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.

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.

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.

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 P = .034). There were 59 deaths in the AS + RT arm and 43 in the AS + RT + CT arm, with fewer deaths resulting from prostate cancer in the AS + RT + CT arm versus AS + RT (23 v 16 deaths, respectively). Six-year rate of distant metastasis was 14% for AS + RT and 9.1% for AS + RT + CT, (HR, 0.60; 95% CI, 0.37 to 0.99; two-sided P = .044). Six-year disease-free survival rate was 55% for AS + RT and 65% for AS + RT + CT (HR, 0.76; 95% CI, 0.58 to 0.99; two-sided P = .043).

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.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2019 Mar 12 [Epub ahead of print]

Seth A Rosenthal, Chen Hu, Oliver Sartor, Leonard G Gomella, Mahul B Amin, James Purdy, Jeff M Michalski, Mark G Garzotto, Nadeem Pervez, Alexander G Balogh, George B Rodrigues, Luis Souhami, M Neil Reaume, Scott G Williams, Raquibul Hannan, Eric M Horwitz, Adam Raben, Christopher A Peters, Felix Y Feng, William U Shipley, Howard M Sandler

1 Sutter Medical Group and Sutter Cancer Centers, Sacramento, CA., 2 NRG Oncology Statistics and Data Management Center, Philadelphia, PA., 4 Tulane University Health Services Center, New Orleans, LA., 5 Thomas Jefferson University Hospital, Philadelphia, PA., 6 Cedars-Sinai Medical Center, Los Angeles, CA., 7 University of California Davis Medical Center, Sacramento, CA., 8 Washington University School of Medicine, St Louis, MO., 9 Oregon Health & Science University, Portland, OR., 10 Cross Cancer Institute, Edmonton, Alberta, Canada., 11 Tom Baker Cancer Centre, Calgary, Alberta, Canada., 12 London Health Sciences Centre, London, Ontario, Canada., 13 McGill University, Montréal, Quebec, Canada., 14 The Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada., 15 Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia., 16 University of Texas Southwestern Medical School, Dallas, TX., 17 Fox Chase Cancer Center, Philadelphia, PA., 18 Christiana Care Health Services Community Clinical Oncology Program, Newark, DE., 19 Northeast Radiation Oncology Center, Dunmore, PA., 20 University of California at San Francisco, San Francisco, CA., 21 Massachusetts General Hospital, Harvard Medical School, Boston, MA.