• Lancet · Jan 2010

    Randomized Controlled Trial Multicenter Study Comparative Study

    Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort.

    • Luca Gianni, Wolfgang Eiermann, Vladimir Semiglazov, Alexey Manikhas, Ana Lluch, Sergey Tjulandin, Milvia Zambetti, Federico Vazquez, Mikhail Byakhow, Mikhail Lichinitser, Miguel Angel Climent, Eva Ciruelos, Belén Ojeda, Mauro Mansutti, Alla Bozhok, Roberta Baronio, Andrea Feyereislova, Claire Barton, Pinuccia Valagussa, and Jose Baselga.
    • Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy. luca.gianni@istitutotumori.mi.it
    • Lancet. 2010 Jan 30; 375 (9712): 377384377-84.

    BackgroundThe 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.MethodsWe 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.FindingsTrastuzumab 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.InterpretationThe 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.FundingF Hoffmann-La Roche.Copyright 2010 Elsevier Ltd. All rights reserved.

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