title: Phase II trial of gemcitabine, prednisone, and zoledronic acid in pretreated patients with hormone refractory prostate cancer.
abstract: OBJECTIVE
  To investigate the impact on biochemical and objective response and on pain improvement of gemcitabine, prednisone, and zoledronic acid in patients with hormone-refractory prostate cancer (HRPC), previously treated with docetaxel-based regimens.
  
  
  METHODS
  The patients were treated with gemcitabine 1000 mg/m2 every 14 days, prednisone 10 mg orally on days 1 to 7 and 14 to 21, and zoledronic acid every 4 weeks. Changes in prostate-specific antigen levels, tumor response, and toxicity were evaluated every month. The pain response, based on pain reduction and analgesic drug reduction, was assessed during therapy.
  
  
  RESULTS
  A total of 22 men (median age 65 years) were treated. Overall, 5 patients (23%) achieved a 50% or greater reduction in prostate-specific antigen level after two cycles; a partial response was observed in 1 (14%) of 7 patients with measurable disease, and 3 (43%) of 7 had stable disease. Of the 22 men, 23% had pain improvement. The most important hematologic toxicity was neutropenia (grade 3 in 18%).
  
  
  CONCLUSIONS
  The combination of gemcitabine, prednisone, and zoledronic acid appears to be associated with biochemical response, pain improvement, and good safety in pretreated patients with HRPC.
authors.affiliation: Dipartimento di Endocrinologia e Oncologia Molecolare e Clinica, Università degli Studi di Napoli Federico II, Napoli, Italy. giuseppedilorenzoncol@hotmail.com
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Di Lorenzo
authors.forename: Riccardo
authors.initials: R
authors.lastname: Autorino
authors.forename: Mario
authors.initials: M
authors.lastname: Giuliano
authors.forename: Emilio
authors.initials: E
authors.lastname: Morelli
authors.forename: Antonio
authors.initials: A
authors.lastname: Giordano
authors.forename: Giorgio
authors.initials: G
authors.lastname: Napodano
authors.forename: Aniello
authors.initials: A
authors.lastname: Russo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Benincasa
authors.forename: Massimino
authors.initials: M
authors.lastname: D'Armiento
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Altieri
authors.forename: Sabino
authors.initials: S
authors.lastname: De Placido
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004164:Diphosphonates / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005500:Follow-Up Studies; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009361:Neoplasm Invasiveness / Q000473:pathology; D009367:Neoplasm Staging; D009376:Neoplasms, Hormone-Dependent; D010147:Pain Measurement; D010166:Palliative Care; D011241:Prednisone / Q000008:administration & dosage; D011336:Probability; D017430:Prostate-Specific Antigen / Q000097:blood / Q000187:drug effects*; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality* / Q000473:pathology; D018570:Risk Assessment; D015996:Survival Rate; D016896:Treatment Outcome; D000077211:Zoledronic Acid; D000093542:Gemcitabine
chemical_list: D004164:Diphosphonates; D007093:Imidazoles; D003841:Deoxycytidine; D000077211:Zoledronic Acid; D017430:Prostate-Specific Antigen; D011241:Prednisone; D000093542:Gemcitabine