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• W1978377931 abstract "Benefit of adjuvant radiation therapy (ART) for men with adverse pathologic factors at radical prostatectomy (RP) has been validated in phase III trials. Despite ART, a high-risk group of patients has been defined with 50% risk of progression at 3 years, a risk factor for prostate cancer specific mortality. RTOG 0621 is a single-arm phase II trial designed to assess whether addition of androgen deprivation (ADT) and docetaxel to ART would increase freedom from progression (FFP) at 3 years from 50% to ≥ 70% in this high-risk group. Eligible patients (pts) had prostatic adenocarcinoma who underwent RP with PSA nadir > 0.2 and Gleason score ≥ 7 or PSA nadir ≤ 0.2 with Gleason score ≥ 8 and ≥ pT3. Pts received 6 months of ADT + RT to the pelvis with prostatic fossa boost to 66.6 Gy followed in one month with 6 cycles of docetaxel 75 mg/m2 every 21 days. The primary objective was to assess whether addition of ADT and docetaxel to ART results in FFP of ≥ 70% as defined as PSA < 0.4 ng/ml, and no clinical failure or death from any cause at 3 years. Multivariate logistic regression was used to model association of factors with FFP. Odds ratios, hazard ratios, and respective 95% confidence intervals were computed. Seventy-six pts meeting eligibility criteria were enrolled. Median follow-up (f/u) was 47 months. Median age: 62 (range: 45-73), T classification: pT2 (4%), pT3 (95%) and pT4 (1%); Gleason 7 (20%) and ≥ 8 (80%); Post-RP PSA: ≤ 0.2 (51%) and > 0.2 (49%) (median, 0.63 IQR 0.40 - 1.79). Surgical margins were positive in 58%. Three year FFP was observed in 54 pts (71%) (95% CI = 61%-81%, p < 0.001). At 3-year follow-up, 21 biochemical (BF), 6 distant (DF), and 1 local failure had occurred. Two deaths occurred, 1 which was prostate-cancer related. Univariate models revealed post-RP PSA was associated with 3yr FFP [OR = 0.08 (95% CI = 0.01, 0.33); p < 0.001], BF HR = 10.04 (95% CI = 2.98, 33.8); p < 0.001] and DF [HR = 20.51 (95% CI = 5.51, 76.33); p < 0.001]. In multivariate models, only PSA was associated with 3-yr FFP (OR = 0.05; p < 0.001) and DF (HR = 11.60; p = 0.02), and Gleason score (HR = 5.32; p = 0.01) and PSA (HR = 20.51; p < 0.001) were associated with BF when controlled for other covariates. Side effects of chemotherapy including grade 1-2 peripheral neuropathy and grade 3-4 neutropenia were common; however, only 3 cases of febrile neutropenia occurred. Late treatment related toxicities included 4 (5%) various CTC v3.0 grade 3 and 2 (3%) cases of grade 4 urinary incontinence. This phase II trial of ADT, docetaxel, and ART for men with high-risk prostate cancer post-prostectomy met the pre-specified study endpoint of 70% 3-year FFS, as compared with historic levels of 50%. This promising result warrants phase III testing of such an integrated local and systemic therapeutic approach to such patients." @default.
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• W1978377931 date "2014-09-01" @default.
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• W1978377931 title "Adjuvant Radiation, Androgen Deprivation, and Docetaxel for High-Risk Prostate Cancer Postprostatectomy: Results of RTOG 0621" @default.
• W1978377931 doi "https://doi.org/10.1016/j.ijrobp.2014.06.019" @default.
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