Randomized trial of cyclophosphamide, methotrexate, and fluorouracil chemotherapy added to tamoxifen as adjuvant therapy in postmenopausal women with node-positive estrogen and/or progesterone receptor-positive breast cancer: A report of the National Cancer Institute of Canada Clinical Trials Group

Journal of Clinical Oncology

Volumn 15, Issue 6, 1997, Pages 2302-2311

  Pritchard, Kathleen I ^a   Paterson, Alexander H ^a   Fine, Sheldon ^a   Paul, Nancy A ^a   Zee, Benny ^a   Shepherd, Lois E ^a   Abu Zahra, Hakam ^a   Ragaz, Joseph ^a   Knowling, Margaret ^a   Levine, Mark N ^a   Verma, Shail ^a   Perrault, Daniele ^a   Walde, P L ^a   Bramwell, Vivien H ^a   Poljicak, Mate ^a   Boyd, Norman ^a   Warr, David ^a   Norris, Brian D ^a   Bowman, David ^a   Armitage, George R ^a   Weizel, Harold ^a   Buckman, Robert A ^a   more..

^a UNIVERSITY OF TORONTO   (Canada)

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOPHOSPHAMIDE; ESTROGEN; ESTROGEN RECEPTOR; FLUOROURACIL; METHOTREXATE; PROGESTERONE; PROGESTERONE RECEPTOR; TAMOXIFEN;

ADULT; ANEMIA; ARTICLE; BREAST CANCER; CANCER SURVIVAL; CLINICAL FEATURE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DISEASE SEVERITY; FEMALE; HUMAN; INFECTION; INTRAVENOUS DRUG ADMINISTRATION; MAJOR CLINICAL STUDY; MUCOSA INFLAMMATION; NAUSEA; ORAL DRUG ADMINISTRATION; POSTMENOPAUSE; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RECURRENCE RISK; THROMBOCYTOPENIA; VOMITING;

EID: 0030979449     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.1997.15.6.2302     Document Type: Article

References (43)

1. Fisher B, Fisher ER, Redmond C: Ten-year results from the NSABP clinical trial evaluating the use of L-phenylalanine mustard (L-PAM) in the management of primary breast cancer. J Clin Oncol 4:929-941, 1986
2. Bonadonna G, Valagussa P, Rossi A, et al: Ten-year experience with CMF-based adjuvant chemotherapy in resectable breast cancer. Breast Cancer Res Treat 5:95-115, 1985
3. Breast Cancer Chemotherapy Consensus Conference. JAMA 254:3461-3463, 1985
4. Nolvadex Adjuvant Trial Organization: Controlled trial of tamoxifen as adjuvant agent in management of early breast cancer. Lancet 1:257-262, 1983
5. Ribeiro G, Palmer MK: Adjuvant tamoxifen for operable carcinoma of the breast: Report of clinical trial by the Christie Hospital and Holt Radium Institute. Br Med J 286:827-830, 1983
6. Pritchard KI, Meakin JW, Boyd NF, et al: A randomized trial of adjuvant tamoxifen in postmenopausal women with axillary node positive breast cancer, in Jones CE, Salmon CE (eds): Adjuvant Therapy of Cancer IV. New York, NY, Grune & Stratton, 1984, pp 339-347
7. National Institute of Health Consensus Development Conference Statement: Treatment of Early Stage Breast Cancer. Bethesda, MD, National Institutes of Health, June 18-21, 1990
8. Glick JH, Gelber RD, Goldhirsch A, et al: Meeting highlights: Adjuvant therapy for primary breast cancer. J Natl Cancer Inst 84:1479-1485, 1992
9. Goldhirsch A, Gelber RD: Adjuvant chemoendocrine therapy or endocrine therapy alone for postmenopausal patients. Ludwig Studies III and IV, in Senn HJ, Goldhirsch A, Belger RD, et al (eds): Recent Results in Cancer Research: Adjuvant Therapy of Primary Breast Cancer. Berlin, Germany, Springer Verlag, 1989, pp 153-162
10. Early Breast Cancer Trialists Collaborative Group: The affects of adjuvant tamoxifen and of cytotoxic therapy on mortality in early breast cancer. An overview of 61 randomized trials among 28,896 women. N Engl J Med 319:1681-1692, 1988
11. Early Breast Cancer Trialists Collaborative Group: Systemic treatment of early breast cancer by hormonal cytotoxic or immune therapy in 133 randomized trials involving 31,000 recurrences and 24,000 deaths among 75,000 women. Lancet 339:1-15, 71, 84, 1992
12. Castiglione-Gertsch M, Johnsen C, Goldhirsch A, et al: The International (Ludwig) Breast Cancer Study Group Trials I-IV: 15 years follow-up. Ann Oncol 5:717-724, 1994
13. Fisher B, Redmond C, Legault-Poisson S, et al: Postoperative chemotherapy and tamoxifen compared with tamoxifen alone in the treatment of positive-node breast cancer patients aged 50 years and older with tumors responsive to tamoxifen. Results from the National Surgical Adjuvant Breast and Bowel Project B-16. J Clin Oncol 8:1005-1018, 1990
14. Pritchard KI, Pater J, Paul N, et al: Thromboembolic complications related to chemotherapy in a National Cancer Institute of Canada randomized trial of tamoxifen versus women with axillary node positive receptor positive breast cancer. Proc Am Soc Clin Oncol 8:25, 1989 (abstr)
15. Pritchard KI, Pater J, Paul NA, et al: Increased thromboembolic complications with concurrent adjuvant tamoxifen and chemotherapy in a randomized breast cancer trial. J Clin Oncol 14:2731-2737, 1996
16. Pritchard KI, Zee B, Paul N, et al: CMF added to tamoxifen as adjuvant therapy in postmenopausal women with node-positive (+ve) estrogen (ER) and/or progesterone receptor (PgR) +ve breast cancer negative results from a randomized clinical trial. Proc Am Soc Clin Oncol 8:25, 1989 (abstr)
17. Pritchard KI, Paterson AHG, Fine S, et al: A randomized trial of CMF chemotherapy added to tamoxifen as adjuvant therapy in postmenopausal women with node-positive (+ve) estrogen (ER) and/ or progesterone receptor (PgR) +ve breast cancer. Proc Am Soc Clin Oncol 11:60, 1992 (abstr)
18. Miller AB, Hoogstraten B, Staquet M, et al: Reporting results of cancer treatment. Cancer 47:207-214, 1981
19. Kaplan EL, Meier P: Nonparametric estimation from incomplete observations. J Am Stat Assoc 53:457-481, 1958
20. Charlson ME, Feinstein AR: Rapid growth rate in breast cancer: A confounding variable in adjuvant chemotherapy trials. Lancet 1:1343-1345, 1982
21. Cox DR: Regression models and life tables. J R Stat Soc B 34:187-220, 1972
22. Nolvadex Adjuvant Trial organization (NATO): Controlled trial of tamoxifen as single agent in the management of early breast cancer - Analysis at eight years. Br J Cancer 57:608-611, 1988
23. Pritchard KI, Meakin JW, Boyd NF, et al: A randomized trial of adjuvant tamoxifen in postmenopausal women with axillary node-positive breast cancer, in Early Breast Cancer Trialists Collaborative Group (eds): Treatment of Early Breast Cancer, vol 1, World Wide Evidence 1985-1990. Oxford, United Kingdom, Oxford Medical, 1990, pp 21-49
24. Cancer Research Campaign Breast Cancer Trials Group: The effect of adjuvant tamoxifen: The latest results from the Cancer Research Campaign Adjuvant Breast Trial. Eur J Cancer 28A: 904-907, 1992
25. Breast Cancer Trials Committee, Scottish Cancer Trials Office: Adjuvant tamoxifen in the management of operable breast cancer: The Scottish trial. Lancet 2:171-175, 1987
26. Rutqvist LE, Cedermark B, Glas U, et al: Radiotherapy, chemotherapy and tamoxifen as adjuvants to surgery in early breast cancer: A summary of these randomized trials. Int J Radiat Oncol 16:629-639, 1989
27. Mouridsen HT, Rose C, Overguard M, et al: Adjuvant treatment of postmenopausal patients with high risk primary breast cancer. Results from the Danish adjuvant trials DBCG 77 C and DBCG 82 C. Acta Oncol 27:699-705, 1988
28. Ryden S, Møller T, Hafstrom L, et al: Adjuvant therapy of breast cancer: Compliance and data validity in a multicenter trial. Control Clin Trials 7:290-305, 1986
29. Hubay CA, Gordon NH, Pearson OH, et al: Eight-year follow-up of adjuvant therapy for stage II breast cancer. World J Surg 9:738-749, 1985
30. Fisher B, Redmond C, Brown A, et al: Adjuvant chemotherapy with and without tamoxifen in the treatment of primary breast cancer. Five-year results from the NSABP trial. J Clin Oncol 4:459-471, 1986
31. Taylor SC IV, Kalish LA, Olson JE, et al: Adjuvant CMFP versus CMFP plus tamoxifen versus observation alone in postmenopausal node positive breast cancer patients. Three year results of an Eastern Co-operative Oncology Group Study. J Clin Oncol 3:144-154, 1985
32. Kaufmann M, Jonat W, Abel U, et al: Adjuvant randomized trials of doxorubicin/cyclophosphamide versus tamoxifen in women with node-positive breast cancer. J Clin Oncol 11:454-460, 1993
33. Ingle JN, Everson LK, Wirand HS, et al: Randomized trial of adjuvant therapy with cyclophosphamide (C), 5-fluorouracil (F), prednisone (P) with or without tamoxifen (T) vs observation following mastectomy in postmenopausal women with node-positive breast cancer. Proc Am Soc Clin Oncol 5:70, 1986 (abstr)
34. Mauriac L, Durand M, Chauvergne J, et al: Adjuvant trial for stage II receptor-positive breast cancer: CMF vs CMF + tamoxifen in a single centre. Breast Cancer Res Treat 11:179-186, 1988
35. Senanayake F: Adjuvant hormonal chemotherapy in early breast cancer: Early results from a controlled trial. Lancet 1:1148-1149, 1984
36. Gérard JP, Héry M. Gedouin D, et al: Postmenopausal patients with node-positive resectable breast cancer. Tamoxifen vs FEC 50 (6 cycles) vs FEC 50 (6 cycles) plus tamoxifen versus control preliminary results of a 4-arm randomized trial. Drugs 45:60-67, 1993 (suppl 2)
37. Boccardo F, Rubagotti A, Amoroso P, et al: Chemotherapy versus tamoxifen versus chemotherapy plus tamoxifen in node-positive, oestrogen-receptor positive breast cancer patients. An update at 7 years of the 1st GROCTA (Breast Cancer Adjuvant Chemohormone Therapy Co-operative Group) Trial. Eur J Cancer 28:673-680, 1992
38. Rivkin SE, Green S, Metch B, et al: Adjuvant CMFVP versus tamoxifen versus concurrent CMFVP and tamoxifen for postmenopausal node-positive estrogen receptor-positive breast cancer patients. A Southwest Oncology Group study. J Clin Oncol 12:2078-2085, 1994
39. Goldenberg GJ, Froese EK: Antagonism of the cytocidal activity and uptake of an melphalan by tamoxifen in human breast cancer cells in vitro. Biochem Pharmacol 34:763-770, 1985
40. Osborne CK, Kitten L, Arteaga CL: Antagonism of chemotherapy-induced cytotoxicity for human breast cancer cells by antiestrogens. J Clin Oncol 7:710-717, 1989
41. Fisher B, Redmond C, Brown A, et al: Influence of tumor estrogen and progesterone receptor levels on the response to tamoxifen and chemotherapy in primary breast cancer. J Clin Oncol 4:227-241, 1983
42. Engelsman E, Klijn JCM, Rubens RD, et al: Classical CMF versus a 3-weekly intravenous CMF schedule in postmenopausal patients with advanced breast cancer. Eur J Cancer 27:966-970, 1991
43. Fisher B, Redmond C, Poisson R, et al: Eight-year results of a randomized clinical trial comparing total mastectomy and lumpectomy with or without irradiation in the treatment of breast cancer. N Engl J Med 320:822-828, 1989