Abstract
PurposeWe 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 MethodsNCIC 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.ResultsOne 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.ConclusionThis 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.
Highlights
Prostate cancer is the most common cancer diagnosed in men in the Western Hemisphere, with approximately 899,000 patients diagnosed and 258,000 deaths worldwide in 2008.1 Patients with locally advanced disease, defined as stage categories T3-4, N0, and M0, are still prevalent in regions where the use of prostatespecific antigen (PSA) screening is not widespread.[2]Previous uncertainties about the roles of radiotherapy (RT) and androgen-deprivation therapy (ADT)[3,4] have been greatly clarified after the publication of randomized trials demonstrating the benefits of ADT added to RT and the benefits of RT added to ADT.[5,6,7] Three reported randomized trials compared ADT alone with to ADT plus RT
Overall survival was significantly improved in the patients allocated to ADTϩRT
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 Ͻ .001)
Summary
Previous uncertainties about the roles of radiotherapy (RT) and androgen-deprivation therapy (ADT)[3,4] have been greatly clarified after the publication of randomized trials demonstrating the benefits of ADT added to RT and the benefits of RT added to ADT.[5,6,7] Three reported randomized trials compared ADT alone with to ADT plus RT. The interim analysis of this intergroup trial has been reported previously[8] and showed a significant overall survival (OS) improvement for patients treated with ADTϩRT (hazard ratio [HR], 0.77; 95% CI, 0.61 to 0.98; P ϭ .033) and improvement in disease-specific survival (DSS). The final, preplanned analysis presented here reports on the longer-term survival outcomes and toxicity. Quality-of-life analyses are reported by Brundage et al.8a
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