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Original Article
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Volume 349:17-26 July 3, 2003 Number 1
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Conventional Adjuvant Chemotherapy with or without High-Dose Chemotherapy and Autologous Stem-Cell Transplantation in High-Risk Breast Cancer
Martin S. Tallman, M.D., Robert Gray, Ph.D., Nicholas J. Robert, M.D., Charles F. LeMaistre, M.D., C. Kent Osborne, M.D., William P. Vaughan, M.D., William J. Gradishar, M.D., Thomas M. Pisansky, M.D., John Fetting, M.D., Elisabeth Paietta, Ph.D., and Hillard M. Lazarus, M.D.

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ABSTRACT

Background The prognosis for women with primary breast cancer and 10 or more involved axillary lymph nodes is poor. High-dose chemotherapy with autologous hematopoietic stem-cell transplantation has been reported to be effective in the adjuvant setting for patients at high risk for relapse.

Methods We randomly assigned 540 female patients with primary breast cancer and at least 10 involved ipsilateral axillary lymph nodes to receive either six cycles of adjuvant chemotherapy with cyclophosphamide, doxorubicin, and fluorouracil (CAF) or the same adjuvant chemotherapy followed by high-dose chemotherapy with cyclophosphamide and thiotepa and autologous hematopoietic stem-cell transplantation.

Results Among the 511 eligible patients, there was no significant difference in disease-free survival, overall survival, or the time to recurrence between those who received CAF alone and those who received CAF plus high-dose chemotherapy and stem-cell transplantation. Among 417 patients fulfilling strict eligibility criteria, the time to recurrence was longer for patients who underwent stem-cell transplantation than for those who received CAF alone. In the transplantation group, nine patients died of transplantation-related complications and a myelodysplastic syndrome or acute myeloid leukemia developed in nine.

Conclusions The addition of high-dose chemotherapy and autologous hematopoietic stem-cell transplantation to six cycles of adjuvant chemotherapy with CAF may reduce the risk of relapse but does not improve the outcome among patients with primary breast cancer and at least 10 involved axillary lymph nodes. Conventional-dose adjuvant chemotherapy remains the standard of care for such patients.


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From the Division of Hematology–Oncology, Northwestern University Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center, Chicago (M.S.T., W.JG.); Dana–Farber Cancer Institute, Boston (R.G.); Inova Fairfax Hospital, Falls Church, Va. (N.J.R.); Texas Transplant Institute, San Antonio (C.F.L.); Breast Center, Baylor College of Medicine and Methodist Hospital, Houston (C.K.O.); University of Alabama at Birmingham, Birmingham (W.P.V.); the Division of Radiation Oncology, Mayo Clinic, Rochester, Minn. (T.M.P.); the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore (J.F.); Our Lady of Mercy Cancer Center, New York Medical College, Bronx (E.P.); and Case Western Reserve University School of Medicine, Ireland Cancer Center, Cleveland (H.M.L.).

Drs. Robert and Lazarus contributed equally to the article.

Address reprint requests to Dr. Tallman at the Division of Hematology–Oncology, Northwestern University Feinberg School of Medicine, Robert H. Lurie Comprehensive Cancer Center, 676 N. St. Clair St., Suite 850, Chicago, IL 60611, or at m-tallman{at}northwestern.edu.

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Related Letters:

High-Dose Chemotherapy for Breast Cancer
Wheatley K., Gray R. G., Ives N. J., Tartarone A., Iodice G., Di Renzo N., Mangano M. M., Dazzi C., Cariello A., Rodenhuis S., van Tinteren H., de Vries E. G.E., Tallman M. S., Robert N. J., Lazarus H. M., Elfenbein G. J.
Extract | Full Text | PDF  
N Engl J Med 2003; 349:1476-1479, Oct 9, 2003. Correspondence

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