1. Adjuvant radiation therapy, androgen deprivation, and docetaxel for high-risk prostate cancer postprostatectomy: Results of NRG Oncology/RTOG study 0621.
- Author
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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, and Sandler HM
- Subjects
- Adenocarcinoma blood, Adenocarcinoma pathology, Adult, Aged, Disease-Free Survival, Docetaxel, Gonadotropin-Releasing Hormone agonists, Humans, Kallikreins blood, Male, Middle Aged, Multivariate Analysis, Neoplasm Grading, Neoplasm Staging, Proportional Hazards Models, Prostate-Specific Antigen blood, Prostatic Neoplasms blood, Prostatic Neoplasms pathology, Radiotherapy, Conformal, Radiotherapy, Intensity-Modulated, Adenocarcinoma therapy, Androgen Antagonists therapeutic use, Anilides therapeutic use, Antineoplastic Agents therapeutic use, Chemoradiotherapy, Adjuvant methods, Nitriles therapeutic use, Prostatectomy, Prostatic Neoplasms therapy, Taxoids therapeutic use, Tosyl Compounds therapeutic use
- Abstract
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., (© 2017 American Cancer Society.)
- Published
- 2017
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