Pierre Blanchard1, Laura Faivre2, François Lesaunier3, Naji Salem4, Nathalie Mesgouez-Nebout5, Elisabeth Deniau-Alexandre6, Frédéric Rolland7, Jean-Marc Ferrero8, Nadine Houédé9, Loïc Mourey10, Christine Théodore11, Ivan Krakowski12, Jean-François Berdah13, Marjorie Baciuchka14, Brigitte Laguerre15, Jean-Louis Davin16, Muriel Habibian17, Stéphane Culine18, Agnès Laplanche2, Karim Fizazi19. 1. Radiation Oncology, Gustave Roussy Cancer Center, Villejuif, France; University of Paris-Sud, Cancer Campus, Villejuif, France. Electronic address: pierre.blanchard@gustaveroussy.fr. 2. Biostatistics, Gustave Roussy Cancer Center, Villejuif, France. 3. Radiation Oncology, Centre Francois Baclesse, Caen, France. 4. Radiation Oncology, Institut Paoli Calmette, Marseille, France. 5. Radiation Oncology, Institut de Cancérologie de l'Ouest, Angers, France. 6. Centre Hospitalier La Roche sur Yon, La Roche sur Yon, France. 7. Medical Oncology, Institut de Cancérologie de l'Ouest, Nantes, France. 8. Medical Oncology, Centre Antoine Lacassagne, Nice, France. 9. Medical Oncology, Institut Bergonié, Bordeaux, France. 10. Institut Claudius Regaud, Toulouse, France. 11. Hospital Foch, Suresnes, France. 12. Centre Alexis Vautrin, Vandoeuvre-lès-Nancy, France. 13. Clinique Sainte Marguerite, Hyeres, France. 14. Centre Hospitalier de la Timone, Marseille, France. 15. Centre Eugène Marquis, Rennes, France. 16. Clinique Sainte Catherine, Avignon, France. 17. R&D UNICANCER, Paris, France; UNICANCER, Paris, France. 18. Department of Medical Oncology, Hopital Saint-Louis, APHP, Paris, France. 19. University of Paris-Sud, Cancer Campus, Villejuif, France; Department of Cancer Medicine, Gustave Roussy Cancer Center, Villejuif, France.
Abstract
PURPOSE: 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 AND MATERIALS: 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.
RCT Entities:
PURPOSE: 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 cancerpatients included in the Groupe d'Etude des Tumeurs Uro-Genitales (GETUG) 12 trial. METHODS AND MATERIALS: 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 cancerpatients.
Authors: Ariel E Marciscano; Ali Ghasemzadeh; Thomas R Nirschl; Debebe Theodros; Christina M Kochel; Brian J Francica; Yuki Muroyama; Robert A Anders; Andrew B Sharabi; Esteban Velarde; Wendy Mao; Kunal R Chaudhary; Matthew G Chaimowitz; John Wong; Mark J Selby; Kent B Thudium; Alan J Korman; David Ulmert; Daniel L J Thorek; Theodore L DeWeese; Charles G Drake Journal: Clin Cancer Res Date: 2018-06-13 Impact factor: 12.531
Authors: Daniela A Ferraro; Urs J Muehlematter; Helena I Garcia Schüler; Niels J Rupp; Martin Huellner; Michael Messerli; Jan Hendrik Rüschoff; Edwin E G W Ter Voert; Thomas Hermanns; Irene A Burger Journal: Eur J Nucl Med Mol Imaging Date: 2019-09-14 Impact factor: 9.236
Authors: Catherine Mercado; Marie-Adele Kress; Robyn A Cyr; Leonard N Chen; Thomas M Yung; Elizabeth G Bullock; Siyuan Lei; Brian T Collins; Andrew N Satinsky; K William Harter; Simeng Suy; Anatoly Dritschilo; John H Lynch; Sean P Collins Journal: Front Oncol Date: 2016-05-06 Impact factor: 6.244