title: Phase II trial with dose titration of paclitaxel for the therapy of human immunodeficiency virus-associated Kaposi's sarcoma.
abstract: OBJECTIVE
  To investigate the antitumor activity and safety of paclitaxel in patients with advanced human immunodeficiency virus (HIV)-associated Kaposi's sarcoma (KS).
  
  
  METHODS
  Twenty-nine patients with advanced HIV-associated KS were enrolled. The patients were overall quite immunosuppressed (median CD4 count, 15 cells/microL). Paclitaxel was initially administered at 135 mg/m2 over 3 hours every 3 weeks without filgrastim support; the dose was increased as tolerated to a maximum of 175 mg/m2. Patients who failed to respond or progressed could then receive filgrastim support or paclitaxel administered over 96 hours.
  
  
  RESULTS
  Of 28 assessable patients, 20 had major responses (18 partial responses [PRs], one clinical complete response [CR], and one CR), for a major response rate of 71.4% (95% confidence interval [CI], 51.3% to 86.8%). Each of the five patients with pulmonary KS responded, as did all four assessable patients who had previously received anthracycline therapy for KS. Of six patients who went on to receive a 96-hour infusion of paclitaxel, five had major responses. Neutropenia was the most frequent dose-limiting toxicity; possible novel toxicities included late fevers, late rash, and eosinophilia. Two patients developed an elevated creatinine concentration and one cardiomyopathy.
  
  
  CONCLUSIONS
  Paclitaxel has substantial activity against advanced HIV-associated KS as a single agent, even in patients with pulmonary involvement or who had previously received anthracyclines. Further research is needed to define the optimal treatment schedule and its role vis-a-vis the other available therapies for this disease.
authors.affiliation: HIV and AIDS Malignancy Branch, National Cancer Institute; the Warren G. Magnuson Clinical Center, Bethesda, MD 20892-1906, USA.
authors.forename: L
authors.initials: L
authors.lastname: Welles
authors.forename: M W
authors.initials: MW
authors.lastname: Saville
authors.forename: J
authors.initials: J
authors.lastname: Lietzau
authors.forename: J M
authors.initials: JM
authors.lastname: Pluda
authors.forename: K M
authors.initials: KM
authors.lastname: Wyvill
authors.forename: I
authors.initials: I
authors.lastname: Feuerstein
authors.forename: W D
authors.initials: WD
authors.lastname: Figg
authors.forename: R
authors.initials: R
authors.lastname: Lush
authors.forename: J
authors.initials: J
authors.lastname: Odom
authors.forename: W H
authors.initials: WH
authors.lastname: Wilson
authors.forename: M T
authors.initials: MT
authors.lastname: Fajardo
authors.forename: R W
authors.initials: RW
authors.lastname: Humphrey
authors.forename: E
authors.initials: E
authors.lastname: Feigal
authors.forename: D
authors.initials: D
authors.lastname: Tuck
authors.forename: S M
authors.initials: SM
authors.lastname: Steinberg
authors.forename: S
authors.initials: S
authors.lastname: Broder
authors.forename: R
authors.initials: R
authors.lastname: Yarchoan
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000150:complications; D000328:Adult; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000627:therapeutic use*; D011336:Probability; D011994:Recombinant Proteins; D012074:Remission Induction; D012514:Sarcoma, Kaposi / Q000188:drug therapy* / Q000209:etiology; D016019:Survival Analysis
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D017239:Paclitaxel; D000069585:Filgrastim