TY - JOUR
T1 - Dose-Escalated Radiotherapy Alone or in Combination with Short-Term Androgen Deprivation for Intermediate-Risk Prostate Cancer
T2 - Results of a Phase III Multi-Institutional Trial
AU - Krauss, Daniel J.
AU - Karrison, Theodore
AU - Martinez, Alvaro A.
AU - Morton, Gerard
AU - Yan, Di
AU - Bruner, Deborah Watkins
AU - Movsas, Benjamin
AU - Elshaikh, Mohamed
AU - Citrin, Deborah
AU - Hershatter, Bruce
AU - Michalski, Jeff M.
AU - Efstathiou, Jason Alexander
AU - Currey, Adam
AU - Kavadi, Vivek S.
AU - Cury, Fabio L.
AU - Lock, Michael
AU - Raben, Adam
AU - Seaward, Samantha Andrews
AU - El-Gayed, Ali
AU - Rodgers, Joseph P.
AU - Sandler, Howard M.
N1 - Publisher Copyright:
© American Society of Clinical Oncology.
PY - 2023/6/10
Y1 - 2023/6/10
N2 - PURPOSEIt remains unknown whether or not short-term androgen deprivation (STAD) improves survival among men with intermediate-risk prostate cancer (IRPC) treated with dose-escalated radiotherapy (RT).METHODSThe NRG Oncology/Radiation Therapy Oncology Group 0815 study randomly assigned 1,492 patients with stage T2b-T2c, Gleason score 7, or prostate-specific antigen (PSA) value >10 and 20 ng/mL to dose-escalated RT alone (arm 1) or with STAD (arm 2). STAD was 6 months of luteinizing hormoneareleasing hormone agonist/antagonist therapy plus antiandrogen. RT modalities were external-beam RT alone to 79.2 Gy or external beam (45 Gy) with brachytherapy boost. The primary end point was overall survival (OS). Secondary end points included prostate cancer mortality (PCSM), non-PCSM, distant metastases (DMs), PSA failure, and rates of salvage therapy.RESULTSMedian follow-up was 6.3 years. Two hundred nineteen deaths occurred, 119 in arm 1 and 100 in arm 2. Five-year OS estimates were 90% versus 91%, respectively (hazard ratio [HR], 0.85; 95% CI, 0.65 to 1.11]; P =.22). STAD resulted in reduced PSA failure (HR, 0.52; P <.001), DM (HR, 0.25; P <.001), PCSM (HR, 0.10; P =.007), and salvage therapy use (HR, 0.62; P =.025). Other-cause deaths were not significantly different (P =.56). Acute grade 3 adverse events (AEs) occurred in 2% of patients in arm 1 and in 12% for arm 2 (P <.001). Cumulative incidence of late grade 3 AEs was 14% in arm 1 and 15% in arm 2 (P =.29).CONCLUSIONSTAD did not improve OS rates for men with IRPC treated with dose-escalated RT. Improvements in metastases rates, prostate cancer deaths, and PSA failures should be weighed against the risk of adverse events and the impact of STAD on quality of life.
AB - PURPOSEIt remains unknown whether or not short-term androgen deprivation (STAD) improves survival among men with intermediate-risk prostate cancer (IRPC) treated with dose-escalated radiotherapy (RT).METHODSThe NRG Oncology/Radiation Therapy Oncology Group 0815 study randomly assigned 1,492 patients with stage T2b-T2c, Gleason score 7, or prostate-specific antigen (PSA) value >10 and 20 ng/mL to dose-escalated RT alone (arm 1) or with STAD (arm 2). STAD was 6 months of luteinizing hormoneareleasing hormone agonist/antagonist therapy plus antiandrogen. RT modalities were external-beam RT alone to 79.2 Gy or external beam (45 Gy) with brachytherapy boost. The primary end point was overall survival (OS). Secondary end points included prostate cancer mortality (PCSM), non-PCSM, distant metastases (DMs), PSA failure, and rates of salvage therapy.RESULTSMedian follow-up was 6.3 years. Two hundred nineteen deaths occurred, 119 in arm 1 and 100 in arm 2. Five-year OS estimates were 90% versus 91%, respectively (hazard ratio [HR], 0.85; 95% CI, 0.65 to 1.11]; P =.22). STAD resulted in reduced PSA failure (HR, 0.52; P <.001), DM (HR, 0.25; P <.001), PCSM (HR, 0.10; P =.007), and salvage therapy use (HR, 0.62; P =.025). Other-cause deaths were not significantly different (P =.56). Acute grade 3 adverse events (AEs) occurred in 2% of patients in arm 1 and in 12% for arm 2 (P <.001). Cumulative incidence of late grade 3 AEs was 14% in arm 1 and 15% in arm 2 (P =.29).CONCLUSIONSTAD did not improve OS rates for men with IRPC treated with dose-escalated RT. Improvements in metastases rates, prostate cancer deaths, and PSA failures should be weighed against the risk of adverse events and the impact of STAD on quality of life.
UR - http://www.scopus.com/inward/record.url?scp=85163236716&partnerID=8YFLogxK
U2 - 10.1200/JCO.22.02390
DO - 10.1200/JCO.22.02390
M3 - Article
C2 - 37104748
AN - SCOPUS:85163236716
SN - 0732-183X
VL - 41
SP - 3203
EP - 3216
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 17
ER -