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Blood, 15 December 2007, Vol. 110, No. 13, pp. 4165-4171. Prepublished online as a Blood First Edition Paper on September 10, 2007; DOI 10.1182/blood-2007-06-097568. This Article Full Text (PDF) All Versions of this Article: blood-2007-06-097568v1 110/13/4165    most recent Alert me when this article is cited Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Little, R. F. Articles by Yarchoan, R. Search for Related Content PubMed PubMed Citation Articles by Little, R. F. Articles by Yarchoan, R. Social Bookmarking                   What's this?  Previous Article  |  Next Article  Submitted June 22, 2007 Accepted September 6, 2007 Phase II study of pegylated liposomal doxorubicin in combination with interleukin-12 for AIDS-related Kaposi's sarcoma Richard F. Little, Karen Aleman, Pallavi Kumar, Kathleen M. Wyvill, James M. Pluda, Elizabeth Read-Connole, Victoria Wang, Stefania Pittaluga, Andrew T. Catanzaro, Seth M. Steinberg, and Robert Yarchoan* HIV and AIDS Malignancy Branch, Center for Cancer Research, National Cancer Institute, Bethesda, MD, United States Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, Bethesda, MD, United States Biostatistics and Data Management Section, Canter for Cancer, National Cancer Institute, Bethesda, MD, United States * Corresponding author; email: yarchoan{at}helix.nih.gov. Thirty six patients with AIDS-associated Kaposi's sarcoma (KS) requiring chemotherapy were treated for six three-week cycles of pegylated liposomal doxorubicin (20 mg/m2) plus interleukin-12 (IL-12) (300 ng/kg subcutaneously twice weekly), followed by 500 ng/kg subcutaneous IL-12 twice weekly for up to three years. All received highly active antiretroviral therapy (HAART). Twenty-two had poor-prognosis KS (T1S1). Thirty patients had a major response, including nine with complete response, yielding an 83.3% major response rate (95% confidence interval 67.2% to 93.6%). Median time to first response was 2 cycles. Median progression was not reached at median potential follow-up of 46.9 months. Of 27 patients with residual disease when starting maintenance IL-12, 15 had a new major response compared to this new baseline. The regimen was overall well tolerated; principal toxicities were neutropenia, anemia, transaminitis, and neuropsychiatric toxicity. Patients had increases in serum IL-12, interferon gamma, and inducible protein-10 (IP-10), and these remained increased at weeks 18 and 34. The regimen of IL-12 plus liposomal doxorubicin yielded rapid tumor responses and a high response rate in patients with AIDS-KS receiving HAART, and responses were sustained on IL-12 maintenance therapy. A randomized trial of IL-12 in this setting may be warranted. This study is registered at http://www.clinicaltrials.gov as #NCT00020449. CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this?

	Copyright © 2007 by American Society of Hematology         Online ISSN: 1528-0020