title: Safety Analysis of Adjuvant Chemotherapy with Docetaxel Administered with or without Anthracyclines to Early Stage Breast Cancer Patients: Combined Results from the Asia- Pacific Breast Initiatives I and II.
abstract: BACKGROUND
  The Asia-Pacific Breast Initiatives (APBI) I and II registries were established to collect safety data for patients with early stage breast cancer receiving adjuvant docetaxel-based regimens in the Asia-Pacific region.
  
  
  METHODS
  Data from the two registries were combined to perform a safety analysis. Participants in the registry were women with early stage operable breast cancer with an intermediate or high risk of recurrence. These women received adjuvant chemotherapy that included docetaxel between 2006 and 2011. Adverse events (AEs) were recorded and analyzed.
  
  
  RESULTS
  Data were collected from 3,224 patients from 13 countries. The mean dose intensity of docetaxel was 24.1, 22.7, 25.1 mg/m2/week among patients receiving docetaxel-based monotherapy, combination therapy and sequential therapy, respectively. Granulocyte colony-stimulating factor (G-CSF) was given with docetaxel to 41.8% of women and 20.6% of women receiving prophylactic antibiotics. Adverse events were reported in 86% of patients (anthracycline-containing regimens vs. non-anthracycline regimens; 87% vs. 80%). The most common adverse events were alopecia, nausea, neutropenia, vomiting, and myalgia. Adverse events NCI CTCAE ≥Grade 3 were reported in 45.4% of patients. Serious adverse events were reported in 13% of patients, of which 2.5% led to study discontinuation. Forty-six deaths (1.4%) were reported, with no significant difference between regimens.
  
  
  CONCLUSIONS
  The safety parameters of adjuvant docetaxel therapy used to treat sequential Asian women were comparable to those reported in clinical trials evaluating the role of adjuvant docetaxel. No unusual adverse events linked to Asia-Pacific region patients were observed.
authors.affiliation: Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea E-mail : sbkim3@amc.seoul.kr.
authors.forename: Sung Bae
authors.initials: SB
authors.lastname: Kim
authors.forename: Ahmed
authors.initials: A
authors.lastname: Sayeed
authors.forename: Antonio H
authors.initials: AH
authors.lastname: Villalon
authors.forename: Zhen Zhou
authors.initials: ZZ
authors.lastname: Shen
authors.forename: Tsz Kok
authors.initials: TK
authors.lastname: Yau
authors.forename: Mazhar Ali
authors.initials: MA
authors.lastname: Shah
authors.forename: Meng Feng
authors.initials: MF
authors.lastname: Hou
authors.forename: Tran Van
authors.initials: TV
authors.lastname: Thuan
authors.forename: Duc Nguyen
authors.initials: DN
authors.lastname: Ba
authors.forename: Tsu-Yi
authors.initials: TY
authors.lastname: Chao
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008137:Longitudinal Studies; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D012449:Safety; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D004317:Doxorubicin; C027260:pirarubicin