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JNCI Journal of the National Cancer Institute 1999 91(21):1847-1856; doi:10.1093/jnci/91.21.1847
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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

Umberto Veronesi, Giuseppe De Palo, Ettore Marubini, Alberto Costa, Franca Formelli, Luigi Mariani, Andrea Decensi, Tiziana Camerini, Marco Rosselli Del Turco, Maria Gaetana Di Mauro, Maria Grazia Muraca, Marcella Del Vecchio, Carmine Pinto, Giuseppe D'Aiuto, Corrado Boni, Tiziana Campa, Andrea Magni, Rosalba Miceli, Marjorie Perloff, Winfred F. Malone, Michael B. Sporn, For the Fenretinide Trial Investigators

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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C. Zou, A.-T. Vlastos, L. Yang, J. Wang, M. Brewer, and M. Follen
Effect of 4-Hydroxyphenylretinamide on Human Cervical Epithelial and Cancer Cell Lines
Reproductive Sciences, January 1, 2003; 10(1): 41 - 48.
[Abstract] [PDF]


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ChestHome page
K. H. Dragnev, D. Stover, and E. Dmitrovsky
Lung Cancer Prevention: The Guidelines
Chest, January 1, 2003; 123 (2009): 60S - 71S.
[Abstract] [Full Text] [PDF]


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Cancer Res.Home page
M. Esteller, M. Guo, V. Moreno, M. A. Peinado, G. Capella, O. Galm, S. B. Baylin, and J. G. Herman
Hypermethylation-associated Inactivation of the Cellular Retinol-Binding-Protein 1 Gene in Human Cancer
Cancer Res., October 15, 2002; 62(20): 5902 - 5905.
[Abstract] [Full Text] [PDF]


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Clin. Cancer Res.Home page
N. Suh, W. W. Lamph, A. L. Glasebrook, T. A. Grese, A. D. Palkowitz, C. R. Williams, R. Risingsong, M. R. Farris, R. A. Heyman, and M. B. Sporn
Prevention and Treatment of Experimental Breast Cancer with the Combination of a New Selective Estrogen Receptor Modulator, Arzoxifene, and a New Rexinoid, LG 100268
Clin. Cancer Res., October 1, 2002; 8(10): 3270 - 3275.
[Abstract] [Full Text] [PDF]


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Molecular Cancer TherapeuticsHome page
A.-M. Simeone, S. Ekmekcioglu, L. D. Broemeling, E. A. Grimm, and A. M. Tari
A Novel Mechanism by Which N-(4-hydroxyphenyl)retinamide Inhibits Breast Cancer Cell Growth: The Production of Nitric Oxide
Mol. Cancer Ther., October 1, 2002; 1(12): 1009 - 1017.
[Abstract] [Full Text] [PDF]


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CirculationHome page
A. Decensi, U. Omodei, C. Robertson, B. Bonanni, A. Guerrieri-Gonzaga, F. Ramazzotto, H. Johansson, S. Mora, M. T. Sandri, M. Cazzaniga, et al.
Effect of Transdermal Estradiol and Oral Conjugated Estrogen on C-Reactive Protein in Retinoid-Placebo Trial in Healthy Women
Circulation, September 3, 2002; 106(10): 1224 - 1228.
[Abstract] [Full Text] [PDF]


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Clin. Cancer Res.Home page
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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JCOHome page
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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ANN INTERN MEDHome page
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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CA Cancer J ClinHome page
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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JAMAHome page
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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Cancer Res.Home page
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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CarcinogenesisHome page
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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FASEB J.Home page
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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Clin. Cancer Res.Home page
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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Cancer Epidemiol. Biomarkers Prev.Home page
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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JCOHome page
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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JCOHome page
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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Clin. Cancer Res.Home page
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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Postgrad. Med. J.Home page
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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JNCI J Natl Cancer InstHome page
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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JNCI J Natl Cancer InstHome page
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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JNCI J Natl Cancer InstHome page
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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Cancer Epidemiol. Biomarkers Prev.Home page
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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JCOHome page
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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J. Clin. Endocrinol. Metab.Home page
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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JNCI J Natl Cancer InstHome page
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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Cancer Epidemiol. Biomarkers Prev.Home page
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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Cancer Epidemiol. Biomarkers Prev.Home page
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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The OncologistHome page
K. H. Dragnev, J. R. Rigas, and E. Dmitrovsky
The Retinoids and Cancer Prevention Mechanisms
Oncologist, October 1, 2000; 5(5): 361 - 368.
[Abstract] [Full Text]


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Clin. Cancer Res.Home page
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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NEJMHome page
R. T. Chlebowski
Reducing the Risk of Breast Cancer
N. Engl. J. Med., July 20, 2000; 343(3): 191 - 198.
[Full Text] [PDF]


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NEJMHome page
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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CarcinogenesisHome page
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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JNCI J Natl Cancer InstHome page
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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CarcinogenesisHome page
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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JNCI J Natl Cancer InstHome page
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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JNCI J Natl Cancer InstHome page
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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J. Nutr.Home page
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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JNCI J Natl Cancer InstHome page
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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JNCI J Natl Cancer InstHome page
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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Cancer Res.Home page
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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