title: Dexrazoxane cardioprotection in advanced breast cancer patients undergoing high-dose epirubicin treatment.
abstract: OBJECTIVE
  We performed a randomized trial to evaluate the cardioprotective effect of dexrazoxane (DEX) in advanced breast cancer patients (ABC) treated with high single-dose epirubicin (EPI). A secondary objective was to determine the role of radioimmunoscintigraphy (RIS) in the assessment of epirubicin cardiotoxicity.
  
  
  METHODS
  Ninety-five patients with ABC were treated with EPI 160 mg/m2 by i.v. bolus every 3 weeks with or without DEX, 1,000 mg/m2 i.v. Cardiac monitoring included multigated radionuclide (MUGA) scan with determination of resting left ventricular ejection fraction (LVEF), and RIS with 111-Indium antimyosin monoclonal antibodies.
  
  
  RESULTS
  The overall response rate was 69% in the EPI arm and 67% in the EPI + DEX arm; median time to response and median time to progression were identical in both arms, being 2 and 8 months, respectively. Median survival was 19 months versus 29 months (p 0.21), respectively. DEX did not appear to contribute to extracardiac EPI toxicity. Congestive heart failure occurred only in the EPI arm (2 instances). LVEF significantly decreased from baseline only in the EPI group. An abnormal tracer uptake at RIS was observed early in both arms, but the increase in heart to lung ratio was much more evident in the control group.
  
  
  CONCLUSIONS
  DEX significantly protects against the development of high dose epirubicin cardiotoxicity apparently without evidence of an adverse impact on antitumor activity and non cardiac toxicity. RIS is a very sensitive technique in detecting anthracycline cardiac damage, but its specificity is low and cannot be considered alone a primary test for guiding anthracycline treatment.
authors.affiliation: Divisione di Oncologia Medica II, Istituto Regina Elena per lo Studio e la Cura dei Tumori, Roma, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Vici
authors.forename: A
authors.initials: A
authors.lastname: Ferraironi
authors.forename: L
authors.initials: L
authors.lastname: Di Lauro
authors.forename: S
authors.initials: S
authors.lastname: Carpano
authors.forename: F
authors.initials: F
authors.lastname: Conti
authors.forename: F
authors.initials: F
authors.lastname: Belli
authors.forename: G
authors.initials: G
authors.lastname: Paoletti
authors.forename: C L
authors.initials: CL
authors.lastname: Maini
authors.forename: M
authors.initials: M
authors.lastname: Lopez
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000790:Angiocardiography / Q000379:methods; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D015251:Epirubicin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006321:Heart / Q000187:drug effects; D006331:Heart Diseases / Q000139:chemically induced* / Q000000981:diagnostic imaging / Q000517:prevention & control; D006801:Humans; D009367:Neoplasm Staging; D011877:Radionuclide Imaging; D011929:Razoxane / Q000008:administration & dosage*
chemical_list: D000903:Antibiotics, Antineoplastic; D002317:Cardiovascular Agents; D015251:Epirubicin; D011929:Razoxane