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Adjuvant radiation therapy, androgen deprivation, and docetaxel for high-risk prostate cancer postprostatectomy: Results of NRG Oncology/RTOG study 0621.

Publication ,  Journal Article
Hurwitz, MD; Harris, J; Sartor, O; Xiao, Y; Shayegan, B; Sperduto, PW; Badiozamani, KR; Lawton, CAF; Horwitz, EM; Michalski, JM; Roof, K ...
Published in: Cancer
July 1, 2017

BACKGROUND: Phase 3 trials have demonstrated a benefit from adjuvant radiation therapy (ART) for men who have adverse factors at radical prostatectomy (RP). However, some patients have a high risk of progression despite ART. The role of systemic therapy with ART in this high-risk group remains to be defined. METHODS: Patients who had either a post-RP prostate-specific antigen (PSA) nadir > 0.2 ng/mL and a Gleason score ≥7 or a PSA nadir ≤0.2 ng/mL, a Gleason score ≥8, and a pathologic tumor (pT) classification ≥ pT3 received 6 months of androgen-deprivation therapy (ADT) plus radiotherapy and 6 cycles of docetaxel. The primary objective was to assess whether the addition of ADT and docetaxel to ART resulted in a freedom from progression (FFP) rate ≥ 70% compared with an expected rate of 50%. Multivariate logistic and Cox regression analyses were used to model associations between factors and outcomes. RESULTS: In total, 74 patients were enrolled. The median follow-up was 4.4 years. The pathologic tumor classification was pT2 in 4% of patients, pT3 in 95%, and pT4 in 1%. The Gleason score was 7 in 18% of patients and ≥8 in 82%. Post-RP PSA levels were ≤0.2 ng/mL in 53% of patients and >0.2 ng/mL in 47%. The 3-year FFP rate was 73% (95% confidence interval, 61%-83%), and the 3-year cumulative incidence of biochemical, distant, and local failure was 26%, 7%, and 0%, respectively. In multivariate models, postprostatectomy PSA nadir was associated with 3-year FFP, Gleason score, and PSA with biochemical failure. Grade 3 and 4 neutropenia was common; however, only 3 episodes of febrile neutropenia occurred. Late toxicities were not impacted by the addition of systemic therapy. CONCLUSIONS: Combined ADT, docetaxel, and ART for men with high-risk prostate cancer after prostatectomy exceeded the prespecified study endpoint of 70% 3-year FFP. Phase 3 trials assessing combined local and systemic therapies for these high-risk patients are warranted. Cancer 2017;123:2489-96. © 2017 American Cancer Society.

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Published In

Cancer

DOI

EISSN

1097-0142

Publication Date

July 1, 2017

Volume

123

Issue

13

Start / End Page

2489 / 2496

Location

United States

Related Subject Headings

  • Tosyl Compounds
  • Taxoids
  • Radiotherapy, Intensity-Modulated
  • Radiotherapy, Conformal
  • Prostatic Neoplasms
  • Prostatectomy
  • Prostate-Specific Antigen
  • Proportional Hazards Models
  • Oncology & Carcinogenesis
  • Nitriles
 

Citation

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MLA
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Hurwitz, M. D., Harris, J., Sartor, O., Xiao, Y., Shayegan, B., Sperduto, P. W., … Sandler, H. M. (2017). Adjuvant radiation therapy, androgen deprivation, and docetaxel for high-risk prostate cancer postprostatectomy: Results of NRG Oncology/RTOG study 0621. Cancer, 123(13), 2489–2496. https://doi.org/10.1002/cncr.30620
Hurwitz, Mark D., Jonathan Harris, Oliver Sartor, Ying Xiao, Bobby Shayegan, Paul W. Sperduto, Kasra R. Badiozamani, et al. “Adjuvant radiation therapy, androgen deprivation, and docetaxel for high-risk prostate cancer postprostatectomy: Results of NRG Oncology/RTOG study 0621.Cancer 123, no. 13 (July 1, 2017): 2489–96. https://doi.org/10.1002/cncr.30620.
Hurwitz MD, Harris J, Sartor O, Xiao Y, Shayegan B, Sperduto PW, et al. Adjuvant radiation therapy, androgen deprivation, and docetaxel for high-risk prostate cancer postprostatectomy: Results of NRG Oncology/RTOG study 0621. Cancer. 2017 Jul 1;123(13):2489–96.
Hurwitz, Mark D., et al. “Adjuvant radiation therapy, androgen deprivation, and docetaxel for high-risk prostate cancer postprostatectomy: Results of NRG Oncology/RTOG study 0621.Cancer, vol. 123, no. 13, July 2017, pp. 2489–96. Pubmed, doi:10.1002/cncr.30620.
Hurwitz MD, Harris J, Sartor O, Xiao Y, Shayegan B, Sperduto PW, Badiozamani KR, Lawton CAF, Horwitz EM, Michalski JM, Roof K, Beyer DC, Zhang Q, Sandler HM. Adjuvant radiation therapy, androgen deprivation, and docetaxel for high-risk prostate cancer postprostatectomy: Results of NRG Oncology/RTOG study 0621. Cancer. 2017 Jul 1;123(13):2489–2496.
Journal cover image

Published In

Cancer

DOI

EISSN

1097-0142

Publication Date

July 1, 2017

Volume

123

Issue

13

Start / End Page

2489 / 2496

Location

United States

Related Subject Headings

  • Tosyl Compounds
  • Taxoids
  • Radiotherapy, Intensity-Modulated
  • Radiotherapy, Conformal
  • Prostatic Neoplasms
  • Prostatectomy
  • Prostate-Specific Antigen
  • Proportional Hazards Models
  • Oncology & Carcinogenesis
  • Nitriles