The efficacy of 9-Cis-retinoic acid (aliretinoin) as a chemopreventive agent for cervical dysplasia: Results of a randomized double-blind clinical trial

Cancer Epidemiology Biomarkers and Prevention

Volumn 12, Issue 2, 2003, Pages 114-119

  Alvarez, Ronald D ^a,e   Conner, Michael G ^b   Weiss, Heidi ^a   Klug, Patricia M ^a   Niwas, Santosh ^a   Manne, Upender ^b   Bacus, James ^d   Kagan, Valeriy ^d   Sexton, Katherine C ^b   Grubbs, Clinton J ^c   Eltoum, Isam Eldin ^b   Grizzle, William E ^b  

^a UNIVERSITY OF ALABAMA AT BIRMINGHAM   (United States)

^b University of Alabama at Birmingham   (United States)

^c Kentucky   (United States)

^d Olympus America Inc   (United States)

^e NONE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALITRETINOIN; HEMOGLOBIN; HIGH DENSITY LIPOPROTEIN; PLACEBO; TRIACYLGLYCEROL;

ADULT; AGED; ARTICLE; CANCER PREVENTION; CANCER REGRESSION; CHEMOPROPHYLAXIS; CLINICAL TRIAL; COLPOSCOPY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DOSE RESPONSE; DRUG CYTOTOXICITY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DRUG WITHDRAWAL; FATIGUE; FEMALE; HEADACHE; HISTOPATHOLOGY; HUMAN; HUMAN TISSUE; HYPERTRIGLYCERIDEMIA; MAJOR CLINICAL STUDY; NAUSEA; PATIENT COMPLIANCE; PRIORITY JOURNAL; TREATMENT OUTCOME; UTERINE CERVIX BIOPSY; UTERINE CERVIX CANCER; UTERINE CERVIX CARCINOMA IN SITU; UTERINE CERVIX DYSPLASIA;

ADOLESCENT; ADULT; ALABAMA; ANTINEOPLASTIC AGENTS; BIOLOGICAL MARKERS; CERVICAL INTRAEPITHELIAL NEOPLASIA; CHEMOPREVENTION; CHOLESTEROL, HDL; DOSE-RESPONSE RELATIONSHIP, DRUG; DOUBLE-BLIND METHOD; DRUG EVALUATION; FEMALE; HEMOGLOBINS; HUMANS; PATIENT COMPLIANCE; SEVERITY OF ILLNESS INDEX; TREATMENT OUTCOME; TRETINOIN; TRIGLYCERIDES; UTERINE CERVICAL DYSPLASIA; UTERINE CERVICAL NEOPLASMS; WOMEN'S HEALTH;

EID: 12244302882     PISSN: 10559965     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (22)

1. Mitchell, M. F., Hittelman, W. K., Lotan, R., Nishioka, K., Tortolero-Luna, G., Richards-Kortum, R., Wharton, J. T., and Hong, W. K. Chemoprevention trials and surrogate end point biomarkers in the cervix. Cancer (Phila.), 76(Suppl. 10): 1956-1977, 1995.
2. Sun, S. Y., and Lotan, R. Retinoids and their receptors in cancer development and chemoprevention. Crit. Rev. Oncol.-Hematol., 41: 41-55, 2002.
3. Geisen, C., Denk, C., Gremm, B., Baust, C., Karger, A., Bollag, W., and Schwarz, E. High-level expression of the retinoic acid receptor β gene in normal cells of the uterine cervix is regulated by the retinoic acid receptor α and is abnormally down-regulated in cervical carcinoma cells. Cancer Res., 57: 1460-1467, 1997.
4. Xu, X. C., Mitchell, M. F., Silva, E., Jetten, A., and Lotan, R. Decreased expression of retinoic acid receptors, transforming growth factor β, involucrin, and comifin in cervical intraepithelial neoplasia. Clin. Cancer Res., 5: 1503-1508, 1999.
5. Bendbrook, D. M., Lu, S., Flanagan, C., Shen-Gunther, J., Angros, L. H., and Lightfoot, S. A. Biological assay for activity and molecular mechanisms of retinoids in cervical tumor cells. Gynecol. Oncol., 66: 114-121, 1997.
6. Geisen, C., Denk, C., Kupper, J. H., and Schwarz, E. Growth inhibition of cervical cancer cells by the human retinoid acid receptor β gene. Int. J. Cancer, 85: 289-295, 2000.
7. Sabachi, A. L., Hendricks, D. T., Bober, M. A., and Birrer, M. J. Retinoic acid receptor β expression and growth inhibition of gynecologic cancer cells by the synthetic retinoid N-(4-hydroxyphenyl) retinamide. J. Natl. Cancer Inst., 90: 597-605, 1998.
8. Lotan, R. Dawson, M. I., Zou, C. C., Jong, L., Lotan, D., and Zou, C. P. Enhanced efficacy of combinations of retinoic acid and retinoid X receptor-selective retinoids and α-interferon in inhibition of cervical carcinoma cell proliferation. Cancer Res., 55: 232-236, 1995.
9. Heyman, R. A., Mangelsdorf, D. J., Dyck, J. A., Stein, R. B., Eichele, G., Evans, R. M., and Thaller, C. 9-cis-retinoic acid is a high affinity ligand for the retinoid X receptor. Cell, 68: 397-406, 1992.
10. Narayanan, B. A., Holladay, E. B., Nixon, D. W., and Mauro, C. T. The effect of all-trans and 9-cis retinoic acid on the steady state level of HPV 16 E6/E7 mRNA and cell cycle in cervical carcinoma cells. Life Sci., 63: 565-573, 1998.
11. Agarwal, C., Chandraratna, R. A., Teng, M., Nagpal, S., Rorke, E. A., and Eckert, R. Differential regulation of human ectocervical epithelial cell line proliferation and differentiation by retinoid X receptor and retinoic acid receptor specific retinoids. Cell Growth Differ., 7: 521-530, 1996.
12. Surwit, E. A., Graham, V., Droegemueller, W., Alberts, D., Chvapil, M., Dorr, R. T., Davis, J. R., and Meyskens, F. L., Jr. Evaluation of topically applied trans-retinoic acid in the treatment of cervical intraepithelial lesions. Am. J. Obstet. Gynecol., 143: 821-823, 1982.
13. Meyskens, F. L., Jr., Graham, V., Chvapil, M., Dorr, R. T., Alberts, D. S., and Surwit, E. A. A phase I trial of β-all-trans-retinoic acid delivered via a collagen sponge and a cervical cap for mild or moderate intraepithelial cervical neoplasia. J. Natl. Cancer Inst., 71: 921-925, 1983.
14. Romney, S. L., Dwyer, A., Slagle, S., Duttagupta, C., Palan, P. R., Basu, J., Calderin, S., and Kadish A. Chemoprevention of cervix cancer: Phase 1-11: A feasibility study involving the topical vaginal administration of retinyl acetate gel. Gynecol. Oncol., 20: 109-119, 1985.
15. Weiner, S. A., Surwit, E. A., Graham, V. E., and Meyskens, F. L., Jr. A phase 1 trial of topically applied trans-retinoic acid in cervical dysplasia-clinical efficacy. Investig. New Drugs, 4: 241-244, 1986.
16. Meyskens, F. L., Jr., Surwit, E., Moon, T. E., Childers, J. M., Davis, J. R., Dorr, R. T., Johnson, C. S., and Alberts, D. S. Enhancement of regression of cervical intraepithelial neoplasia II (moderate dysplasia) with topically applied all-trans-retinoic acid: a randomized trial. J. Natl. Cancer Inst., 86: 539-543, 1994.
17. Follen, M., Atkinson, E. N., Schottenfeld, D., Malpica, A., West, L, Lippman, S., Zou, C., Hittelman, W. N., Lotan, R., and Hong, W. K. A randomized clinical trial of 4-hydroxyphenylretinamide for high-grade squamous intraepithelial lesions of the cervix. Clin. Cancer Res., 7: 3356-3365, 2001.
18. Oster, A. G. Natural history of cervical intraepithelial neoplasia: a critical review. Int. J. Gynecol. Pathol., 12: 186-192, 1993.
19. Mitchell, M. F., Hittelman, W. N., Hong, W. K., Lotan, R., and Schottenfeld, D. The natural history of cervical intraepithelial neoplasia: an argument for intermediate endpoint biomarkers. Cancer Epidemiol. Biomark. Prev., 3: 619-626, 1994.
20. Follen, M., Meyskens, F. L., Atkinson, E. N., and Schettenfeld, D. Why most randomized phase II cervical cancer chemoprevention trials are uninformative: lessons for the future. J. Natl. Cancer Inst., 93: 1293-1296, 2001.
21. Bacus, J. W., Bacus, J. V., Stoner, G. D., Moon, R. C., Kelloff, G. J., and Boone, C. W. Quantitation of preinvasive neoplastic progression in animal models of chemical carcinogenesis. J. Cell. Biochem., 28/29(Suppl.): 21-38, 1997.
22. Bacus, J. W., Boone, C. W., Bacus, J. V., Follen, M., Kelloff, G. J., Kagan, V., and Lippman, S. M. Image morphometric nuclear grading of intraepithelial neoplastic lesions with applications to cancer chemoprevention trials. Cancer Epidemiol. Biomark. Prev., 8: 1087-1094, 1999.