Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Sep 20;39(27):3022-3033.
doi: 10.1200/JCO.21.00855. Epub 2021 Jul 26.

Short Androgen Suppression and Radiation Dose Escalation in Prostate Cancer: 12-Year Results of EORTC Trial 22991 in Patients With Localized Intermediate-Risk Disease

Michel Bolla  1 , Anouk Neven  2 , Philippe Maingon  3 , Christian Carrie  4 , Ana Boladeras  5 , Demetrios Andreopoulos  6 , Antoine Engelen  7 , Santhanam Sundar  8 , Elzbieta M van der Steen-Banasik  9 , John Armstrong  10 , Karine Peignaux-Casasnovas  11 , Jihane Boustani  12 , Fernanda G Herrera  13 , Bradley R Pieters  14 , Annerie Slot  15 , Amit Bahl  16 , Christopher D Scrase  17 , David Azria  18 , Jan Jansa  19 , Joe M O'Sullivan  20 , Alphonsus C M Van Den Bergh  21 , Laurence Collette  2 ; EORTC Radiation Oncology Group
Affiliations

Short Androgen Suppression and Radiation Dose Escalation in Prostate Cancer: 12-Year Results of EORTC Trial 22991 in Patients With Localized Intermediate-Risk Disease

Michel Bolla et al. J Clin Oncol. .

Abstract

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 α = 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] = 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).

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.

PubMed Disclaimer

Conflict of interest statement

Philippe MaingonHonoraria: IpsenConsulting or Advisory Role: BMS France, AstraZenecaSpeakers' Bureau: Varian Medical Systems Christian CarrieTravel, Accommodations, Expenses: AstraZeneca Santhanam SundarHonoraria: Bayer UK, Clovis OncologyConsulting or Advisory Role: RocheSpeakers' Bureau: PfizerTravel, Accommodations, Expenses: Roche, Bayer, Bristol Myers Squibb John ArmstrongEmployment: HealthbeaconStock and Other Ownership Interests: HealthbeaconTravel, Accommodations, Expenses: Ipsen Fernanda G. HerreraConsulting or Advisory Role: BioProtect LtdSpeakers' Bureau: Johnson & JohnsonResearch Funding: Bristol Myers Squibb Bradley R. PietersResearch Funding: Elekta Amit BahlHonoraria: Pfizer, Sanofi/Aventis, BMS, Roche, Merck, BayerResearch Funding: Janssen, SanofiTravel, Accommodations, Expenses: Bayer, Roche David AzriaStock and Other Ownership Interests: NovaGrayPatents, Royalties, Other Intellectual Property: Patent of individual radiosensitivity in breast and prostate cancers Jan JansaHonoraria: Janssen Oncology, BayerTravel, Accommodations, Expenses: Bayer Joe M. O'SullivanConsulting or Advisory Role: Bayer, Janssen, Astellas Pharma, Sanofi, NovartisSpeakers' Bureau: Bayer, Janssen, NovartisResearch Funding: Bayer Laurence ColletteEmployment: IDDINo other potential conflicts of interest were reported.

Publication types

Substances

Associated data

LinkOut - more resources