Luteinizing hormone-releasing hormone agonists in premenopausal hormone receptor-positive breast cancer

Clinical Breast Cancer

Volumn 7, Issue 6, 2007, Pages 455-464

  Tan, Sing Huang ^a   Wolff, Antonio C ^b  

^a NATIONAL UNIVERSITY HOSPITAL   (Singapore)

^b JOHNS HOPKINS UNIVERSITY   (United States)

Author keywords

Aromatase inhibitors; Gonadotrophins; Leuprolide; Oophorectomy; Tamoxifen

Indexed keywords

ABARELIX; ACYLINE; ANASTROZOLE; ANTIESTROGEN; ANTINEOPLASTIC AGENT; AROMATASE INHIBITOR; BUSERELIN; CETRORELIX; CYCLOPHOSPHAMIDE; DEGARELIX; DOXORUBICIN; EPIRUBICIN; FLUOROURACIL; FORMESTANE; GANIRELIX; GONADORELIN AGONIST; GONADORELIN ANTAGONIST; GOSERELIN; ITURELIX; LEUPRORELIN; METHOTREXATE; NAFARELIN; ORNTIDE; POLYGLACTIN; TAMOXIFEN; TEVERELIX; TRIPTORELIN; UNCLASSIFIED DRUG; VOROZOLE; ZOLEDRONIC ACID;

ADJUVANT THERAPY; AMENORRHEA; BONE ATROPHY; BREAST CANCER; CANCER ADJUVANT THERAPY; CANCER MORTALITY; CANCER RECURRENCE; CANCER SURVIVAL; CARDIOVASCULAR DISEASE; CLINICAL TRIAL; COMBINATION CHEMOTHERAPY; CONTROLLED CLINICAL TRIAL; DRUG APPROVAL; DRUG CONTRAINDICATION; DRUG DOSE COMPARISON; DRUG EFFICACY; DRUG EXCRETION; DRUG FORMULATION; DRUG INDICATION; DRUG MECHANISM; DRUG SUBSTITUTION; DRUG WITHDRAWAL; FERTILIZATION IN VITRO; FOOD AND DRUG ADMINISTRATION; GONADOTROPIN RELEASE; GYNECOLOGIC DISEASE; HOT FLUSH; HUMAN; LIBIDO DISORDER; MENTAL INSTABILITY; META ANALYSIS; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; OVARIECTOMY; OVARY FUNCTION; PREMENOPAUSE; PROSTATE CANCER; RANDOMIZED CONTROLLED TRIAL; RECEPTOR DOWN REGULATION; REVIEW; SYSTEMATIC REVIEW; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; URINARY TRACT DISEASE;

EID: 33947258448     PISSN: 15268209     EISSN: None     Source Type: Journal    
DOI: 10.3816/CBC.2007.n.002     Document Type: Review

References (93)

1. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2006. CA Cancer J Clin 2006; 56:106-130.
2. American Cancer Society, Breast Cancer Facts and Figures, 2005-2006.
3. Walker RA, Lees E, Webb MB, et al. Breast carcinomas occurring in young women (< 35 years) are different. Br J Cancer 1996; 74:1796-1800.
4. Dowsett M. Estrogen receptor: methodology matters. J Clin Oncol 2006; 24:5626-5628.
5. Beatson G. On the treatment of inoperable cases of carcinoma of the mamma: suggestions for a new method of treatment with illustrative cases. Lancet 1896; ii:104-107.
6. Beatson G. The treatment of inoperable carcinoma of the female mamma. Glasgow Med J 1911; 76:81.
7. Lett H. An analysis of 99 cases of inoperable carcinoma of the breast treated by oophorectomy. Lancet 1905; i:227-228.
8. Paterson R, Russell MH. Clinical trials in malignant disease. Breast cancer: value of irradiation of the ovaries. J Faculty Radiologists 1959, 10:130-133.
9. Karten MJ, Rivier JE. Gonadotropin-releasing hormone analog design. Structure-function studies toward the development of agonists and antagonists: rationale and perspective. Endocrine Rev 1986; 7:44-66.
10. Weckermann D, Harzmann R. Hormone therapy in prostate cancer: LHRH antagonists versus LHRH analogues. Eur Urol 2004; 46:279-284.
11. Kiesel LA, Rody A, Greb RR, et al. Clinical use of GnRH analogues. Clin Endocrinol 2002; 56:677-687.
12. Naor Z, Shacham S, Harris D, et al. Signal transduction of the gonadotropin releasing hormone (GnRH) receptor: cross-talk of calcium, protein kinase C (PKC), and arachidonic acid. Cell Mol Neurobiol 1995;15:527-544.
13. Porter RN, Smith W, Craft IL, et al. Induction of ovulation for in-vitro fertilisation using buserelin and gonadotropins. Lancet 1984; 2:1284-1285.
14. Crowley WF Jr, McArthur JW. Simulation of the normal menstrual cycle in Kallman's syndrome by pulsatile administration of luteinizing hormone-releasing hormone (LHRH). J Clin Endocrinol Metab 1980; 51:173-175.
15. Skarin G, Nillius SJ, Wibell L, et al. Chronic pulsatile low dose GnRH therapy for induction of testosterone production and spermatogenesis in a man with secondary hypogonadotropic hypogonadism. J Clin Endocrinol Metab 1982; 55:723-726.
16. Herbst KL. Gonadotropin-releasing hormone antagonists. Curr Opin Pharmacol 2003; 3:660-666.
17. Lindner CH, Braendle W, Bettendorf G. Endocrine profiles during GnRH-agonist therapy using different application forms. Proceedings of the 13th World Congress of Gynecology and Obstetrics 1991. Abstract #1491.
18. Rossmanith WG, Wirth U, Sasse V et al. Treatment with different GnRH analogues in women: preliminary evidence for disparant effects on serum androgen concentrations. Horm Metab Res 1991; 23:198-199.
19. Parinaud J, Oustry P, Perineau M, et al. Randomized trial of three luteinizing hormone-releasing hormone analogues used for ovarian stimulation in an in vitro fertilization program. Fertil Steril 1992; 57:1265-1268.
20. Filicori M, Flamigni C, Cognigni G, et al. Comparison of the suppressive capacity of different depot gonadotropin-releasing hormone analogs in women. J Clin Endocrinol Metab 1993; 77:130-133.
21. Perren TJ, Clayton RN, Blackledge G, et al. Pharmacokinetic and endocrinological parameters of a slow-release depot preparation of the GnRH analogue ICI 118630 (Zoladex) compared with a subcutaneous bolus and continuous subcutaneous infusion of the same drug in patients with prostatic cancer. Cancer Chemother Pharmacol 1986;18:39-43.
22. Kotake T, Usami M, Sonoda T, et al. LH-RH agonist, Zoladex (goserelin), depot formulation in the treatment of prostatic cancer. Randomized dose-finding trial in Japan. Am J Clin Oncol 1988; 11(2 suppl):S108-S111.
23. Clayton RN, Bailey LC, Cottam J, et al. A radioimmunoassay for GnRH agonist analogue in serum of patients with prostate cancer treated with D-Ser (tBu)6 AZA Gly10 GnRH. Clin Endocrinol 1985; 22:453-462.
24. Ezan E, Drieu K, Chapelat M, et al. Radioimmunoassay of [D-Trp6]-luteinizing hormone-releasing hormone: its application to animal pharmacokinetic studies after single injection and long-acting formulation administration. Regul Pept 1986; 14:155-167.
25. Ogawa Y, Yamamoto M, Takada S, et al. Controlled-release of leuprolide acetate from polylactic acid or copoly(lactic/glycolic) acid microcapsules: influence of molecular weight and copolymer ratio of polymer. Chem Pharm Bull 1988; 36:1502-1507.
26. Filicori M. Gonadotrophin-releasing hormone agonists. A guide to use and selection. Drugs 1994; 48:41-58.
27. Klijn JG. LH-RH agonists in the treatment of metastatic breast cancer: ten years' experience and recent results. Cancer Res 1992; 124:75-90.
28. Boccardo F, Rubagotti A, Amoroso D, et al. Endocrinological and clinical evaluation of two depot formulations of leuprolide acetate in pre- and perimenopausal breast cancer patients. Cancer Chemother Pharmacol 1999; 43:461-466.
29. Dowsett M, Jacobs S, Aherne J, et al. Clinical and endocrine effects of leuprorelin acetate in pre- and postmenopausal patients with advanced breast cancer. Clin Ther 1992; 14(A suppl):97-103.
30. Zoladex 10.8mg [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2005.
31. Buchanan RB, Blamey RW, Durrant KR, et al. A randomized comparison of tamoxifen with surgical oophorectomy in premenopausal patients with advanced breast cancer. J Clin Oncol 1986; 4:1326-1330.
32. Veronesi U, Pizzocaro G, Rossi A. Oophorectomy for advanced carcinoma of the breast. Surg Gynecol Obstet 1975; 141:569-570.
33. Puga FJ, Welch JS, Bisel HF. Therapeutic oophorectomy in disseminated carcinoma of the breast. Arch Surg 1976; 111:877-880.
34. Blamey RW, Jonat W, Kaufmann M, et al. Goserelin depot in the treatment of premenopausal advanced breast cancer. Eur J Cancer 1992; 28A:810-814.
35. Lissoni P, Barni S, Crispino S, et al. Endocrine and clinical effects of an LHRH analogue in pretreated advanced breast cancer. Tumori 1988; 74:303-308.
36. Klijn JG. Long-term LHRH-agonist treatment in metastatic breast cancer as a single treatment and in combination with other additive endocrine treatments. Med Oncol Tumor Pharmacother 1984; 1:123-128.
37. Klijn JG, de Jong FH, Lamberts SW, et al. LHRH-agonist treatment in clinical and experimental human breast cancer. J Steroid Biochem 1985; 23:867-873.
38. Untch M. Primary endocrine therapy as pre- and perimenopausal metastatic breast carcinoma with leuprorelin acetate depot. German Leuprorelin Study Group [in German]. Zentralbl Gynakol 1998; 120:284-292.
39. Dowsett M, Mehta A, Mansi J, et al. A dose-comparative endocrine-clinical study of leuprorelin in premenopausal breast cancer patients. Br J Cancer 1990; 62:834-837.
40. Harvey HA, Lipton A, Max DT, et al. Medical castration produced by the GnRH analogue leuprolide to treat metastatic breast cancer. J Clin Oncol 1985; 3:1068-1072.
41. Neskovic-Konstantinovic ZB, Vuletic LB, Nikolic-Stanojevic LI, et al. Therapeutic and endocrine effects of Decapeptyl, synthetic LH-RH agonistic analogue in premenopausal women with metastatic breast cancer. A pilot phase II study. Oncology 1994; 51:95-101.
42. Garcia-Giralt E, Beuzeboc P, Dieras V, et al. Phase II trial of decapeptyl (D-TRP-6), a potent luteinizing hormone-releasing hormone analogue in untreated advanced breast cancer. Am J Clin Oncol 1996; 19:455-458.
43. Doberauer C, Niederle N, Schmidt CG. Advanced male breast cancer treatment with the LH-RH analogue buserelin alone or in combination with the antiandrogen flutamide. Cancer 1988; 62:474-478.
44. Vorobiof DA, Falkson G. Nasally administered buserelin inducing complete remission of lung metastases in male breast cancer. Cancer 1987; 59:688-689.
45. Boccardo F, Rubagotti A, Perrotta A, et al. Ovarian ablation versus goserelin with or without tamoxifen in pre-perimenopausal patients with advanced breast cancer: results of a multicentric Italian study. Ann Oncol 1994; 5:337-342.
46. Taylor CW, Green S, Dalton WS, et al. Multicenter randomized clinical trial of goserelin versus surgical ovariectomy in premenopausal patients with receptor-positive metastatic breast cancer: an Intergroup study. J Clin Oncol 1998; 16:994-999.
47. Crump M, Sawka CA, DeBoer G, et al. An individual patient-based meta-analysis of tamoxifen versus ovarian ablation as first line endocrine therapy for premenopausal women with metastatic breast cancer. Breast Cancer Res Treat 1997; 44:201-210.
48. Klijn JG, Blamey RW, Boccardo F, et al. Combined tamoxifen and luteinizing hormone-releasing hormone (LHRH) agonist versus LHRH agonist alone in premenopausal advanced breast cancer: a meta-analysis of four randomized trials. J Clin Oncol 2001; 19:343-353.
49. Klijn JG, Beex LV, Mauriac L, et al. Combined treatment with buserelin and tamoxifen in premenopausal metastatic breast cancer: a randomized study. J Natl Cancer Inst 2000; 92:903-911.
50. Smith IE, Dowsett M, Yap YS, et al. Adjuvant aromatase inhibitors for early breast cancer after chemotherapy-induced amenorrhoea: caution and suggested guidelines. J Clin Oncol 2006; 24:2444-2447.
51. Stein RC, Dowsett M, Hedley A, et al. The clinical and endocrine effects of 4-hydroxyandrostenedione alone and in combination with goserelin in premenopausal women with advanced breast cancer. Br J Cancer 1990; 62:679-683.
52. Dowsett M, Stein RC, Coombes RC. Aromatization inhibition alone or in combination with GnRH agonists for the treatment of premenopausal breast cancer patients. J Steroid Biochem Mol Biol 1992; 43:155-159.
53. Dowsett M, Doody D, Miall S, et al. Vorozole results in greater oestrogen suppression than formestane in postmenopausal women and when added to goserelin in premenopausal women with advanced breast cancer. Breast Cancer Res Treat 1999; 56:25-34.
54. Celio L, Martinetti A, Ferrari L, et al. Premenopausal breast cancer patients treated with a gonadotropin-releasing hormone analog alone or in combination with an aromatase inhibitor: a comparative endocrine study. Anticancer Res 1999; 19:2261-2268.
55. Forward DP, Cheung KL, Jackson L, et al. Clinical and endocrine data for goserelin plus anastrozole as second-line endocrine therapy for premenopausal advanced breast cancer. Br J Cancer 2004; 90:590-594.
56. Gnant MF, Mlineritsch B, Luschin-Ebengreuth G, et al. Zoledronic acid effectively prevents cancer treatment-induced bone loss in premenopausal women receiving adjuvant endocrine therapy for hormone-responsive breast cancer: a report from the Austrian Breast and Colorectal Cancer Study Group. J Clin Oncol 2007. [Epub ahead of print].
57. Giordano SH, Hortobagyi GN. Leuprolide acetate plus aromatase inhibition for male breast cancer. J Clin Oncol 2006; 24:42-43.
58. Early Breast Cancer Trialists' Collaborative Group. Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy. 133 randomised trials involving 31,000 recurrences and 24,000 deaths among 75,000 women. Lancet 1992; 339:71-85.
59. Early Breast Cancer Trialists' Collaborative Group. Ovarian ablation in early breast cancer: overview of the randomised trials. Lancet 1996; 348:1189-1196.
60. Early Breast Cancer Trialists' Cooperative Group. Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005; 365:1687-1717.
61. Jonat W, Kaufmann M, Sauerbrei W, et al. Goserelin versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy in premenopausal patients with node-positive breast cancer: the Zoladex Early Breast Cancer Research Association Study. J Clin Oncol 2002; 20:4628-4635.
62. Schmid P, Untch M, Wallwiener D, et al. Cyclophosphamide, methotrexate and fluorouracil (CMF) versus hormonal ablation with leuprorelin acetate as adjuvant treatment of node-positive, premenopausal breast cancer patients: preliminary results of the TABLE-study (Takeda Adjuvant Breast cancer study with Leuprorelin Acetate). Anticancer Res 2002; 22:2325-2332.
63. von Minckwitz G, Graf E, Geberth M, et al. CMF versus goserelin as adjuvant therapy for node-negative, hormone-receptor-positive breast cancer in premenopausal patients: a randomised trial (GABG trial IV-A-93). Eur J Cancer 2006; 42:1780-1788.
64. Castiglione-Gertsch M, O'Neill A, Price KN, et al. Adjuvant chemotherapy followed by goserelin versus either modality alone for premenopausal lymph node-negative breast cancer: a randomized trial. J Natl Cancer Inst 2003; 95:1833-1846.
65. Boccardo F, Rubagotti A, Amoroso D, et al. Cyclophosphamide, methotrexate, and fluorouracil versus tamoxifen plus ovarian suppression as adjuvant treatment of estrogen receptor-positive pre-/perimenopausal breast cancer patients: results of the Italian Breast Cancer Adjuvant Study Group 02 randomized trial. J Clin Oncol 2000; 18:2718-2727.
66. Jakesz R, Hausmaninger H, Kubista E, et al. Randomized adjuvant trial of tamoxifen and goserelin versus cyclophosphamide, methotrexate, and fluorouracil: evidence for the superiority of treatment with endocrine blockade in premenopausal patients with hormone-responsive breast cancer - Austrian Breast and Colorectal Cancer Study Group Trial 5. J Clin Oncol 2002; 20:4621-4627.
67. Roche H, Kerbrat P, Bonneterre J, et al. Complete hormonal blockade versus epirubicin-based chemotherapy in premenopausal, one to three node-positive, and hormone-receptor positive, early breast cancer patients: 7-year follow-up results of French Adjuvant Study Group 06 randomized trial. Ann Oncol 2006; 17:1221-1227.
68. De Matteis A, Montedoro D, Nuzzo F, et al. Hormonotherapy with goserelin depot after adjuvant chemotherapy in premenopausal women with early breast cancer: is there any benefit? Eur J Cancer 1998; 34(5 suppl):44-47.
69. Arriagada R, Le MG, Spielmann M, et al. Randomized trial of adjuvant ovarian suppression in 926 premenopausal patients with early breast cancer treated with adjuvant chemotherapy. Ann Oncol 2005; 16:389-396.
70. Davidson NE, O'Neill AM, Vukov AM, et al. Chemoendocrine therapy for premenopausal women with axillary lymph node-positive, steroid hormone receptor-positive breast cancer: results from INT 0101 (E5188). J Clin Oncol 2005; 23:5973-5982.
71. De Placido S, De Laurentiis M, De Lena M, et al. A randomised factorial trial of sequential doxorubicin and CMF vs CMF and chemotherapy alone vs chemotherapy followed by goserelin plus tamoxifen as adjuvant treatment of node-positive breast cancer. Br J Cancer 2005; 92:467-474.
72. Baum M, Hackshaw A, Houghton J, et al. Adjuvant goserelin in premenopausal patients with early breast cancer: results from the ZIPP study. Eur J Cancer 2006; 42:895-904.
73. Rutqvist LE. Zoladex and tamoxifen as adjuvant therapy in premenopausal breast cancer:a randomised trial by the Cancer Research Campaign(CRC) Breast Cancer Trials Group, the Stockholm Breast Cancer Study Group, the South-East Sweden Breast Cancer Group and the Gruppo Interdisciplinare Valutazione Interventi in Oncologia(G. I.V.I.O). Proc Am Soc Clin Oncol 1999; 18:67a (Abstract #251).
74. Soreide JA, Varhaug JE, Fjosne HE, et al. Adjuvant endocrine treatment (goserelin vs tamoxifen) in pre-menopausal patients with operable node positive stage II breast cancer. A prospective randomized national multicenter study. Eur J Surg Oncol 2002; 28:505-510.
75. Robert NJ, Wang M, Cella D, et al. Phase III comparison of tamoxifen versus tamoxifen with ovarian ablation in premenopausal women with axillary node-negative receptor-positive breast cancer less than or equal to 3 cm. Proc Am Soc Clin Oncol 2003; 22:5 (Abstract #16).
76. International Breast Cancer Study Group. Randomized controlled trial of ovarian function suppression plus tamoxifen versus the same endocrine therapy plus chemotherapy: is chemotherapy necessary for premenopausal women with node-positive, endocrine-responsive breast cancer? First results of International Breast Cancer Study Group Trial 11-93. Breast 2001; 10(3 suppl):130-138.
77. Pagani O, O'Neill A, Castiglione M, et al. Prognostic impact of amenorrhoea after adjuvant chemotherapy in premenopausal breast cancer patients with axillary node involvement: results of the International Breast Cancer Study Group (IBCSG) Trial VI. Eur J Cancer 1998; 34:632-640.
78. Bianco AR, Del Mastro L, Gallo C, et al. Prognostic role of amenorrhea induced by adjuvant chemotherapy in premenopausal patients with early breast cancer. Br J Cancer 1991; 63:799-803.
79. Goldhirsch A, Gelber RD, Yothers G, et al. Adjuvant therapy for very young women with breast cancer: need for tailored treatments. J Natl Cancer Inst Monogr 2001; 30:44-51.
80. Petrek JA, Naughton MJ, Case LD, et al. Incidence, time course, and determinants of menstrual bleeding after breast cancer treatment: a prospective study. J Clin Oncol 2006; 24:1045-1051.
81. Cuzick J, on behalf of the LHRH-Agonist Overview Group. Wolfson Institute of Preventive Medicine, London, United Kingdom. The impact of LHRH agonists on breast cancer recurrence and mortality: an overview of the randomized trials. Breast Cancer Res Treat 2006; 100(1 suppl):S10 (Abstract #15).
82. Goldhirsch A, Glick JH, Gelber RD, et al. Meeting highlights: international expert consensus on the primary therapy of early breast cancer 2005. Ann Oncol 2005; 16:1569-1583.
83. Carlson RW, Brown E, Burstein HJ, et al. NCCN Task Force report: adjuvant therapy for breast cancer. J Natl Compr Canc Netw 2006; 4(1 suppl):S1-26.
84. Bernhard J, Zahrieh D, Castiglione-Gertsch M, et al. Impact of adjuvant chemotherapy followed by goserelin compared with either modality alone on amenorrhea, hot flashes, and quality of life in premenopausal patients with lymph node-negative breast cancer: results on the effect of age from the International Breast Cancer Study Group. J Clin Oncol 2006; 25:263-270.
85. de Haes H, Olschewski M, Kaufmann M, et al. Quality of life in goserelin-treated versus cyclophosphamide + methotrexate + fluorouracil-treated premenopausal and perimenopausal patients with node-positive, early breast cancer: the Zoladex Early Breast Cancer Research Association Trialists Group. J Clin Oncol 2003; 21:4510-4516.
86. Hillner BE, Ingle JN, Chlebowski RT, et al. American Society of Clinical Oncology 2003 update on the role of bisphosphonates and bone health issues in women with breast cancer. J Clin Oncol 2003; 21:4042-4057.
87. Jaschke A, Bastert G, Solomayer EF, et al. Adjuvant clodronate treatment improves the overall survival of primary breast cancer patients with micrometastases to bone marrow- a longtime follow-up. J Clin Oncol 2004; 22(14 suppl):529.
88. Powles T, McCloskey E, Kurkilahti M. Oral clodronate for adjuvant treatment of operable breast cancer: results of a randomized, double-blind, placebo-controlled multicenter trial. J Clin Oncol 2004; 22 (14 suppl):528.
89. Saarto T, Vehmanen L, Blomqvist C, et al. Ten-year follow-up of a randomized controlled trial of adjuvant clodronate treatment in node-positive breast cancer patients. J Clin Oncol 2004; 22(14 suppl):527.
90. Delmas PD, Balena R, Confravreux E, et al. Bisphosphonate risedronate prevents bone loss in women with artificial menopause due to chemotherapy of breast cancer: a double-blind, placebo-controlled study. J Clin Oncol 1997; 15:955-962.
91. Hughes LL, Gray RJ, Solin LJ, et al. Efficacy of radiotherapy for ovarian ablation: results of a breast intergroup study. Cancer 2004; 101:969-972.
92. Featherstone CJ, Harnett AN, Brunt AM, et al. Methods of ovarian suppression used in the UK. Breast 2002; 11:23-29.
93. Love RR, Due NB, Allred DC, et al. Oophorectomy and tamoxifen adjuvant therapy in premenopausal Vietnamese and Chinese women with operable breast cancer. J Clin Oncol 2002; 20:2559-2566.