title: Phase II study of carboplatin and etoposide in patients with anaplastic progressive metastatic castration-resistant prostate cancer (mCRPC) with or without neuroendocrine differentiation: results of the French Genito-Urinary Tumor Group (GETUG) P01 trial.
abstract: BACKGROUND
  In the evolution of metastatic castration-resistant prostate cancer (mCRPC), patients present visceral metastases with or without neuroendocrine differentiation in 20% of cases.
  
  
  METHODS
  We assessed the efficacy and toxicity of a platinum-based chemotherapy regimen in mCRPC patients with either neuroendocrine differentiation defined by high serum levels of chromogranin A (CgA) and neuron-specific enolase (NSE) or visceral metastases. Patients received the combination of carboplatin and etoposide every 3 weeks. Efficacy end points included prostate-specific antigen (PSA) and neuroendocrine marker response, objective response and toxicity.
  
  
  RESULTS
  Of the 60 patients included from April 2005 to January 2008, 78.6% had bone metastases, 46.4% had lymph node involvement and 57.1% had liver and/or lung localizations. The objective response rate was 8.9% in the 46 patients with measurable disease. A neuroendocrine response was observed in 31% of cases for NSE and 7% for CgA. The PSA response rate was 8%. The most common grade 3-4 treatment-related toxic effects were neutropenia (65.5%), thrombocytopenia (32.7%) and anemia (27.3%). There was 7.2% febrile neutropenia, with one toxicity-related death. The median follow-up was 9.3 months [95% confidence interval (CI) 0.2-27.1] and the median overall survival 9.6 months (95% CI 8.7-12.7).
  
  
  CONCLUSIONS
  The benefit-risk ratio of this regimen seems unfavorable due to poor response and high toxicity.
authors: Department of Medical Oncology, Centre Léon Bérard, Lyon. Electronic address: flechon@lyon.fnclcc.fr.
authors: A
authors: A
authors: Fléchon
authors: Department of Medical Oncology, Centre Val d'Aurelle, Montpellier.
authors: D
authors: D
authors: Pouessel
authors: Department of Biostatistic, Centre Léon Bérard, Lyon.
authors: C
authors: C
authors: Ferlay
authors: Department of Biostatistic, Centre Léon Bérard, Lyon.
authors: D
authors: D
authors: Perol
authors: Department of Medical Oncology, Institut Curie, Paris.
authors: P
authors: P
authors: Beuzeboc
authors: Department of Medical Oncology, Institut Paoli-Calmettes, Marseille.
authors: G
authors: G
authors: Gravis
authors: Department of Medical Oncology, Centre François Baclesse, Caen.
authors: F
authors: F
authors: Joly
authors: Department of Medical Oncology, Hôpital Européen Georges Pompidou, Paris.
authors: S
authors: S
authors: Oudard
authors: Department of Medical Oncology, Fondation Hôpital Saint Joseph, Paris.
authors: G
authors: G
authors: Deplanque
authors: Department of Medical Oncology, Centre G.F. Leclerc, Dijon.
authors: S
authors: S
authors: Zanetta
authors: Department of Medical Oncology, Centre G.F. Leclerc, Dijon.
authors: P
authors: P
authors: Fargeot
authors: Department of Medical Oncology, CHD Les Oudairies, La Roche Sur Yon.
authors: F
authors: F
authors: Priou
authors: Department of Medical Oncology, Centre Léon Bérard, Lyon.
authors: J P
authors: JP
authors: Droz
authors: Department of Medical Oncology, Hôpital Henri Mondor, Créteil, France.
authors: S
authors: S
authors: Culine
mesh_terms: D000230:Adenocarcinoma / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002454:Cell Differentiation / Q000502:physiology; D053379:Chromogranin A / Q000097:blood; D018572:Disease-Free Survival; D005047:Etoposide / Q000008:administration & dosage; D006801:Humans; D008297:Male; D009362:Neoplasm Metastasis; D009376:Neoplasms, Hormone-Dependent / Q000097:blood / Q000188:drug therapy / Q000473:pathology; D055099:Neuroendocrine Cells / Q000473:pathology*; D009919:Orchiectomy; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology
chemical_list: D053379:Chromogranin A; D005047:Etoposide; D016190:Carboplatin