title: Outcome According to Elective Pelvic Radiation Therapy in Patients With High-Risk Localized Prostate Cancer: A Secondary Analysis of the GETUG 12 Phase 3 Randomized Trial.
abstract: OBJECTIVE
  The role of pelvic elective nodal irradiation (ENI) in the management of prostate cancer is controversial. This study analyzed the role of pelvic radiation therapy (RT) on the outcome in high-risk localized prostate cancer patients included in the Groupe d'Etude des Tumeurs Uro-Genitales (GETUG) 12 trial.
  
  
  METHODS
  Patients with a nonpretreated high-risk localized prostate cancer and a staging lymphadenectomy were randomly assigned to receive either goserelin every 3 months for 3 years and 4 cycles of docetaxel plus estramustine or goserelin alone. Local therapy was administered 3 months after the start of systemic treatment. Performance of pelvic ENI was left to the treating physician. Only patients treated with primary RT were included in this analysis. The primary endpoint was biochemical progression-free survival (bPFS).
  
  
  RESULTS
  A total of 413 patients treated from 2002 to 2006 were included, of whom 358 were treated using primary RT. A total of 208 patients received pelvic RT and 150 prostate-only RT. Prostate-specific antigen (PSA) concentration, Gleason score, or T stage did not differ according to performance of pelvic RT; pN+ patients more frequently received pelvic RT than pN0 patients (P<.0001). Median follow-up was 8.8 years. In multivariate analysis, bPFS was negatively impacted by pN stage (hazard ratio [HR]: 2.52 [95% confidence interval [CI]: 1.78-3.54], P<.0001), Gleason score 8 or higher (HR: 1.41 [95% CI: 1.03-1.93], P=.033) and PSA higher than 20 ng/mL (HR: 1.41 [95% CI: 1.02-1.96], P=.038), and positively impacted by the use of chemotherapy (HR: 0.66 [95% CI: 0.48-0.9], P=.009). There was no association between bPFS and use of pelvic ENI in multivariate analysis (HR: 1.10 [95% CI: 0.78-1.55], P=.60), even when analysis was restricted to pN0 patients (HR: 0.88 [95% CI: 0.59-1.31], P=.53). Pelvic ENI was not associated with increased acute or late patient reported toxicity.
  
  
  CONCLUSIONS
  This unplanned analysis of a randomized trial failed to demonstrate a benefit of pelvic ENI on bPFS in high-risk localized prostate cancer patients.
authors.affiliation: Radiation Oncology, Gustave Roussy Cancer Center, Villejuif, France; University of Paris-Sud, Cancer Campus, Villejuif, France. Electronic address: pierre.blanchard@gustaveroussy.fr.
authors.forename: Pierre
authors.initials: P
authors.lastname: Blanchard
authors.affiliation: Biostatistics, Gustave Roussy Cancer Center, Villejuif, France.
authors.forename: Laura
authors.initials: L
authors.lastname: Faivre
authors.affiliation: Radiation Oncology, Centre Francois Baclesse, Caen, France.
authors.forename: François
authors.initials: F
authors.lastname: Lesaunier
authors.affiliation: Radiation Oncology, Institut Paoli Calmette, Marseille, France.
authors.forename: Naji
authors.initials: N
authors.lastname: Salem
authors.affiliation: Radiation Oncology, Institut de Cancérologie de l'Ouest, Angers, France.
authors.forename: Nathalie
authors.initials: N
authors.lastname: Mesgouez-Nebout
authors.affiliation: Centre Hospitalier La Roche sur Yon, La Roche sur Yon, France.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Deniau-Alexandre
authors.affiliation: Medical Oncology, Institut de Cancérologie de l'Ouest, Nantes, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Rolland
authors.affiliation: Medical Oncology, Centre Antoine Lacassagne, Nice, France.
authors.forename: Jean-Marc
authors.initials: JM
authors.lastname: Ferrero
authors.affiliation: Medical Oncology, Institut Bergonié, Bordeaux, France.
authors.forename: Nadine
authors.initials: N
authors.lastname: Houédé
authors.affiliation: Institut Claudius Regaud, Toulouse, France.
authors.forename: Loïc
authors.initials: L
authors.lastname: Mourey
authors.affiliation: Hospital Foch, Suresnes, France.
authors.forename: Christine
authors.initials: C
authors.lastname: Théodore
authors.affiliation: Centre Alexis Vautrin, Vandoeuvre-lès-Nancy, France.
authors.forename: Ivan
authors.initials: I
authors.lastname: Krakowski
authors.affiliation: Clinique Sainte Marguerite, Hyeres, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Berdah
authors.affiliation: Centre Hospitalier de la Timone, Marseille, France.
authors.forename: Marjorie
authors.initials: M
authors.lastname: Baciuchka
authors.affiliation: Centre Eugène Marquis, Rennes, France.
authors.forename: Brigitte
authors.initials: B
authors.lastname: Laguerre
authors.affiliation: Clinique Sainte Catherine, Avignon, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Davin
authors.affiliation: R&D UNICANCER, Paris, France; UNICANCER, Paris, France.
authors.forename: Muriel
authors.initials: M
authors.lastname: Habibian
authors.affiliation: Department of Medical Oncology, Hopital Saint-Louis, APHP, Paris, France.
authors.forename: Stéphane
authors.initials: S
authors.lastname: Culine
authors.affiliation: Biostatistics, Gustave Roussy Cancer Center, Villejuif, France.
authors.forename: Agnès
authors.initials: A
authors.lastname: Laplanche
authors.affiliation: University of Paris-Sud, Cancer Campus, Villejuif, France; Department of Cancer Medicine, Gustave Roussy Cancer Center, Villejuif, France.
authors.forename: Karim
authors.initials: K
authors.lastname: Fizazi
mesh_terms: D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D017024:Chemotherapy, Adjuvant; D016001:Confidence Intervals; D018572:Disease-Free Survival; D000077143:Docetaxel; D004961:Estramustine / Q000008:administration & dosage; D017273:Goserelin / Q000008:administration & dosage; D006801:Humans; D008197:Lymph Node Excision; D015182:Lymphatic Irradiation; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D020360:Neoadjuvant Therapy / Q000379:methods; D060787:Neoplasm Grading; D009367:Neoplasm Staging; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D018931:Antineoplastic Agents, Hormonal; D043823:Taxoids; D017273:Goserelin; D000077143:Docetaxel; D004961:Estramustine; D017430:Prostate-Specific Antigen