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Neoadjuvant treatment with docetaxel plus lapatinib, trastuzumab, or both followed by an anthracycline based chemotherapy in HER2-positive breast cancer: results of the randomised phase II EORTC 10054 study.
MedLine Citation:
PMID:  25467016     Owner:  NLM     Status:  Publisher    
BACKGROUND: Neoadjuvant trials conducted using a double HER2-blockade with lapatinib and trastuzumab, combined with different paclitaxel-containing chemotherapy regimens, have shown high pathological complete response (pCR) rates, but at the cost of important toxicity. We hypothesised that this toxicity might be due to a specific interaction between paclitaxel and lapatinib. This trial assesses the toxicity and activity of the combination of docetaxel with lapatinib and trastuzumab.
PATIENTS AND METHODS: Patients with stage IIA to IIIC HER2-positive breast cancer received six cycles of chemotherapy (three cycles of docetaxel followed by three cycles of fluorouracil, epirubicin, cyclophosphamide). They were randomised 1:1:1 to receive during the first three cycles either lapatinib (1000 mg orally daily), trastuzumab (4 mg/kg loading dose followed by 2 mg/kg weekly), or trastuzumab+lapatinib at the same dose. The primary endpoint was pCR rate defined as ypT0/is. Secondary endpoints included safety and toxicity. pCR rate defined as ypT0/is ypN0 was assessed as an exploratory analysis. In June 2012, arm A was closed for futility based on the results from other studies.
RESULTS: From October 2010 to January 2013, 128 patients were included in 14 centres. The percentage of the 122 evaluable patients with pCR in the breast, and pCR in the breast and nodes, was numerically highest in the lapatinib+trastuzumab group (60% and 56%, respectively), intermediate in the trastuzumab group (52% and 52%), and lowest in the lapatinib group (46% and 36%). Frequency (%) of the most common grade 3-4 toxicities in the lapatinib /trastuzumab/lapatinib+trastuzumab arms were: febrile neutropenia 23/15/10, diarrhea 9/2/18, infection (other) 9/4/8, and hepatic toxicity 0/2/8.
CONCLUSIONS: This study demonstrates a numerically modest pCR rate increase with double anti-HER2 blockade plus chemotherapy, but suggests that the use of docetaxel rather than paclitaxel may not reduce toxicity. This study is registered with, number NCT00450892.
H Bonnefoi; W Jacot; M Saghatchian; C Moldovan; L Venat-Bouvet; K Zaman; E Matos; T Petit; A Bodmer; N Quenel-Tueux; C Chakiba; P Vuylsteke; G Jerusalem; E Brain; O Tredan; C G M Messina; L Slaets; D Cameron
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2014-12-1
Journal Detail:
Title:  Annals of oncology : official journal of the European Society for Medical Oncology / ESMO     Volume:  -     ISSN:  1569-8041     ISO Abbreviation:  Ann. Oncol.     Publication Date:  2014 Dec 
Date Detail:
Created Date:  2014-12-3     Completed Date:  -     Revised Date:  2014-12-4    
Medline Journal Info:
Nlm Unique ID:  9007735     Medline TA:  Ann Oncol     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email:
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