Phase III comparison of tamoxifen versus tamoxifen plus ovarian function suppression in premenopausal women with node-negative, hormone receptor-positive breast cancer (E-3193, INT-0142): A trial of the eastern cooperative oncology group

Journal of Clinical Oncology

Volumn 32, Issue 35, 2014, Pages 3948-3958

  Tevaarwerk, Amye J ^a   Wang, Molin ^b   Zhao, Fengmin ^c   Fetting, John H ^d   Cella, David ^e   Wagner, Lynne I ^e   Martino, Silvana ^f   Ingle, James N ^g   Sparano, Joseph A ^h   Solin, Lawrence J ⁱ   Wood, William C ^j   Robert, Nicholas J ^k  

^a UNIVERSITY OF WISCONSIN MADISON   (United States)

^b HARVARD UNIVERSITY   (United States)

^c DANA FARBER CANCER INSTITUTE   (United States)

^d JOHNS HOPKINS UNIVERSITY   (United States)

^e NORTHWESTERN UNIVERSITY   (United States)

^f Angeles Clinic and Research Institute   (United States)

^g MAYO CLINIC   (United States)

^h MONTEFIORE MEDICAL CENTER   (United States)

ⁱ ALBERT EINSTEIN MEDICAL CENTER   (United States)

^j EMORY UNIVERSITY   (United States)

^k Virginia Cancer Specialists   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

GOSERELIN; LEUPRORELIN; TAMOXIFEN; ANTINEOPLASTIC AGENT; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; ESTROGEN RECEPTOR; PROGESTERONE RECEPTOR;

ADULT; AMENORRHEA; ANEMIA; ANXIETY DISORDER; ARTICLE; BLOOD CLOTTING DISORDER; BREAST CANCER; CANCER CHEMOTHERAPY; CANCER SIZE; CANCER SURVIVAL; COMPARATIVE STUDY; CONFUSION; CONTROLLED STUDY; DEPRESSION; DISEASE FREE SURVIVAL; DIZZINESS; DRUG HYPERSENSITIVITY; EDEMA; ENDOMETRIOSIS; ESTROGEN RECEPTOR POSITIVE BREAST CANCER; FEMALE; FOLLOW UP; HOT FLUSH; HUMAN; HYPERTENSION; HYPOGLYCEMIA; INSOMNIA; LIBIDO DISORDER; MAJOR CLINICAL STUDY; MASTECTOMY; MENOPAUSAL SYNDROME; NEUROLOGIC DISEASE; NIGHT SWEAT; OVARIAN FUNCTION SUPPRESSION; OVERALL SURVIVAL; PAIN; PARTIAL MASTECTOMY; PHASE 3 CLINICAL TRIAL; PREMENOPAUSE; PRURITUS; QUALITY OF LIFE; RANDOMIZED CONTROLLED TRIAL; SELF REPORT; SEXUAL BEHAVIOR; SEXUAL FUNCTION; SIDE EFFECT; SOMNOLENCE; TREATMENT OUTCOME; VAGINAL DRYNESS; WEIGHT GAIN; BREAST NEOPLASMS; CLINICAL TRIAL; DRUG EFFECTS; LYMPH NODE; LYMPH NODE METASTASIS; METABOLISM; MIDDLE AGED; MULTICENTER STUDY; OVARY; PATHOLOGY;

ADULT; ANTINEOPLASTIC AGENTS, HORMONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BREAST NEOPLASMS; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; LYMPH NODES; LYMPHATIC METASTASIS; MIDDLE AGED; OVARY; PREMENOPAUSE; QUALITY OF LIFE; RECEPTORS, ESTROGEN; RECEPTORS, PROGESTERONE; TAMOXIFEN; TREATMENT OUTCOME;

EID: 84918571561     PISSN: 0732183X     EISSN: 15277755     Source Type: Journal    
DOI: 10.1200/JCO.2014.55.6993     Document Type: Article

References (40)

1. Nunn T: On cancer of the breast. London, United Kingdom, J. & A. Churchill, 1882, pp 71
2. Beatson GT: On the treatment of inoperable cases of carcinoma of the mamma: Suggestions for a new method of treatment, with illustrative cases. Lancet 148:162-165, 1896
3. Thomson A: Analysis of cases in which oophorectomy was performed for inoperable carcinoma of the breast. Br Med J 2:1538-1541, 1902
4. [No authors listed]: Adjuvant ovarian ablation versus CMF chemotherapy in premenopausal women with pathological stage II breast carcinoma: The Scottish trial - Scottish Cancer Trials Breast Group and ICRF Breast Unit, Guy's Hospital, London. Lancet 341:1293-1298, 1993
5. 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 20:4621-4627, 2002
6. International Breast Cancer Study Group (IBCSG), Castiglione-Gertsch M, O'Neill A, 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 95:1833-1846, 2003
7. 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 23:5973-5982, 2005
8. LHRH-Agonists in Early Breast Cancer Overview Group1, Cuzick J, Ambroisine L, et al: Use of luteinising-hormone-releasing hormone agonists as adjuvant treatment in premenopausal patients with hormone-receptor-positive breast cancer: A meta-analysis of individual patient data from randomised adjuvant trials. Lancet 369:1711-1723, 2007
9. Roché 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 randomised trial. Ann Oncol 17:1221-1227, 2006
10. Early Breast Cancer Trialists' Collaborative Group (EBCTCG): Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials. Lancet 365:1687-1717, 2005
11. Gnant M, Mlineritsch B, Stoeger H, et al: Adjuvant endocrine therapy plus zoledronic acid in premenopausal women with early-stage breast cancer: 62-month follow-up from the ABCSG-12 randomised trial. Lancet Oncol 12:631-641, 2011
12. Griggs JJ, Somerfield MR, Anderson H, et al: American Society of Clinical Oncology endorsement of the Cancer Care Ontario practice guideline on adjuvant ovarian ablation in the treatment of premenopausal women with early-stage invasive breast cancer. J Clin Oncol 29:3939-3942, 2011
13. 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 42:1780-1788, 2006
14. 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 22:2325-2332, 2002
15. Schmid P, Untch M, Kossé V, et al: Leuprorelin acetate every-3-months depot versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant treatment in premenopausal patients with nodepositive breast cancer: The TABLE study. J Clin Oncol 25:2509-2515, 2007
16. Kaufmann M, Graf E, Jonat W, et al: A randomised trial of goserelin versus control after adjuvant, risk-adapted chemotherapy in premenopausal patients with primary breast cancer: GABG-IV B-93. Eur J Cancer 43:2351-2358, 2007
17. Hackshaw A, Baum M, Fornander T, et al: Long-term effectiveness of adjuvant goserelin in premenopausal women with early breast cancer. J Natl Cancer Inst 101:341-349, 2009
18. Arriagada R, Lê 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 16:389-396, 2005
19. 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 18:2718-2727, 2000
20. Adjuvant Breast Cancer Trials Collaborative Group: Ovarian ablation or suppression in premenopausal early breast cancer: Results from the international adjuvant breast cancer ovarian ablation or suppression randomized trial. J Natl Cancer Inst 99:516-525, 2007
21. Pagani O, Regan MM, Walley BA, et al: Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med 371:107-118, 2014
22. Hughes LL, Gray RJ, Solin LJ, et al: Efficacy of radiotherapy for ovarian ablation: Results of a breast intergroup study. Cancer 101:969-972, 2004
23. National Cancer Institute, National Institutes of Health, Department of Health and Human Services: Common Toxicity Criteria Manual, version 1.0. Bethesda, MD, National Cancer Institute, 1982
24. Moos RH, Leiderman DB: Toward a menstrual cycle symptom typology. J Psychosom Res 22:31-40, 1978
25. Thirlaway K, Fallowfield L, Cuzick J: The Sexual Activity Questionnaire: A measure of women's sexual functioning. Qual Life Res 5:81-90, 1996
26. Cella DF, Tulsky DS, Gray G, et al: The Functional Assessment of Cancer Therapy scale: Development and validation of the general measure. J Clin Oncol 11:570-579, 1993
27. Agresti A: Categorical Data Analysis, Hoboken, NJ, Wiley, 1958
28. Kaplan EL, Meier P: Nonparametric estimation from incomplete observation. J Am Stat Assoc 53:457-481, 1958
29. Cox DR: Regression models and life tables. J R Stat Soc B 34:187-220, 1972
30. Schluchter MD: Methods for the analysis of informatively censored longitudinal data. Stat Med 11:1861-1870, 1992
31. Efron B: Bootstrap methods: Another look at the jackknife. Ann Stat 7:1-26, 1979
32. Eton DT, Cella D, Yost KJ, et al: A combination of distribution- and anchor-based approaches determined minimally important differences (MIDs) for four endpoints in a breast cancer scale. J Clin Epidemiol 57:898-910, 2004
33. Cella D, Fallowfield L, Barker P, et al: Quality of life of postmenopausal women in the ATAC ("Arimidex", tamoxifen, alone or in combination) trial after completion of 5 years' adjuvant treatment for early breast cancer. Breast Cancer Res Treat 100:273-284, 2006
34. 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 21:4510-4516, 2003
35. Berglund G, Nystedt M, Bolund C, et al: Effect of endocrine treatment on sexuality in premenopausal breast cancer patients: A prospective randomized study. J Clin Oncol 19:2788-2796, 2001
36. Gnant M, Mlineritsch B, Schippinger W, et al: Endocrine therapy plus zoledronic acid in premenopausal breast cancer. N Engl J Med 360:679-691, 2009
37. 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 20:4628-4635, 2002
38. Thomson CS, Twelves CJ, Mallon EA, et al: Adjuvant ovarian ablation vs CMF chemotherapy in premenopausal breast cancer patients: Trial update and impact of immunohistochemical assessment of ER status. Breast 11:419-429, 2002
39. 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 92:467-474, 2005
40. Ejlertsen B, Mouridsen HT, Jensen MB, et al: Similar efficacy for ovarian ablation compared with cyclophosphamide, methotrexate, and fluorouracil: From a randomized comparison of premenopausal patients with node-positive, hormone receptor-positive breast cancer. J Clin Oncol 24:4956-4962, 2006