Preliminary results on safety and activity of a randomized, double-blind, 2 X 2 trial of low-dose tamoxifen and fenretinide for breast cancer prevention in premenopausal women

Journal of Clinical Oncology

Volumn 24, Issue 1, 2006, Pages 129-135

  Guerrieri Gonzaga, Aliana ^a   Robertson, Chris ^a   Bonanni, Bernardo ^a   Serrano, Davide ^a   Cazzaniga, Massimiliano ^a   Mora, Serena ^a   Gulisano, Marcella ^a   Johansson, Harriet ^a   Intra, Mattia ^a   Latronico, Antuono ^a   Franchi, Dorella ^a   Pelosi, Giuseppe ^a   Johnson, Karen ^a   Decensi, Andrea ^a  

^a EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

FENRETINIDE; PLACEBO; SOMATOMEDIN C; TAMOXIFEN; ANTINEOPLASTIC AGENT; RETINOL;

ADULT; ARTICLE; BREAST CANCER; CANCER PREVENTION; CANCER RISK; CARCINOMA IN SITU; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DEEP VEIN THROMBOSIS; DOUBLE BLIND PROCEDURE; DRUG ACTIVITY; DRUG SAFETY; ENDOMETRIUM CANCER; FEMALE; FOLLOW UP; HUMAN; ISCHEMIC OPTIC NEUROPATHY; LOW DRUG DOSE; LUNG CARCINOMA; OVARY CYST; PREMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; BLOOD; BREAST TUMOR; DRUG EFFECT; ENDOMETRIUM; MIDDLE AGED; PATHOLOGY;

ADULT; ANTINEOPLASTIC AGENTS; BREAST NEOPLASMS; DOUBLE-BLIND METHOD; ENDOMETRIUM; FEMALE; FENRETINIDE; HUMANS; INSULIN-LIKE GROWTH FACTOR I; MIDDLE AGED; PREMENOPAUSE; TAMOXIFEN; VITAMIN A;

EID: 33644839534     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2005.02.9934     Document Type: Article

References (47)

1. Fisher B, Costantino JP, Wickerham DL, et al: Tamoxifen for prevention of breast cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst 90:1371-1388, 1998
2. Early Breast Cancer Trialists' Collaborative Group: Tamoxifen for early breast cancer: An overview of the randomised trials. Lancet 351:1451-1467, 1998
3. Wickerham DL, Fisher B, Wolmark N, et al: Association of tamoxifen and uterine sarcoma. J Clin Oncol 20:2758-2760, 2002
4. Cuzick J, Forbes J, Edwards R, et al: First results from the International Breast Cancer Intervention Study (IBIS-I): A randomised prevention trial. Lancet 360:817-824, 2002
5. Rutqvist LE, Johansson H, Signomklao T, et al: Adjuvant tamoxifen therapy for early stage breast cancer and second primary malignancies: Stockholm Breast Cancer Study Group. J Natl Cancer Inst 87:645-651, 1995
6. Decensi A, Robertson C, Viale G, et al: A randomized trial of low-dose tamoxifen on breast cancer proliferation and blood estrogenic biomarkers. J Natl Cancer Inst 95:779-790, 2003
7. Decensi A, Serrano D, Bonanni B, et al: Breast cancer prevention trials using retinoids. J Mammary Gland Biol Neoplasia 8:19-30, 2003
8. Veronesi U, De Palo G, Marubini E, et al: Randomized trial of fenretinide to prevent second breast malignancy in women with early breast cancer. J Natl Cancer Inst 91:1847-1856, 1999
9. Torrisi R, Pensa F, Orengo MA, et al: The synthetic retinoid fenretinide lowers plasma insulin-like growth factor I levels in breast cancer patients. Cancer Res 53:4769-4771, 1993
10. Torrisi R, Parodi S, Fontana V, et al: Effect of fenretinide on plasma IGF-I and IGFBP-3 in early breast cancer patients. Int J Cancer 76:787-790, 1998
11. Decensi A, Veronesi U, Miceli R, et al: Relationships between plasma insulin-like growth factor-I and insulin-like growth factor binding protein-3 and second breast cancer risk in a prevention trial of fenretinide. Clin Cancer Res 9:4722-4729, 2003
12. Hankinson SE, Willett WC, Colditz GA, et al: Circulating concentrations of insulin-like growth factor-I and risk of breast cancer. Lancet 351:1393-1396, 1998
13. Toniolo P, Bruning PF, Akhmedkhanov A, et al: Serum insulin-like growth factor-I and breast cancer. Int J Cancer 88:828-832, 2000
14. Schernhammer ES, Holly JM, Pollak MN, et al: Circulating levels of insulin-like growth factors, their binding proteins, and breast cancer risk. Cancer Epidemiol Biomarkers Prev 14:699-704, 2005
15. Decensi A, Bonanni B, Guerrieri-Gonzaga A, et al: Biologic activity of tamoxifen at low doses in healthy women. J Natl Cancer Inst 90:1461-1467, 1998
16. Boyd NF, Byng JW, Jong RA, et al: Quantitative classification of mammographic densities and breast cancer risk: Results from the Canadian National Breast Screening Study. J Natl Cancer Inst 87:670-675, 1995
17. Byrne C, Schairer C, Wolfe J, et al: Mammographic features and breast cancer risk: Effects with time, age, and menopause status. J Natl Cancer Inst 87:1622-1629, 1995
18. Cuzick J, Warwick J, Pinney E, et al: Tamoxifen and breast density in women at increased risk of breast cancer. J Natl Cancer Inst 96:621-628, 2004
19. O'Shaughnessy JA, Kelloff GJ, Gordon GB, et al: Treatment and prevention of intraepithelial neoplasia: An important target for accelerated new agent development. Clin Cancer Res 8:314-346, 2002
20. Zujewski J, Pai L, Wakefield L, et al: Tamoxifen and fenretinide in women with metastatic breast cancer. Breast Cancer Res Treat 57:277-283, 1999
21. Conley B, O'Shaughnessy J, Prindiville S, et al: Pilot trial of the safety, tolerability, and retinoid levels of N-(4-hydroxyphenyl) retinamide in combination with tamoxifen in patients at high risk for developing invasive breast cancer. J Clin Oncol 18:275-283, 2000
22. Singletary SE, Atkinson EN, Hoque A, et al: Phase II clinical trial of N-(4-Hydroxyphenyl) retinamide and tamoxifen administration before definitive surgery for breast neoplasia. Clin Cancer Res 8:2835-2842, 2002
23. Formelli F, Clerici M, Campa T, et al: Five-year administration of fenretinide: Pharmacokinetics and effects on plasma retinol concentrations. J Clin Oncol 11:2036-2042, 1993
24. Hilditch JR, Lewis J, Peter A, et al: A menopause-specific quality of life questionnaire: Development and psychometric properties. Maturitas 24:161-175, 1996
25. Goldstein SR, Scheele WH, Rajagopalan SK, et al: A 12-month comparative study of raloxifene, estrogen, and placebo on the postmenopausal endometrium. Obstet Gynecol 95:95-103, 2000
26. McCormick DL, Mehta RG, Thompson CA, et al: Enhanced inhibition of mammary carcinogenesis by combined treatment with N-(4-hydroxyphenyl)retinamide and ovariectomy. Cancer Res 42:508-512, 1982
27. McCormick DL, Moon RC: Retinoid-tamoxifen interaction in mammary cancer chemoprevention. Carcinogenesis 7:193-196, 1986
28. Moon RC, Kelloff GJ, Detrisac CJ, et al: Chemoprevention of MNU-induced mammary tumors in the mature rat by 4-HPR and tamoxifen. Anticancer Res 12:1147-1153, 1992
29. Ratko TA, Detrisac CJ, Dinger NM, et al: Chemopreventive efficacy of combined retinoid and tamoxifen treatment following surgical excision of a primary mammary cancer in female rats. Cancer Res 49:4472-4476, 1989
30. Zujewski J, Lawrence J, Lemon S, et al: Pilot trial of tamoxifen (tam) and fenretinide (4-HPR) in women at high risk of developing invasive breast cancer. Proc Am Assoc Cancer Res 38:46, 1997 (abstr 1763)
31. Cobleigh MA, Gray R, Graham M, et al: Fenretinide (FEN) vs placebo in postmenopausal breast cancer patients receiving adjuvant tamoxifen (TAM): An Eastern Cooperative Oncology Group phase III intergroup trial (EB193, INT-0151). Proc Am Soc Clin Oncol 19:86a, 2000 (abstr 328)
32. Chalas E, Costantino JP, Wickerham DL, et al: Benign gynecologic conditions among participants in the Breast Cancer Prevention Trial. Am J Obstet Gynecol 192:1230-1237, 2005
33. Veronesi U, Maisonneuve P, Costa A, et al: Drop-outs in tamoxifen prevention trials. Lancet 353:244, 1999
34. Day R, Ganz PA, Costantino JP, et al: Health-related quality of life and tamoxifen in breast cancer prevention: A report from the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Clin Oncol 17:2659-2669, 1999
35. Powles T, Eeles R, Ashley S, et al: Interim analysis of the incidence of breast cancer in the Royal Marsden Hospital tamoxifen randomised chemoprevention trial. Lancet 352:98-101, 1998
36. Gerber B, Krause A, Muller H, et al: Effects of adjuvant tamoxifen on the endometrium in postmenopausal women with breast cancer: A prospective long-term study using transvaginal ultrasound. J Clin Oncol 18:3464-3470, 2000
37. Cohen I, Perel E, Tepper R, et al: Dose-dependent effect of tamoxifen therapy on endometrial pathologies in postmenopausal breast cancer patients. Breast Cancer Res Treat 53:255-262, 1999
38. Decensi A, Fontana V, Bruno S, et al: Effect of tamoxifen on endometrial proliferation. J Clin Oncol 14:434-440, 1996
39. Mourits MJ, de Vries EG, Willemse PH, et al: Ovarian cysts in women receiving tamoxifen for breast cancer. Br J Cancer 79:1761-1764, 1999
40. Jordan VC, Fritz NF, Langan-Fahey S, et al: Alteration of endocrine parameters in premenopausal women with breast cancer during long-term adjuvant therapy with tamoxifen as the single agent. J Natl Cancer Inst 83:1488-1491, 1991
41. Fung MF, Reid A, Faught W, et al: Prospective longitudinal study of ultrasound screening for endometrial abnormalities in women with breast cancer receiving tamoxifen. Gynecol Oncol 91:154-159, 2003
42. Cohen I, Azaria R, Bernheim J, et al: Risk factors of endometrial polyps resected from postmenopausal patients with breast carcinoma treated with tamoxifen. Cancer 92:1151-1155, 2001
43. Ciolino HP, Wang TT, Sathyamoorthy N: Inhibition of aromatase activity and expression in MCF-7 cells by the chemopreventive retinoid N-(4-hydroxyphenyl)-retinamide. Br J Cancer 83:333-337, 2000
44. Broaddus RR, Xie S, Hsu CJ, et al: The chemopreventive agents 4-HPR and DFMO inhibit growth and induce apoptosis in uterine leiomyomas. Am J Obstet Gynecol 190:686-692, 2004
45. Aranda A, Pascual A: Nuclear hormone receptors and gene expression. Physiol Rev 81:1269-1304, 2001
46. Decensi A, Johansson H, Miceli R, 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 10:1047-1053, 2001
47. Fisher B, Dignam J, Wolmark N, et al: Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial. Lancet 353:1993-2000, 1999