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

Seth A. Rosenthal, Chen Hu, Oliver Sartor, Leonard G. Gomella, Mahul B. Amin, James Purdy, Jeff M. Michalski, Mark 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 & 1 others Howard M. Sandler

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

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 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). 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.

Original languageEnglish (US)
Pages (from-to)1159-1168
Number of pages10
JournalJournal of Clinical Oncology
Volume37
Issue number14
DOIs
StatePublished - Jan 1 2019

Fingerprint

docetaxel
Androgens
Prostatic Neoplasms
Radiotherapy
Drug Therapy
Disease-Free Survival
Survival Rate
Neoplasm Metastasis

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

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

In: Journal of Clinical Oncology, Vol. 37, No. 14, 01.01.2019, p. 1159-1168.

Research output: Contribution to journalArticle

Rosenthal, SA, Hu, C, Sartor, O, Gomella, LG, Amin, MB, Purdy, J, Michalski, JM, Garzotto, M, Pervez, N, Balogh, AG, Rodrigues, GB, Souhami, L, Reaume, MN, Williams, SG, Hannan, R, Horwitz, EM, Raben, A, Peters, CA, Feng, FY, Shipley, WU & Sandler, HM 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, vol. 37, no. 14, pp. 1159-1168. https://doi.org/10.1200/JCO.18.02158
Rosenthal, Seth A. ; Hu, Chen ; Sartor, Oliver ; Gomella, Leonard G. ; Amin, Mahul B. ; Purdy, James ; Michalski, Jeff M. ; Garzotto, Mark ; Pervez, Nadeem ; Balogh, Alexander G. ; Rodrigues, George B. ; Souhami, Luis ; Reaume, M. Neil ; Williams, Scott G. ; Hannan, Raquibul ; Horwitz, Eric M. ; Raben, Adam ; Peters, Christopher A. ; Feng, Felix Y. ; Shipley, William U. ; Sandler, Howard M. / 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. In: Journal of Clinical Oncology. 2019 ; Vol. 37, No. 14. pp. 1159-1168.
@article{53431055609d4bf0a5598602488ab940,
title = "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",
abstract = "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 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). 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.",
author = "Rosenthal, {Seth A.} and Chen Hu and Oliver Sartor and Gomella, {Leonard G.} and Amin, {Mahul B.} and James Purdy and Michalski, {Jeff M.} and Mark Garzotto and Nadeem Pervez and Balogh, {Alexander G.} and Rodrigues, {George B.} and Luis Souhami and Reaume, {M. Neil} and Williams, {Scott G.} and Raquibul Hannan and Horwitz, {Eric M.} and Adam Raben and Peters, {Christopher A.} and Feng, {Felix Y.} and Shipley, {William U.} and Sandler, {Howard M.}",
year = "2019",
month = "1",
day = "1",
doi = "10.1200/JCO.18.02158",
language = "English (US)",
volume = "37",
pages = "1159--1168",
journal = "Journal of Clinical Oncology",
issn = "0732-183X",
publisher = "American Society of Clinical Oncology",
number = "14",

}

TY - JOUR

T1 - Effect of chemotherapy with docetaxel with androgen suppression and radiotherapy for localized high-risk prostate cancer

T2 - The randomized phase III NRG Oncology RTOG 0521 Trial

AU - Rosenthal, Seth A.

AU - Hu, Chen

AU - Sartor, Oliver

AU - Gomella, Leonard G.

AU - Amin, Mahul B.

AU - Purdy, James

AU - Michalski, Jeff M.

AU - Garzotto, Mark

AU - Pervez, Nadeem

AU - Balogh, Alexander G.

AU - Rodrigues, George B.

AU - Souhami, Luis

AU - Reaume, M. Neil

AU - Williams, Scott G.

AU - Hannan, Raquibul

AU - Horwitz, Eric M.

AU - Raben, Adam

AU - Peters, Christopher A.

AU - Feng, Felix Y.

AU - Shipley, William U.

AU - Sandler, Howard M.

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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 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). 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.

AB - 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 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). 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.

UR - http://www.scopus.com/inward/record.url?scp=85063945379&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85063945379&partnerID=8YFLogxK

U2 - 10.1200/JCO.18.02158

DO - 10.1200/JCO.18.02158

M3 - Article

VL - 37

SP - 1159

EP - 1168

JO - Journal of Clinical Oncology

JF - Journal of Clinical Oncology

SN - 0732-183X

IS - 14

ER -