title: A phase II study of gemcitabine, carboplatin and bevacizumab for the treatment of platinum-sensitive recurrent ovarian cancer.
abstract: OBJECTIVE
  The doublet gemcitabine and carboplatin is effective for the treatment of recurrent ovarian cancer, while multi-agent chemotherapy with bevacizumab may add additional benefit. This phase II study tested the efficacy and safety of a biweekly gemcitabine, carboplatin, and bevacizumab combination in patients with platinum-sensitive recurrent ovarian, peritoneal, or tubal cancer (ROC).
  
  
  METHODS
  Eligible patients received concurrent gemcitabine 1000 mg/m(2), carboplatin area under the curve 3, and bevacizumab 10 mg/kg administered intravenously on days 1 and 15 every 28 days for six cycles or up to 24 cycles if clinical benefit occurred. The primary end points were progression-free survival (PFS) by RECIST, and safety; the secondary end points were objective response rates and overall survival.
  
  
  RESULTS
  Overall, 45 patients were enrolled. The median PFS was 13.3 months (95% CI, 11.3 to 15.3). The objective response rate was 69%. Grade 4 hematologic toxicities included neutropenia (27%) and thrombocytopenia (2%). Grades 3 and 4 non-hematologic toxicities included fatigue (18%), pain (9%), and nausea/vomiting (4%). There were 2 episodes of cerebrovascular accidents, 2 noted DVTs, and no episodes of bowel perforation. Median OS was 36.1 months (95% CI, 26.7 to 45.5).
  
  
  CONCLUSIONS
  Biweekly gemcitabine, carboplatin, and bevacizumab were an effective regimen in recurrent ovarian cancer, with comparable toxicity to recently reported day 1 gemcitabine, carboplatin, bevacizumab, and day 8 gemcitabine. Response rate and PFS are improved from reported outcomes of the gemcitabine carboplatin doublet. The degree to which biweekly dosing may present a more rationale schedule for this triplet should be evaluated further.
authors.affiliation: Division of Gynecologic Oncology, The Ohio State University College of Medicine, Columbus, OH, USA. Electronic address: eric.eisenhauer@uc.edu.
authors.forename: Eric L
authors.initials: EL
authors.lastname: Eisenhauer
authors.affiliation: Division of Gynaecology, European Institute of Oncology, Milano, Italy.
authors.forename: Vanna
authors.initials: V
authors.lastname: Zanagnolo
authors.affiliation: Division of Gynecologic Oncology, The Ohio State University College of Medicine, Columbus, OH, USA.
authors.forename: David E
authors.initials: DE
authors.lastname: Cohn
authors.affiliation: Division of Gynecologic Oncology, The Ohio State University College of Medicine, Columbus, OH, USA.
authors.forename: Ritu
authors.initials: R
authors.lastname: Salani
authors.affiliation: Division of Gynecologic Oncology, The Ohio State University College of Medicine, Columbus, OH, USA.
authors.forename: David M
authors.initials: DM
authors.lastname: O'Malley
authors.affiliation: Division of Gynecologic Oncology, St. Vincent Indianapolis Hospital, Indianapolis, IN, USA.
authors.forename: Gregory
authors.initials: G
authors.lastname: Sutton
authors.affiliation: Division of Gynecologic Oncology, St. Vincent Indianapolis Hospital, Indianapolis, IN, USA.
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Callahan
authors.affiliation: Division of Gynecologic Oncology, The Ohio State University College of Medicine, Columbus, OH, USA.
authors.forename: Bobbi
authors.initials: B
authors.lastname: Cobb
authors.affiliation: Division of Gynecologic Oncology, The Ohio State University College of Medicine, Columbus, OH, USA.
authors.forename: Jeffrey M
authors.initials: JM
authors.lastname: Fowler
authors.affiliation: Division of Gynecologic Oncology, The Ohio State University College of Medicine, Columbus, OH, USA.
authors.forename: Larry J
authors.initials: LJ
authors.lastname: Copeland
mesh_terms: D000328:Adult; D000368:Aged; D020533:Angiogenesis Inhibitors / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D016190:Carboplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D000093542:Gemcitabine
chemical_list: D020533:Angiogenesis Inhibitors; D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D000068258:Bevacizumab; D016190:Carboplatin; D000093542:Gemcitabine
keywords: Bevacizumab; Chemotherapy; Gemcitabine; Ovarian cancer; Platinum-sensitive; Recurrent