title: Randomized, placebo-controlled study of oregovomab for consolidation of clinical remission in patients with advanced ovarian cancer.
abstract: OBJECTIVE
  To assess oregovomab as consolidation treatment of advanced ovarian cancer and refine the immunotherapeutic strategy for subsequent study.
  
  
  METHODS
  Patients with stage III/IV ovarian cancer who had a complete clinical response to primary treatment were randomly assigned to oregovomab or placebo administered at weeks 0, 4, and 8, and every 12 weeks up to 2 years or until recurrence. The primary end-point was time to relapse (TTR).
  
  
  RESULTS
  One hundred forty-five patients were treated with oregovomab (n = 73) or placebo (n = 72). For the population overall, median TTR was not different between treatments at 13.3 months for oregovomab and 10.3 months for placebo (P =.71). Immune responses were induced in most actively treated patients. This was associated with prolonged TTR. Quality of life was not adversely impacted by treatment. Adverse events were reported with similar frequency in oregovomab and placebo groups, indicating a benign safety profile. A long-term survival follow-up is ongoing. Cox analysis of relapse data identified significant factors: performance status, CA-125 before third cycle, and baseline CA-125. Further evaluation identified a subpopulation with favorable prognostic indicators designated as the successful front-line therapy (SFLT) population. For the SFLT population, TTR was 24.0 months in the oregovomab group compared with 10.8 months for placebo (unadjusted hazard ratio of 0.543 [95% CI, 0.287 to 1.025]), a hypothesis-generating observation.
  
  
  CONCLUSIONS
  Consolidation therapy with oregovomab did not significantly improve TTR overall. A set of confirmatory phase III studies has been initiated to determine whether the SFLT population derives benefit from oregovomab treatment.
authors.affiliation: David Geffen School of Medicine at UCLA, Division of Gynecologic Oncology, University of California at Los Angeles, CA 90095-1740, USA. jberek@mednet.ucla.edu
authors.forename: Jonathan S
authors.initials: JS
authors.lastname: Berek
authors.forename: Peyton T
authors.initials: PT
authors.lastname: Taylor
authors.forename: Alan
authors.initials: A
authors.lastname: Gordon
authors.forename: Mary J
authors.initials: MJ
authors.lastname: Cunningham
authors.forename: Neil
authors.initials: N
authors.lastname: Finkler
authors.forename: James
authors.initials: J
authors.lastname: Orr
authors.forename: Saul
authors.initials: S
authors.lastname: Rivkin
authors.forename: Birgit C
authors.initials: BC
authors.lastname: Schultes
authors.forename: Theresa L
authors.initials: TL
authors.lastname: Whiteside
authors.forename: Christopher F
authors.initials: CF
authors.lastname: Nicodemus
mesh_terms: D000328:Adult; D000368:Aged; D000906:Antibodies / Q000032:analysis; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents / Q000627:therapeutic use; D018394:CA-125 Antigen / Q000032:analysis / Q000276:immunology*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D010051:Ovarian Neoplasms / Q000276:immunology / Q000628:therapy*; D010919:Placebos
chemical_list: D000906:Antibodies; D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; D000970:Antineoplastic Agents; D018394:CA-125 Antigen; D010919:Placebos; C107428:oregovomab