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Annals of Oncology Advance Access originally published online on December 6, 2005
Annals of Oncology 2006 17(3):409-414; doi:10.1093/annonc/mdj096
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© 2005 European Society for Medical Oncology

Pre-operative systemic (neo-adjuvant) therapy with trastuzumab and docetaxel for HER2-overexpressing stage II or III breast cancer: results of a multicenter phase II trial

B. P. Coudert1,*, L. Arnould1, L. Moreau2, P. Chollet3, B. Weber4, L. Vanlemmens5, C. Moluçon1, N. Tubiana6, S. Causeret1, J.-L. Misset7, S. Feutray1, D. Mery-Mignard8, J. Garnier9 and P. Fumoleau1

1 Oncology, Surgery, Radiology CAC GF Leclerc, Dijon; 2 Oncology, Clinique des Domes, Clermont Ferrand; 3 Oncology, CAC J Perrin, Clermont Ferrand; 4 Oncology, CAC A Vautrin, Nancy; 5 Oncology, CAC O Lambret, Lille; 6 Oncology, CHU, Limoges; 7 Oncology, Hal St Louis, Paris; 8 Oncology, Sanofi-Aventis, Paris; 9 Oncology, Roche, Neuilly sur Seine, France

* Correspondence to: Dr B. P. Coudert, Centre GF Leclerc, 1 rue du Pr Marion, 21000 Dijon, France. Tel: +33-380-737-720; Fax: +33-380-737-712; E-mail: bcoudert{at}dijon.fnclcc.fr

Background: Trastuzumab plus chemotherapy has become the standard of care for women with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. Trastuzumab-based pre-operative systemic (neo-adjuvant) therapy (PST) also appears promising, warranting further investigation.

Patients and methods: Patients with HER2-positive, stage II/III non-inflammatory, operable breast cancer requiring a mastectomy (but who wished to conserve the breast) received weekly trastuzumab and 3-weekly docetaxel for six cycles before surgery. The primary end point was pathological complete response (pCR) rate, determined from surgical specimens.

Results: Thirty-three patients were enrolled. The majority (79%) had T2 tumors, with 42% being N1/2. Twenty-nine patients completed six cycles of therapy and one patient withdrew prematurely due to progressive disease. A complete or partial objective clinical response was seen in 96% (73% and 23%, respectively) of patients. Surgery was performed in 30 patients, breast conserving in 23 (77%). In an intention-to-treat analysis, tumor and nodal pCR was seen in 14 (47%) patients. Treatment was generally well tolerated. Grade 3/4 neutropenia occurred in 85% of patients while febrile neutropenia was encountered in 18%. Only three patients withdrew prematurely due to toxicity. No symptomatic cardiac dysfunction was reported.

Conclusions: PST with trastuzumab plus docetaxel achieved promising efficacy, with a high pCR rate and good tolerability, in women with stage II or III HER2-positive breast cancer.

Key words: breast cancer, docetaxel, efficacy, neo-adjuvant treatment, safety, trastuzumab


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