title: Is There a Role for Pelvic Irradiation in Localized Prostate Adenocarcinoma? Update of the Long-Term Survival Results of the GETUG-01 Randomized Study.
abstract: To report the long-term results of the French Genitourinary Study Group (GETUG)-01 study in terms of event-free survival (EFS) and overall survival (OS) and assess the potential interaction between hormonotherapy and pelvic nodes irradiation.
  
  
  
  Between December 1998 and June 2004, 446 patients with T1b-T3, N0pNx, M0 prostate carcinoma were randomly assigned to either pelvic nodes and prostate or prostate-only radiation therapy. Patients were stratified into 2 groups: "low risk" (T1-T2 and Gleason score 6 and prostate-specific antigen <3× the upper normal limit of the laboratory) (92 patients) versus "high risk" (T3 or Gleason score >6 or prostate-specific antigen >3× the upper normal limit of the laboratory). Short-term 6-month neoadjuvant and concomitant hormonal therapy was allowed only for high-risk patients. Radiation therapy was delivered with a 3-dimensional conformal technique, using a 4-field technique for the pelvic volume (46 Gy). The total dose recommended to the prostate moved from 66 Gy to 70 Gy during the course of the study. Criteria for EFS included biologic prostate-specific antigen recurrences and/or a local or metastatic progression.
  
  
  
  With a median follow-up of 11.4 years, the 10-year OS and EFS were similar in the 2 treatment arms. A higher but nonsignificant EFS was observed in the low-risk subgroup in favor of pelvic nodes radiation therapy (77.2% vs 62.5%; P=.18). A post hoc subgroup analysis showed a significant benefit of pelvic irradiation when the risk of lymph node involvement was <15% (Roach formula). This benefit seemed to be limited to patients who did not receive hormonal therapy.
  
  
  
  Pelvic nodes irradiation did not statistically improve EFS or OS in the whole population but may be beneficial in selected low- and intermediate-risk prostate cancer patients treated with exclusive radiation therapy.
authors: Department of Radiation Oncology, Centre Léon Bérard, Lyon, France. Electronic address: Pascal.pommier@lyon.unicancer.fr.
authors: Pascal
authors: P
authors: Pommier
authors: Department of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.
authors: Sylvie
authors: S
authors: Chabaud
authors: Department of Radiation Oncology, Centre Hospitalo-Universitaire H. Mondor, Créteil, France.
authors: Jean-Leon
authors: JL
authors: Lagrange
authors: Department of Radiation Oncology, Institut Bergognié, Bordeaux, France.
authors: Pierre
authors: P
authors: Richaud
authors: Department of Radiation Oncology, Centre Eugène Marquis, Rennes, France.
authors: Elisabeth
authors: E
authors: Le Prise
authors: Department of Radiation Oncology, Institut Andrée Dutreix, Dunkerque, France.
authors: Jean-Philippe
authors: JP
authors: Wagner
authors: Department of Radiation Oncology, Institut de Cancérologie de Montpellier, Montpellier, France.
authors: David
authors: D
authors: Azria
authors: Department of Radiation Oncology, Institut de Cancérologie de Lorraine, Nancy, France.
authors: Veronique
authors: V
authors: Beckendorf
authors: Department of Radiation Oncology, Centre Hospitalier de Roanne, Roanne, France.
authors: Jean-Philippe
authors: JP
authors: Suchaud
authors: Department of Radiation Oncology, Centre Oscar Lambret, Lille, France.
authors: Valerie
authors: V
authors: Bernier
authors: Department of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.
authors: David
authors: D
authors: Perol
authors: Department of Radiation Oncology, Centre Léon Bérard, Lyon, France.
authors: Christian
authors: C
authors: Carrie
mesh_terms: D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D018572:Disease-Free Survival; D019583:Dose Fractionation, Radiation; D005500:Follow-Up Studies; D005602:France; D007987:Gonadotropin-Releasing Hormone / Q000819:agonists; D006801:Humans; D015182:Lymphatic Irradiation / Q000379:methods* / Q000401:mortality; D008297:Male; D060787:Neoplasm Grading; D009364:Neoplasm Recurrence, Local / Q000097:blood; D009367:Neoplasm Staging; D010388:Pelvis; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy / Q000401:mortality* / Q000473:pathology / Q000532:radiotherapy*; D020266:Radiotherapy, Conformal / Q000379:methods; D013997:Time Factors
chemical_list: D018931:Antineoplastic Agents, Hormonal; D007987:Gonadotropin-Releasing Hormone; D017430:Prostate-Specific Antigen