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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)

  • Christian Carrie 1,
  • Nicolas Magné 2,
  • Patricia Burban-Provost 3,
  • Paul Sargos 4,
  • Igor Latorzeff 5,
  • Stephane Supiot 6,
  • Yazid Belkacemi 7,
  • Didier Peiffert 8,
  • Nedla Allouache 9,
  • Bernard M. Dubray 10,
  • Stephanie Servagi Vernat 11,
  • Jean-Philippe Suchaud 12,
  • Gilles Crehange 13,
  • Stéphane Guerif 14,
  • Meryem Brihoum 15,
  • Nicolas Barbier 16,
  • Pierre Graff-Cailleaud 17,
  • Alain Ruffion 18,
  • Sylvie Chabaud 19
1 Leon Berard Center, Radiotherapy Department, Lyon, France 2 Medical Oncology Department, AP-HP, Salpetriere Hospital, University Paris VI, Paris, France 3 Hopital Privé Des Cotes D'armor, Plerin, France 4 Bergoni, Bordeaux, France 5 Clinique Pasteur Groupe Oncorad Garonne, Toulouse, France 6 Institut de Cancerologie de l'Ouest - Rene Gauducheau, Nantes, France 7 APHP, Paris, France 8 Hôpital de Brabois Adultes, Vandœuvre-Lès-Nancy, France 9 Centre Francois Baclesse, Caen Cedex 05, France 10 CRLCC Henri Becquerel, Rouen, France 11 Institut Jean Godinot, Reims, France 12 Centre hospitalier Roanne, Roanne, France 13 Georges-François Leclerc Cancer Center, Dijon, France 14 CHU Poitiers, Poitiers, France 15 UNICANCER, Paris, France 16 Centre Catalan d'Oncologie, Perpignan, France 17 Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France 18 Department of Urology, Centre Hospitalier Lyon Sud, Pierre-Benite, France 19 Statistician - GINECO - Centre Léon-Bérard, Lyon, France

Publication: May 2019

https://meetinglibrary.asco.org/record/172942/abstract

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