title: A phase III trial of docetaxel-estramustine in high-risk localised prostate cancer: a planned analysis of response, toxicity and quality of life in the GETUG 12 trial.
abstract: OBJECTIVE
  To assess docetaxel-estramustine in patients with localised high-risk prostate cancer.
  
  
  METHODS
  After staging pelvic lymph node dissection, patients with high-risk prostate cancer randomly received androgen deprivation therapy (ADT) (3 years)+DE (4 cycles of docetaxel 70 mg/m(2)/3 weeks+estramustine 10mg/kg/dd1-5) or ADT alone. Local therapy was administered at 3 months.
  
  
  RESULTS
  Four hundred and thirteen patients were accrued: T3-T4 (67%), Gleason score ~8 (42%), PSA >20 ng/mL (59%), pN+ (29%). In the chemotherapy arm, 94% of patients received the planned four cycles of docetaxel. Local treatment consisted of radiotherapy in 358 patients (87%) (median dose 74 Gy in both arms). ADT was given for 36 months in both arms. A PSA response (PSA ~0.2 ng/mL after 3 months of treatment) was obtained in 34% and 15% in the ADT+DE arm and in the ADT arm, respectively (p<0.0001). Febrile neutropenia occurred in only 2%. Moderate to severe hot flashes occurred less often in the ADT+DE arm (2% versus 22%; p<0.001). There was no toxicity-related death, no secondary leukaemia, and no excess second cancers. Chemotherapy had a negative impact on quality of life (global health status, p = 0.01; fatigue, p = 0.003; role functioning, p = 0.003; social functioning, p = 0.006) at 3 months but this effect disappeared at 1 year.
  
  
  CONCLUSIONS
  Docetaxel-estramustine can be combined safely with standard therapy in high-risk prostate cancer, with a promising PSA response rate and no negative impact on quality of life after 1 year. Long-term follow-up is required to assess the impact on relapse and survival.
authors: Institut Gustave Roussy, Villejuif, France. fizazi@igr.fr
authors: Karim
authors: K
authors: Fizazi
authors: Francois
authors: F
authors: Lesaunier
authors: Remy
authors: R
authors: Delva
authors: Gwenaëlle
authors: G
authors: Gravis
authors: Frederic
authors: F
authors: Rolland
authors: Frank
authors: F
authors: Priou
authors: Jean-Marc
authors: JM
authors: Ferrero
authors: Nadine
authors: N
authors: Houedé
authors: Loïc
authors: L
authors: Mourey
authors: Christine
authors: C
authors: Theodore
authors: Ivan
authors: I
authors: Krakowski
authors: Jean-François
authors: JF
authors: Berdah
authors: Marjorie
authors: M
authors: Baciuchka
authors: Brigitte
authors: B
authors: Laguerre
authors: Aude
authors: A
authors: Fléchon
authors: Alain
authors: A
authors: Ravaud
authors: Isabelle
authors: I
authors: Cojean-Zelek
authors: Stéphane
authors: S
authors: Oudard
authors: Jean-Luc
authors: JL
authors: Labourey
authors: Jean-Léon
authors: JL
authors: Lagrange
authors: Paule
authors: P
authors: Chinet-Charrot
authors: Claude
authors: C
authors: Linassier
authors: Gaël
authors: G
authors: Deplanque
authors: Philippe
authors: P
authors: Beuzeboc
authors: Jean
authors: J
authors: Geneve
authors: Jean-Louis
authors: JL
authors: Davin
authors: Elodie
authors: E
authors: Tournay
authors: Stephane
authors: S
authors: Culine
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000532:radiotherapy; D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003131:Combined Modality Therapy / Q000379:methods; D000077143:Docetaxel; D004961:Estramustine / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy; D011788:Quality of Life; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D000726:Androgen Antagonists; D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel; D004961:Estramustine