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Journal of Clinical Oncology, Vol 8, 1483-1496, Copyright © 1990 by American Society of Clinical Oncology

ARTICLES

Two months of doxorubicin-cyclophosphamide with and without interval reinduction therapy compared with 6 months of cyclophosphamide, methotrexate, and fluorouracil in positive-node breast cancer patients with tamoxifen-nonresponsive tumors: results from the National Surgical Adjuvant Breast and Bowel Project B-15

B Fisher, AM Brown, NV Dimitrov, R Poisson, C Redmond, RG Margolese, D Bowman, N Wolmark, DL Wickerham and CG Kardinal
National Surgical Adjuvant Breast and Bowel Project Headquarters, Pittsburgh, PA 15261.

The National Surgical Adjuvant Breast and Bowel Project (NSABP) implemented protocol B-15 to compare 2 months of Adriamycin (doxorubicin; Adria Laboratories, Columbus, OH) and cyclophosphamide (AC) with 6 months of conventional cyclophosphamide, methotrexate, and fluorouracil (CMF) in patients with breast cancer nonresponsive to tamoxifen (TAM, T). A second aim was to determine whether AC followed in 6 months by intravenous (IV) CMF was more effective than AC without reinduction therapy. Through 3 years of follow-up, findings from 2,194 patients indicate no significant difference in disease-free survival (DFS, P = .5), distant disease-free survival (DDFS, P = .5) or survival (S, P = .8) among the three groups. Since the outcome from AC and CMF was almost identical, the issue arises concerning which regimen is more appropriate for the treatment of breast cancer patients. AC seems preferable since, following total mastectomy, AC was completed on day 63 versus day 154 for conventional CMF; patients visited health professionals three times as often for conventional CMF as for AC; women on AC received therapy on each of 4 days versus on each of 84 days for conventional CMF; and nausea-control medication was given for about 84 days to conventional CMF patients versus for about 12 days to patients on AC. The difference in the amount of alopecia between the two treatment groups was less than anticipated. While alopecia was almost universally observed following AC therapy, 71% of the CMF patients also had hair loss and, in 41%, the loss was greater than 50%. This study and NSABP B-16, which evaluates the worth of AC therapy in TAM-responsive patients, indicate the merit of 2 months of AC therapy for all positive-node breast cancer patients.
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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
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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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C. L. Shapiro and A. Recht
Side Effects of Adjuvant Treatment of Breast Cancer
N. Engl. J. Med., June 28, 2001; 344(26): 1997 - 2008.
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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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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
J. Clin. Oncol., March 1, 2001; 19(5): 1539 - 1569.
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B. Fisher, S. Anderson, E. Tan-Chiu, N. Wolmark, D. L. Wickerham, E. R. Fisher, N. V. Dimitrov, J. N. Atkins, N. Abramson, S. Merajver, et al.
Tamoxifen and Chemotherapy for Axillary Node-Negative, Estrogen Receptor-Negative Breast Cancer: Findings From National Surgical Adjuvant Breast and Bowel Project B-23
J. Clin. Oncol., February 15, 2001; 19(4): 931 - 942.
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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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P. Fumoleau, F. Chauvin, M. Namer, R. Bugat, M. Tubiana-Hulin, J. P. Guastalla, T. Delozier, P. Kerbrat, Y. Devaux, J. Bonneterre, et al.
Intensification of Adjuvant Chemotherapy: 5-Year Results of a Randomized Trial Comparing Conventional Doxorubicin and Cyclophosphamide With High-Dose Mitoxantrone and Cyclophosphamide With Filgrastim in Operable Breast Cancer With 10 or More Involved Axillary Nodes
J. Clin. Oncol., February 1, 2001; 19(3): 612 - 620.
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S. Paik, J. Bryant, E. Tan-Chiu, G. Yothers, C. Park, D. L. Wickerham, and N. Wolmark
HER2 and Choice of Adjuvant Chemotherapy for Invasive Breast Cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-15
J Natl Cancer Inst, December 20, 2000; 92(24): 1991 - 1998.
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H. Ozer, J. O. Armitage, C. L. Bennett, J. Crawford, G. D. Demetri, P. A. Pizzo, C. A. Schiffer, T. J. Smith, G. Somlo, J. C. Wade, et al.
2000 Update of Recommendations for the Use of Hematopoietic Colony-Stimulating Factors: Evidence-Based, Clinical Practice Guidelines
J. Clin. Oncol., October 20, 2000; 18(20): 3558 - 3585.
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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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I. Kuter
Breast Cancer Update
Oncologist, August 1, 2000; 5(4): 285 - 292.
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M. Extermann, L. Balducci, and G. H. Lyman
What Threshold for Adjuvant Therapy in Older Breast Cancer Patients?
J. Clin. Oncol., April 1, 2000; 18(8): 1709 - 1717.
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M. H. Gail, J. P. Costantino, J. Bryant, R. Croyle, L. Freedman, K. Helzlsouer, and V. Vogel
Weighing the Risks and Benefits of Tamoxifen Treatment for Preventing Breast Cancer
J Natl Cancer Inst, November 3, 1999; 91(21): 1829 - 1846.
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J. Clin. Oncol., July 1, 1999; 17(7): 2293c - 2293.
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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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C. Hudis, A. Seidman, J. Baselga, G. Raptis, D. Lebwohl, T. Gilewski, M. Moynahan, N. Sklarin, D. Fennelly, J. P.A. Crown, et al.
Sequential Dose-Dense Doxorubicin, Paclitaxel, and Cyclophosphamide for Resectable High-Risk Breast Cancer: Feasibility and Efficacy
J. Clin. Oncol., January 1, 1999; 17(1): 93 - 93.
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F. J. Esteva and G. N. Hortobagyi
Integration of Systemic Chemotherapy in the Management of Primary Breast Cancer
Oncologist, October 1, 1998; 3(5): 300 - 313.
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C. A. Hudis and L. Norton
Adjuvant Drug Treatment for Resectable Breast Cancer
Oncologist, December 1, 1997; 2(6): 351 - 358.
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A. Recht, S. E. Come, I. C. Henderson, R. S. Gelman, B. Silver, D. F. Hayes, L. N. Shulman, and J. R. Harris
The Sequencing of Chemotherapy and Radiation Therapy after Conservative Surgery for Early-Stage Breast Cancer
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B. Thurlimann and H.-J. Senn
The Changing Approach to the Treatment of Early Breast Cancer
N. Engl. J. Med., May 23, 1996; 334(21): 1397 - 1399.
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G. Bonadonna, P. Valagussa, A. Moliterni, M. Zambetti, and C. Brambilla
Adjuvant Cyclophosphamide, Methotrexate, and Fluorouracil in Node-Positive Breast Cancer -- The Results of 20 Years of Follow-Up
N. Engl. J. Med., April 6, 1995; 332(14): 901 - 906.
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H.-J. Muller, C. H. Gleiter, U. Gundert-Remy, D. Melnychuk, L. C. Panasci, C. M.L. Coppin, J. H. Goldie, C. Sauter, J. Garey, S. Lehrer, et al.
Adjuvant Therapy for Breast Cancer
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