title: Paclitaxel is safe and effective in the treatment of advanced AIDS-related Kaposi's sarcoma.
abstract: OBJECTIVE
  Liposomal anthracyclines are the present standard treatment for advanced AIDS-related Kaposi's sarcoma (KS). No effective therapies have been defined for use after treatment failure of these agents. A phase II trial was thus conducted with paclitaxel in patients with advanced KS to assess safety and antitumor activity.
  
  
  METHODS
  A regimen of paclitaxel at a dose of 100 mg/m(2) was given every 2 weeks to patients with advanced AIDS-related KS. Patients were treated until complete remission, disease progression, or unacceptable toxicity occurred.
  
  
  RESULTS
  Fifty-six patients with advanced AIDS-related KS were accrued. Tumor-associated edema was present in 70% of patients and visceral involvement in 45%. Forty patients (71%) had received prior systemic therapy; 31 of these were resistant to an anthracycline. The median entry CD4(+) lymphocyte count was 20 cells/mm(3) (range, 0 to 358). A median of 10 cycles (range, 1 to 54+) of paclitaxel was administered. Fifty-nine percent of patients showed complete (n = 1) or partial response (n = 32) to paclitaxel. The median duration of response was 10.4 months (range, 2.8 to 26.7+ months) and the median survival was 15.4 months. The main side effects of therapy were grade 3 or 4 neutropenia in 61% of patients and mild-to-moderate alopecia in 87%.
  
  
  CONCLUSIONS
  Paclitaxel at 100 mg/m(2) given every 2 weeks is active and well tolerated in the treatment of advanced and previously treated AIDS-related KS. The median duration of response is among the longest observed for any regimen or single agent reported for AIDS-related KS. Paclitaxel at this dosage and schedule is a treatment option for patients with advanced AIDS-related KS, including those who have experienced treatment failure of prior systemic therapy.
authors.affiliation: Departments of Medicine and Pharmacy, University of Southern California, Kenneth Norris Cancer Hospital and Research Institute, Los Angeles, CA, USA. parkashg@hsc.usc.edu
authors.forename: P S
authors.initials: PS
authors.lastname: Gill
authors.forename: A
authors.initials: A
authors.lastname: Tulpule
authors.forename: B M
authors.initials: BM
authors.lastname: Espina
authors.forename: S
authors.initials: S
authors.lastname: Cabriales
authors.forename: J
authors.initials: J
authors.lastname: Bresnahan
authors.forename: M
authors.initials: M
authors.lastname: Ilaw
authors.forename: S
authors.initials: S
authors.lastname: Louie
authors.forename: N F
authors.initials: NF
authors.lastname: Gustafson
authors.forename: M A
authors.initials: MA
authors.lastname: Brown
authors.forename: C
authors.initials: C
authors.lastname: Orcutt
authors.forename: B
authors.initials: B
authors.lastname: Winograd
authors.forename: D T
authors.initials: DT
authors.lastname: Scadden
mesh_terms: D000163:Acquired Immunodeficiency Syndrome / Q000150:complications*; D000328:Adult; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004487:Edema / Q000175:diagnosis / Q000188:drug therapy; D005260:Female; D005770:Gastrointestinal Neoplasms / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality; D006801:Humans; D008175:Lung Neoplasms / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D012074:Remission Induction; D012514:Sarcoma, Kaposi / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D012878:Skin Neoplasms / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel