Combined treatment with buserelin and tamoxifen in premenopausal metastatic breast cancer: A randomized study

Journal of the National Cancer Institute

Volumn 92, Issue 11, 2000, Pages 903-911

  Klijn, Jan G M ^j   Beex, Louk V A M ^a   Mauriac, Louis ^b   Van Zijl, Jacobus A ^c   Veyret, Corinne ^d   Wildiers, Johan ^e   Jassem, Jacek ^e   Piccart, Martine ^f   Burghouts, Jos ^g   Becquart, Dominique ^h   Seynaeve, Carolien ^e   Mignolet, Françoise ⁱ   Duchateau, Luc ⁱ  

^a RADBOUD UNIVERSITY MEDICAL CENTER   (Netherlands)

^b INSTITUT BERGONIÉ   (France)

^c STELLENBOSCH UNIVERSITY   (South Africa)

^d CENTRE HENRI BECQUEREL   (France)

^e UZ St Rafael ^*

^f JULES BORDET INSTITUTE   (Belgium)

^g JEROEN BOSCH HOSPITAL   (Netherlands)

^h MIDDELHEIM HOSPITAL   (Belgium)

ⁱ EORTC DATA CENTER   (Belgium)

^j ERASMUS MC CANCER INSTITUTE   (Netherlands)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ANTIESTROGEN; BUSERELIN; ESTRADIOL; ESTROGEN RECEPTOR; GONADORELIN AGONIST; PROGESTERONE RECEPTOR; TAMOXIFEN;

ADULT; ANTINEOPLASTIC ACTIVITY; ARTICLE; BREAST CANCER; CANCER HORMONE THERAPY; CANCER SURVIVAL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG EFFECT; ESTRADIOL BLOOD LEVEL; FEMALE; HUMAN; HUMAN TISSUE; MAJOR CLINICAL STUDY; MULTICENTER STUDY; PREMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SURVIVAL TIME;

EID: 0034616656     PISSN: 00278874     EISSN: None     Source Type: Journal    
DOI: 10.1093/jnci/92.11.903     Document Type: Article

References (56)

1. Clarke R, Dickson RB, Lippman ME. Hormonal aspects of breast cancer. Growth factors, drugs and stromal interactions. Crit Rev Oncol Hematol 1992;12:1-23.
2. Klijn JG, Berns PM, Bontenbal M, Alexieva-Figusch J, Foekens JA. Clinical breast cancer, new developments in selection and endocrine treatment of patients. J Steroid Biochem Mol Biol 1992;43:211-21.
3. Lonning PE, Helle SI, Frost VJ, Holly JM, Hall K. Alterations in plasma IGF-1 caused by hormone manipulation; of relevance to the mechanism of action and acquired resistance to endocrine treatment in breast cancer? Endocrine Related Cancer 1995;2;127-30.
4. Bontenbal M, Foekens JA, Lamberts SW, de Jong FH, van Putten WL, Braun HJ, et al. Feasibility, endocrine and anti-tumour effects of a triple endocrine therapy with tamoxifen, a somatostatin analogue and an antiprolactin in post-menopausal metastatic breast cancer: a randomized study with long-term follow-up. Br J Cancer 1998;77:115-22.
5. Santen RJ, Manni A, Harvey H, Redmond C. Endocrine treatment of breast cancer in women. Endocr Rev 1990;11:221-65.
6. Wong K, Henderson IC. Management of metastatic breast cancer. World J Surg 1994;18:98-111.
7. Howell A, Dowsett M. Recent advances in endocrine therapy of breast cancer. BMJ 1997;315:863-6.
8. Buzdar AU, Hortobagyi G. Update on endocrine therapy for breast cancer. Clin Cancer Res 1998;4:527-34.
9. Osborne CK. Tamoxifen in the treatment of breast cancer. N Engl J Med 1998;339:1609-18.
10. Fossati R, Confalonieri C, Torri V, Ghislandi E, Penna A, Pistotti V, et. al. Cytotoxic and hormonal treatment for metastatic breast cancer: a systematic review of published randomized trials involving 31,510 women. J Clin Oncol 1998;16:3439-60.
11. Beatson AT. On the treatment of inoperable cases of carcinoma mamma: suggestions for a new method of treatment with illustrative cases. Lancet 1896;2:104-17.
12. DeSombre ER, Johnson ES, White WF. Regression of rat mammary tumors effected by a gonadoliberin analog. Cancer Res 1976;36:3830-3.
13. Klijn JG, de Jong FH. Treatment with a luteinising-hormone-releasing-hormone analogue (buserelin) in premenopausal patients with metastatic breast cancer. Lancet 1982;1:1213-6.
14. Klijn JG. LHRH analogs in the treatment of metastatic breast cancer: ten years' experience. In: Hoffken K, editor. Peptides in oncology: LHRH agonists and antagonists. Berlin (Germany): Springer-Verlag; 1992. p. 75-90.
15. Foekens JA, Klijn JG. Direct antitumor effects of LHRH analogs. In: Hoffken K, editor. Peptides in oncology: LHRH agonists and antagonists. Berlin (Germany): Springer-Verlag; 1992. p. 7-17.
16. Kaufmann M, Jonat W, Kleeberg U, Eiermann W, Janicke F, Hilfrich J, et al. Goserelin, a depot gonadotrophin-releasing hormone agonist in the treatment of premenopausal patients with metastatic breast cancer. German Zoladex Trial Group. J Clin Oncol 1989;7:1113-9.
17. Klijn JG, van Geel AN, de Jong FH, Sandow J, Krauss B. The relation between pharmacokinetics and endocrine effects of buserelin implants in patients with mastalgia. Clin Endocrinol (Oxf) 1991;34:253-8.
18. Blamey RW, Jonat W, Kaufmann M, Bianco AR, Namer M. Goserelin depot in the treatment of premenopausal advanced breast cancer. Eur J Cancer 1992;28A:810-4.
19. Taylor CW, Green S, Dalton WS, Martino S, Rector D, Ingle JN, 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;16:994-9.
20. Manni A, Pearson OH. Antiestrogen-induced remissions in premenopausal women with stage IV breast cancer: effects on ovarian function. Cancer Treat Rep 1980;64:779-85.
21. Sunderland MC, Osborne CK. Tamoxifen in premenopausal patients with metastatic breast cancer: a review. J Clin Oncol 1991;9:1283-97.
22. Ingle JN, Krook JE, Green SJ, Kubista TP, Everson LK, Ahmann DL, et al. Randomized trial of bilateral oophorectomy versus tamoxifen in premenopausal women with metastatic breast cancer. J Clin Oncol 1986;4:178-85.
23. Buchanan RB, Blarney RW, Durrant KR, Howell A, Paterson AG, Preece PE, et al. A randomized comparison of tamoxifen with surgical oophorectomy in premenopausal patients with advanced breast cancer. J Clin Oncol 1986;4:1326-30.
24. Masamura S, Santner SJ, Heitjan DF, Santen RJ. Estrogen deprivation causes estradiol hypersensitivity in human breast cancer cells. J Clin Endocrinol Metab 1995;80:2918-25.
25. Klijn JG, de Jong FH, Blankenstein MA, Docter R, Alexieva-Figusch J, Blonk-van der Wijst J, et al. Anti-tumor and endocrine effects of chronic LHRH agonist treatment (Buserelin) with or without tumoxifen in premenopausal metastatic breast cancer. Breast Cancer Res Treat 1984;4: 209-20.
26. Klijn JG, Foekens JA. Long-term peptide hormone treatment with LHRH agonist in metastatic breast cancer. In: Santen RJ, Juhos E, editors. Endocrine-dependent breast cancer: critical assessment of recent advances. Bern (Switzerland): Hans Huber Publishers; 1988. p. 92-103.
27. Robertson JF, Walker KJ, Nicholson RI, Blamey RW. Combined endocrine effects of LHRH agonist (Zoladex) and tamoxifen (Nolvadex) therapy in premenopausal women with breast cancer. Br J Surg 1989;76:1262-5.
28. Walker KJ, Walker RF, Turkes A, Robertson JF, Blarney RW, Griffiths K, et al. Endocrine effects of combination antioestrogen and LH-RH agonist therapy in premenopausal patients with advanced breast cancer. Eur J Cancer Clin Oncol 1989;25:651-4.
29. Nicholson RI, Walker KJ, McClelland RA, Dixon A, Robertson JF, Blarney RW. Zoladex plus tamoxifen versus Zoladex alone in pre-and peri-menopausal metastatic breast cancer. J Steroid Biochem Mol Biol 1990;37:989-95.
30. Revision of the standards for the assessment of hormone receptors in human breast cancer; report of the second E.O.R.T.C. Workshop, held on 16-17 March, 1979, in the Netherlands Cancer Institute. Eur J Cancer 1980;16:1513-5.
31. Foekens JA, Portengen H, van Putten WL, Peters HA, Krijnen HL, Alexieva-Figusch J, et al. Prognostic value of estrogen and progesterone receptors measured by enzyme immunoassays in human breast tumor cytosols. Cancer Res 1989;49:5823-8.
32. Hayward JL, Carbone PP, Heuson JC, Kumaoka S, Segaloff A, Rubens RD. Assessment of response to therapy in advanced breast cancer: a project of the Programme on Clinical Oncology of the International Union Against Cancer, Geneva, Switzerland. Cancer 1977;39:1289-94.
33. Mantel N, Haenszel W. Statistical aspects of the analysis of data from retrospective studies of disease. J Natl Cancer Inst 1959;22:719-48.
34. nd ed. New York (NY): Springer-Verlag; 1981.
35. Kaplan EL, Meier P. Non-parametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
36. Cox DR. Regression models and life tables (with discussion). J R Stat Soc B 1972;34:187-220.
37. Cox DR, Oakes J. Analysis of survival data. London (U.K.): Chapman & Hall; 1984.
38. Kruskal WH, Wallis WA. Use of ranks in one-criterion variance analysis. JASA 1952;47:583-621.
39. Bishop YV, Fienberg SE, Holland PW. Discrete multivariate analysis. Cambridge (MA): MIT Press; 1975.
40. Boccardo F, Rubagotti A, Perrotta A, Amoroso D, Balestrero M, De Matteis 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;5:337-42.
41. Jonat W, Kaufmann M, Blarney RW, Howell A, Collins JP, Coates A, et al. A randomised study to compare the effect of the luteinising hormone releasing hormone (LHRH) analogue goserelin with or without tamoxifen in pre-and perimenopausal patients with advanced breast cancer. Eur J Cancer 1995;31A:137-42.
42. Klijn JG, Blarney RW, Boccardo F, Tominaga T, Jonat W, Kaufmann M, et al. A new standard treatment for advanced premenopausal breast cancer: a meta-analysis of the combined hormonal agent trialists group (CHAT) [abstract]. Eur J Cancer 1998;34:abstract 405.
43. Alexieva-Figusch J, van Putten WL, Blankenstein MA, Blonk-Van Der Wijst J, Klijn JG. The prognostic value and relationships of patient characteristics, estrogen and progestin receptors, and site of relapse in primary breast cancer. Cancer 1988;61:758-68.
44. Early Breast Cancer Trialists' Collaborative Group. Polychemotherapy for early breast cancer: an overview of the randomised trials. Lancet 1998; 352:930-42.
45. Trudeau ME, Pritchard KI. Adjuvant endocrine therapy of breast cancer. In: Henderson IC, editor. Adjuvant therapy of breast cancer. Boston (MA): Kluwer Academic; 1992. p. 69-115.
46. del Mastro L, Costantini M, Bianco AR. Adjuvant chemotherapy in breast cancer. N Engl J Med 1995;333:596.
47. Jordan VC. Chemotherapy is antihormonal therapy - how much proof do oncologists need? [editorial]. Eur J Cancer 1998;34:606-8.
48. Pagani O, O'Neill A, Castiglione M, Gelber RD, Goldhirsch A, Rudenstam CM, 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;34:632-40.
49. Jakesz R, Hausmaninger H, Sumonigg H, Kubista E, Depisch D, Fridrik M, et al. Comparison of adjuvant therapy with tamoxifen and goserelin vs. CMF in premenopausal stage I and II hormone-responsive breast cancer patients: four-year results of Austrian Breast Cancer Study Group (ABCSG) Trial 5 [abstract]. Proc ASCO 1999;18:abstract 250.
50. Ejlertsen B, Dombernowsky P, Mouridsen HT, Kamby C, Kjaer M, Rose C. et al. Comparable effect of ovarian ablation and CMF chemotherapy in premenopausal hormone receptor positive breast cancer patients [abstract]. Proc ASCO 1999;18:abstract 248.
51. Mourits MJ, de Vries EG, Willemse EH, ten Hoor KA, Hollema H, Sluiter WJ, et al. Ovarian cysts in women receiving tamoxifen for breast cancer. Br J Cancer 1999;79:1761-4.
52. Roche H, Michura J, de Lafontan B, Reme-Saumon M, Martel P, Dubois JB, et al. Castration and tamoxifen versus chemotherapy (FAC) for premenopausal node and receptor positive breast cancer patients: a randomized trial with 7 years' median follow-up [abstract]. Proc ASCO 1996;15: abstract 134.
53. Boccardo F, Rubagotti A, Amoroso D, Mesiti M, Minutoli N, Aldrighetti D, et al. CMF versus tamoxifen plus goserelin as adjuvant treatment of ER positive pre-perimenopausal breast cancer patients. Preliminary results of the GROCTA 02 study [abstract]. Proc ASCO 1998;17:abstract 382.
54. Davidson N, O'Neill A, Vukov A, Osborne CK, Martino S, White D, et al. Effect of chemohormonal therapy in premenopausal node-positive receptor-positive breast cancer: an Eastern Cooperative Oncology Group Phase III Intergroup Trial (INT-0101) [abstract]. Proc ASCO 1999;18:abstract 249.
55. Stein RC, Dowsett M, Hedley A, Gazet JC, Ford HT, Coombes RC. 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;62:679-83.
56. Hamilton A, Piccart M. The third-generation non-steroidal aromatase inhibitors: a review of their clinical benefits in the second-line hormonal treatment of advanced breast cancer. Ann Oncol 1999;10:377-84.