title: Clinical benefits of non-taxane chemotherapies in unselected patients with symptomatic metastatic castration-resistant prostate cancer after docetaxel: the GETUG-P02 study.
abstract: OBJECTIVE
  To evaluate the overall benefits of non-taxane chemotherapies in a non-selected population including unfit patients presenting with symptoms and pain.
  
  
  METHODS
  This randomized phase II study reports data from 92 patients (52% >70 years old; 40% with a performance score of 2) previously treated with taxane-based chemotherapy, collected from 15 centres in France. Patients received i.v. mitoxantrone (MTX), oral vinorelbine, or oral etoposide, together with oral prednisone. Palliative benefit (pain response without progression of the disease), biological and tumoural responses, and toxicity profile as well as geriatric assessment (in elderly population) were analysed on an intention-to-treat basis.
  
  
  RESULTS
  The palliative response rate was 17% for the whole population, and reached 29% when considering the MTX arm. Pain control was achieved in 40% of the patients. The median overall survival was 10.4 months, and was longer in palliative responders. Few grade 3-4 toxicities were observed. The subgroup analysis of elderly patients showed similar results regarding the number and dose intensity of treatments, efficacy and safety.
  
  
  CONCLUSIONS
  In a population including frail and/or elderly patients, who are poorly represented in most clinical studies, non-taxane chemotherapy may remain a relevant option for metastatic prostate cancer having relapsed after a docetaxel-based regimen. Although new treatment options are now approved, the decision-making process should take into account their expected benefit/risk ratio based on the patient status.
authors.affiliation: Medical Oncology-Clinical Research Department, Centre François Baclesse - CHU Côte de Nacre, Caen, France; Universite Basse Normandie, Caen, France.
authors.forename: Florence
authors.initials: F
authors.lastname: Joly
authors.forename: Remy
authors.initials: R
authors.lastname: Delva
authors.forename: Loïc
authors.initials: L
authors.lastname: Mourey
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Sevin
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Bompas
authors.forename: Lionel
authors.initials: L
authors.lastname: Vedrine
authors.forename: Alain
authors.initials: A
authors.lastname: Ravaud
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Eymard
authors.forename: Nicole
authors.initials: N
authors.lastname: Tubiana-Mathieu
authors.forename: Claude
authors.initials: C
authors.lastname: Linassier
authors.forename: Nadine
authors.initials: N
authors.lastname: Houede
authors.forename: Aline
authors.initials: A
authors.lastname: Guillot
authors.forename: François
authors.initials: F
authors.lastname: Ringensen
authors.forename: Oana
authors.initials: O
authors.lastname: Cojocarasu
authors.forename: Bruno
authors.initials: B
authors.lastname: Valenza
authors.forename: Alexandra
authors.initials: A
authors.lastname: Leconte
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Lheureux
authors.forename: Bénédicte
authors.initials: B
authors.lastname: Clarisse
authors.forename: Stéphane
authors.initials: S
authors.lastname: Oudard
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000077143:Docetaxel; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage / Q000009:adverse effects; D009362:Neoplasm Metastasis; D010166:Palliative Care; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects; D064129:Prostatic Neoplasms, Castration-Resistant / Q000188:drug therapy* / Q000473:pathology; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D014747:Vinblastine; D005047:Etoposide; D008942:Mitoxantrone; D000077235:Vinorelbine; D011241:Prednisone
keywords: chemotherapy; elderly; hormone therapy; mitoxantrone; prostate cancer; taxanes