PURPOSE: We have previously reported that radiotherapy (RT) added to androgen-deprivation therapy (ADT) improves survival in men with locally advanced prostate cancer. Here, we report the prespecified final analysis of this randomized trial.
PATIENTS AND METHODS: NCIC Clinical Trials Group PR.3/Medical Research Council PR07/Intergroup T94-0110 was a randomized controlled trial of patients with locally advanced prostate cancer. Patients with T3-4, N0/Nx, M0 prostate cancer or T1-2 disease with either prostate-specific antigen (PSA) of more than 40 μg/L or PSA of 20 to 40 μg/L plus Gleason score of 8 to 10 were randomly assigned to lifelong ADT alone or to ADT+RT. The RT dose was 64 to 69 Gy in 35 to 39 fractions to the prostate and pelvis or prostate alone. Overall survival was compared using a log-rank test stratified for prespecified variables.
RESULTS: One thousand two hundred five patients were randomly assigned between 1995 and 2005, 602 to ADT alone and 603 to ADT+RT. At a median follow-up time of 8 years, 465 patients had died, including 199 patients from prostate cancer. Overall survival was significantly improved in the patients allocated to ADT+RT (hazard ratio [HR], 0.70; 95% CI, 0.57 to 0.85; P < .001). Deaths from prostate cancer were significantly reduced by the addition of RT to ADT (HR, 0.46; 95% CI, 0.34 to 0.61; P < .001). Patients on ADT+RT reported a higher frequency of adverse events related to bowel toxicity, but only two of 589 patients had grade 3 or greater diarrhea at 24 months after RT.
CONCLUSION: This analysis demonstrates that the previously reported benefit in survival is maintained at a median follow-up of 8 years and firmly establishes the role of RT in the treatment of men with locally advanced prostate cancer.
Mason MD, Parulekar WR, Sydes MR, Brundage M, Kirkbride P, Gospodarowicz M, Cowan R, Kostashuk EC, Anderson J, Swanson G, Parmar MK, Hayter C, Jovic G, Hiltz A, Hetherington J, Sathya J, Barber JB, McKenzie M, El-Sharkawi S, Souhami L, Hardman PD, Chen BE, Warde P Are you the author?
Cardiff University School of Medicine, Velindre Hospital; Velindre Hospital, Cardiff; Medical Research Council Clinical Trials Unit at University College London, London; The Clatterbridge Cancer Centre National Health Service Foundation Trust, Wirral; Christie Hospital, University of Manchester, Manchester; Sheffield Teaching Hospitals, National Health Service Foundation Trust, Sheffield; Castle Hill Hospital, Hull; South West Wales Cancer Centre, Swansea; The James Cook University Hospital, Middlesbrough, United Kingdom; NCIC Clinical Trials Group, Queen's University; Cancer Centre of Southeastern Ontario, Kingston; University of Toronto, Princess Margaret Cancer Centre; University of Toronto, Carlo Fidani Peel Regional Cancer Center, Toronto, Ontario; Fraser Valley Cancer Centre, Surrey; Vancouver Cancer Centre, Vancouver, British Columbia; Memorial University of Newfoundland, St Johns, Newfoundland and Labrador, Canada; McGill University, Montreal, Quebec, Canada; University of Texas Health Science Center, San Antonio, TX. .
Reference: J Clin Oncol. 2015 Feb 17. (Epub ahead of print)