title: 70 Gy versus 80 Gy in localized prostate cancer: 5-year results of GETUG 06 randomized trial.
abstract: OBJECTIVE
  To perform a randomized trial comparing 70 and 80 Gy radiotherapy for prostate cancer.
  
  
  METHODS
  A total of 306 patients with localized prostate cancer were randomized. No androgen deprivation was allowed. The primary endpoint was biochemical relapse according to the modified 1997-American Society for Therapeutic Radiology and Oncology and Phoenix definitions. Toxicity was graded using the Radiation Therapy Oncology Group 1991 criteria and the late effects on normal tissues-subjective, objective, management, analytic scales (LENT-SOMA) scales. The patients' quality of life was scored using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item cancer-specific and 25-item prostate-specific modules.
  
  
  RESULTS
  The median follow-up was 61 months. According to the 1997-American Society for Therapeutic Radiology and Oncology definition, the 5-year biochemical relapse rate was 39% and 28% in the 70- and 80-Gy arms, respectively (p = .036). Using the Phoenix definition, the 5-year biochemical relapse rate was 32% and 23.5%, respectively (p = .09). The subgroup analysis showed a better biochemical outcome for the higher dose group with an initial prostate-specific antigen level >15 ng/mL. At the last follow-up date, 26 patients had died, 10 of their disease and none of toxicity, with no differences between the two arms. According to the Radiation Therapy Oncology Group scale, the Grade 2 or greater rectal toxicity rate was 14% and 19.5% for the 70- and 80-Gy arms (p = .22), respectively. The Grade 2 or greater urinary toxicity was 10% at 70 Gy and 17.5% at 80 Gy (p = .046). Similar results were observed using the LENT-SOMA scale. Bladder toxicity was more frequent at 80 Gy than at 70 Gy (p = .039). The quality-of-life questionnaire results before and 5 years after treatment were available for 103 patients with no differences found between the 70- and 80-Gy arms.
  
  
  CONCLUSIONS
  High-dose radiotherapy provided a better 5-year biochemical outcome with slightly greater toxicity.
authors.affiliation: Centre Alexis Vautrin, Vandoeuvre les Nancy, France. v.beckendorf@nancy.fnclcc.fr
authors.forename: Véronique
authors.initials: V
authors.lastname: Beckendorf
authors.forename: Stéphane
authors.initials: S
authors.lastname: Guerif
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Le Prisé
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Cosset
authors.forename: Agnes
authors.initials: A
authors.lastname: Bougnoux
authors.forename: Bruno
authors.initials: B
authors.lastname: Chauvet
authors.forename: Naji
authors.initials: N
authors.lastname: Salem
authors.forename: Olivier
authors.initials: O
authors.lastname: Chapet
authors.forename: Sylvain
authors.initials: S
authors.lastname: Bourdain
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Bachaud
authors.forename: Philippe
authors.initials: P
authors.lastname: Maingon
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Hannoun-Levi
authors.forename: Luc
authors.initials: L
authors.lastname: Malissard
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Simon
authors.forename: Pascal
authors.initials: P
authors.lastname: Pommier
authors.forename: Men
authors.initials: M
authors.lastname: Hay
authors.forename: Bernard
authors.initials: B
authors.lastname: Dubray
authors.forename: Jean-Léon
authors.initials: JL
authors.lastname: Lagrange
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Luporsi
authors.forename: Pierre
authors.initials: P
authors.lastname: Bey
mesh_terms: D000368:Aged; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D007989:Libido / Q000528:radiation effects; D008297:Male; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000401:mortality; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000401:mortality / Q000532:radiotherapy*; D011788:Quality of Life; D011879:Radiotherapy Dosage; D020266:Radiotherapy, Conformal / Q000379:methods*; D012007:Rectum / Q000528:radiation effects; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D001743:Urinary Bladder / Q000528:radiation effects
chemical_list: D017430:Prostate-Specific Antigen