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.
abstract: OBJECTIVE
  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%.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Oncology Centre, King Faisal Specialist Hospital and Research Centre, MBC 64, P.O. Box 3354, Riyadh, 11211, Saudi Arabia. ttwegieri@kfshrc.edu.sa.
authors.forename: Taher
authors.initials: T
authors.lastname: A L-Tweigeri
authors.affiliation: Oncology Centre, King Faisal Specialist Hospital and Research Centre, MBC 64, P.O. Box 3354, Riyadh, 11211, Saudi Arabia.
authors.forename: Adher
authors.initials: A
authors.lastname: AlSayed
authors.affiliation: Department of Medicine, Faculty of Medicine, Kuwait University, Kuwait, Kuwait.
authors.forename: Shafika
authors.initials: S
authors.lastname: Alawadi
authors.affiliation: Egypt Atomic Energy Authority, Cairo, Egypt.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Ibrahim
authors.affiliation: Faculty of Medicine, Alminia University, Minya, Egypt.
authors.forename: Wafaa
authors.initials: W
authors.lastname: Ashour
authors.affiliation: Tawam Hospital, AL-Ain, UAE.
authors.forename: Hassan
authors.initials: H
authors.lastname: Jaafar
authors.affiliation: Ministry of National Guard, Health Affairs, Riyadh, Saudi Arabia.
authors.forename: Omalkhair
authors.initials: O
authors.lastname: Abulkhair
authors.affiliation: King Fahad Medical City, Riyadh, Saudi Arabia.
authors.forename: Huda
authors.initials: H
authors.lastname: A L-Abdulkarim
authors.affiliation: Faculty of Medicine, AL-Azhar University, Cairo, Egypt.
authors.forename: Hassan
authors.initials: H
authors.lastname: Khalid
authors.affiliation: Oncology Centre, King Faisal Specialist Hospital and Research Centre, MBC 64, P.O. Box 3354, Riyadh, 11211, Saudi Arabia.
authors.forename: Dahish
authors.initials: D
authors.lastname: Ajarim
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D003520:Cyclophosphamide / Q000627:therapeutic use; D000077143:Docetaxel; D015251:Epirubicin / Q000627:therapeutic use; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D043823:Taxoids / Q000008:administration & dosage; D000068878:Trastuzumab / Q000008:administration & dosage; D016896:Treatment Outcome; D064726:Triple Negative Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D002945:Cisplatin; D003520:Cyclophosphamide; D000077143:Docetaxel; D015251:Epirubicin; D005472:Fluorouracil; D018719:Erb-b2 Receptor Tyrosine Kinases; D043823:Taxoids; D000068878:Trastuzumab
keywords: Anthracycline; Cisplatin/docetaxel; Locally advanced breast cancer; Neoadjuvant chemotherapy; Trastuzumab and pathologic complete response