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).

Authors

Christian Carrie

Christian Carrie

Leon Berard Center, Radiotherapy Department, Lyon, France

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

Organizations

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

Research Funding

Other

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

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Oral Abstract Session

Session Title

Genitourinary (Prostate) Cancer

Track

Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track

Prostate Cancer - Advanced Disease

Clinical Trial Registration Number

NCT00423475

Citation

J Clin Oncol 37, 2019 (suppl; abstr 5001)

DOI

10.1200/JCO.2019.37.15_suppl.5001

Abstract #

5001

Abstract Disclosures