title: OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer.
abstract: OBJECTIVE
  This randomized, multicenter, blinded, placebo-controlled phase III trial tested the efficacy and safety of bevacizumab (BV) with gemcitabine and carboplatin (GC) compared with GC in platinum-sensitive recurrent ovarian, primary peritoneal, or fallopian tube cancer (ROC).
  
  
  METHODS
  Patients with platinum-sensitive ROC (recurrence ≥ 6 months after front-line platinum-based therapy) and measurable disease were randomly assigned to GC plus either BV or placebo (PL) for six to 10 cycles. BV or PL, respectively, was then continued until disease progression. The primary end point was progression-free survival (PFS) by RECIST; secondary end points were objective response rate, duration of response (DOR), overall survival, and safety.
  
  
  RESULTS
  Overall, 484 patients were randomly assigned. PFS for the BV arm was superior to that for the PL arm (hazard ratio [HR], 0.484; 95% CI, 0.388 to 0.605; log-rank P < .0001); median PFS was 12.4 v 8.4 months, respectively. The objective response rate (78.5% v 57.4%; P < .0001) and DOR (10.4 v 7.4 months; HR, 0.534; 95% CI, 0.408 to 0.698) were significantly improved with the addition of BV. No new safety concerns were noted. Grade 3 or higher hypertension (17.4% v < 1%) and proteinuria (8.5% v < 1%) occurred more frequently in the BV arm. The rates of neutropenia and febrile neutropenia were similar in both arms. Two patients in the BV arm experienced GI perforation after study treatment discontinuation.
  
  
  CONCLUSIONS
  GC plus BV followed by BV until progression resulted in a statistically significant improvement in PFS compared with GC plus PL in platinum-sensitive ROC.
authors.affiliation: Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. aghajanc@mskcc.org
authors.forename: Carol
authors.initials: C
authors.lastname: Aghajanian
authors.forename: Stephanie V
authors.initials: SV
authors.lastname: Blank
authors.forename: Barbara A
authors.initials: BA
authors.lastname: Goff
authors.forename: Patricia L
authors.initials: PL
authors.lastname: Judson
authors.forename: Michael G
authors.initials: MG
authors.lastname: Teneriello
authors.forename: Amreen
authors.initials: A
authors.lastname: Husain
authors.forename: Mika A
authors.initials: MA
authors.lastname: Sovak
authors.forename: Jing
authors.initials: J
authors.lastname: Yi
authors.forename: Lawrence R
authors.initials: LR
authors.lastname: Nycum
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D000068258:Bevacizumab; D000077216:Carcinoma, Ovarian Epithelial; D018450:Disease Progression; D018572:Disease-Free Survival; D004311:Double-Blind Method; D019008:Drug Resistance, Neoplasm; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010534:Peritoneal Neoplasms / Q000188:drug therapy*; D010919:Placebos; D012008:Recurrence
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D010919:Placebos; D000068258:Bevacizumab