|ITEM METADATA RECORD
|Title: ||Adjuvant radiotherapy after radical prostatectomy in patients with pathologically high risk prostate cancer: 10-year follow-up results|
|Authors: ||Van Poppel, Hendrik|
Da Pozzo, L
De Reijke, Th M
Bosset, J. F
Van Velthoven, R
Van De Beek, C
Van Den Bergh, A. C. M
Van Tienhoven, G
Collette, L #
|Issue Date: ||Mar-2011 |
|Publisher: ||Elsevier Science|
|Host Document: ||European Urology Supplements vol:10 issue:2 pages:93-93|
|Conference: ||Annual Congress of the European Association of Urology edition:26 location:Vienna, Austria date:18-22 March 2011|
|Article number: ||227|
|Abstract: ||Introduction & Objectives: From 1992 to 2001, 1005 patients (pts) entered the randomized EORTC trial 22911 comparing immediate external beam irradiation(RT) versus wait-and-see (WS) for pts with positive surgical margins or pT3 after
radical prostatectomy (RP) (Lancet 2005). We report the 10-year follow-up results.
Materials & Methods: Eligible pts were ≤75 years with WHO PS 0-1; cT1-3N0M0 (UICC 1983) prostate cancer who had undergone RP with pN0 and ≥ 1 pathological risk factors of: capsular perforation, positive surgical margins, and/or invasion of the seminal vesicles. RT (60Gy in 6 wks to the surgical bed) started within 4 months of RP. The primary trial endpoint was biochemical progression-free survival (time from randomization to twice confirmed PSA increase over nadir or first clinical failure or death). Results at 5 years were presented after an interim analysis (P<0.02). Updated results are presented at the 2-sided significance level α=0.047. The trial is registered with ClinicalTrials.gov, number NCT00002511.
Results: A total of 503 pts entered the RT arm and 502 the WS arm. Patients’median age was 65 years (range 47-75). Median pre-operative PSA was 12.4 ng/ml; 69.5% of pts had a postoperative PSA≤0.2 ng/ml. After 10.6 years median
follow-up, the 10-year biochemical progression-free survival rate was 60.6% (CI: 55.7-65.9%) with RT versus 41.1% on WS (CI: 36.4-45.8%); HR=0.49 (CI: 0.41-0.59), P<0.0001. The 10-y clinical progression-free survival rate was 70.3% (CI: 65.5-74.6) and 64. 8% (CI: 59.8-69.3%), respectively (HR= 0.81, CI: 0.65-1.01, P=0.054). With RT, the 10-year cumulative incidence of loco-regional failure was decreased from 16.6% to 7.3% (P<0.0001). The 10-year cumulative incidence of distant metastases (11.0% vs. 10.1% with RT; P>0.1) nor overall survival (10-y survival rates 76.9% vs. 80.7% with RT, P>0.1) were impacted. The results were similar when the analysis was restricted to patients with postoperative PSA≤0.2 ng/ml. In the WS group, 56.4% of relapsing patients received salvage irradiation and
22.9% androgen deprivation therapy, 3.4% other treatments and the remainder no active treatment thus far. Salvage treatment was initiated upon PSA relapse in most relapsing patients. The cumulative rate of grade 3 toxicity at 10 years was 5.3% after RT and 2.5% after WS (P=0.052). Subgroup analyses suggest a significant interaction between patient age (≤70 vs. >70 years) and benefit from immediate RT(interaction P<0.05 for biochemical progression-free survival, clinical progressionfree survival and overall survival).
Conclusions: At 10 years, conventional post-operative RT improves biochemical progression-free survival and local control without significantly impacting distant metastases or overall survival.
|Publication status: ||published|
|KU Leuven publication type: ||IMa|
|Appears in Collections:||Laboratory of Experimental Radiotherapy|
Urology Section (-)
Department of Health and Technology - UC Leuven
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