title: Results from a monocentric phase II trial of erlotinib in patients with metastatic prostate cancer.
abstract: BACKGROUND
  Erlotinib is an orally active small-molecule tyrosine kinase inhibitor targeted against human epidermal growth factor receptor 1/epidermal growth factor receptor (ErbB1), known to be overexpressed in a variety of cancers, including prostate cancer.
  
  
  METHODS
  This was a phase II monocentric study of 30 patients with advanced or metastatic prostate cancer, 29 had castration-resistant prostate cancer and 23 had received prior chemotherapy. Patients received erlotinib: 150 mg/day, increased to 200 mg at week 4, and continued until progression or unacceptable toxicity. Efficacy was defined as a decrease or stabilization of prostate-specific antigen (PSA) without clinical progression. Clinical benefit was evaluated by Karnofsky performance status and pain intensity, and response was an improvement in one of these parameters without worsening in the other.
  
  
  RESULTS
  Median age was 69 years (range 51-77 years), and median PSA 102 ng/ml (range 3-1213 ng/ml). Dose escalation to 200 mg was possible in 16 (55%) patients. Moderate toxicity was observed. No patient had a decrease in PSA, 14% had stabilization, less than the >or=20% expected. PSA-doubling time, evaluated before and after erlotinib, was increased for 10 patients (P = 0.0058). Clinical benefit was achieved in 40% of patients.
  
  
  CONCLUSIONS
  Erlotinib demonstrated an improvement in clinical benefit. Future directions should include evaluating its use in less advanced prostate cancer.
authors.affiliation: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille, France. gravisg@marseille.fnclcc.fr
authors.forename: G
authors.initials: G
authors.lastname: Gravis
authors.forename: F
authors.initials: F
authors.lastname: Bladou
authors.forename: N
authors.initials: N
authors.lastname: Salem
authors.forename: A
authors.initials: A
authors.lastname: Gonçalves
authors.forename: B
authors.initials: B
authors.lastname: Esterni
authors.forename: J
authors.initials: J
authors.lastname: Walz
authors.forename: S
authors.initials: S
authors.lastname: Bagattini
authors.forename: M
authors.initials: M
authors.lastname: Marcy
authors.forename: S
authors.initials: S
authors.lastname: Brunelle
authors.forename: P
authors.initials: P
authors.lastname: Viens
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D000284:Administration, Oral; D000368:Aged; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D000069347:Erlotinib Hydrochloride; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011336:Probability; D011379:Prognosis; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011799:Quinazolines / Q000008:administration & dosage* / Q000009:adverse effects; D018570:Risk Assessment; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride; D017430:Prostate-Specific Antigen