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Previous Volume 354:809-820 February 23, 2006 Number 8 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Perspective by Chien, K. R. 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 We compared docetaxel with vinorelbine for the adjuvant treatment of early breast cancer. Women with tumors that overexpressed HER2/neu were also assigned to receive concomitant treatment with trastuzumab or no such treatment.

Methods We randomly assigned 1010 women with axillary-node–positive or high-risk node-negative cancer to receive three cycles of docetaxel or vinorelbine, followed by (in both groups) three cycles of fluorouracil, epirubicin, and cyclophosphamide. The 232 women whose tumors had an amplified HER2/neu gene were further assigned to receive or not to receive nine weekly trastuzumab infusions. The primary end point was recurrence-free survival.

Results Recurrence-free survival at three years was better with docetaxel than with vinorelbine (91 percent vs. 86 percent; hazard ratio for recurrence or death, 0.58; 95 percent confidence interval, 0.40 to 0.85; P=0.005), but overall survival did not differ between the groups (P=0.15). Within the subgroup of patients who had HER2/neu-positive cancer, those who received trastuzumab had better three-year recurrence-free survival than those who did not receive the antibody (89 percent vs. 78 percent; hazard ratio for recurrence or death, 0.42; 95 percent confidence interval, 0.21 to 0.83; P=0.01). Docetaxel was associated with more adverse effects than was vinorelbine. Trastuzumab was not associated with decreased left ventricular ejection fraction or cardiac failure.

Conclusions Adjuvant treatment with docetaxel, as compared with vinorelbine, improves recurrence-free survival in women with early breast cancer. A short course of trastuzumab administered concomitantly with docetaxel or vinorelbine is effective in women with breast cancer who have an amplified HER2/neu gene. (International Standard Randomised Controlled Trial number, ISRCTN76560285 [controlled-trials.com].)

Source Information

From the Department of Oncology, Helsinki University Central Hospital, Helsinki (H.J., P.B., T.A., T.U., A.H., M.T., A.-S.J., I.E.); the Department of Oncology, Tampere University Hospital (P.-L.K.-L., T.S.), and the Laboratory of Cancer Biology, Institute of Medical Technology, University of Tampere and Tampere University Hospital (J.I.), Tampere; the Department of Oncology, Kuopio University Hospital, Kuopio (V.K.); Satakunta Central Hospital, Pori (R.A.); Hämeenlinna Central Hospital, Hämeenlinna (R.K.); the Department of Oncology and Radiotherapy, Oulu University Hospital, Oulu (T.T.-H.); the Department of Oncology, Turku University Central Hospital, Turku (S.J.); South Karelia Central Hospital, Lappeenranta (M.F.); Kotka Central Hospital, Kotka (L.H.); Vaasa Central Hospital, Vaasa (S.I.); Kokkola Central Hospital, Kokkola (K.J.); Jyväskylä Central Hospital, Jyväskylä (M.P.); Kajaani Central Hospital, Kajaani (M.R.); Kemi Central Hospital, Kemi (J.K.-K.); and 4Pharma, Turku (M.L.) — all in Finland.

Address reprint requests to Dr. Joensuu at the Department of Oncology, Helsinki University Central Hospital, Haartmaninkatu 4, P.O.B. 180, FIN-00029 Helsinki, Finland.

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Related Letters:

Trastuzumab Treatment in Breast Cancer
Montemurro F., Valabrega G., Aglietta M., Joensuu H., Bono P., Kellokumpu-Lehtinen P.
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N Engl J Med 2006; 354:2186, May 18, 2006. Correspondence

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