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Fritz Schröder Chris Bangma Javier C. Angulo Antonio Alcaraz Marc Colombel Tom McNicholas Teuvo L. Tammela Indrani Nandy Ramiro Castro 《European urology》2013
Background
Rising prostate-specific antigen (PSA) levels after radical therapy are indicative of recurrent or residual prostate cancer (PCa). This biochemical recurrence typically predates clinically detectable metastatic disease by several years. Management of patients with biochemical recurrence is controversial.Objective
To assess the effect of dutasteride on progression of PCa in patients with biochemical failure after radical therapy.Design, setting, and participants
Randomised, double-blind, placebo-controlled trial in 294 men from 64 centres across 9 European countries.Intervention
The 5α-reductase inhibitor, dutasteride.Outcome measurements and statistical analysis
The primary end point was time to PSA doubling from start of randomised treatment, analysed by log-rank test stratified by previous therapy and investigative-site cluster. Secondary end points included time to disease progression and the proportion of subjects with disease progression.Results and limitations
Of the 294 subjects randomised (147 in each treatment group), 187 (64%) completed 24 mo of treatment and 107 discontinued treatment prematurely (71 [48%] of the placebo group, 36 [24%] of the dutasteride group). Dutasteride significantly delayed the time to PSA doubling compared with placebo after 24 mo of treatment (p < 0.001); the relative risk (RR) reduction was 66.1% (95% confidence interval [CI], 50.35–76.90) for the overall study period. Dutasteride also significantly delayed disease progression (which included PSA- and non-PSA-related outcomes) compared with placebo (p < 0.001); the overall RR reduction in favour of dutasteride was 59% (95% CI, 32.53–75.09). The incidence of adverse events (AEs), serious AEs, and AEs leading to study withdrawal were similar between the treatment groups. A limitation was that investigators were not blinded to PSA levels during the study.Conclusions
Dutasteride delayed the biochemical progression of PCa in patients with biochemical failure after radical therapy for clinically localised disease. The safety and tolerability of dutasteride were generally consistent with previous experience.Clinical trial registry
ClinicalTrials.gov, NCT00558363. 相似文献33.
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Matthew Bohm Ronghui Xu Yiran Zhang Sashidhar Varma Monika Fischer Gursimran Kochhar Brigid Boland Siddharth Singh Robert Hirten Ryan Ungaro Eugenia Shmidt Karen Lasch Vipul Jairaith David Hudesman Shannon Chang Dana Lukin Arun Swaminath Bruce E. Sands Jean-Frederic Colombel Sunanda Kane Edward V. Loftus Jr Bo Shen Corey A. Siegel William J. Sandborn Parambir S. Dulai the VICTORY Collaboration 《Alimentary pharmacology & therapeutics》2020,52(4):669-681
35.
Mege-Lechevallier F Cherasse A Ronze S Colombel M Scoazec JY 《Annales de pathologie》2007,27(1):43-46
Transitional cell carcinoma with osseous metaplasia of the stroma is a rare variant of urothelial carcinoma which must be distinguished from sarcomatoid carcinoma. We report here a further observation of this tumor variant, in a very unusual location, the ureter, in order to underline the radiological and pathological characteristics useful for the correct diagnosis, and to point out the problems of differential diagnosis. The diagnosis was made in an 85-year-old patient, presenting with chronic right lombalgias. Imaging studies showed a calcified thickening of the right ureter, associated with a major dilatation of the right excretory cavities and a parenchymal atrophy of the right kidney. A right nephro-ureterectomy was performed. Macroscopical examination showed an ossified, ill-limited tumor, measuring 4 cm in diameter, infiltrating the right ureteral wall. At histological examination, the lesion was identified as a high grade transitional cell carcinoma with extensive osseous metaplasia of the stroma. There was no evidence for a sarcomatous component (absence of mesenchymal cell proliferation, absence of mitosis in stromal cells). An early locoregional recurrence was observed three months after surgery. Our case report underlines the radiological and histological features of a rare variant of transitional cell carcinoma, which may be diagnosed by pre-operative imaging studies and which must be distinguished from a highly aggressive sarcomatoid carcinoma. 相似文献
36.
Long‐term safety of adalimumab in clinical trials in adult patients with Crohn's disease or ulcerative colitis
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Géraldine Pignot Pierre Bigot Jean-Christophe Bernhard Fabien Bouliere Thomas Bessede Karim Bensalah Laurent Salomon Nicolas Mottet Laurent Bellec Michel Soulié Jean-Marie Ferrière Christian Pfister Julien Drai Marc Colombel Arnauld Villers Jerome Rigaud Olivier Bouchot Francesco Montorsi Jean-Jacques Patard 《Urologic oncology》2014,32(7):1024-1030
ObjectivesTo analyze to what extent partial nephrectomy (PN) is superior to radical nephrectomy (RN) in preserving renal function outcome in relation to tumor size indication.Methods and materialsClinical data from 973 patients operated at 9 academic institutions were retrospectively analyzed. Glomerular filtration rate (GFR) before and after surgery was calculated with the abbreviated Modification of the Diet in Renal Disease equation. For a fair comparison between the 2 techniques, all imperative indications for PN were excluded. A shift to a less favorable GFR group following surgery was considered clinically significant.ResultsMedian age at diagnosis was 60 years (19–91). Tumor size was smaller than 4 cm in 665 (68.3%) cases and larger than 4 cm in 308 (31.7%) cases. PN and RN were performed in 663 (68.1%) and 310 (31.9%) patients, respectively. In univariate analysis, patients undergoing PN had a smaller risk for developing significant GFR change following surgery than those undergoing RN did. This was true for tumors≤4 cm (P = 0.0001) and for tumors>4 cm (P = 0.0001). In multivariate analysis, the following criteria were independent predictive factors for developing significant postoperative GFR loss: the use of RN (P = 0.0001), preoperative GFR<60 ml/min (P = 0.0001), tumor size≥4 cm (P = 0.0001), and older age at diagnosis (P = 0.0001).ConclusionsThe renal function benefit carried out by elective PN over RN persists even when expanding nephron-sparing surgery indications beyond the traditional 4-cm cutoff. 相似文献