title: First-line treatment in senior adults with metastatic castration-resistant prostate cancer: A prospective international registry.
abstract: OBJECTIVE
  To compare the efficacy and tolerability of taxane and nontaxane therapy in senior adults with chemonaïve metastatic castration-resistant prostate cancer (mCRPC), and examine the effect of patient health status on outcomes.
  
  
  METHODS
  Between 2009 and 2011, 333 patients aged≥70 years with mCRPC were enrolled in a prospective international registry. Patients were categorized as having received taxane-based or nontaxane therapy, and classified as fit, vulnerable, frail, or terminal, according to investigator judgement or International Society of Geriatric Oncology guidelines. Efficacy measures included overall survival (OS) and progression-free survival. Grade 3/4 toxicities were recorded. Predictors of OS were identified using multivariate Cox regression.
  
  
  RESULTS
  The proportions of fit/vulnerable/frail patients were 65%/14%/17% (International Society of Geriatric Oncology), and 39%/43%/17% (investigator). In single-factor analyses, taxane therapy improved OS (hazard ratio [95%CI] = 0.53 [0.30-0.93]; P = 0.027) and progression-free survival (hazard ratio [95% CI] = 0.55 [0.40-0.76]; P<0.001) vs. nontaxane therapy. Patients with frailty also benefited from taxane therapy (adapted regimen in 52%). In multivariate analysis, taxanes improved OS even with poor prognostic factors present (P = 0.017); age was unrelated to prognosis. Taxane therapy was well tolerated; most common grade 3/4 toxicities (taxane vs. nontaxane) were fatigue (17% vs. 4%), nausea/vomiting (14% vs. 5%) and neutropenia (10% vs. 1%).
  
  
  CONCLUSIONS
  The results of this nonrandomized, observational study suggest that first-line taxane therapy may benefit senior adults with mCRPC more than alternative therapies. Treatment decisions should not be based on chronological age.
authors.affiliation: Department of Cancer Environment Research Unit, Léon-Bérard Cancer Center, Claude-Bernard-Lyon1 University, Lyon, France. Electronic address: jpdroz@orange.fr.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Droz
authors.affiliation: Department Medical Oncology, University of Athens, Athens, Greece.
authors.forename: Eleni
authors.initials: E
authors.lastname: Efstathiou
authors.affiliation: Department of Urology, SB Göztepe Training and Research Hospital, Istanbul, Turkey.
authors.forename: Asif
authors.initials: A
authors.lastname: Yildirim
authors.affiliation: Department of Urology, Instituto Nacional de Cancerología, Mexico City, Mexico.
authors.forename: Paula
authors.initials: P
authors.lastname: Cabrera
authors.affiliation: Department of Urology, Asan Medical Center, Songpa-Gu, Seoul, Korea.
authors.forename: Choung
authors.initials: C
authors.lastname: Soo Kim
authors.affiliation: Department of Urology, Faculty of Medicine, La Rabta Hospital, Tunis, Tunisia.
authors.forename: Ali
authors.initials: A
authors.lastname: Horchani
authors.affiliation: Department of Urology, Universitätsklinikum Aachen, Aachen, Germany.
authors.forename: Axel
authors.initials: A
authors.lastname: Heidenreich
authors.affiliation: Department of Urology, Hospital do Cancer-A.C. Camargo, Sao Paulo, Brazil.
authors.forename: José Augusto
authors.initials: JA
authors.lastname: Rinck-Junior
authors.affiliation: Sanofi Oncology, Paris, France.
authors.forename: Simon
authors.initials: S
authors.lastname: Hitier
authors.affiliation: Department of Urology, Hacettepe University, Ankara, Turkey.
authors.forename: Haluk
authors.initials: H
authors.lastname: Ӧzen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001952:Bridged-Ring Compounds / Q000008:administration & dosage / Q000009:adverse effects; D005221:Fatigue / Q000139:chemically induced; D006801:Humans; D007391:International Cooperation; D053208:Kaplan-Meier Estimate; D008297:Male; D009325:Nausea / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D017063:Outcome Assessment, Health Care / Q000379:methods / Q000706:statistics & numerical data; D016016:Proportional Hazards Models; D011446:Prospective Studies; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000473:pathology; D012042:Registries / Q000706:statistics & numerical data*; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D014839:Vomiting / Q000139:chemically induced
chemical_list: D001952:Bridged-Ring Compounds; D043823:Taxoids; C080625:taxane
keywords: Comorbidity; Docetaxel; Geriatric assessment; Taxoids