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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 1/2016

01-01-2016 | Original Article

A multicenter prospective phase II trial of neoadjuvant epirubicin, cyclophosphamide, and 5-fluorouracil (FEC100) followed by cisplatin–docetaxel with or without trastuzumab in locally advanced breast cancer

Authors: Taher AL-Tweigeri, Adher AlSayed, Shafika Alawadi, Mohamed Ibrahim, Wafaa Ashour, Hassan Jaafar, Omalkhair Abulkhair, Huda AL-Abdulkarim, Hassan Khalid, Dahish Ajarim, Gulf Oncology Research Group (GORG-001)

Published in: Cancer Chemotherapy and Pharmacology | Issue 1/2016

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Abstract

Purpose

To evaluate the efficacy and safety profile of the (FEC100) followed by cisplatin/docetaxel with and without trastuzumab as primary chemotherapy for patients with locally advanced breast cancer (LABC).

Methods

Eighty patients with LABC (T2–T4, N0–N2, M0) were enrolled to receive 24 weeks of neoadjuvant chemotherapy using epirubicin, cyclophosphamide, and 5-fluorouracil (FEC100) followed by cisplatin and docetaxel, plus trastuzumab if HER2 positive. The primary endpoint was pathologic complete response (pCR) in breast and axilla in separate HER2-negative and HER2-positive cohort.

Results

Eighty patients were evaluable for analysis of which 51 were HER2 negative and 29 HER2 positive: median age: 43 years, premenopausal: 82 %, median tumor size: 7.0 cm (4–10), stage IIB: 25 % and IIIA/IIIB: 75 %, both ER/PR positive: 56 %, HER2 positive (3+) by IHC staining: 36 %. Clinical complete response was seen in 48 %, and clinical partial response was seen in 52 %. Overall the pathologic complete response (pCR) was 36 % in breast, 64 % in axilla, and 32 % in both breast and axilla. Analysis of pCR in breast and axilla, as a function of the hormonal receptor (HR) and HER2, was as follows: HR+/HER2−: 11 %; HR+/HER+: 56 %; HR−/HER2−: 36 %; HR−/HER2+: 62 %.

Conclusion

In this series of locally advanced breast cancer, the combination of (FEC100) followed by cisplatin/docetaxel with and without trastuzumab was very active obtaining an impressive rate of pCR, particularly in HER2-positive and triple negative disease, which merits further investigation.
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Metadata
Title
A multicenter prospective phase II trial of neoadjuvant epirubicin, cyclophosphamide, and 5-fluorouracil (FEC100) followed by cisplatin–docetaxel with or without trastuzumab in locally advanced breast cancer
Authors
Taher AL-Tweigeri
Adher AlSayed
Shafika Alawadi
Mohamed Ibrahim
Wafaa Ashour
Hassan Jaafar
Omalkhair Abulkhair
Huda AL-Abdulkarim
Hassan Khalid
Dahish Ajarim
Gulf Oncology Research Group (GORG-001)
Publication date
01-01-2016
Publisher
Springer Berlin Heidelberg
Published in
Cancer Chemotherapy and Pharmacology / Issue 1/2016
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-015-2906-5

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