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	Full Text PDF PDA Full Text PowerPoint Slide Set Editorial by Elfenbein, G. J. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background The use of high-dose adjuvant chemotherapy for high-risk primary breast cancer is controversial. We studied its efficacy in patients with 4 to 9 or 10 or more tumor-positive axillary lymph nodes.

Methods Patients younger than 56 years of age who had undergone surgery for breast cancer and who had no distant metastases were eligible if they had at least four tumor-positive axillary lymph nodes. Patients in the conventional-dose group received fluorouracil, epirubicin, and cyclophosphamide (FEC) every three weeks for five courses, followed by radiotherapy and tamoxifen. The high-dose treatment was identical, except that high-dose chemotherapy (6 g of cyclophosphamide per square meter of body-surface area, 480 mg of thiotepa per square meter, and 1600 mg of carboplatin per square meter) with autologous peripheral-blood hematopoietic progenitor-cell transplantation replaced the fifth course of FEC.

Results Of the 885 patients, 442 were assigned to the high-dose group and 443 to the conventional-dose group. After a median follow-up of 57 months, the actuarial 5-year relapse-free survival rates were 59 percent in the conventional-dose group and 65 percent in the high-dose group (hazard ratio for relapse in the high-dose group, 0.83; 95 percent confidence interval, 0.66 to 1.03; P=0.09). In the group with 10 or more positive nodes, the relapse-free survival rates were 51 percent in the conventional-dose group and 61 percent in the high-dose group (P=0.05 by the log-rank test; hazard ratio for relapse, 0.71; 95 percent confidence interval, 0.50 to 1.00).

Conclusions High-dose alkylating therapy improves relapse-free survival among patients with stage II or III breast cancer and 10 or more positive axillary lymph nodes. This benefit may be confined to patients with HER-2/neu-negative tumors.

Source Information

From the Netherlands Cancer Institute, Amsterdam (S.R., H.T., H.L.P.); the Erasmus Medical Center–Daniel den Hoed Cancer Center, Rotterdam (M.B.); University Hospital Nijmegen, Nijmegen (L.V.A.M.B.); Free University Medical Center, Amsterdam (J.W.); University Hospital Maastricht, Maastricht (J.W., P.H.); Academic Medical Center, Amsterdam, and Medical Center Enschede, Enschede (D.J.R.); University Medical Center Leiden, Leiden (M.A.N.); University Medical Center Utrecht, Utrecht (E.E.V.); and University Hospital Groningen, Groningen (E.M.V., E.G.E.V.) — all in the Netherlands.

Address reprint requests to Dr. Rodenhuis at the Netherlands Cancer Institute, Department of Medical Oncology, Plesmanlaan 121, 1066 CX Amsterdam, the Netherlands, or at sroden{at}nki.nl.

Full Text of this Article

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.
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N Engl J Med 2003; 349:1476-1479, Oct 9, 2003. Correspondence

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