Document Detail

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.
MedLine Citation:
PMID:  20113825     Owner:  NLM     Status:  MEDLINE    
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.
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; Jose Baselga
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Publication Detail:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Lancet     Volume:  375     ISSN:  1474-547X     ISO Abbreviation:  Lancet     Publication Date:  2010 Jan 
Date Detail:
Created Date:  2010-02-01     Completed Date:  2010-02-18     Revised Date:  2013-05-08    
Medline Journal Info:
Nlm Unique ID:  2985213R     Medline TA:  Lancet     Country:  England    
Other Details:
Languages:  eng     Pagination:  377-84     Citation Subset:  AIM; IM    
Copyright Information:
Copyright 2010 Elsevier Ltd. All rights reserved.
Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
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MeSH Terms
Adenocarcinoma / drug therapy*,  pathology
Antibodies, Monoclonal / therapeutic use*
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Breast Neoplasms / drug therapy*,  pathology
Chemotherapy, Adjuvant
Combined Modality Therapy
Cyclophosphamide / administration & dosage
Disease-Free Survival
Doxorubicin / administration & dosage
Fluorouracil / administration & dosage
Follow-Up Studies
Genes, erbB-2 / genetics
Infusions, Intravenous
Methotrexate / administration & dosage
Middle Aged
Neoadjuvant Therapy
Paclitaxel / administration & dosage
Proportional Hazards Models
Prospective Studies
Receptor, erbB-2 / drug effects*
Time Factors
Reg. No./Substance:
0/Antibodies, Monoclonal; 0/Antibodies, Monoclonal, Humanized; 23214-92-8/Doxorubicin; 33069-62-4/Paclitaxel; 50-18-0/Cyclophosphamide; 51-21-8/Fluorouracil; 59-05-2/Methotrexate; EC, erbB-2; P188ANX8CK/trastuzumab
Comment In:
Lancet. 2010 Jan 30;375(9712):349-50   [PMID:  20113810 ]

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