title: Biweekly doxorubicin/ketoconazole as second-line treatment in docetaxel-resistant, hormone-refractory prostate cancer.
abstract: OBJECTIVE
  Docetaxel is an effective first-line treatment for hormone-refractory prostate cancer. Nevertheless, the prognosis subsequent to progression after first-line therapy is poor and no second-line treatment has been established.
  
  
  METHODS
  A total of 34 patients with androgen-independent prostate cancer received doxorubicin, 30 mg/m(2), every 2 weeks and ketoconazole daily, 400 mg orally every 8 hours. All patients had been treated with docetaxel and had disease progression within 6 months after completion of first-line treatment.
  
  
  RESULTS
  Of the 32 evaluable patients, 13 (43.7%, 95% confidence interval [CI] 26.3% to 62.3%) had a prostate-specific antigen (PSA) response, and 4 (28%, 95% CI 8.4% to 58.1%) of 14 patients with measurable disease had a response to therapy. The median time to progression (TTP) was 3.9 months (95% CI 2.0 to 5.9), and the median overall survival (OS) was 13 months (95% CI 8.7 to 17.3). Toxicity was mild, with only 4 cases of nonhematologic grade 3 or 4 toxicity. The most frequent toxicity was nail changes (33 of 34 patients), which was mainly grade 1 (30 cases).
  
  
  CONCLUSIONS
  The combination of biweekly doxorubicin and ketoconazole is an effective, well-tolerated, second-line therapy for hormone-refractory prostate cancer.
authors.affiliation: Department of Clinical Therapeutics, University of Athens Medical School, Athens, Greece.
authors.forename: George
authors.initials: G
authors.lastname: Lainakis
authors.forename: Antoniou
authors.initials: A
authors.lastname: Nikos
authors.forename: Alivizatos
authors.initials: A
authors.lastname: Gerassimos
authors.forename: Chrisofos
authors.initials: C
authors.lastname: Michael
authors.forename: Mitsoyiannis
authors.initials: M
authors.lastname: Iraklis
authors.forename: Livadas
authors.initials: L
authors.lastname: Konstantinos
authors.forename: Varkarakis
authors.initials: V
authors.lastname: Ioannis
authors.forename: Katsifotis
authors.initials: K
authors.lastname: Harilaos
authors.forename: Meletios A
authors.initials: MA
authors.lastname: Dimopoulos
authors.forename: Aristotelis
authors.initials: A
authors.lastname: Bamias
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage*; D000935:Antifungal Agents / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D004359:Drug Therapy, Combination; D005500:Follow-Up Studies; D006801:Humans; D007654:Ketoconazole / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D043823:Taxoids / Q000627:therapeutic use
chemical_list: D000903:Antibiotics, Antineoplastic; D000935:Antifungal Agents; D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D004317:Doxorubicin; D007654:Ketoconazole