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Does post-operative radiotherapy (P-RXT) after radical prostatectomy (Px) improve progression-free survival (PFS) in pT3N0 prostate cancer (PC)? (EORTC 22911)
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2004
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UrologySurgical OncologyRadiation MedicineRadiation TherapyGenitourinary CancerTreatment VerificationPt3n0 Prostate CancerMedicineRadical ProstatectomyClinical PfsRandomized TrialProstatic DiseasePost-operative RadiotherapyClinical Radiation OncologyOncologyRadiation OncologyGynecology OncologyCancer Research
4504 Background:In 1992, as radical prostatectomy was more frequently applied to clinical T1–2N0M0 prostate cancer, the EORTC has undertaken a randomized trial of immediate post-operative treatment versus wait-and-see policy, for patients with high risk factors of local relapse on pathological specimen. We present the first efficacy results of this study. Methods: Eligible patients were ≤75 years old, WHO performance status (PS) 0–1, had T0–3N0M0 PC preoperatively and ≥1 pathological risk factor of: capsule invasion, positive surgical margins, invasion of seminal vesicles. P-XRT was 60Gy conventional external radiation delivered over 6 weeks. The trial was powered to detect a hazard ratio (HR) of 0.77 with 80% power with two-sided α=0.05 with regard to clinical or biological progression-free survival. Results: 1005 pts were accrued by end 2001 (P-XRT: 503, Px: 502). Median age was 65.4 years, PS 0 in 93.8%, median pre- and post-operative PSA 12.3 and 0.2 ng/ml, respectively. All but 41pts on P-XRT were irradiated with median dose 60Gy (range: 50–74). The trial was reviewed by an IDMC in December 2003, after a median follow-up of 5 years and early disclosure of the trial results was recommended. Biochemical PFS (time to twice confirmed PSA increase over nadir or first clinical failure or death) at 5 years was 72.2% (CI: 67.7–76.8) on P-XRT and 51.8% (CI: 46.8–56.8), HR=0.52 (CI: 0.42–0.64), P<0.0001. Clinical PFS was improved from 74.8% to 83.3% at 5 years (HR=0.68, CI: 0.52–0.89, P=0.004). The incidence of loco-regional failure was significantly decreased (P<0.0001). Further follow-up is needed to assess the impact on distant metastases and overall survival. P-XRT is associated with an increased risk of immediate and late grade 1–2 side effects. Grade 3 side effect rates so far were less than 5% in both groups. Conclusions: Post-operative radiotherapy results in improved biochemical and clinical PFS. This benefit is to be weighed against the treatment side effects. Further follow-up is needed to assess the impact on overall survival. No significant financial relationships to disclose.