Activity of thalidomide in AIDS-related Kaposi's sarcoma and correlation with HHV8 titre.
A phase II study of thalidomide was conducted to evaluate its efficacy and toxicity in the treatment of cutaneous AIDS-related Kaposi's sarcoma (AIDS-KS). To evaluate whether clinical response is correlated with titre of human herpesvirus 8 (HHV8) DNA in peripheral blood, levels were determined by serial end-point dilution at enrolment and 4-6 weeks later. Seventeen male HIV-seropositive patients with histopathologically diagnosed KS were treated with thalidomide 100mg orally once nightly for 8 weeks. Response evaluation was performed using AIDS Clinical Trials Group (ACTG) criteria and analysis was by intention to treat. Six of 17 patients achieved a partial response (35%: 95% confidence interval 10-61%). Eight patients withdrew (6 owing to toxicity, one to early progression and one to non-compliance). HHV8 DNA load decreased by at least 3log10 to undetectable levels in 3 of the 5 virologically assessable partial responders. This preliminary study demonstrates that thalidomide has activity in the treatment of AIDS-KS and that clinical response is associated with a reduction of HHV8 DNA titre in peripheral blood.
Fife
K
K
Medical Oncology Unit, Charing Cross Hospital, London, UK. k.fife@cxwms.ac.uk
Howard
M R
MR
Gracie
F
F
Phillips
R H
RH
Bower
M
M
D017088:AIDS-Related Opportunistic Infections / Q000188:drug therapy*; D000328:Adult; D003879:Dermatologic Agents / Q000627:therapeutic use*; D019288:Herpesvirus 8, Human / Q000187:drug effects*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016133:Polymerase Chain Reaction; D012514:Sarcoma, Kaposi / Q000188:drug therapy*; D013792:Thalidomide / Q000627:therapeutic use*
D003879:Dermatologic Agents; D013792:Thalidomide