OBJECTIVES/HYPOTHESIS: 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. STUDY DESIGN: 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.
RCT Entities:
OBJECTIVES/HYPOTHESIS: 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. STUDY DESIGN: A pilot randomized, open, phase II study. METHODS:HIV-infectedpatients 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-infectedpatients.
Authors: Anthony B Eason; Sang-Hoon Sin; Mohsin Shah; Hong Yuan; Douglas J Phillips; Miriam Droste; Abdijapar Shamshiev; Dirk P Dittmer Journal: PLoS One Date: 2020-05-14 Impact factor: 3.240