title: Concurrent and adjuvant docetaxel with three-dimensional conformal radiation therapy plus androgen deprivation for high-risk prostate cancer: preliminary results of a multicentre phase II trial.
abstract: OBJECTIVE
  We evaluate the feasibility of concomitant and adjuvant docetaxel combined with three-dimensional conformal radiotherapy (3D-CRT) and androgen deprivation in high-risk prostate carcinomas.
  
  
  METHODS
  Fifty men with high-risk localized prostate cancer (16), locally advanced (28) or very high-risk prostate cancer (6) were included. Seventy Gy were delivered on prostate and seminal vesicles in 35 fractions, concurrently with weekly docetaxel (20mg/m(2)). Three weeks after the completion of 3D-CRT, docetaxel was given for 3 cycles (60mg/m(2)), every 3 weeks. Patients had to receive LHRH agonist during 3 years.
  
  
  RESULTS
  The intent to treat analysis shows that four patients out of 15 stopped prematurely the chemotherapy due to grade 3-4 acute toxicity. In the per protocol analysis, 46 patients completed a full-dose chemoradiation regimen representing 413 cycles: five patients experienced a grade 3 toxicity, and 15 patients experienced a grade 2 toxicity. With a median follow-up of 54 months, the 5-year clinical disease-free survival was 66.72% and the 5-year survival was 92.15%.
  
  
  CONCLUSIONS
  3D-CRT with androgen deprivation and concurrent weekly docetaxel, followed by three cycles of adjuvant docetaxel may be considered as feasible in high-risk prostate cancer and deserved to be evaluated in a phase III randomized trial.
authors.affiliation: Department of Oncology-Radiotherapy, Centre Hospitalier Universitaire, Grenoble, France. Michel.bolla@ujf-grenoble.fr
authors.forename: Michel
authors.initials: M
authors.lastname: Bolla
authors.forename: Jean Michel
authors.initials: JM
authors.lastname: Hannoun-Levi
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Ferrero
authors.forename: Philippe
authors.initials: P
authors.lastname: Maingon
authors.forename: Joëlle
authors.initials: J
authors.lastname: Buffet-Miny
authors.forename: Agnès
authors.initials: A
authors.lastname: Bougnoux
authors.forename: Jacques
authors.initials: J
authors.lastname: Bauer
authors.forename: Jean-Luc
authors.initials: JL
authors.lastname: Descotes
authors.forename: Philippe
authors.initials: P
authors.lastname: Fourneret
authors.forename: Florence
authors.initials: F
authors.lastname: Jover
authors.forename: Marc
authors.initials: M
authors.lastname: Colonna
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D000077143:Docetaxel; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D018714:Radiotherapy, Adjuvant; D020266:Radiotherapy, Conformal; D012307:Risk Factors; D016019:Survival Analysis; D043823:Taxoids / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel