Κυριακή 1 Μαρτίου 2015

RT FOR LOCALLY ADVANCED PROSTATE CANCER

 2015 Feb 17. pii: JCO.2014.57.7510. [Epub ahead of print]

Final Report of the Intergroup Randomized Study of Combined Androgen-Deprivation Therapy Plus RadiotherapyVersus Androgen-Deprivation Therapy Alone in Locally Advanced Prostate Cancer.

Abstract

PURPOSE: 

We have previously reported that radiotherapy (RT) added to androgen-deprivation therapy (ADT) improves survival in men with locallyadvanced 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.

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