TY - JOUR
T1 - Short Androgen Suppression and Radiation Dose Escalation in Prostate Cancer
T2 - 12-Year Results of EORTC Trial 22991 in Patients With Localized Intermediate-Risk Disease
AU - Bolla, Michel
AU - Neven, Anouk
AU - Maingon, Philippe
AU - Carrie, Christian
AU - Boladeras, Ana
AU - Andreopoulos, Demetrios
AU - Engelen, Antoine
AU - Sundar, Santhanam
AU - van der Steen-Banasik, Elzbieta M.
AU - Armstrong, John
AU - Peignaux-Casasnovas, Karine
AU - Boustani, Jihane
AU - Herrera, Fernanda G.
AU - Pieters, Bradley R.
AU - Slot, Annerie
AU - Bahl, Amit
AU - Scrase, Christopher D.
AU - Azria, David
AU - Jansa, Jan
AU - O’Sullivan, Joe M.
AU - Van Den Bergh, Alphonsus C.M.
AU - Collette, Laurence
AU - Van Den Bergh, A. C.M.
AU - Carrie, C.
AU - Villa, S.
AU - Kitsios, N.
AU - Poortmans, Ph
AU - Bolla, M.
AU - Sundar, S.
AU - Van Der Steen-Banasik, E. M.
AU - Armstrong, J.
AU - Maingon, P.
AU - Bosset, J. F.
AU - Zouhair, A.
AU - Herrera, F. G.
AU - Pieters, B. R.
AU - Slot, A.
AU - Hopkins, K.
AU - Bahl, A.
AU - Ben Yosef, R.
AU - Budach, V.
AU - Boehmer, D.
AU - Scrase, C. D.
AU - Renard, L.
AU - Azria, D.
AU - Magrini, S. M.
AU - De Bari, B.
AU - Jansa, J.
AU - Lartigau, E.
AU - Matuszewska,
AU - the EORTC Radiation Oncology Group
N1 - Funding Information:
AstraZeneca supplied the luteinizing hormone–releasing hormone (LHRH) analog, goserelin acetate (ZOLADEX), and an educational grant to support the study but had no role in its design or conduct, the analysis or interpretation of the data, or the preparation of the manuscript. This publication was also supported by donations from Ligue Nationale contre le Cancer from France as well as from Kom op tegen Kanker (Stand up to Cancer), the Flemish cancer society from Belgium.
Publisher Copyright:
Copyright © 2022 American Society of Clinical Oncology. All rights reserved.
PY - 2021/9/20
Y1 - 2021/9/20
N2 - PURPOSE 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. PATIENT AND METHODS 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 a 5 5%. RESULTS 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] 5 0.53; CI, 0.41 to 0.70; P, .001 and HR 5 0.67; CI, 0.49 to 0.90; P 5 .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 5 0.74; CI, 0.53 to 1.02; P 5 .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 5 0.74; CI, 0.53 to 1.04; P 5 .082). CONCLUSION 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.
AB - PURPOSE 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. PATIENT AND METHODS 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 a 5 5%. RESULTS 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] 5 0.53; CI, 0.41 to 0.70; P, .001 and HR 5 0.67; CI, 0.49 to 0.90; P 5 .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 5 0.74; CI, 0.53 to 1.02; P 5 .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 5 0.74; CI, 0.53 to 1.04; P 5 .082). CONCLUSION 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.
UR - http://www.scopus.com/inward/record.url?scp=85116958418&partnerID=8YFLogxK
U2 - 10.1200/JCO.21.00855
DO - 10.1200/JCO.21.00855
M3 - Article
C2 - 34310202
AN - SCOPUS:85116958418
SN - 0732-183X
VL - 39
SP - 3022
EP - 3033
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 27
ER -