title: Doxorubicin-paclitaxel: a safe regimen in terms of cardiac toxicity in metastatic breast carcinoma patients. Results from a European Organization for Research and Treatment of Cancer multicenter trial.
abstract: BACKGROUND
  The potential cardiotoxicity of the doxorubicin-paclitaxel regimen, when paclitaxel is given shortly after the end of the anthracycline infusion, is an issue of concern, as suggested by small single institution Phase II studies.
  
  
  METHODS
  In a large multicenter Phase III trial, 275 anthracycline naive metastatic breast carcinoma patients were randomized to receive either doxorubicin (60 mg/m(2)) followed 30 minutes later by paclitaxel (175 mg/m(2) 3-hour infusion; AT) or a standard doxorubicin-cyclophosphamide regimen (AC; 60/600 mg/m(2)). Both treatments were given once every 3 weeks for a maximum of six cycles. Close cardiac monitoring was implemented in the study design.
  
  
  RESULTS
  Congestive heart failure (CHF) occurred in three patients in the AT arm and in one patient in the AC arm (P = 0.62). Decreases in left ventricular ejection fraction to below the limit of normal were documented in 33% AT and 19% AC patients and were not predictive of CHF development.
  
  
  CONCLUSIONS
  AT is devoid of excessive cardiac risk among metastatic breast carcinoma patients, when the maximum planned cumulative dose of doxorubicin does not exceed 360 mg/m(2).
authors.affiliation: IDBBC Unit, EORTC-IDBBC, Jules Bordet Institute, Boulevard de Waterloo 121, 7th floor, 1000 Brussels, Belgium. laura.biganzoli@bordet.be
authors.forename: Laura
authors.initials: L
authors.lastname: Biganzoli
authors.forename: Tanja
authors.initials: T
authors.lastname: Cufer
authors.forename: Peter
authors.initials: P
authors.lastname: Bruning
authors.forename: Robert E
authors.initials: RE
authors.lastname: Coleman
authors.forename: Luc
authors.initials: L
authors.lastname: Duchateau
authors.forename: Bernardo
authors.initials: B
authors.lastname: Rapoport
authors.forename: Marianne
authors.initials: M
authors.lastname: Nooij
authors.forename: François
authors.initials: F
authors.lastname: Delhaye
authors.forename: D
authors.initials: D
authors.lastname: Miles
authors.forename: Aaron
authors.initials: A
authors.lastname: Sulkes
authors.forename: A
authors.initials: A
authors.lastname: Hamilton
authors.forename: Martine
authors.initials: M
authors.lastname: Piccart
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003520:Cyclophosphamide / Q000008:administration & dosage; D018450:Disease Progression; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006321:Heart / Q000187:drug effects*; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D012307:Risk Factors; D012449:Safety; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D004317:Doxorubicin; D003520:Cyclophosphamide; D017239:Paclitaxel