title: A randomized phase II study evaluating the combination of carboplatin-based chemotherapy with pertuzumab versus carboplatin-based therapy alone in patients with relapsed, platinum-sensitive ovarian cancer.
abstract: BACKGROUND
  Pertuzumab, a humanized monoclonal antibody targeting human epidermal growth factor receptor (HER)-mediated signalling, has shown activity in ovarian cancer in preclinical models and in the clinic. This randomized phase II study evaluated efficacy and safety of pertuzumab in combination with carboplatin-based chemotherapy in patients with platinum-sensitive, recurrent advanced ovarian cancer.
  
  
  METHODS
  Patients were randomized to receive six cycles of chemotherapy (carboplatin and either paclitaxel (Taxol) or gemcitabine) with or without pertuzumab. The primary end point was progression-free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumors and/or by CA 125 measurements. Secondary end points evaluated the response rate, safety profile, duration of response, time to progression and overall survival for both treatment arms.
  
  
  RESULTS
  A total of 149 patients received either chemotherapy with pertuzumab (arm A, n=74) or chemotherapy alone (arm B, n=75). There was no significant difference either in median PFS or in the secondary end points between the two arms. No differences were seen in an exploratory biomarker analysis of HER3 mRNA expression between the two arms. Pertuzumab was well tolerated, with no increase in cardiac adverse events compared with chemotherapy alone.
  
  
  CONCLUSIONS
  The addition of pertuzumab to carboplatin-based chemotherapy did not substantially prolong PFS in unselected patients with platinum-sensitive ovarian cancer.
authors.affiliation: CRUK Department of Medical Oncology, The Royal Marsden Hospital and The Institute of Cancer Research, Surrey, UK. stan.kaye@rmh.nhs.uk
authors.forename: S B
authors.initials: SB
authors.lastname: Kaye
authors.forename: C J
authors.initials: CJ
authors.lastname: Poole
authors.forename: A
authors.initials: A
authors.lastname: Dańska-Bidzińska
authors.forename: L
authors.initials: L
authors.lastname: Gianni
authors.forename: G
authors.initials: G
authors.lastname: Del Conte
authors.forename: V
authors.initials: V
authors.lastname: Gorbunova
authors.forename: E
authors.initials: E
authors.lastname: Novikova
authors.forename: A
authors.initials: A
authors.lastname: Strauss
authors.forename: M
authors.initials: M
authors.lastname: Moczko
authors.forename: V A
authors.initials: VA
authors.lastname: McNally
authors.forename: G
authors.initials: G
authors.lastname: Ross
authors.forename: I
authors.initials: I
authors.lastname: Vergote
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D012008:Recurrence
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D016190:Carboplatin; C485206:pertuzumab