2019 ASCO Annual Meeting!
Session: Genitourinary (Prostate) Cancer
Type: Oral Abstract Session
Time: Friday May 31, 2:45 PM to 5:45 PM
Location: Arie Crown Theater
Interest of short hormonotherapy (HT) associated with radiotherapy (RT) as salvage treatment for metastatic free survival (MFS) after radical prostatectomy (RP): Update at 9 years of the GETUG-AFU 16 phase III randomized trial (NCT00423475).
Genitourinary (Prostate) Cancer
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr 5001)
Author(s): Christian Carrie, Nicolas Magné, Patricia Burban-Provost, Paul Sargos, Igor Latorzeff, Stephane Supiot, Yazid Belkacemi, Didier Peiffert, Nedla Allouache, Bernard M. Dubray, Stephanie Servagi Vernat, Jean-Philippe Suchaud, Gilles Crehange, Stéphane Guerif, Meryem Brihoum, Nicolas Barbier, Pierre Graff-Cailleaud, Alain Ruffion, Sylvie Chabaud; Leon Berard Center, Radiotherapy Department, Lyon, France; Medical Oncology Department, AP-HP, Salpetriere Hospital, University Paris VI, Paris, France; Hopital Privé Des Cotes D'armor, Plerin, France; Bergoni, Bordeaux, France; Clinique Pasteur Groupe Oncorad Garonne, Toulouse, France; Institut de Cancerologie de l'Ouest - Rene Gauducheau, Nantes, France; APHP, Paris, France; Hôpital de Brabois Adultes, Vandœuvre-Lès-Nancy, France; Centre Francois Baclesse, Caen Cedex 05, France; CRLCC Henri Becquerel, Rouen, France; Institut Jean Godinot, Reims, France; Centre hospitalier Roanne, Roanne, France; Georges-François Leclerc Cancer Center, Dijon, France; CHU Poitiers, Poitiers, France; UNICANCER, Paris, France; Centre Catalan d'Oncologie, Perpignan, France; Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France; Department of Urology, Centre Hospitalier Lyon Sud, Pierre-Benite, France; Statistician - GINECO - Centre Léon-Bérard, Lyon, France
Background: RT is the standard salvage treatment after RP. The role of HT is not formally demonstrated to date. This trial assessed the efficacy of RT alone vs RT+HT in terms of progression-free survival (PFS), metastase-free survival (MFS) and overall survival (OS) in patients with biological relapse (BR) after RP. After a median follow-up (FU) duration of 5.3 years, we previously reported [Carrie C, Lancet Oncol 2016] a benefit in PFS (80% vs 62% PFS free at 5 years; p < 0.0001) in the combined arm, whatever the risk subgroups. Methods: Patients (pts) were randomized (1:1) to RT alone or RT+HT (goserelin, for 6 months). The randomization was stratified according to radiotherapy modality and risk group. Low risk was defined as Gleason score < 8, surgical margins+, psa doubling time > 8 months and no seminal vesicle involment. Assuming a 45% 5-year PFS of 45% in the RT arm, the trial required 369 pts per arm to detect an improvement of 12% on PFS in RT+HT arm (90% power and 5% bilateral alpha risk), possibly translating into a 10% gain in OS (75% to 85% with 80% power). Biological relapse (BR) was defined according to ASTRO-consensus. Results: At the time of data cutoff (March 2019), the median duration follow-up was 112 months. We confirm the benefit of RT+HT on PFS (HR = 0.54 [CI95% = 0.43-0.68] ; p < 0.0001) whatever the risk subgroup (HR = 0.47 [CI95% = 0.28-0.80] and 0.56 [CI95% = 0.44-0.73] for low and high risk patients, respectively. Metastatic free survival (MFS) is significantly improved in the combined arm (HR = 0.73 [CI95% = 0.54-0.98] ; p = 0.034) with 69% [CI95% = 63-74] versus 75% [CI95% = 70-80] of MFS at 10 years for RT alone and RT+HT, respectively. Conclusions: Salvage radiotherapy combined with short term HT significantly improved 10-years metastatic free survival compared with salvage radiotherapy alone. GETUG-16 considered in the context of previously published results from RTOG-9601, confirm that this strategy can be considered as the new standard for salvage treatment after radical prostatectomy. Clinical trial information: NCT00423475