Volume 378, Issue 9788, Pages (July 2011)

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Volume 378, Issue 9788, Pages 338-346 (July 2011) Prednisone versus tamoxifen in patients with idiopathic retroperitoneal fibrosis: an open- label randomised controlled trial Dr Augusto Vaglio, MD, Alessandra Palmisano, MD, Federico Alberici, MD, Umberto Maggiore, MD, Stefania Ferretti, MD, Rocco Cobelli, MD, Francesco Ferrozzi, MD, Domenico Corradi, MD, Carlo Salvarani, MD, Prof Carlo Buzio, MD The Lancet Volume 378, Issue 9788, Pages 338-346 (July 2011) DOI: 10.1016/S0140-6736(11)60934-3 Copyright © 2011 Elsevier Ltd Terms and Conditions

Figure 1 Trial profile The Lancet 2011 378, 338-346DOI: (10.1016/S0140-6736(11)60934-3) Copyright © 2011 Elsevier Ltd Terms and Conditions

Figure 2 Variations in size of idiopathic retroperitoneal fibrosis and representative CT scans (A) Percentage variations in the mean maximal thickness of the retroperitoneal mass during the treatment period in the prednisone and tamoxifen groups. Mean maximum thickness was calculated as the average of maximal peri-aortic and peri-iliac thickness. The reduction in mass thickness was significantly greater in the prednisone group than in the tamoxifen group, at month 4 (p=0·0462) and at month 8 after randomisation (p=0·0314). Comparisons were done according to the intention-to-treat principle. (B) (1–3) Abdominal contrast-enhanced CT scans in a patient treated with prednisone show that the periaortic retroperitoneal mass (1, arrow) markedly shrinks at month 4 after randomisation (2, arrow) and stabilises at the month-8 scan (3, arrow). (4–6) Abdominal contrast-enhanced CT scans in a patient treated with tamoxifen who developed relapse during treatment show that the periaortic tissue (4, arrow) is reduced in size at month 4 (5, arrow) and enlarges at relapse (6, arrow). The Lancet 2011 378, 338-346DOI: (10.1016/S0140-6736(11)60934-3) Copyright © 2011 Elsevier Ltd Terms and Conditions

Figure 3 Kaplan-Meier estimate of the time from randomisation to the first relapse in the two treatment groups The Lancet 2011 378, 338-346DOI: (10.1016/S0140-6736(11)60934-3) Copyright © 2011 Elsevier Ltd Terms and Conditions