ABSTRACT
I. Introduction ............................................................................................................... 257
II. Study Objectives ....................................................................................................... 259
III. Investigational Plan ................................................................................................... 259 A. Study Design ....................................................................................................... 259 B. Drugs, Administration and Duration of Treatment ............................................ 259 C. Patient Population ............................................................................................... 260 D. Plasma Pharmacokinetics ................................................................................... 260 E. Measurement of Doxorubicin and Doxorubicinol in KS Tissue
Biopsies by High Performance Liquid Chromatography (HPLC) .................... 261
IV. Results ....................................................................................................................... 262 A. Patient Demographics ......................................................................................... 262 B. Pharmacokinetics ................................................................................................ 262 C. Safety: Adverse Events ....................................................................................... 263
V. Discussion and Conclusions ...................................................................................... 264 A. Safety .................................................................................................................. 264 B. Pharmacokinetics ................................................................................................ 264 C. Tumor Localization ............................................................................................. 265 D. Conclusions ......................................................................................................... 265
References ........................................................................................................................... 266
Reports of the development of Kaposi' s sarcoma (KS) in previously healthy young homosexual men in 1981 marked the onset of the epidemic of acquired immunodeficiency syndrome (AIDS) in the U.S. 13 KS is the most common neoplasm in patients with human immunodeficiency virus (HIV) infection, having been diagnosed in 15 to 20% of all patients with AIDS in the U.S.4 Although the percentage of AIDS patients developing KS is declining,5 the prevalence continues to rise, and recent studies suggest that patients now being diagnosed with KS have more severe disease and less favorable prognoses than those diagnosed early in the epidemic.6.7
rarely life-threatening; most patients with AIDS and KS ultimately died of opportunistic infections that developed as a result of profound immunodeficiency. More recently, however, patients are developing extensive visceral KS, and dying of systemic disease.7 This may be a consequence of a decrease in deaths due to opportunistic infections.
