© 1999 by Oxford University Press
Journal of the National Cancer Institute, Vol. 91, No. 21, 1847-1856,
November 3, 1999
© 1999 Oxford University Press
Randomized Trial of Fenretinide to Prevent Second Breast Malignancy in Women With Early Breast Cancer
Affiliations of authors: U. Veronesi, A. Costa, A. Decensi, Istituto Europeo di Oncologia, Milan, Italy; G. De Palo, F. Formelli, L. Mariani, T. Camerini, M. G. Di Mauro, M. Del Vecchio, T. Campa, A. Magni, R. Miceli, Istituto Nazionale Tumori, Milan; E. Marubini, Istituto di Statistica Medica e Biometria, Università di Milano; M. Rosselli Del Turco, M. G. Muraca, Centro per la Prevenzione Oncologica, Firenze, Italy; C. Pinto, Istituto di Oncologia "F. Addarii," Bologna, Italy; G. D'Aiuto, Istituto Nazionale Tumori, Naples, Italy; C. Boni, Ospedale "Santa Maria Maggiore," Reggio Emilia, Italy; M. Perloff, W. F. Malone, Chemoprevention Branch, Division of Cancer Prevention and Control, National Cancer Institute, Bethesda, MD; M. B. Sporn, Dartmouth Medical School, Hanover, NH.
Correspondence to: Alberto Costa, M.D., European Institute of Oncology, Via Ripamonti 435, 20141 Milan, Italy (e-mail: acosta{at}ieo.it).
BACKGROUND: Fenretinide, a vitamin A analogue, has been shown to inhibit breast carcinogenesis in preclinical studies. We determined the efficacy of fenretinide in preventing a second breast malignancy in women with breast cancer. METHODS: We randomly assigned 2972 women, aged 30-70 years, with surgically removed stage I breast cancer or ductal carcinoma in situ to receive for 5 years either fenretinide orally (200 mg/day) or no treatment. The primary end point was the incidence of contralateral breast cancer or ipsilateral breast cancer 7 years after randomization. Other end points considered post hoc were the same outcomes stratified by menopausal status, incidence of distant metastases, overall mortality, and tumors in other organs. The hazards of breast cancer occurrence were determined by Cox proportional hazards regression analysis. Statistical tests were two-sided. RESULTS: At a median observation time of 97 months, there were no statistically significant differences in the occurrence of contralateral breast cancer (P = .642) or ipsilateral breast cancer (P = .177) between the two arms. However, an interaction was detected between fenretinide treatment and menopausal status in both outcomes (P for interaction in both outcomes = .045), with a possible beneficial effect in premenopausal women (contralateral breast cancer: adjusted hazard ratio [HR] = 0.66, and 95% confidence interval [CI] = 0.41-1.07; ipsilateral breast cancer: adjusted HR = 0.65, and 95% CI = 0.46-0.92) and an opposite effect in postmenopausal women (contralateral breast cancer: adjusted HR = 1.32, and 95% CI = 0.82-2.15; ipsilateral breast cancer: adjusted HR = 1.19, and 95% CI = 0.75-1.89). There were no statistically significant differences between the two arms in tumors in other organs, incidence of distant metastasis, and all-cause mortality. CONCLUSIONS: Fenretinide treatment of women with breast cancer for 5 years appears to have no statistically significant effect on the incidence of second breast malignancies overall, although a possible benefit was detected in premenopausal women. These studies, particularly the post hoc analyses, are considered exploratory and need to be confirmed.
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S. E. Singletary, E. N. Atkinson, A. Hoque, N. Sneige, A. A. Sahin, H. A. Fritsche Jr., R. Lotan, T. Lu, W. N. Hittelman, T. B. Bevers, et al. Phase II Clinical Trial of N-(4-Hydroxyphenyl)retinamide and Tamoxifen Administration before Definitive Surgery for Breast Neoplasia Clin. Cancer Res., September 1, 2002; 8(9): 2835 - 2842. [Abstract] [Full Text] [PDF]
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R. T. Chlebowski, N. Col, E. P. Winer, D. E. Collyar, S. R. Cummings, V. G. Vogel III, H. J. Burstein, A. Eisen, I. Lipkus, and D. G. Pfister American Society of Clinical Oncology Technology Assessment of Pharmacologic Interventions for Breast Cancer Risk Reduction Including Tamoxifen, Raloxifene, and Aromatase Inhibition J. Clin. Oncol., August 1, 2002; 20(15): 3328 - 3343. [Abstract] [Full Text] [PDF]
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 L. S. Kinsinger, R. Harris, S. H. Woolf, H. C. Sox, and K. N. Lohr Chemoprevention of Breast Cancer: A Summary of the Evidence for the U.S. Preventive Services Task Force Ann Intern Med, July 2, 2002; 137(1): 59 - 69. [Abstract] [Full Text] [PDF]
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M. N. Barnes, W. E. Grizzle, C. J. Grubbs, and E. E. Partridge Paradigms for Primary Prevention of Ovarian Carcinoma CA Cancer J Clin, July 1, 2002; 52(4): 216 - 225. [Abstract] [Full Text] [PDF]
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K. M. Fairfield and R. H. Fletcher Vitamins for Chronic Disease Prevention in Adults: Scientific Review JAMA, June 19, 2002; 287(23): 3116 - 3126. [Abstract] [Full Text] [PDF]
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Z. Li, Z. H. Meng, R. Chandrasekaran, W.-L. Kuo, C. C. Collins, J. W. Gray, and S. H. Dairkee Biallelic Inactivation of the Thyroid Hormone Receptor {beta}1 Gene in Early Stage Breast Cancer Cancer Res., April 1, 2002; 62(7): 1939 - 1943. [Abstract] [Full Text] [PDF]
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S. Bruno, C. Tenca, D. Saverino, E. Ciccone, and C. E. Grossi Apoptosis of squamous cells at different stages of carcinogenesis following 4-HPR treatment Carcinogenesis, March 1, 2002; 23(3): 447 - 456. [Abstract] [Full Text] [PDF]
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 F. TOSETTI, N. FERRARI, S. DE FLORA, and A. ALBINI Angioprevention': angiogenesis is a common and key target for cancer chemopreventive agents FASEB J, January 1, 2002; 16(1): 2 - 14. [Abstract] [Full Text] [PDF]
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M. Follen, E. N. Atkinson, D. Schottenfeld, A. Malpica, L. West, S. Lippman, C. Zou, W. N. Hittelman, R. Lotan, and W. K. Hong A Randomized Clinical Trial of 4-Hydroxyphenylretinamide for High-Grade Squamous Intraepithelial Lesions of the Cervix Clin. Cancer Res., November 1, 2001; 7(11): 3356 - 3365. [Abstract] [Full Text] [PDF]
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A. Decensi, H. Johansson, R. Miceli, L. Mariani, T. Camerini, E. Cavadini, M. G. Di Mauro, A. Barreca, A. G. Gonzaga, S. Diani, et al. Long-Term Effects of Fenretinide, a Retinoic Acid Derivative, on the Insulin-like Growth Factor System in Women with Early Breast Cancer Cancer Epidemiol. Biomarkers Prev., October 1, 2001; 10(10): 1047 - 1053. [Abstract] [Full Text] [PDF]
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A. Goldhirsch, J. H. Glick, R. D. Gelber, A. S. Coates, and H.-J. Senn Meeting Highlights: International Consensus Panel on the Treatment of Primary Breast Cancer J. Clin. Oncol., September 15, 2001; 19(18): 3817 - 3827. [Full Text] [PDF]
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S. M. Lippman and M. R. Spitz Lung Cancer Chemoprevention: An Integrated Approach J. Clin. Oncol., September 15, 2001; 19(90001): 74s - 82. [Abstract] [Full Text] [PDF]
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D. Shan, A. K. Gopal, and O. W. Press Synergistic Effects of the Fenretinide (4-HPR) and Anti-CD20 Monoclonal Antibodies on Apoptosis Induction of Malignant Human B Cells Clin. Cancer Res., August 1, 2001; 7(8): 2490 - 2495. [Abstract] [Full Text] [PDF]
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 R A Sharma, A J Gescher, K J O'Byrne, and W P Steward Familiar drugs may prevent cancer Postgrad. Med. J., August 1, 2001; 77(910): 492 - 497. [Abstract] [Full Text] [PDF]
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A. Gupta, R. Nines, K. A. Rodrigo, R. A. Aziz, P. S. Carlton, D. L. Gray, V. E. Steele, M. A. Morse, and G. D. Stoner Effects of Dietary N-(4-Hydroxyphenyl)retinamide on N-Nitrosomethylbenzylamine Metabolism and Esophageal Tumorigenesis in the Fischer 344 Rat J Natl Cancer Inst, July 4, 2001; 93(13): 990 - 998. [Abstract] [Full Text] [PDF]
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S. M. Lippman, J. J. Lee, D. D. Karp, E. E. Vokes, S. E. Benner, G. E. Goodman, F. R. Khuri, R. Marks, R. J. Winn, W. Fry, 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, April 18, 2001; 93(8): 605 - 618. [Abstract] [Full Text] [PDF]
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U. Veronesi and A. Decensi Retinoids for Ovarian Cancer Prevention: Laboratory Data Set the Stage for Thoughtful Clinical Trials J Natl Cancer Inst, April 4, 2001; 93(7): 486 - 488. [Full Text] [PDF]
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J. L. Clifford, A. L. Sabichi, C. Zou, X. Yang, V. E. Steele, G. J. Kelloff, R. Lotan, and S. M. Lippman Effects of Novel Phenylretinamides on Cell Growth and Apoptosis in Bladder Cancer Cancer Epidemiol. Biomarkers Prev., April 1, 2001; 10(4): 391 - 395. [Abstract] [Full Text]
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T. Camerini, L. Mariani, G. De Palo, E. Marubini, M. G. Di Mauro, A. Decensi, A. Costa, and U. Veronesi Safety of the Synthetic Retinoid Fenretinide: Long-Term Results From a Controlled Clinical Trial for the Prevention of Contralateral Breast Cancer J. Clin. Oncol., March 15, 2001; 19(6): 1664 - 1670. [Abstract] [Full Text] [PDF]
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 C. Deal, J. Ma, F. Wilkin, J. Paquette, F. Rozen, B. Ge, T. Hudson, M. Stampfer, and M. Pollak Novel Promoter Polymorphism in Insulin-Like Growth Factor-Binding Protein-3: Correlation with Serum Levels and Interaction with Known Regulators J. Clin. Endocrinol. Metab., March 1, 2001; 86(3): 1274 - 1280. [Abstract] [Full Text]
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S. Menard, T. Camerini, L. Mariani, G. Tomasic, S. Pilotti, A. Costa, G. De Palo, and U. Veronesi Re: Randomized Trial of Fenretinide to Prevent Second Breast Malignancy in Women With Early Breast Cancer J Natl Cancer Inst, February 7, 2001; 93(3): 240 - 241. [Full Text] [PDF]
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A. Decensi, R. Torrisi, S. Bruno, M. Costantini, A. Curotto, G. Nicolò, B. Malcangi, L. Baglietto, G. P. Bruttini, B. Gatteschi, et al. Randomized Trial of Fenretinide in Superficial Bladder Cancer Using DNA Flow Cytometry as an Intermediate End Point Cancer Epidemiol. Biomarkers Prev., October 1, 2000; 9(10): 1071 - 1078. [Abstract] [Full Text]
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E. Singletary, R. Lieberman, N. Atkinson, N. Sneige, A. Sahin, S. Tolley, M. Colchin, T. Bevers, C. Stelling, B. Fornage, et al. Novel Translational Model for Breast Cancer Chemoprevention Study: Accrual to a Presurgical Intervention with Tamoxifen and N-[4-Hydroxyphenyl] Retinamide Cancer Epidemiol. Biomarkers Prev., October 1, 2000; 9(10): 1087 - 1090. [Abstract] [Full Text]
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J. M. Kurie, J. S. Lee, F. R. Khuri, L. Mao, R. C. Morice, J. J. Lee, G. L. Walsh, A. Broxson, S. M. Lippman, J. Y. Ro, et al. N-(4-Hydroxyphenyl)Retinamide in the Chemoprevention of Squamous Metaplasia and Dysplasia of the Bronchial Epithelium Clin. Cancer Res., August 1, 2000; 6(8): 2973 - 2979. [Abstract] [Full Text]
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R. N. Hoover Cancer -- Nature, Nurture, or Both N. Engl. J. Med., July 13, 2000; 343(2): 135 - 136. [Full Text]
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L. A. Hansen, C. C. Sigman, F. Andreola, S. A. Ross, G. J. Kelloff, and L. M. De Luca Retinoids in chemoprevention and differentiation therapy Carcinogenesis, July 1, 2000; 21(7): 1271 - 1279. [Abstract] [Full Text] [PDF]
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M. B. Sporn Retinoids and Demethylating Agents-- Looking for Partners J Natl Cancer Inst, May 17, 2000; 92(10): 780 - 781. [Full Text] [PDF]
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M. B. Sporn and N. Suh Chemoprevention of cancer Carcinogenesis, March 1, 2000; 21(3): 525 - 530. [Abstract] [Full Text] [PDF]
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U. Veronesi, G. De Palo, E. Marubini, A. Costa, L. Mariani, F. Formelli, and A. Decensi Re: Vitamin A Analogue for Breast Cancer Prevention: a Grade of F or Incomplete? J Natl Cancer Inst, February 2, 2000; 92(3): 274 - 274. [Full Text] [PDF]
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F. L. Meyskens Jr. Re: Vitamin A Analogue for Breast Cancer Prevention: a Grade of F or Incomplete? J Natl Cancer Inst, February 2, 2000; 92(3): 274a - 274a. [Full Text] [PDF]
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 S. M. Lippman and R. Lotan Advances in the Development of Retinoids as Chemopreventive Agents J. Nutr., February 1, 2000; 130(2): 479 - 479. [Abstract] [Full Text]
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S. Piantadosi Vitamin A Analogue for Breast Cancer Prevention: a Grade of F or Incomplete? J Natl Cancer Inst, November 3, 1999; 91(21): 1794 - 1794. [Full Text] [PDF]
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S. M. Lippman and P. H. Brown Tamoxifen Prevention of Breast Cancer: an Instance of the Fingerpost J Natl Cancer Inst, November 3, 1999; 91(21): 1809 - 1819. [Full Text] [PDF]
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N. Suh, Y. Wang, C. R. Williams, R. Risingsong, T. Gilmer, T. M. Willson, and M. B. Sporn A New Ligand for the Peroxisome Proliferator-Activated Receptor-{{gamma}} (PPAR-{{gamma}}), GW7845, Inhibits Rat Mammary Carcinogenesis Cancer Res., November 1, 1999; 59(22): 5671 - 5673. [Abstract] [Full Text] [PDF]
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