title: Phase III multicenter trial of doxorubicin plus cyclophosphamide followed by paclitaxel compared with doxorubicin plus paclitaxel followed by weekly paclitaxel as adjuvant therapy for women with high-risk breast cancer.
abstract: OBJECTIVE
  This study compared disease-free survival (DFS) obtained with two different regimens of adjuvant therapy in high-risk breast cancer.
  
  
  METHODS
  Women (who had performance status [PS] of 0 to 1) with operable, histologically confirmed, stage I to III adenocarcinoma of the breast were eligible. Patients had undergone primary surgery with no residual tumor. Treatments were as follows: arm 1 was doxorubicin 60 mg/m(2) plus cyclophosphamide 600 mg/m(2) every 3 weeks for four cycles followed by paclitaxel 175 mg/m(2) every 3 weeks for four cycles (ie, AC-P); and arm 2 was doxorubicin 50 mg/m(2) plus paclitaxel 200 mg/m(2) every 3 weeks for four cycles followed by paclitaxel 80 mg/m(2) weekly for 12 weeks.
  
  
  RESULTS
  Overall, 1,830 patients were enrolled and 1,801 were treated: arm 1 (n = 906; AC-->P) and arm 2 (n = 895; AP-WP). Overall, patients had a PS of 0 (88%), had estrogen receptor and progesterone receptor-positive disease (52%), had one to three positive nodes (46%), and were postmenopausal (57%); the median age was 52 years. Currently, 1,640 patients (90%) are alive. The 6-year DFS was 79% to 80% in both groups. Disease relapse was the cause of death for 83 patients in arm 1 and in 66 patients of arm 2. Overall 6-year survival rates were 82% and 87% in arms 1 and 2, respectively. Reasons for patients being taken off study treatment included toxicity (13% in arm 1 v 20% in arm 2), progressive disease or recurrence (7% v 5%), and consent withdrawn (9% v 8%), respectively. The most frequent toxicities were hematologic, including neutropenia and leukopenia followed by neuropathy, myalgia, nausea, fatigue, headache, arthralgia, and vomiting.
  
  
  CONCLUSIONS
  The results indicate that the AP-WP regimen is an equally effective and tolerable option for the adjuvant treatment of patients with high-risk breast cancer. The substitution of paclitaxel for cyclophosphamide results in comparable effectiveness of the regimen.
authors.affiliation: US Oncology Research, The Woodlands, TX, USA. dloesch@carismpi.com
authors.forename: David
authors.initials: D
authors.lastname: Loesch
authors.forename: F Anthony
authors.initials: FA
authors.lastname: Greco
authors.forename: Neil N
authors.initials: NN
authors.lastname: Senzer
authors.forename: Howard A
authors.initials: HA
authors.lastname: Burris
authors.forename: John D
authors.initials: JD
authors.lastname: Hainsworth
authors.forename: Stephen
authors.initials: S
authors.lastname: Jones
authors.forename: Svetislava J
authors.initials: SJ
authors.lastname: Vukelja
authors.forename: John
authors.initials: J
authors.lastname: Sandbach
authors.forename: Frankie
authors.initials: F
authors.lastname: Holmes
authors.forename: Scot
authors.initials: S
authors.lastname: Sedlacek
authors.forename: John
authors.initials: J
authors.lastname: Pippen
authors.forename: Deborah
authors.initials: D
authors.lastname: Lindquist
authors.forename: Kristi
authors.initials: K
authors.lastname: McIntyre
authors.forename: Joanne L
authors.initials: JL
authors.lastname: Blum
authors.forename: Manuel R
authors.initials: MR
authors.lastname: Modiano
authors.forename: Kristi A
authors.initials: KA
authors.lastname: Boehm
authors.forename: Feng
authors.initials: F
authors.lastname: Zhan
authors.forename: Lina
authors.initials: L
authors.lastname: Asmar
authors.forename: Nicholas
authors.initials: N
authors.lastname: Robert
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; 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; D003520:Cyclophosphamide / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D012307:Risk Factors; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004317:Doxorubicin; D003520:Cyclophosphamide; D017239:Paclitaxel