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Journal of Clinical Oncology, Vol 16, 2651-2658, Copyright © 1998 by American Society of Clinical Oncology

ARTICLES

Randomized trial of intensive cyclophosphamide, epirubicin, and fluorouracil chemotherapy compared with cyclophosphamide, methotrexate, and fluorouracil in premenopausal women with node-positive breast cancer. National Cancer Institute of Canada Clinical Trials Group

MN Levine, VH Bramwell, KI Pritchard, BD Norris, LE Shepherd, H Abu-Zahra, B Findlay, D Warr, D Bowman, J Myles, A Arnold, T Vandenberg, R MacKenzie, J Robert, J Ottaway, M Burnell, CK Williams and D Tu
Hamilton Regional Cancer Centre, McMaster University, ON, Canada.

PURPOSE: To determine the relative efficacy of an intensive cyclophosphamide, epirubicin, and fluorouracil (CEF) adjuvant chemotherapy regimen compared with cyclophosphamide, methotrexate, and fluorouracil (CMF) in node-positive breast cancer. PATIENTS AND METHODS: Premenopausal women with node-positive breast cancer were randomly allocated to receive either cyclophosphamide 100 mg/m2 orally days 1 through 14; methotrexate 40 mg/m2 intravenously (i.v.) days 1 and 8; and fluorouracil 600 mg/m2 i.v. days 1 and 8 or cyclophosphomide 75 mg/m2 orally days 1 through 14; epirubicin 60 mg/m2 i.v. days 1 and 8; and fluorouracil 500 mg/m2 i.v. days 1 and 8. Each cycle was administered monthly for 6 months. Patients administered CEF received antibiotic prophylaxis with cotrimoxazole two tablets twice a day for the duration of chemotherapy. RESULTS: The median follow-up was 59 months. One hundred sixty-nine of the 359 CMF patients developed recurrence compared with 132 of the 351 CEF patients. The corresponding 5-year relapse-free survival rates were 53% and 63%, respectively (P = .009). One hundred seven CMF patients died compared with 85 CEF patients. The corresponding 5-year actuarial survival rates were 70% and 77%, respectively (P = .03). The rate of hospitalization for febrile neutropenia was 1.1% in the CMF group compared with 8.5% in the CEF group. There was one case of congestive heart failure in a patient who received CMF compared with none in the CEF group. Acute leukemia occurred in five patients in the CEF group. CONCLUSION: The results of this trial show the superiority of CEF over CMF in terms of both disease-free and overall survival in premenopausal women with axillary node-positive breast cancer.
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Doxorubicin in combination with fluorouracil and cyclophosphamide (i.v. FAC regimen, day 1, 21) versus methotrexate in combination with fluorouracil and cyclophosphamide (i.v. CMF regimen, day 1, 21) as adjuvant chemotherapy for operable breast cancer: a study by the GEICAM group
Ann. Onc., June 1, 2003; 14(6): 833 - 842.
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R. Arriagada and J. Gutierrez
Anthracyclines: is more, better and/or more dangerous?
Ann. Onc., May 1, 2003; 14(5): 663 - 665.
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C. Bernard-Marty, M. Mano, M. Paesmans, C. Accettura, R. Munoz-Bermeo, T. Richard, K. Kleiber, F. Cardoso, J. P. Lobelle, D. Larsimont, et al.
Second malignancies following adjuvant chemotherapy: 6-year results from a Belgian randomized study comparing cyclophosphamide, methotrexate and 5-fluorouracil (CMF) with an anthracycline-based regimen in adjuvant treatment of node-positive breast cancer patients
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M.-C. Le Deley, T. Leblanc, A. Shamsaldin, M.-A. Raquin, B. Lacour, D. Sommelet, A. Chompret, J.-M. Cayuela, C. Bayle, A. Bernheim, et al.
Risk of Secondary Leukemia After a Solid Tumor in Childhood According to the Dose of Epipodophyllotoxins and Anthracyclines: A Case-Control Study by the Societe Francaise d'Oncologie Pediatrique
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J.-M. A. Nabholtz
In Reply:
J. Clin. Oncol., March 15, 2003; 21(6): 1191 - 1192.
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P. Therasse, L. Mauriac, M. Welnicka-Jaskiewicz, P. Bruning, T. Cufer, H. Bonnefoi, E. Tomiak, K. I. Pritchard, A. Hamilton, and M.J. Piccart
Final Results of a Randomized Phase III Trial Comparing Cyclophosphamide, Epirubicin, and Fluorouracil With a Dose-Intensified Epirubicin and Cyclophosphamide + Filgrastim as Neoadjuvant Treatment in Locally Advanced Breast Cancer: An EORTC-NCIC-SAKK Multicenter Study
J. Clin. Oncol., March 1, 2003; 21(5): 843 - 850.
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P. J. Goodwin, J. T. Black, L. J. Bordeleau, and P. A. Ganz
Health-Related Quality-of-Life Measurement in Randomized Clinical Trials in Breast Cancer--Taking Stock
J Natl Cancer Inst, February 19, 2003; 95(4): 263 - 281.
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P. Fumoleau, P. Kerbrat, P. Romestaing, P. Fargeot, A. Bremond, M. Namer, S. Schraub, M.-J. Goudier, J. Mihura, A. Monnier, et al.
Randomized Trial Comparing Six Versus Three Cycles of Epirubicin-Based Adjuvant Chemotherapy in Premenopausal, Node-Positive Breast Cancer Patients: 10-Year Follow-Up Results of the French Adjuvant Study Group 01 Trial
J. Clin. Oncol., January 15, 2003; 21(2): 298 - 305.
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K. I. Pritchard
Adjuvant Therapy for Premenopausal Women With Breast Cancer: Is It Time for Another Paradigm Shift?
J. Clin. Oncol., December 15, 2002; 20(24): 4611 - 4614.
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D. Rischin, S. P. Ackland, J. Smith, M. B. Garg, S. Clarke, M. J. Millward, G. C. Toner, and J. Zalcberg
Phase I and pharmacokinetic study of docetaxel in combination with epirubicin and cyclophosphamide in advanced cancer: dose escalation possible with granulocyte colony-stimulating factor, but not with prophylactic antibiotics
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C. Hudis
Breast Cancer and Leukemia: The Forest for the Trees?
Ann. Surg. Oncol., October 1, 2002; 9(8): 717 - 718.
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A. U. Buzdar, S. E. Singletary, V. Valero, D. J. Booser, N. K. Ibrahim, Z. Rahman, R. L. Theriault, R. Walters, E. Rivera, T. L. Smith, et al.
Evaluation of Paclitaxel in Adjuvant Chemotherapy for Patients with Operable Breast Cancer: Preliminary Data of a Prospective Randomized Trial
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A. Di Leo, D. Gancberg, D. Larsimont, M. Tanner, T. Jarvinen, G. Rouas, S. Dolci, J.-Y. Leroy, M. Paesmans, J. Isola, et al.
HER-2 Amplification and Topoisomerase II{alpha} Gene Aberrations as Predictive Markers in Node-positive Breast Cancer Patients Randomly Treated Either with an Anthracycline-based Therapy or with Cyclophosphamide, Methotrexate, and 5-Fluorouracil
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P. J. Goodwin, M. Ennis, K. I. Pritchard, M. E. Trudeau, J. Koo, Y. Madarnas, W. Hartwick, B. Hoffman, and N. Hood
Fasting Insulin and Outcome in Early-Stage Breast Cancer: Results of a Prospective Cohort Study
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National Institutes of Health Consensus Developmen
National Institutes of Health Consensus Development Conference Statement: Adjuvant Therapy for Breast Cancer, November 1-3, 2000
J Natl Cancer Inst Monographs, December 1, 2001; 2001(30): 5 - 15.
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G. N Hortobagyi
Progress in Systemic Chemotherapy of Primary Breast Cancer: an Overview
J Natl Cancer Inst Monographs, December 1, 2001; 2001(30): 72 - 79.
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M. J Piccart, C. Lohrisch, L. Duchateau, and M. Buyse
Taxanes in the Adjuvant Treatment of Breast Cancer: Why Not Yet?
J Natl Cancer Inst Monographs, December 1, 2001; 2001(30): 88 - 95.
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A. H. Partridge, H. J. Burstein, and E. P. Winer
Side Effects of Chemotherapy and Combined Chemohormonal Therapy in Women With Early-Stage Breast Cancer
J Natl Cancer Inst Monographs, December 1, 2001; 2001(30): 135 - 142.
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A. Goldhirsch, J. H. Glick, R. D. Gelber, A. S. Coates, and H.-J. Senn
Meeting Highlights: International Consensus Panel on the Treatment of Primary Breast Cancer
J. Clin. Oncol., September 15, 2001; 19(18): 3817 - 3827.
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National Institutes of Health Consensus Development Conference Statement: Adjuvant Therapy for Breast Cancer, November 1-3, 2000
J Natl Cancer Inst, July 4, 2001; 93(13): 979 - 989.
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M. J. Piccart, A. Di Leo, M. Beauduin, A. Vindevoghel, J. Michel, C. Focan, A. Tagnon, F. Ries, P. Gobert, C. Finet, et al.
Phase III Trial Comparing Two Dose Levels of Epirubicin Combined With Cyclophosphamide With Cyclophosphamide, Methotrexate, and Fluorouracil in Node-Positive Breast Cancer
J. Clin. Oncol., June 15, 2001; 19(12): 3103 - 3110.
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M.T. Meinardi, D.J. van Veldhuisen, J.A. Gietema, W.V. Dolsma, F. Boomsma, M.P. van den Berg, C. Volkers, J. Haaksma, E.G.E. de Vries, D.Th. Sleijfer, et al.
Prospective Evaluation of Early Cardiac Damage Induced by Epirubicin-Containing Adjuvant Chemotherapy and Locoregional Radiotherapy in Breast Cancer Patients
J. Clin. Oncol., May 15, 2001; 19(10): 2746 - 2753.
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M. Summerhayes
Trastuzumab in the treatment of HER2 positive breast cancer
Journal of Oncology Pharmacy Practice, March 1, 2001; 7(1): 9 - 25.
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A. Recht, S. B. Edge, L. J. Solin, D. S. Robinson, A. Estabrook, R. E. Fine, G. F. Fleming, S. Formenti, C. Hudis, J. J. Kirshner, et al.
Postmastectomy Radiotherapy: Clinical Practice Guidelines of the American Society of Clinical Oncology
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M. Levine
Clinical practice guidelines for the care and treatment of breast cancer: adjuvant systemic therapy for node-positive breast cancer (summary of the 2001 update)
Can. Med. Assoc. J., March 1, 2001; 164(5): 644 - 646.
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M. N. Levine and A. Eisen
Anthracycline Adjuvant Chemotherapy: How Much Is Enough?
J. Clin. Oncol., February 1, 2001; 19(3): 599 - 601.
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Benefit of a High-Dose Epirubicin Regimen in Adjuvant Chemotherapy for Node-Positive Breast Cancer Patients With Poor Prognostic Factors: 5-Year Follow-Up Results of French Adjuvant Study Group 05 Randomized Trial
J. Clin. Oncol., February 1, 2001; 19(3): 602 - 611.
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A. Katz, E. A. Strom, T. A. Buchholz, H. D. Thames, C. D. Smith, A. Jhingran, G. Hortobagyi, A. U. Buzdar, R. Theriault, S. E. Singletary, et al.
Locoregional Recurrence Patterns After Mastectomy and Doxorubicin-Based Chemotherapy: Implications for Postoperative Irradiation
J. Clin. Oncol., August 15, 2000; 18(15): 2817 - 2827.
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G. Dranitsaris
The cost of blood transfusions in cancer patients: a reanalysis of a Canadian economic evaluation
Journal of Oncology Pharmacy Practice, June 1, 2000; 6(2): 37 - 42.
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J. O'Shaughnessy
High Dose Chemotherapy for Breast Cancer: Taking Stock
Oncologist, February 1, 2000; 5(1): 14 - 17.
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D. Kandioler-Eckersberger, C. Ludwig, M. Rudas, S. Kappel, E. Janschek, C. Wenzel, H. Schlagbauer-Wadl, M. Mittlböck, M. Gnant, G. Steger, et al.
TP53 Mutation and p53 Overexpression for Prediction of Response to Neoadjuvant Treatment in Breast Cancer Patients
Clin. Cancer Res., January 1, 2000; 6(1): 50 - 56.
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P. J. Goodwin, M. Ennis, K. I. Pritchard, M. Trudeau, and N. Hood
Risk of Menopause During the First Year After Breast Cancer Diagnosis
J. Clin. Oncol., August 1, 1999; 17(8): 2365 - 2365.
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J.A. Wils, J.M. Bliss, M. Marty, G. Coombes, C. Fontaine, F. Morvan, T. Olmos, F.R. Perez-Lopez, P. Vassilopoulos, E. Woods, et al.
Epirubicin Plus Tamoxifen Versus Tamoxifen Alone in Node-Positive Postmenopausal Patients With Breast Cancer: A Randomized Trial of the International Collaborative Cancer Group
J. Clin. Oncol., July 1, 1999; 17(7): 1988 - 1988.
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A. Recht, R. Gray, N. E. Davidson, B. L. Fowble, L. J. Solin, F. J. Cummings, G. Falkson, H. C. Falkson, S. G. Taylor IV, and D. C. Tormey
Locoregional Failure 10 Years After Mastectomy and Adjuvant Chemotherapy With or Without Tamoxifen Without Irradiation: Experience of the Eastern Cooperative Oncology Group
J. Clin. Oncol., June 1, 1999; 17(6): 1689 - 1689.
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R. L. Basser, L. B. To, J. P. Collins, C. G. Begley, D. Keefe, J. Cebon, J. Bashford, S. Durrant, J. Szer, D. Kotasek, et al.
Multicycle High-Dose Chemotherapy and Filgrastim-Mobilized Peripheral-Blood Progenitor Cells in Women With High-Risk Stage II or III Breast Cancer: Five-Year Follow-Up
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