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Adjuvant radiation therapy, androgen deprivation, and docetaxel for high-risk prostate cancer postprostatectomy: Results of NRG Oncology/RTOG study 0621
- Source :
- Cancer. 123:2489-2496
- Publication Year :
- 2017
- Publisher :
- Wiley, 2017.
-
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.
- Subjects :
- Oncology
Cancer Research
medicine.medical_specialty
business.industry
Prostatectomy
medicine.medical_treatment
030232 urology & nephrology
urologic and male genital diseases
medicine.disease
Radiation therapy
03 medical and health sciences
Prostate-specific antigen
Prostate cancer
0302 clinical medicine
Docetaxel
030220 oncology & carcinogenesis
Internal medicine
medicine
Cumulative incidence
business
Chemoradiotherapy
Febrile neutropenia
medicine.drug
Subjects
Details
- ISSN :
- 0008543X
- Volume :
- 123
- Database :
- OpenAIRE
- Journal :
- Cancer
- Accession number :
- edsair.doi...........aef54cdda3e6684a2c42f6853b70f4c3