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| |  Adjuvant Radiotherapy After Radical Prostatectomy Provides Progression-Free Survival Benefits Independent of Margin Length: Presented at EMUC By Chris Berrie BARCELONA, Spain -- November 30, 2009 -- Adjuvant radiotherapy (ART) after radical prostatectomy (RP) provides biochemical progression-free survival (PFS) benefits for patients with prostate cancer who have positive surgical margins and extraprostatic extension, researchers noted at the 2nd European Multidisciplinary Meeting on Urological Cancers (EMUC). This benefit is independent of margin length. Recent randomised clinical trials have indicated that ART after RP increases patient survival. Thomas Wiegel, MD, University Hospital Ulm, Ulm, Germany, noted that, although the presence of positive margins has importance, the question remains: Does the extent of these margins matter, and does ART work for focal and/or extensive extent? Dr. Wiegel presented the results of a subgroup analysis of a multicentre, randomised, phase 3 trial here on November 29. The aim of the subgroup analysis was to investigate the influence of ART on the length of positive surgical margin and the length of extraprostatic extension versus a “wait and see” approach. In the main trial, 388 eligible patients with pT3 (locally advanced) prostate cancer were randomised to either ART (60 Gy; n = 194) or “wait and see” (n = 194); all had achieved undetectable prostate-specific antigen (PSA) levels following RP. Central pathological review was carried out for 265 (87%) of the 304 patients who received these treatments. Of these subjects, an equal number in each group (88 men) had positive surgical margins, with median lengths of 2.8 and 3.3 mm, respectively. Similarly, both of the full centrally reviewed populations of 140 ART and 125 “wait and see” patients had a median extraprostatic extension of 1.7 mm. The effects of ART on biochemical PFS at 5 years demonstrated similar survivals and positive benefits for those with positive margins both less than 2 mm (73% vs 43% for “wait and see”; P = .120) and 2 mm or greater (73% vs 49%: P < .05). Indicated Dr. Wiegel, “ART works, independent of length of positive margins.” For patients with extraprostatic extension, ART was similarly beneficial, with those having less than 1 mm of extraprostatic extension experiencing significant improvements in biochemical PFS at 5 years (83% vs 65% for “wait and see”; P = .043). For those who had extensions of 1 mm or greater, however, while there was again significant PFS benefit provided by ART (65% vs 46%; P = .019), there was also a decrease of about 20% in PFS compared with those patients whose extensions were less than 1 mm. This subgroup analysis provides new data demonstrating that the length of extraprostatic extension is a prognostic factor in these patients, noted Dr. Wiegel. “One can speculate that a higher dose of more than 60 Gy is necessary to sterilise patients with greater extension,” he noted. “This, of course, should be validated in prospective trials.” EMUC was jointly organised by the United European Gastroenterology Federation (UEGF) and the World Gastroenterology Organisation (WGO), together with the World Organisation of Digestive Endoscopy (OMED) and the British Society of Gastroenterology (BSG). [Presentation title: Impact of the Length of Positive Surgical Margins and Extraprostatic Extension on the Results of Adjuvant Radiotherapy After Radical Prostatectomy: Subgroup Analyses of the German Phase 3 Trial. Oral Presentation O2]
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