title: Five-year update of an expanded phase II study of dose-dense and -intense doxorubicin, paclitaxel and cyclophosphamide (ATC) in high-risk breast cancer.
abstract: OBJECTIVE
  This study evaluated the safety and efficacy of dose-dense and -intense sequential doxorubicin (A), paclitaxel (T) and cyclophosphamide (C) as adjuvant therapy for breast cancer (BC) with >or=4 ipsilateral axillary lymph nodes.
  
  
  METHODS
  Patients were recruited after BC surgery if >or=4 axillary nodes were involved by metastatic cancer. Planned treatment was A 90 mg/m(2) three times every 14 days (q14d x 3), T 250 mg/m(2) q14d x 3 and C 3 g/m(2) q14d x 3 combined with filgrastim support.
  
  
  RESULTS
  The study enrolled 85 eligible patients. The median number of lymph nodes involved was 9. Mean dose intensity was >94% of planned for each drug. Common grade 3 toxicities included nausea and/or vomiting (24%), mucositis (18%), neuropathy (16%), palmar-plantar erythrodysesthesia (12%), myalgia (6%) and arthralgia (6%). Grade 3/4 neutropenia occurred in 77 (91%) patients, and 32 (38%) patients had neutropenic fever. One patient developed acute leukemia. Sixty-nine (81%) patients are alive, and 59 (69%) patients are alive and free of distant disease at a median follow-up of 5 years.
  
  
  CONCLUSIONS
  ATC is a feasible regimen for adjuvant therapy of high-risk BC, with a relatively low rate of relapse at the 5-year follow up.
authors.affiliation: Jersey Shore University Medical Center, Neptune, N.J., USA.
authors.forename: Maysa M
authors.initials: MM
authors.lastname: Abu-Khalaf
authors.forename: Stephen
authors.initials: S
authors.lastname: Windsor
authors.forename: Keita
authors.initials: K
authors.lastname: Ebisu
authors.forename: Saritha
authors.initials: S
authors.lastname: Salikooti
authors.forename: Gowri
authors.initials: G
authors.lastname: Ananthanarayanan
authors.forename: Gina G
authors.initials: GG
authors.lastname: Chung
authors.forename: Michael P
authors.initials: MP
authors.lastname: DiGiovanna
authors.forename: Bruce G
authors.initials: BG
authors.lastname: Haffty
authors.forename: Martin
authors.initials: M
authors.lastname: Abrams
authors.forename: Leonard R
authors.initials: LR
authors.lastname: Farber
authors.forename: Arlene D
authors.initials: AD
authors.lastname: Hsu
authors.forename: Michael
authors.initials: M
authors.lastname: Reiss
authors.forename: Daniel
authors.initials: D
authors.lastname: Zelterman
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Burtness
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D003520:Cyclophosphamide / Q000008:administration & dosage*; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage*; D013997:Time Factors
chemical_list: D004317:Doxorubicin; D003520:Cyclophosphamide; D017239:Paclitaxel