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| Content Provider | World Health Organization (WHO)-Global Index Medicus |
|---|---|
| Author | Vazquez, Federico Baronio, Roberta Barton, Claire Valagussa, Pinuccia Tjulandin, Sergey Manikhas, Alexey Eiermann, Wolfgang Feyereislova, Andrea Climent, Miguel Angel Ciruelos, Eva Lluch, Ana Byakhow, Mikhail Mansutti, Mauro Ojeda, Belén Lichinitser, Mikhail Gianni, Luca Bozhok, Alla Baselga, Jose Semiglazov, Vladimir Zambetti, Milvia |
| Description | Author Affiliation: Gianni L ( Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy. luca.gianni@istitutotumori.mi.it) |
| Abstract | BACKGROUND: The monoclonal antibody trastuzumab has survival benefit when given with chemotherapy to patients with early, operable, and metastatic breast cancer that has HER2 (also known as ERBB2) overexpression or amplification. We aimed to assess event-free survival in patients with HER2-positive locally advanced or inflammatory breast cancer receiving neoadjuvant chemotherapy with or without 1 year of trastuzumab. METHODS: We compared 1 year of treatment with trastuzumab (given as neoadjuvant and adjuvant treatment; n=117) with no trastuzumab (118), in women with HER2-positive locally advanced or inflammatory breast cancer treated with a neoadjuvant chemotherapy regimen consisting of doxorubicin, paclitaxel, cyclophosphamide, methotrexate, and fluorouracil. Randomisation was done with a computer program and minimisation technique, taking account of geographical area, disease stage, and hormone receptor status. Investigators were informed of treatment allocation. A parallel cohort of 99 patients with HER2-negative disease was included and treated with the same chemotherapy regimen. Primary endpoint was event-free survival. Analysis was by intention to treat. This study is registered, number ISRCTN86043495. FINDINGS: Trastuzumab significantly improved event-free survival in patients with HER2-positive breast cancer (3-year event-free survival, 71% [95% CI 61-78; n=36 events] with trastuzumab, vs 56% [46-65; n=51 events] without; hazard ratio 0.59 [95% CI 0.38-0.90]; p=0.013). Trastuzumab was well tolerated and, despite concurrent administration with doxorubicin, only two patients (2%) developed symptomatic cardiac failure. Both responded to cardiac drugs. INTERPRETATION: The addition of neoadjuvant and adjuvant trastuzumab to neoadjuvant chemotherapy should be considered for women with HER2-positive locally advanced or inflammatory breast cancer to improve event-free survival, survival, and clinical and pathological tumour responses. FUNDING: F Hoffmann-La Roche. |
| ISSN | 01406736 |
| e-ISSN | 1474547X |
| Journal | The Lancet |
| Issue Number | 9712 |
| Volume Number | 375 |
| Language | English |
| Publisher | Elsevier |
| Publisher Date | 2010-01-30 |
| Publisher Place | Great Britain (UK) |
| Access Restriction | Open |
| Subject Keyword | Adenocarcinoma Drug Therapy Antibodies, Monoclonal Therapeutic Use Antineoplastic Combined Chemotherapy Protocols Breast Neoplasms Receptor, ErbB-2 Drug Effects Pathology Antibodies, Monoclonal, Humanized Chemotherapy, Adjuvant Combined Modality Therapy Cyclophosphamide Administration & Dosage Disease-Free Survival Doxorubicin Fluorouracil Follow-Up Studies Genes, ErbB-2 Genetics Infusions, Intravenous Methotrexate Neoadjuvant Therapy Paclitaxel Proportional Hazards Models Prospective Studies Time Factors Trastuzumab Clinical Trial, Phase III Comparative Study Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't Medicine |
| Content Type | Text |
| Resource Type | Article |
| Subject | Medicine |
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