title: Taxol in advanced, hormone-refractory carcinoma of the prostate. A phase II trial of the Eastern Cooperative Oncology Group.
abstract: BACKGROUND
  Recent clinical trials have documented activity for combinations of chemotherapeutic agents that target the microtubular apparatus in patients with hormone-refractory prostate cancer. Taxol has a novel antimicrotubular mechanism, acting by stabilizing polymerized tubulin.
  
  
  METHODS
  Twenty-three patients with hormone-refractory prostate cancer and bidimensionally measurable disease were treated with Taxol by 24-hour continuous infusion at 135-170 mg/M2 every 21 days for a maximum of 6 cycles.
  
  
  RESULTS
  Eighty-five courses of Taxol were administered to 23 patients. One patient (4.3%) experienced a partial response lasting 9 months, and four other patients with radiographically stable disease had minor reductions in the serum prostate-specific antigen (PSA) of 16-24%. Eleven patients (47.8%) had stable disease, and progressive disease developed in 9 patients (39.1%) during therapy. Median survival was 9 months. Leukopenia was the dose-limiting toxicity with 13% of patients having Grade 3 and 61% having Grade 4 toxicity, and granulocytopenic fever developed in 26%. Three patients experienced sudden cardiovascular events while participating in the study, including one patient with a nonfatal, non-Q-wave myocardial infarction that occurred during a taxol infusion, and two patients who had sudden deaths 9 days and 30 days after receiving their last taxol dose, respectively.
  
  
  CONCLUSIONS
  In the subset of patients with hormone-refractory prostate cancer and bidimensionally measurable disease, Taxol at this dosage has only minor activity.
authors.affiliation: Indiana University Medical Center, Indianapolis.
authors.forename: B J
authors.initials: BJ
authors.lastname: Roth
authors.forename: B Y
authors.initials: BY
authors.lastname: Yeap
authors.forename: G
authors.initials: G
authors.lastname: Wilding
authors.forename: B
authors.initials: B
authors.lastname: Kasimis
authors.forename: D
authors.initials: D
authors.lastname: McLeod
authors.forename: P J
authors.initials: PJ
authors.lastname: Loehrer
mesh_terms: D000368:Aged; D016757:Death, Sudden, Cardiac / Q000209:etiology; D004351:Drug Resistance; D004967:Estrogens / Q000627:therapeutic use; D007987:Gonadotropin-Releasing Hormone / Q000627:therapeutic use; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000139:chemically induced; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate
chemical_list: D004967:Estrogens; D007987:Gonadotropin-Releasing Hormone; D017239:Paclitaxel