title: Intralesional bevacizumab in patients with human immunodeficiency virus-associated Kaposi's sarcoma in the upper airway.
abstract: OBJECTIVE
  The aim of this study was to evaluate the efficacy and safety of intralesional bevacizumab, a monoclonal antibody against vascular endothelial growth factor, in patients with human immunodeficiency virus (HIV)-associated Kaposi's sarcoma of the upper airway receiving antiretroviral therapy.
  
  
  METHODS
  A pilot randomized, open, phase II study.
  
  
  METHODS
  HIV-infected patients with Kaposi's sarcoma lesions of the upper airway in the T0 stage were randomized to receive antiretroviral therapy alone or antiretroviral therapy with intralesional bevacizumab. The primary end point was the assessment of changes in tumor size according to the Response Evaluation Criteria In Solid Tumors (RECIST); the secondary end point was safety.
  
  
  RESULTS
  Of the 14 patients with Kaposi's sarcoma included in the study, seven were assigned to the bevacizumab group and seven to the control group. The median age was 30.5 years (interquartile range [IQR], 24.7-38.2). Four patients (28.5%) had >150 CD4 T cells/mm(3). Nine patients had lesions in the oral cavity; three patients had pharyngeal disease; one patient had laryngeal involvement; and one patient had oral cavity, pharyngeal, and laryngeal involvement. Four patients had complete response (28.5%), two had partial response, six had stable disease, and two had progressive disease. The median time to complete response was 13 weeks (IQR, 7.5-36.5). No statistical differences between groups were observed (P = .124). In the bevacizumab group, one patient had a grade I adverse event, and another patient had a grade II adverse event.
  
  
  CONCLUSIONS
  Intralesional administration of bevacizumab was well tolerated but had no impact on upper respiratory tract Kaposi's sarcoma lesions of HIV-infected patients.
authors.affiliation: Center for Research in Infectious Diseases, National Institute of Respiratory Diseases, Mexico City, Mexico.
authors.forename: Yuria
authors.initials: Y
authors.lastname: Ablanedo-Terrazas
authors.forename: Claudia
authors.initials: C
authors.lastname: Alvarado-de la Barrera
authors.forename: Christopher E
authors.initials: CE
authors.lastname: Ormsby
authors.forename: Matilde
authors.initials: M
authors.lastname: Ruiz-Cruz
authors.forename: Gustavo
authors.initials: G
authors.lastname: Reyes-Terán
mesh_terms: D000328:Adult; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage; D044966:Anti-Retroviral Agents / Q000008:administration & dosage*; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage*; D000068258:Bevacizumab; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D015658:HIV Infections / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D006801:Humans; D015552:Injections, Intralesional; D053208:Kaplan-Meier Estimate; D007822:Laryngeal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000821:virology; D007828:Laryngoscopy / Q000379:methods; D008297:Male; D009062:Mouth Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000821:virology; D010865:Pilot Projects; D018570:Risk Assessment; D012514:Sarcoma, Kaposi / Q000188:drug therapy* / Q000401:mortality / Q000821:virology; D018709:Statistics, Nonparametric; D015996:Survival Rate; D016896:Treatment Outcome; D014827:Vocal Cords / Q000187:drug effects / Q000473:pathology; D055815:Young Adult
chemical_list: D020533:Angiogenesis Inhibitors; D044966:Anti-Retroviral Agents; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab
keywords: Human immunodeficiency virus; Kaposi's sarcoma; bevacizumab; larynx; pharynx