TY - JOUR
T1 - Combined androgen deprivation therapy and radiation therapy for locally advanced prostate cancer
T2 - A randomised, phase 3 trial
AU - Warde, Padraig
AU - Mason, Malcolm
AU - Ding, Keyue
AU - Kirkbride, Peter
AU - Brundage, Michael
AU - Cowan, Richard
AU - Gospodarowicz, Mary
AU - Sanders, Karen
AU - Kostashuk, Edmund
AU - Swanson, Greg
AU - Barber, Jim
AU - Hiltz, Andrea
AU - Parmar, Mahesh Kb
AU - Sathya, Jinka
AU - Anderson, John
AU - Hayter, Charles
AU - Hetherington, John
AU - Sydes, Matthew R.
AU - Parulekar, Wendy
N1 - Funding Information:
This study was supported by US National Cancer Institute ( grant CA077202 ), Canadian Cancer Society Research Institute ( grant 14469 ), the UK Medical Research Council ( grant G9805643 ), and the UK National Cancer Research Network.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2011
Y1 - 2011
N2 - Whether the addition of radiation therapy (RT) improves overall survival in men with locally advanced prostate cancer managed with androgen deprivation therapy (ADT) is unclear. Our aim was to compare outcomes in such patients with locally advanced prostate cancer. Patients with: locally advanced (T3 or T4) prostate cancer (n=1057); or organ-confined disease (T2) with either a prostate-specific antigen (PSA) concentration more than 40 ng/mL (n=119) or PSA concentration more than 20 ng/mL and a Gleason score of 8 or higher (n=25), were randomly assigned (done centrally with stratification and dynamic minimisation, not masked) to receive lifelong ADT and RT (65-69 Gy to the prostate and seminal vesicles, 45 Gy to the pelvic nodes). The primary endpoint was overall survival. The results presented here are of an interim analysis planned for when two-thirds of the events for the final analysis were recorded. All efficacy analyses were done by intention to treat and were based on data from all patients. This trial is registered at controlledtrials.com as ISRCTN24991896 and Clinicaltrials.gov as NCT00002633. Between 1995 and 2005, 1205 patients were randomly assigned (602 in the ADT only group and 603 in the ADT and RT group); median follow-up was 6·0 years (IQR 4·4-8·0). At the time of analysis, a total of 320 patients had died, 175 in the ADT only group and 145 in the ADT and RT group. The addition of RT to ADT improved overall survival at 7 years (74, 95 CI 70-78 vs 66, 60-70; hazard ratio [HR] 0·77, 95 CI 0·61-0·98, p=0·033). Both toxicity and health-related quality-of-life results showed a small effect of RT on late gastrointestinal toxicity (rectal bleeding grade >3, three patients (0·5) in the ADT only group, two (0·3) in the ADT and RT group; diarrhoea grade >3, four patients (0·7) vs eight (1·3); urinary toxicity grade >3, 14 patients (2·3) in both groups). The benefits of combined modality treatment - ADT and RT - should be discussed with all patients with locally advanced prostate cancer. Canadian Cancer Society Research Institute, US National Cancer Institute, and UK Medical Research Council.
AB - Whether the addition of radiation therapy (RT) improves overall survival in men with locally advanced prostate cancer managed with androgen deprivation therapy (ADT) is unclear. Our aim was to compare outcomes in such patients with locally advanced prostate cancer. Patients with: locally advanced (T3 or T4) prostate cancer (n=1057); or organ-confined disease (T2) with either a prostate-specific antigen (PSA) concentration more than 40 ng/mL (n=119) or PSA concentration more than 20 ng/mL and a Gleason score of 8 or higher (n=25), were randomly assigned (done centrally with stratification and dynamic minimisation, not masked) to receive lifelong ADT and RT (65-69 Gy to the prostate and seminal vesicles, 45 Gy to the pelvic nodes). The primary endpoint was overall survival. The results presented here are of an interim analysis planned for when two-thirds of the events for the final analysis were recorded. All efficacy analyses were done by intention to treat and were based on data from all patients. This trial is registered at controlledtrials.com as ISRCTN24991896 and Clinicaltrials.gov as NCT00002633. Between 1995 and 2005, 1205 patients were randomly assigned (602 in the ADT only group and 603 in the ADT and RT group); median follow-up was 6·0 years (IQR 4·4-8·0). At the time of analysis, a total of 320 patients had died, 175 in the ADT only group and 145 in the ADT and RT group. The addition of RT to ADT improved overall survival at 7 years (74, 95 CI 70-78 vs 66, 60-70; hazard ratio [HR] 0·77, 95 CI 0·61-0·98, p=0·033). Both toxicity and health-related quality-of-life results showed a small effect of RT on late gastrointestinal toxicity (rectal bleeding grade >3, three patients (0·5) in the ADT only group, two (0·3) in the ADT and RT group; diarrhoea grade >3, four patients (0·7) vs eight (1·3); urinary toxicity grade >3, 14 patients (2·3) in both groups). The benefits of combined modality treatment - ADT and RT - should be discussed with all patients with locally advanced prostate cancer. Canadian Cancer Society Research Institute, US National Cancer Institute, and UK Medical Research Council.
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U2 - 10.1016/S0140-6736(11)61095-7
DO - 10.1016/S0140-6736(11)61095-7
M3 - Article
C2 - 22056152
AN - SCOPUS:83955165856
VL - 378
SP - 2104
EP - 2111
JO - The Lancet
JF - The Lancet
SN - 0140-6736
IS - 9809
ER -