 1.35 to 2.31]) and a treatment-by-smoking interaction (HR for treatment-by-current-versus-never-smoking status = 3.11 [95% CI = 1.00 to 9.71]). Mortality was affected by tumor stage (HR for T2 versus T1 = 1.39 [95% CI = 1.10 to 1.77]), histology (HR for squamous versus nonsquamous = 1.31 [95% CI = 1.03 to 1.68]), and a treatment-by-smoking interaction (HR for treatment-by-current-versus-never-smoking = 4.39 [95% CI = 1.11 to 17.29]). Mucocutaneous toxicity (P<.001) and noncompliance (40% versus 25% at 3 years) were higher in the isotretinoin arm than in the placebo arm. Conclusions: Isotretinoin treatment did not improve the overall rates of SPTs, recurrences, or mortality in stage I NSCLC. Secondary multivariate and subset analyses suggested that isotretinoin was harmful in current smokers and beneficial in never smokers.
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