Fenretinide breast cancer prevention trial: Drug and retinol plasma levels in relation to age and disease outcome

Cancer Epidemiology Biomarkers and Prevention

Volumn 12, Issue 1, 2003, Pages 34-41

  Formelli, Franca ^a   Camerini, Tiziana ^a   Cavadini, Elena ^a   Appierto, Valentina ^a   Villani, Maria Grazia ^a   Costa, Alberto ^b   De Palo, Giuseppe ^a   Di Mauro, Maria Gaetana ^a   Veronesi, Umberto ^c  

^a NATIONAL CANCER INSTITUTE   (Italy)

^b IRCCS   (Italy)

^c EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG METABOLITE; FENRETINIDE; N (4 METHOXYPHENYL)RETINAMIDE; PLASMA PROTEIN; RETINOL; UNCLASSIFIED DRUG;

ADULT; AGE; ARTICLE; BREAST CANCER; CANCER PREVENTION; CANCER RECURRENCE; CANCER RISK; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG BLOOD LEVEL; DRUG PROTEIN BINDING; FEMALE; FOLLOW UP; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; ITALY; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PLASMA; POSTMENOPAUSE; PREMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SECOND CANCER;

ADULT; AGE FACTORS; AGED; ANTICARCINOGENIC AGENTS; BREAST NEOPLASMS; FEMALE; FENRETINIDE; HUMANS; ITALY; MIDDLE AGED; NEOPLASM RECURRENCE, LOCAL; PROGNOSIS; TIME FACTORS; VITAMIN A;

EID: 0037242412     PISSN: 10559965     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (28)

1. Veronesi, U., De Palo, G., Marubini, E., Costa, A., Formelli, F., Mariani, L., Decensi, A., Camerini, T., Rosselli Del Turco, M., Di Mauro, M. G., Miceli, R., and Sporn, M. B. Randomized trial of fenretinide to prevent second breast malignancy in women with early breast cancer. J. Natl. Cancer Inst. (Bethesda), 91: 1847-1856, 1999.
2. Torrisi, R., Pensa, F., Orengo, M. A., Catsafados, E., Ponzani, P., Boccardo, F., Costa, A., and Decensi, A. The synthetic retinoid fenretinide lowers plasma insulin-like growth factor I levels in breast cancer patients. Cancer Res., 53: 4769-4771, 1993.
3. Decensi, A., Johansson, H., Miceli, R., Mariani, L., Camerini, T., Cavadini, E., Di Mauro, M. G., Barreca, A., Guerrieri Gonzaga, A., Diani, S., Sandri, M. T., De Palo, G., and Formelli, F. 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., 10: 1047-1053, 2001.
4. Formelli, F., Clerici, M., Campa, T., Di Mauro, M. G., Magni, A., Mascotti, G., Moglia, D., De Palo, G., Costa, A., and Veronesi, U. Five-year administration of fenretinide: pharmacokinetics and effects on plasma retinol cancentrations. J. Clin. Oncol., 11: 2036-2042, 1993.
5. Formelli, F., Carsana, R., Costa, A., Buranelli, F., Campa, T., Dossena, G., Magni, A., and Pizzichetta, M. Plasma retinol level reduction by the synthetic retinoid fenretinide: a one year follow-up study of breast cancer patients. Cancer Res., 49: 6149-6152, 1989.
6. Wald, N. J., Boreham, J., Hayward, J. L., and Bulbrook, R. D. Plasma retinol, β-carotene and vitamin E levels in relation to the future risk of breast cancer. Br. J. Cancer, 49: 321-324, 1984.
7. Mehta, R. R., Hart, G., Beattie, C. W., and Das Gupta, T. K. Significance of plasma retinol binding protein levels in recurrence of breast tumors in women. Oncology, 44: 350-355, 1987.
8. Marubini, E., Decarli, A., Costa, A., Mazzoleni, C., Andreoli, C., Barbieri, A., Capitelli, E., Carlucci, M., Cavallo, F., Monferroni, N., Pastorino, U., and Salvini, S. The relationship of dietary intake and serum levels of retinol and beta-carotene with breast cancer. Cancer (Phila.), 61: 173-180, 1988.
9. Basu, T. K., and Sasmal, P. Plasma vitamin A, retinol-binding protein, and prealbumin in postoperative breast cancer patients. Int. J. Vitam. Nutr. Res., 58: 281-283, 1988.
10. Criqui, M. H., Bangdiwala, S., Goodman, D. S., Blaner, W. S., Morris, J. S., Kritchevsky, S., Lippel, K., Mebane, I., and Tyroler, H. A. Selenium, retinol, retinol-binding protein, and uric acid associations with cancer mortality in a population-based prospective case-control study. Ann. Epidemiol., 1: 385-393, 1991.
11. De Palo, G., Camerini, T., Marubini, E., Costa, A., Formelli, F., Del Vecchio, M., Mariani, L., Miceli, R., Mascotti, G., Magni, A., Campa, T., Di Mauro, M. G., Attili, A., Maltoni, C., Rosselli Del Turco, M., Decensi, A., D'Aiuto, G., and Veronesi, U. Chemoprevention trial of contralateral breast cancer with fenretinide. Rationale, design, methodology, organization, data management, statistics and accrual. Tumori, 83: 884-894, 1997.
12. Camerini, T., Mariani, L., De Palo, G., Marubini, E., Di Mauro, M. G., Decensi, A., Costa, A., and Veronesi, U. Safety of the synthetic retinoid fenretinide: long-term results from a controlled clinical trial for the prevention of contralateral breast cancer. J. Clin. Oncol., 19: 1664-1670, 2001.
13. SAS/STAT User's Guide, Version 6, Ed. 4, Vol. 1 and 2. Cary, NC: SAS Institute, Inc., 1990.
14. Mariani, L., Miceli, R., Formelli, F., and Marubini, E. Direct and indirect assessment of treatment compliance: an empirical comparison of the two methods based on the data arising from a randomized clinical trial. J. Epidemiol. Biostat., 2: 219-224, 1997.
15. Garry, P. J., Hunt, W. C., Bandrofchak, J. L., VanderJagt, D., and Goodwin, J. S. Vitamin A intake and plasma retinol levels in healthy elderly men and women. Am. J. Clin. Nutr., 46: 989-994, 1987.
16. Russell, M. J., Thomas, B. S., and Bulbrook, R. D. A prospective study of the relationship between serum vitamins A and E and risk of breast cancer. Br. J. Cancer, 57: 213-215, 1988.
17. Smith, D. K., Greene, J. M., Leonard, S. B., Kuske, T. T., Feldman, D. S., and Feldman, E. B. Vitamin A in hypercholesterolemia. Am. J. Med. Sci., 304: 20-24, 1992.
18. Jordan, P., Brubacher, D., Moser, U., Stahelin, H. R., and Gey, K. F. Vitamin E and vitamin A concentrations in plasma adjusted for cholesterol and triglycerides by multiple regression. Clin. Chem., 41: 924-927, 1995.
19. Gal, I., Parkinson, C., and Craft, I. Effects of oral contraceptives on human plasma vitamin-A levels. Br. Med. J., 2: 436-438, 1971.
20. Vahlquist, A., Johnsson, A., and Nygren, K-G. Vitamin A transporting plasma proteins and female sex hormones. Am. J. Clin. Nutr., 32: 1433-1438, 1979.
21. Palan, P. R., Romney, S. L., Vermund, S. H., Mikhail, M. G., and Basu, J. Effects of smoking and oral contraception on plasma β-carotene levels in healthy women. Am. J. Obstet. Gynecol., 161: 881-885, 1989.
22. Formelli, F., Barua, A. B., and Olson, J. A. Bioactives of N-(4-hydroxyphenyl)retinamide and retinoyl-glucuronide. FASEB J., 10: 1014-1024, 1996.
23. Urien, S., Claudepierre, P., Nguyen, P., Chassany, O., Meyer, J., Brandt, R., and Tillement, J. P. Binding of retinoid analogues to albumin and lipoproteins of human plasma. Int. J. Clin. Pharmacol. Res., 14: 115-118, 1994.
24. Gueddari, N., Madoulet, C., Lefebvre, P., Berthou, L., Chomienne, C., and Jardillier, J. C. Partial restoration of all trans retinoic acid (ATRA) sensitivity by compactin in ATRA-resistant leukemic cells (ATRA-R HL-60). Leuk. Res., 24: 543-548, 2000.
25. Avis, I., Mathias, A., Unsworth, E. J., Miller, M. J., Cuttitta, F., Mulshine, J. L., and Jakowlew, S. B. Analysis of small cell lung cancer cell growth inhibition by 13-cis-retinoic acid: importance of bioavailability. Cell Growth Differ., 6: 485-492, 1995.
26. Hsu, S-L., Wu, W-S., Tyan, Y-S., and Chou, C. K. Retinoic acid-induced apoptosis is prevented by serum albumin and enhanced by lipiodol in human hepatoma Hep3B cells. Cancer Lett., 129: 205-214, 1998.
27. Berni, R., and Formelli, F. In vitro interaction of fenretinide with plasma retinol-binding protein and its functional consequences. FEBS Lett., 1: 43-45, 1992.
28. Guo, X., Nanus, D. M., Ruiz, A., Rando, R. R., Bok, D., and Gudas, L. J. Reduced levels of retinyl esters and vitamin A in human renal cancers. Cancer Res., 61: 2774-2781, 2001.