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Identification of Patients With Prostate Cancer Who Benefit From Immediate Postoperative Radiotherapy: EORTC 22911

Theodorus H. Van der Kwast, Michel Bolla, Hein Van Poppel, Paul Van Cangh, Kris Vekemans, Luigi Da Pozzo, Jean-Francois Bosset, Karl H. Kurth, Fritz H. Schröder, Laurence Collette

Department of Pathology and Laboratory Medicine, Mount Sinai Hospital and University Health Network, Toronto, Canada; Department of Radiotherapy, Centre Hospitalier Universitaire Grenoble; Department of Radiotherapy and Oncology, Hopital Jean Minjoz, Besancon, France; Department of Urology, Universiteits Ziekenhuis Gasthuisberg, Leuven; Department of Urology, Hopital St Luc; Statistics Department, European Organisation for Research and Treatment of Cancer Data Center, Brussels; Virga Jesse Ziekenhuis, Hasselt, Belgium; Department of Urology, Ospedale San Rafaele, Milano, Italy; Department of Urology, Academisch Medisch Centrum, Amsterdam; and the Department of Urology, Erasmus Medisch Centrum Rotterdam, the Netherlands

Address reprint requests to Theodorus H. Van der Kwast, MD, PhD, Department of Pathology, 11th floor, University Health Network, 200 Elizabeth St, Toronto, Ontario, Canada M5G 2C4; e-mail: theo.vdkwast{at}uhn.on.ca

Purpose The randomized controlled European Organisation for Research and Treatment of Cancer (EORTC) trial 22911 studied the effect of radiotherapy after prostatectomy in patients with adverse risk factors. Review pathology data of specimens from participants in this trial were analyzed to identify which factors predict increased benefit from adjuvant radiotherapy.

Patients and Methods After prostatectomy, 1,005 patients with stage pT3 and/or positive surgical margins were randomly assigned to a wait-and-see (n = 503) and an adjuvant radiotherapy (60 Gy conventional irradiation) arm (n = 502). Pathologic review data were available for 552 patients from 11 participating centers. The interaction between the review pathology characteristics and treatment benefit was assessed by log-rank test for heterogeneity (P < .05).

Results Margin status assessed by review pathology was the strongest predictor of prolonged biochemical disease-free survival with immediate postoperative radiotherapy (heterogeneity, P < .01): by year 5, immediate postoperative irradiation could prevent 291 events/1,000 patients with positive margins versus 88 events/1,000 patients with negative margins. The hazard ratio for immediate irradiation was 0.38 (95% CI, 0.26 to 0.54) and 0.88 (95% CI, 0.53 to 1.46) in the groups with positive and negative margins, respectively. We could not identify a significant impact of the positive margin localization.

Conclusion Provided careful pathology of the prostatectomy is performed, our results suggest that immediate postoperative radiotherapy might not be recommended for prostate cancer patients with negative surgical margins. These findings require validation on an independent data set.

Supported by Grants No. 5U10 CA11488-21 through 5U10 CA11488-37 from the National Cancer Institute (Bethesda, MD) and by a grant from the Ligue Nationale contre le Cancer (Grenoble, France). The contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Presented in part at the Annual Meeting of the European Association of Urology, April 6, 2006, Paris, France, and the Congress of the American Urological Association, May 23, 2006, Atlanta, GA.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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