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[Abstract]

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.

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.

[Author information]

Mason MD1, Parulekar WR2, Sydes MR2, Brundage M2, Kirkbride P2, Gospodarowicz M2, Cowan R2, Kostashuk EC2, Anderson J2, Swanson G2, Parmar MK2, Hayter C2, Jovic G2, Hiltz A2, Hetherington J2, Sathya J2, Barber JB2, McKenzie M2, El-Sharkawi S2, Souhami L2, Hardman PD2, Chen BE2, Warde P2.

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.

2Malcolm 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.