title: First-line treatment of advanced ovarian cancer with paclitaxel/carboplatin with or without epirubicin (TEC versus TC)--a gynecologic cancer intergroup study of the NSGO, EORTC GCG and NCIC CTG.
abstract: BACKGROUND
  The addition of anthracyclines to platinum-based chemotherapy may provide benefit in survival in ovarian cancer patients. We evaluated the effect on survival of adding epirubicin to standard carboplatin and paclitaxel.
  
  
  METHODS
  We carried out a prospectively randomized phase III study comparing carboplatin plus paclitaxel (TC; area under the curve 5 and 175 mg/m(2)) with the same combination and epirubicin (TEC; 75 mg/m(2) i.v.). Between March 1999 and August 2001, 887 patients with epithelial ovarian, tubal or peritoneal cancer International Federation of Gynecology and Obstetrics stages IIB-IV were randomized to receive either TC (442 patients) or TEC (445 patients).
  
  
  RESULTS
  Median time to progression was 16.4 months in the TEC arm and 16.0 months in the TC arm (hazard ratio 0.99; 95% confidence interval [CI]: 0.9-1.2). Median overall survival time was 42.4 months for the TEC arm and 40.2 for the TC arm (hazard ratio 0.96; 95% CI: 0.8-1.1). Grade 3/4 hematologic toxic effects and most grade 3/4 non-hematologic toxic effects were more frequent in the TEC arm. Accordingly, a quality-of-life analysis showed inferiority of TEC versus TC.
  
  
  CONCLUSIONS
  The addition of epirubicin to standard carboplatin and paclitaxel treatment did not improve survival in patients with advanced ovarian, tubal or peritoneal cancer.
authors.affiliation: Department of Gynecological Cancer, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
authors.forename: K
authors.initials: K
authors.lastname: Lindemann
authors.affiliation: Department of Medical Statistics, University of Southern Denmark, Odense, Denmark.
authors.forename: R D
authors.initials: RD
authors.lastname: Christensen
authors.affiliation: Department of Obstetrics and Gynecology, University Hospital Leuven, Leuven, Belgium.
authors.forename: I
authors.initials: I
authors.lastname: Vergote
authors.affiliation: Department of Gynecologic Oncology, University of British Columbia, Vancouver, Canada.
authors.forename: G
authors.initials: G
authors.lastname: Stuart
authors.affiliation: Institute of Oncology, Catalán Hospital, Catalania, Spain.
authors.forename: M A
authors.initials: MA
authors.lastname: Izquierdo
authors.affiliation: Department of Gynecological Cancer, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway.
authors.forename: J
authors.initials: J
authors.lastname: Kærn
authors.affiliation: Department of Oncology, Herlev University Hospital, Herlev, Denmark.
authors.forename: H
authors.initials: H
authors.lastname: Havsteen
authors.affiliation: Department of Oncology, Queen's University, Kingston, Ontario, Canada.
authors.forename: E
authors.initials: E
authors.lastname: Eisenhauer
authors.affiliation: Department of Gynecologic Oncology, Lund University Hospital, Lund, Sweden.
authors.forename: M
authors.initials: M
authors.lastname: Ridderheim
authors.affiliation: Department of Gynecologic Oncology, Queen Elizabeth Hospital, Gateshead, UK.
authors.forename: A B
authors.initials: AB
authors.lastname: Lopez
authors.affiliation: Department of Oncology, Division of Medical Oncology, Juravinski Cancer Centre, Hamilton, Ontario, Canada.
authors.forename: H
authors.initials: H
authors.lastname: Hirte
authors.affiliation: Department of Oncology, Karolinska University Hospital, Stockholm, Sweden.
authors.forename: E
authors.initials: E
authors.lastname: Aavall-Lundquvist
authors.affiliation: Department of Oncology, University Hospital, Split, Croatia.
authors.forename: E
authors.initials: E
authors.lastname: Vrdoljak
authors.affiliation: Department of Oncology, Clatterbridge Hospital, Wirral, UK.
authors.forename: J
authors.initials: J
authors.lastname: Green
authors.affiliation: Department of Gynecological Cancer, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway; Department of Gynecological Cancer, Institute for Medical Informatics, Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway. Electronic address: gunnar.b.kristensen@gmail.com.
authors.forename: G B
authors.initials: GB
authors.lastname: Kristensen
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D017239:Paclitaxel / Q000008:administration & dosage; D010349:Patient Compliance; D011446:Prospective Studies; D011788:Quality of Life; D016019:Survival Analysis
chemical_list: D015251:Epirubicin; D016190:Carboplatin; D017239:Paclitaxel