The European Organisation for Research and Treatment of Cancer (EORTC) trial 22991 (NCT00021450) showed that 6 months of concomitant and adjuvant androgen suppression (AS) improves event- (EFS, Phoenix) and clinical disease-free survival (DFS) of intermediate- and high-risk localized prostatic carcinoma, treated by external-beam radiotherapy (EBRT) at 70-78 Gy. We report the long-term results in intermediate-risk patients treated with 74 or 78 Gy EBRT, as per current guidelines.
Of 819 patients randomly assigned between EBRT or EBRT plus AS started on day 1 of EBRT, 481 entered with intermediate risk (International Union Against Cancer TNM 1997 cT1b-c or T2a with prostate-specific antigen (PSA) ≥ 10 ng/mL or Gleason ≤ 7 and PSA ≤ 20 ng/mL, N0M0) and had EBRT planned at 74 (342 patients, 71.1%) or 78 Gy (139 patients, 28.9%). We report the trial primary end point EFS, DFS, distant metastasis-free survival (DMFS), and overall survival (OS) by intention-to-treat stratified by EBRT dose at two-sided α = 5%.
At a median follow-up of 12.2 years, 92 of 245 patients and 132 of 236 had EFS events in the EBRT plus AS and EBRT arm, respectively, mostly PSA relapse (48.7%) or death (45.1%). EBRT plus AS improved EFS and DFS (hazard ratio [HR] = 0.53; CI, 0.41 to 0.70; P < .001 and HR = 0.67; CI, 0.49 to 0.90; P = .008). At 10 years, DMFS was 79.3% (CI, 73.4 to 84.0) with EBRT plus AS and 72.7% (CI, 66.2 to 78.2) with EBRT (HR = 0.74; CI, 0.53 to 1.02; P = .065). With 140 deaths (EBRT plus AS: 64; EBRT: 76), 10-year OS was 80.0% (CI, 74.1 to 84.7) with EBRT plus AS and 74.3% (CI, 67.8 to 79.7) with EBRT, but not statistically significantly different (HR = 0.74; CI, 0.53 to 1.04; P = .082).
Six months of concomitant and adjuvant AS statistically significantly improves EFS and DFS in intermediate-risk prostatic carcinoma, treated by irradiation at 74 or 78 Gy. The effects on OS and DMFS did not reach statistical significance.
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021 Jul 26 [Epub ahead of print]
Michel Bolla, Anouk Neven, Philippe Maingon, Christian Carrie, Ana Boladeras, Demetrios Andreopoulos, Antoine Engelen, Santhanam Sundar, Elzbieta M van der Steen-Banasik, John Armstrong, Karine Peignaux-Casasnovas, Jihane Boustani, Fernanda G Herrera, Bradley R Pieters, Annerie Slot, Amit Bahl, Christopher D Scrase, David Azria, Jan Jansa, Joe M O'Sullivan, Alphonsus C M Van Den Bergh, Laurence Collette, EORTC Radiation Oncology Group
Radiotherapy Department Grenoble, Grenoble Alpes University, Centre Hospitalier Universitaire de Grenoble, Grenoble, France., European Organization for Research and Treatment of Cancer, Brussels, Belgium., Sorbonne University, APHP Sorbonne University, La Pitié Salpêtrière, Paris, France., Radiotherapy Department, Leon Bérard Center, Lyon, France., Radiation Oncology Department, Catalan Institute of Oncology-University Hospital Germans Trias I Pujol, Badalona, Barcelona, Catalonia, Spain., Radiotherapy Department, Bank of Cyprus Oncology Centre, Nicosia, Cyprus., Institute Verbeeten, Tilburg, the Netherlands., Nottingham University Hospitals NHS Trust-City Hospital, Consultant Medical Oncologist, Nottingham, United Kingdom., Radiotherapiegroep Arnhem, Arnhem, the Netherlands., Radiation Oncology Department, All Ireland Cooperative Oncology Research Group, St Luke's Hospital, Dublin, Ireland., Radiotherapy Department, Georges-Francois-Leclerc Centre, Dijon, France., Radiotherapy Department, University Hospital of Besancon-Jean Minjoz Hospital, Besancon, France., Radiation Oncology and Immuno-Oncology Service, University Hospital of Lausanne, Lausanne, Switzerland., Department of Radiation Oncology, Amsterdam University Medical Centers/University of Amsterdam, Amsterdam, the Netherlands., Radiotherapeutisch Instituut Friesland, Leeuwarden, the Netherlands., University Hospitals Bristol National Health Service Foundation Trust-Bristol Haematology and Oncology Centre, Bristol Avon, United Kingdom., Ipswich Hospital National Health Services Trust, Ipswich, United Kingdom., Institut du Cancer de Montpellier, Université de Montpellier, INSERM U1194, Montpellier, France., Klinika Onkologie a Radioterapie-Fakultni nemocnice Hradec Kralove, Hradec Kralove, Czech Republic., Patrick G Johnston Centre for Cancer Research, Queen's University Belfast, Belfast, Ireland., Radiotherapy Department, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.