title: Carboplatin and pegylated liposomal doxorubicin for advanced ovarian cancer: preliminary activity results of the MITO-2 phase III trial.
abstract: BACKGROUND
  Based on the efficacy of pegylated liposomal doxorubicin (PLD) in relapsed ovarian cancer, we are conducting a phase III study comparing carboplatin plus either paclitaxel or PLD as first-line therapy in advanced ovarian cancer. Because of limited phase I and II data on PLD plus carboplatin in this setting, we conducted an interim activity analysis.
  
  
  METHODS
  Patients with stage 1c-IV epithelial ovarian cancer were randomized to carboplatin AUC 5 plus either paclitaxel 175 mg/m(2) or PLD 30 mg/m(2) every 3 weeks for 6 cycles. The interim activity analysis was planned according to a single-stage phase II design with an auspicated 50% response rate; 50 patients eligible for response assessment were required. Response was defined according to RECIST (Response Evaluation Criteria in Solid Tumors).
  
  
  RESULTS
  A complete response was achieved in 14 patients (28%) and a partial response in 20 (40%), which produced an overall response rate of 68%. The activity exceeded the minimum required for study continuation. Stable disease was reported in an additional 10 patients (20%).
  
  
  CONCLUSIONS
  The adopted schedule of PLD plus carboplatin demonstrates activity as a first-line treatment for advanced ovarian cancer.
authors.affiliation: Oncologia Medica B, Istituto Nazionale Tumori, Naples, Italy. sandro.pignata@fondazionepascale.it
authors.forename: S
authors.initials: S
authors.lastname: Pignata
authors.forename: G
authors.initials: G
authors.lastname: Scambia
authors.forename: A
authors.initials: A
authors.lastname: Savarese
authors.forename: E
authors.initials: E
authors.lastname: Breda
authors.forename: R
authors.initials: R
authors.lastname: Sorio
authors.forename: C
authors.initials: C
authors.lastname: Pisano
authors.forename: D
authors.initials: D
authors.lastname: Lorusso
authors.forename: F
authors.initials: F
authors.lastname: Cognetti
authors.forename: A
authors.initials: A
authors.lastname: Vernaglia Lombardi
authors.forename: V
authors.initials: V
authors.lastname: Gebbia
authors.forename: P
authors.initials: P
authors.lastname: Scollo
authors.forename: A
authors.initials: A
authors.lastname: Morabito
authors.forename: G
authors.initials: G
authors.lastname: Signoriello
authors.forename: F
authors.initials: F
authors.lastname: Perrone
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D019540:Area Under Curve; D016190:Carboplatin / Q000008:administration & dosage / Q000627:therapeutic use*; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage / Q000627:therapeutic use*; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D000970:Antineoplastic Agents; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D016190:Carboplatin; D017239:Paclitaxel