title: The potential risk of neoadjuvant chemotherapy in breast cancer patients--results from a prospective randomized trial of the Austrian Breast and Colorectal Cancer Study Group (ABCSG-07).
abstract: OBJECTIVE
  To evaluate the impact that pre- and postoperatively administered chemotherapy with cyclophosphamide, methotrexate and fluorouracil (CMF) and postoperative chemotherapy vs. postoperative chemotherapy alone have on long-term prognosis.
  
  
  METHODS
  The ABCSG conducted a nationwide randomized phase III trial in high-risk endocrine non-responsive breast cancer patients comparing pre- and postoperative chemotherapy containing CMF as preoperative treatment vs. postoperative chemotherapy alone between 1991 and 1999. From 1996 the ABCSG-07 protocol was amended to also allow randomization of high-risk endocrine-responsive patients. Of 423 eligible patients with high-risk primary breast cancer, 203 patients were randomly assigned to preoperatively receive three cycles of CMF (cyclophosphamide, methotrexate, fluorouracil; 600/40/600 mg/m(2)) intravenously on day 1 and 8, while 195 patients received postoperative chemotherapy alone. In both groups, three cycles of CMF were given initially, and another three cycles of CMF were administered in node-negative patients, whereas node-positive patients received three cycles of EC (epirubicin, cyclophosphamide; 70/600 mg/m(2)).
  
  
  RESULTS
  Overall response rate to preoperative chemotherapy with three cycles of CMF was 56.2%; complete pathological response was achieved in 12 patients (5.9%). Recurrence-free survival was significantly better in patients receiving chemotherapy postoperatively (HR 0.7, 0.515-0.955; P = 0.024). No survival difference was observed between the two therapy groups (HR 0.800, 0.563-1.136; P = 0.213).
  
  
  CONCLUSIONS
  Preoperative chemotherapy with CMF has to be considered as insufficient in high-risk breast cancer patients. Delayed surgery and anthracycline-based chemotherapy result in shorter recurrence-free survival but not overall survival.
authors: Department of Gynecology, Innsbruck Medical University, Innsbruck, Austria. susanne.taucher@i-med.ac.at
authors: Susanne
authors: S
authors: Taucher
authors: Guenther G
authors: GG
authors: Steger
authors: Raimund
authors: R
authors: Jakesz
authors: Christoph
authors: C
authors: Tausch
authors: Viktor
authors: V
authors: Wette
authors: Walter
authors: W
authors: Schippinger
authors: Werner
authors: W
authors: Kwasny
authors: Georg
authors: G
authors: Reiner
authors: Richard
authors: R
authors: Greil
authors: Peter
authors: P
authors: Dubsky
authors: Sabine
authors: S
authors: Poestlberger
authors: Joerg
authors: J
authors: Tschmelitsch
authors: Hellmut
authors: H
authors: Samonigg
authors: Michael
authors: M
authors: Gnant
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant / Q000379:methods*; D015179:Colorectal Neoplasms / Q000378:metabolism*; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D008495:Medical Oncology / Q000379:methods; D008727:Methotrexate / Q000008:administration & dosage; D008875:Middle Aged; D011446:Prospective Studies; D012306:Risk; D016896:Treatment Outcome
chemical_list: D003520:Cyclophosphamide; D005472:Fluorouracil; D008727:Methotrexate