title: Phase II trial assessing granulocyte-macrophage-colony stimulating factor, ketoconazole plus mitoxantrone in metastatic castration-resistant prostate cancer progressing after docetaxel treatments.
abstract: BACKGROUND
  This study evaluated objective response and safety for the combination of granulocyte macrophage-colony stimulating factor (GM-CSF), ketoconazole, and mitoxantrone in castration-resistant prostate cancer (CRPC) patients who previously failed docetaxel-based chemotherapy.
  
  
  METHODS
  Treatment consisted of 400 mg TID ketoconazole, 12 mg/m(2) mitoxantrone every 3 weeks, and 250 μg/m(2) GM-CSF.
  
  
  RESULTS
  Twenty-nine patients were evaluable for response. Median overall survival (OS) for all patients was 18.03 months. Patients with a higher PSA decrease experienced an increased OS and progression-free survival (PFS).
  
  
  CONCLUSIONS
  This combination demonstrated significant antitumor activity with reversible toxicity in CRPC patients who previously failed docetaxel-based therapy.
authors: The University of Texas Health Science Center at Houston, Department of Internal Medicine, Division of Oncology, Houston, Texas 77030, USA. robert.amato@uth.tmc.edu
authors: Robert J
authors: RJ
authors: Amato
authors: Somyata
authors: S
authors: Saxena
authors: Mika
authors: M
authors: Stepankiw
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000077143:Docetaxel; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007654:Ketoconazole / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage; D009919:Orchiectomy; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D008942:Mitoxantrone; D017430:Prostate-Specific Antigen; D007654:Ketoconazole