title: Phase II study of bevacizumab with liposomal doxorubicin for patients with platinum- and taxane-resistant ovarian cancer.
abstract: BACKGROUND
  Suppression of neoangiogenesis and pegylated liposomal doxorubicin (PLD) each contribute to the management of platinum-resistant/refractory ovarian cancer. The aim of this study is to test the combination of bevacizumab and PLD in women with resistant or refractory ovarian cancer.
  
  
  METHODS
  Eligibility criteria were no more than two prior treatments with platinum-containing regimens and one additional regimen, without anthracyclines. Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m(2)). The primary end point was progression-free survival (PFS) at 6 months; the secondary end points included side-effects, overall response rates (ORR) and survival (OS).
  
  
  RESULTS
  Forty-six patients were enrolled. The average number of courses administered was 7. The median PFS was 6.6 months (range 1-24.6 months) according to Gynecologic Cancer Intergroup Committee (GCIC) criteria and 7.8 months (range 2-13.3 months) according to Response Evaluation Criteria in Solid Tumors (RECIST). The median OS was 33.2 months (range 3-37.5+ months). The ORR was 30.2% [95% confidence interval (CI) 17.2-46.1] and the clinical benefit rate (CBR) was 86.1% (95% CI 72.1-94.7). Adverse events included mucosal and dermal erosions (30% grade 3) and asymptomatic cardiac dysfunction. Additional toxic effects included hypertension, headache, renal dysfunction and proteinuria, wound healing delay, and one episode each of central nervous system (CNS) ischemia and hemolytic uremic syndrome.
  
  
  CONCLUSIONS
  PLD with bevacizumab has improved activity in recurrent ovarian cancer with increased toxicity.
authors.affiliation: Department of Hematology/Oncology, University of Vermont Cancer Center, Burlington. Electronic address: claire.verschraegen@vtmednet.org.
authors.forename: C F
authors.initials: CF
authors.lastname: Verschraegen
authors.affiliation: Departments of Obstetrics and Gynecology, New York University Cancer Institute, New York.
authors.forename: S
authors.initials: S
authors.lastname: Czok
authors.affiliation: Departments of Gynecologic Oncology, USA.
authors.forename: C Y
authors.initials: CY
authors.lastname: Muller
authors.affiliation: Departments of Obstetrics and Gynecology, New York University Cancer Institute, New York.
authors.forename: L
authors.initials: L
authors.lastname: Boyd
authors.affiliation: Departments of Mathematics, USA.
authors.forename: S J
authors.initials: SJ
authors.lastname: Lee
authors.affiliation: Departments of Gynecologic Oncology, USA.
authors.forename: T
authors.initials: T
authors.lastname: Rutledge
authors.affiliation: Departments of Obstetrics and Gynecology, New York University Cancer Institute, New York.
authors.forename: S
authors.initials: S
authors.lastname: Blank
authors.affiliation: Departments of Obstetrics and Gynecology, New York University Cancer Institute, New York.
authors.forename: B
authors.initials: B
authors.lastname: Pothuri
authors.affiliation: Radiology, University of New Mexico Cancer Center, Albuquerque, USA.
authors.forename: S
authors.initials: S
authors.lastname: Eberhardt
authors.affiliation: Departments of Medicine, New York University Cancer Institute, New York.
authors.forename: F
authors.initials: F
authors.lastname: Muggia
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D000068258:Bevacizumab; D001952:Bridged-Ring Compounds / Q000494:pharmacology; D000077216:Carcinoma, Ovarian Epithelial; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000009:adverse effects / Q000627:therapeutic use*; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000401:mortality*; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality*; D010984:Platinum / Q000494:pharmacology; D043823:Taxoids / Q000494:pharmacology; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D000903:Antibiotics, Antineoplastic; D061067:Antibodies, Monoclonal, Humanized; D001952:Bridged-Ring Compounds; D043823:Taxoids; C080625:taxane; D000068258:Bevacizumab; D010984:Platinum; D004317:Doxorubicin