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Published on: March 6, 2018
Final Report of the Intergroup Randomized Study of Combined Androgen-Deprivation Therapy Plus Radiotherapy Versus
Malcolm D Mason1, Wendy R Parulekar2, Matthew R Sydes2
1Malcolm D. Mason, Cardiff University School of Medicine, Velindre Hospital; James B.P. Barber, Velindre Hospital, Cardiff; Matthew R. Sydes, Mahesh K.B. Parmar, Gordana Jovic, Medical Research Council Clinical Trials Unit at University College London, London; Peter Kirkbride, The Clatterbridge Cancer Centre National Health Service Foundation Trust, Wirral; Richard Cowan, Christie Hospital, University of Manchester, Manchester; John Anderson, Sheffield Teaching Hospitals, National Health Service Foundation Trust, Sheffield; John Hetherington, Castle Hill Hospital, Hull; Salah El-Sharkawi, South West Wales Cancer Centre, Swansea; P.D. John Hardman, The James Cook University Hospital, Middlesbrough, United Kingdom; Wendy R. Parulekar, Andrea Hiltz, and Bingshu E. Chen, NCIC Clinical Trials Group, Queen's University; Michael Brundage, Cancer Centre of Southeastern Ontario, Kingston; Mary Gospodarowicz and Padraig Warde, University of Toronto, Princess Margaret Cancer Centre; Charles Hayter, University of Toronto, Carlo Fidani Peel Regional Cancer Center, Toronto, Ontario; Edmund C. Kostashuk, Fraser Valley Cancer Centre, Surrey; Michael McKenzie, Vancouver Cancer Centre, Vancouver, British Columbia; Jinka Sathya, Memorial University of Newfoundland, St Johns, Newfoundland and Labrador, Canada; Luis Souhami, McGill University, Montreal, Quebec, Canada; and Gregory Swanson, University of Texas Health Science Center, San Antonio, TX. masonmd@cardiff.ac.uk.
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 microg/L or PSA of 20 to 40 microg/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.
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