Effect of Chemotherapy With Docetaxel With Androgen Suppression and Radiotherapy for Localized High-Risk Prostate Cancer: The Randomized Phase III NRG Oncology RTOG 0521 Trial.
PURPOSE: Radiotherapy (RT) plus long-term androgen suppression (AS) are a standard treatment option for patients with high-risk localized prostate cancer. We hypothesized that docetaxel chemotherapy (CT) could improve overall survival (OS) and clinical outcomes among patients with high-risk prostate cancer.
PATIENTS AND METHODS: The multicenter randomized NRG Oncology RTOG 0521 study enrolled patients with high-risk nonmetastatic disease between 2005 and 2009. Patients were randomly assigned to receive standard long-term AS plus RT with or without adjuvant CT.
RESULTS: A total of 612 patients were enrolled; 563 were evaluable. Median prostate-specific antigen was 15.1 ng/mL; 53% had a Gleason score 9 to 10 cancer; 27% had cT3 to cT4 disease. Median follow-up was 5.7 years. Treatment was well tolerated in both arms. Four-year OS rate was 89% (95% CI, 84% to 92%) for AS + RT and 93% (95% CI, 90% to 96%) for AS + RT + CT (hazard ratio [HR], 0.69; 90% CI, 0.49 to 0.97; one-sided
CONCLUSION: For patients with high-risk nonmetastatic prostate cancer, CT with docetaxel improved OS from 89% to 93% at 4 years, with improved disease-free survival and reduction in the rate of distant metastasis. The trial suggests that docetaxel CT may be an option to be discussed with selected men with high-risk prostate cancer.
Published In/Presented At
Rosenthal, S. A., Hu, C., Sartor, O., Gomella, L. G., Amin, M. B., Purdy, J., Michalski, J. M., Garzotto, M. G., Pervez, N., Balogh, A. G., Rodrigues, G. B., Souhami, L., Reaume, M. N., Williams, S. G., Hannan, R., Horwitz, E. M., Raben, A., Peters, C. A., Feng, F. Y., Shipley, W. U., … Sandler, H. M. (2019). Effect of Chemotherapy With Docetaxel With Androgen Suppression and Radiotherapy for Localized High-Risk Prostate Cancer: The Randomized Phase III NRG Oncology RTOG 0521 Trial. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 37(14), 1159–1168. https://doi.org/10.1200/JCO.18.02158
Medicine and Health Sciences | Oncology
Department of Radiation Oncology