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Studies of DOXIL for AIDS-related KS (Pre-HAART). Note: A total of 10 DOXIL studies of varying design were completed for AIDS related KS. Publications of DOXIL for AIDS-related KS (HAART Era). Results of Randomized Studies of Liposomal Anthracyclines.
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Studies of DOXIL for AIDS-related KS(Pre-HAART) Note: A total of 10 DOXIL studies of varying design were completed for AIDS related KS
Results of Randomized Studies of Liposomal Anthracyclines NOTE: # = number; eval. = evaluable; A = Adriamycin (doxorubicin); B = bleomycin; V = vincristine; NS = not significant; NR = not reported. * includes complete and partial responses † this study reported mean survival times of 239 days for DOXIL, versus 160 days for bleomycin and vincristine.
Documentation for ACTG Criteria • Biopsy • Cutaneous lesions • Number • Character (flat or raised) • Tumor-associated edema • 3-5 marker lesions • Bi-dimensional measurement • Visceral lesions • Radiographic evaluation • Bronchoscopy and endoscopy
Clinical Presentation of Patients Treated with DOXIL • Advanced KS with: • No prior HAART • HAART intolerant or failure • Virologic and immunologic response to HAART • Rapid KS progression on starting HAART (IRIS)
Kaposi Sarcoma Incidence AIDS-related KS approval Study 30-38 Source: SEER Cancer Statistics Review, 1975-2002