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
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
© 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
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
![]()
CiteULike
Connotea
Del.icio.us What's this?
This article has been cited by other articles:
![]() |
J. M. Park, M. Terabe, J. C. Steel, G. Forni, Y. Sakai, J. C. Morris, and J. A. Berzofsky Therapy of Advanced Established Murine Breast Cancer with a Recombinant Adenoviral ErbB-2/neu Vaccine Cancer Res., March 15, 2008; 68(6): 1979 - 1987. [Abstract] [Full Text] [PDF] |
||||
![]() |
S. Chia, S. M. Swain, D. R. Byrd, and D. A. Mankoff Locally Advanced and Inflammatory Breast Cancer J. Clin. Oncol., February 10, 2008; 26(5): 786 - 790. [Full Text] [PDF] |
||||
![]() |
A. Saad, R. Beto, J. Abraham, and S. C. Remick Cardiovascular Safety and Toxicity Profile of New Molecularly Targeted Anticancer Agents ASCO Educational Book, January 1, 2008; 2008(1): 428 - 434. [Abstract] [Full Text] [PDF] |
||||
![]() |
L. Arnould, P. Arveux, J. Couturier, M. Gelly-Marty, C. Loustalot, F. Ettore, C. Sagan, M. Antoine, F. Penault-Llorca, B. Vasseur, et al. Pathologic Complete Response to Trastuzumab-Based Neoadjuvant Therapy Is Related to the Level of HER-2 Amplification Clin. Cancer Res., November 1, 2007; 13(21): 6404 - 6409. [Abstract] [Full Text] [PDF] |
||||
![]() |
B. P. Coudert, R. Largillier, L. Arnould, P. Chollet, M. Campone, D. Coeffic, F. Priou, J. Gligorov, X. Martin, V. Trillet-Lenoir, et al. Multicenter Phase II Trial of Neoadjuvant Therapy With Trastuzumab, Docetaxel, and Carboplatin for Human Epidermal Growth Factor Receptor-2 Overexpressing Stage II or III Breast Cancer: Results of the GETN(A)-1 Trial J. Clin. Oncol., July 1, 2007; 25(19): 2678 - 2684. [Abstract] [Full Text] [PDF] |
||||
![]() |
F. Penault-Llorca, C. Abrial, M.-A. Mouret-Reynier, I. Raoelfils, X. Durando, M. Leheurteur, P. Gimbergues, J. Tortochaux, H. Cure, and P. Chollet Achieving Higher Pathological Complete Response Rates in HER-2-Positive Patients With Induction Chemotherapy Without Trastuzumab in Operable Breast Cancer Oncologist, April 1, 2007; 12(4): 390 - 396. [Abstract] [Full Text] [PDF] |
||||




