| Titel |
Final Report of the Intergroup Randomized Study of
Combined Androgen-Deprivation Therapy Plus
Radiotherapy Versus Androgen-Deprivation Therapy Alone
in Locally Advanced Prostate Cancer
Malcolm D. Mason, Wendy R. Parulekar, Matthew R. Sydes, Michael Brundage, Peter Kirkbride,
Mary Gospodarowicz, Richard Cowan, Edmund C. Kostashuk, John Anderson, Gregory Swanson,
Mahesh K.B. Parmar, Charles Hayter, Gordana Jovic, Andrea Hiltz, John Hetherington, Jinka Sathya,
James B.P. Barber, Michael McKenzie, Salah El-Sharkawi, Luis Souhami, P.D. John Hardman,
Bingshu E. Chen, and Padraig Warde
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
g/LorPSAof20to40g/LplusGleasonscoreof8to10wererandomlyassignedto
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.
J Clin Oncol © 2015 American Society of Clinical Oncology. Licensed under the Creative
Commons Attribution 3.0 License: http://creativecommons.org/licenses/by/3.0/
 |
Quellen |
1.) Gospodarowicz MK, et al.:
Final Analysis of Intergroup Randomizes Phase III Study of Andogen Deprivation Therapie (ADT) +- Radiation Therapy (RT) in Locally Advanced Prostate Cancer.
ASTRO-Kongress Boston 2013
IJROBP 84(2012): Supplement S2
Warde P, Mason M, Ding K, et al: Combined
androgen deprivation therapy and radiation therapy
for locally advanced prostate cancer: A randomised,
phase 3 trial. Lancet 378:2104-2111, 2011
Impact of Radiotherapy When Added to Androgen-
Deprivation Therapy for Locally Advanced Prostate Cancer:
Long-Term Quality-of-Life Outcomes From the NCIC CTG
PR3/MRC PR07 Randomized Trial
Michael Brundage,
J Clin Oncol 33:2151-2157. © 2015 b
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