title: High-dose versus low-dose cisplatin in combination with cyclophosphamide and epidoxorubicin in suboptimal ovarian cancer: a randomized study of the Gruppo Oncologico Nord-Ovest.
abstract: OBJECTIVE
  The aim of the study was to compare high-versus low-dose cisplatin in combination with cyclophosphamide and epidoxorubicin as primary chemotherapy for suboptimal stage III and IV ovarian cancer.
  
  
  METHODS
  One hundred forty-five patients were randomized to receive six courses of cisplatin 50 or 100 mg/m2 plus epidoxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2. The two treatment arms were well balanced; all patients had greater than 2 cm and 37.2% had greater than 5 cm of residual disease; 29.6% had stage IV disease.
  
  
  RESULTS
  Patients in the high-dose arm received a double dose-intensity and double total dose of cisplatin. The high-dose regimen induced significantly more episodes of leukopenia (47.8% v 32.8%, P = .05), thrombocytopenia (21.7% v 3.2%, P = .003), anemia (37.6% v 12.5%, P = .002), nephrotoxicity (six v one patient), and neurotoxicity (30.4% v 6.3%, P = .002). There were no significant differences in efficacy in terms of clinical response rate (high-dose 57.5% v low-dose 61.1%), pathologic complete response (CR) (9.6% v 18.1%), median survival times (29 v 24 months), and median progression-free survival (18 v 13 months).
  
  
  CONCLUSIONS
  This study shows that doubling the dose-intensity and total dose of cisplatin in combination with epidoxorubicin and cyclophosphamide has significant toxic effects and does not improve clinical outcome in patients with suboptimal ovarian cancer.
authors.affiliation: Gruppo Oncologico Nord-Ovest, Pisa, Italy.
authors.forename: P F
authors.initials: PF
authors.lastname: Conte
authors.forename: M
authors.initials: M
authors.lastname: Bruzzone
authors.forename: F
authors.initials: F
authors.lastname: Carnino
authors.forename: A
authors.initials: A
authors.lastname: Gadducci
authors.forename: R
authors.initials: R
authors.lastname: Algeri
authors.forename: A
authors.initials: A
authors.lastname: Bellini
authors.forename: F
authors.initials: F
authors.lastname: Boccardo
authors.forename: I
authors.initials: I
authors.lastname: Brunetti
authors.forename: E
authors.initials: E
authors.lastname: Catsafados
authors.forename: S
authors.initials: S
authors.lastname: Chiara
authors.forename: G
authors.initials: G
authors.lastname: Foglia
authors.forename: L
authors.initials: L
authors.lastname: Gallo
authors.forename: L
authors.initials: L
authors.lastname: Iskra
authors.forename: S
authors.initials: S
authors.lastname: Mammoliti
authors.forename: G
authors.initials: G
authors.lastname: Parodi
authors.forename: N
authors.initials: N
authors.lastname: Ragni
authors.forename: R
authors.initials: R
authors.lastname: Rosso
authors.forename: S
authors.initials: S
authors.lastname: Rugiati
authors.forename: A
authors.initials: A
authors.lastname: Rubagotti
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage; D004334:Drug Administration Schedule; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008875:Middle Aged; D018365:Neoplasm, Residual / Q000188:drug therapy; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D015251:Epirubicin; D003520:Cyclophosphamide; D002945:Cisplatin