title: Abagovomab as maintenance therapy in patients with epithelial ovarian cancer: a phase III trial of the AGO OVAR, COGI, GINECO, and GEICO--the MIMOSA study.
abstract: OBJECTIVE
  To determine whether abagovomab maintenance therapy prolongs recurrence-free (RFS) and overall survival (OS) in patients with ovarian cancer in first clinical remission.
  
  
  METHODS
  Patients with International Federation of Gynecology and Obstetrics stage III to IV ovarian cancer in complete clinical remission after primary surgery and platinum- and taxane-based chemotherapy were randomly assigned at a ratio of 2:1 in a phase III, double-blind, placebo-controlled, multicenter study. Abagovomab 2 mg or placebo was administered as 1-mL suspension once every 2 weeks for 6 weeks (induction phase) and then once every 4 weeks (maintenance phase) until recurrence or up to 21 months after random assignment of the last patient. The primary end point was RFS; secondary end points were OS and immunologic response.
  
  
  RESULTS
  Characteristics of the 888 patients included: mean age, 56.3 years; Eastern Cooperative Oncology Group performance status, ≤ 1 in > 99% of patients; serous papillary subtype, 81.5%; stage III, 85.9%; and cancer antigen 125 ≤ 35 U/mL after third cycle, 80.9%. Mean exposure to study treatment (± standard deviation) was 449.7 ± 333.08 days. Hazard ratio (HR) of RFS for the treatment group using tumor size categorization (≤ 1 cm, > 1 cm) was 1.099 (95% CI, 0.919 to 1.315; P = .301). HR of OS using tumor size categorization (≤ 1 cm, > 1 cm) was 1.150 (95% CI, 0.872 to 1.518; P = .322). The most frequently reported type of adverse event was an injection site reaction in 445 patients (50.2%), followed by injection site erythema and fatigue in 227 (25.6%) and 212 patients (23.9%), respectively. By the final visit, median anti-anti-idiotypic antibody level was 493,000.0 ng/mL, indicating a robust response.
  
  
  CONCLUSIONS
  Abagovomab administered as repeated monthly injections is safe and induces a measurable immune response. Administration as maintenance therapy for patients with ovarian cancer in first remission does not prolong RFS or OS.
authors.affiliation: Kliniken Essen-Mitte, Germany. sabbatip@mskcc.org
authors.forename: Paul
authors.initials: P
authors.lastname: Sabbatini
authors.forename: Philipp
authors.initials: P
authors.lastname: Harter
authors.forename: Giovanni
authors.initials: G
authors.lastname: Scambia
authors.forename: Jalid
authors.initials: J
authors.lastname: Sehouli
authors.forename: Werner
authors.initials: W
authors.lastname: Meier
authors.forename: Pauline
authors.initials: P
authors.lastname: Wimberger
authors.forename: Klaus H
authors.initials: KH
authors.lastname: Baumann
authors.forename: Christian
authors.initials: C
authors.lastname: Kurzeder
authors.forename: Barbara
authors.initials: B
authors.lastname: Schmalfeldt
authors.forename: David
authors.initials: D
authors.lastname: Cibula
authors.forename: Mariusz
authors.initials: M
authors.lastname: Bidzinski
authors.forename: Antonio
authors.initials: A
authors.lastname: Casado
authors.forename: Andrea
authors.initials: A
authors.lastname: Martoni
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Colombo
authors.forename: Robert W
authors.initials: RW
authors.lastname: Holloway
authors.forename: Luigi
authors.initials: L
authors.lastname: Selvaggi
authors.forename: Andrew
authors.initials: A
authors.lastname: Li
authors.forename: Jose
authors.initials: J
authors.lastname: del Campo
authors.forename: Karel
authors.initials: K
authors.lastname: Cwiertka
authors.forename: Tamas
authors.initials: T
authors.lastname: Pinter
authors.forename: Jan B
authors.initials: JB
authors.lastname: Vermorken
authors.forename: Eric
authors.initials: E
authors.lastname: Pujade-Lauraine
authors.forename: Simona
authors.initials: S
authors.lastname: Scartoni
authors.forename: Monica
authors.initials: M
authors.lastname: Bertolotti
authors.forename: Cecilia
authors.initials: C
authors.lastname: Simonelli
authors.forename: Angela
authors.initials: A
authors.lastname: Capriati
authors.forename: Carlo Alberto
authors.initials: CA
authors.lastname: Maggi
authors.forename: Jonathan S
authors.initials: JS
authors.lastname: Berek
authors.forename: Jacobus
authors.initials: J
authors.lastname: Pfisterer
mesh_terms: D002288:Adenocarcinoma, Mucinous / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D058846:Antibodies, Monoclonal, Murine-Derived; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000077216:Carcinoma, Ovarian Epithelial; D018284:Cystadenocarcinoma, Serous / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D004311:Double-Blind Method; D016889:Endometrial Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D005500:Follow-Up Studies; 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; D011379:Prognosis; D015996:Survival Rate
chemical_list: D000911:Antibodies, Monoclonal; D058846:Antibodies, Monoclonal, Murine-Derived; C518318:abagovomab