Jean Baptiste Beauval1,2, Guillaume Ploussard3,4, Bastien Cabarrou4, Mathieu Roumiguié5,4, Adil Ouzzane6, Jérome Gas5, Annabelle Goujon7, Gautier Marcq6, Romain Mathieu8, Sébastien Vincendeau8, Xavier Cathelineau7, Pierre Mongiat-Artus9, Laurent Salomon10, Michel Soulié5,4, Arnaud Méjean11, Alexandre de La Taille10, Morgan Rouprêt12, François Rozet7. 1. Department of Urology, Andrology and Renal Transplantation, CHU Rangueil, Paul-Sabatier University, 1, av J Pouilhès, 31059, Toulouse Cedex, France. jbbeauval@gmail.com. 2. Institut Claudius Regaud, IUCT-O, 31059, Toulouse, France. jbbeauval@gmail.com. 3. Department of Urology, Clinique St Jean du Languedoc, Toulouse, France. 4. Institut Claudius Regaud, IUCT-O, 31059, Toulouse, France. 5. Department of Urology, Andrology and Renal Transplantation, CHU Rangueil, Paul-Sabatier University, 1, av J Pouilhès, 31059, Toulouse Cedex, France. 6. Department of Urology, Andrology and Renal Transplantation, CHU Lille, Lille, France. 7. Department of Urology, Institut Mutualiste Monsouris, Paris-Descartes University, Paris, France. 8. Department of Urology, Andrology and Renal Transplantation, CHU Rennes, Rennes, France. 9. Department of Urology, Andrology and Renal Transplantation Hôpital Saint-Louis, Paris-7 Denis Diderot University, Paris, France. 10. Department of Urology, Andrology and Renal Transplantation, CHU Mondor, Créteil, France. 11. Department of Urology and Renal transplantation, HEGP, Paris, France. 12. Department of Urology, Andrology and Renal Transplantation, CHU La Pitié Salpétrière, Paris, France.
Abstract
BACKGROUND: Prognoses for intermediate-risk prostate cancer (PCa) remain heterogeneous. Improved substratification could optimize treatment and monitoring strategies. The objective was to validate this subclassification in a radical prostatectomy (RP) series. METHODS: Between 2000 and 2011, 4038 patients who underwent RP for intermediate-risk PCa in seven French academic centers were included. Unfavorable intermediate-risk (UIR) PCa was defined as having a primary Gleason score of 4, ≥50% positive biopsy cores (PPBC), or more than one D'Amico intermediate-risk factor (i.e., cT2b, PSA 10-20, or Gleason score 7). Remaining PCa cases were classified as favorable. Main endpoints were pathologic results (pT stage, final Gleason score, surgical margin status), and oncologic outcomes were assessed according to PSA recurrence-free survival (PSA-RFS). Univariate and multivariate analyses were performed using the log-rank test and the Cox proportional hazards model. RESULTS: Median follow-up was 48 months (95% CI = [45-49]). Patients with UIR had worse PSA-RFS (68.17 vs. 81.98% at 4 years, HR = 1.97, 95% CI = [1.71; 2.27], p < 0.0001) compared to those with a favorable disease. The need for adjuvant therapy was significantly greater for UIR patients (43.5 vs. 29.2%, p < 0.0001). In multivariate analysis, primary Gleason score of 4 (HR = 1.81, 95% CI = [1.55; 2.12], p < 0.0001) and PPBC ≥ 50% (HR = 1.26, 95% CI = [1.02; 1.56], p = 0.0286) were significant preoperative predictors for worse PSA-RFS. CONCLUSIONS: This study highlights the heterogeneity of NCCN intermediate-risk patients and validates (in a large RP cohort) the previously proposed subclassification for this group. This classification can significantly predict both pathologic and oncologic outcomes. This easy-to-use stratification could help physicians' decision making. Prospective study and new tools as genomic tests and novel molecular-based approaches can improve this stratification in the future for patient counseling.
BACKGROUND: Prognoses for intermediate-risk prostate cancer (PCa) remain heterogeneous. Improved substratification could optimize treatment and monitoring strategies. The objective was to validate this subclassification in a radical prostatectomy (RP) series. METHODS: Between 2000 and 2011, 4038 patients who underwent RP for intermediate-risk PCa in seven French academic centers were included. Unfavorable intermediate-risk (UIR) PCa was defined as having a primary Gleason score of 4, ≥50% positive biopsy cores (PPBC), or more than one D'Amico intermediate-risk factor (i.e., cT2b, PSA 10-20, or Gleason score 7). Remaining PCa cases were classified as favorable. Main endpoints were pathologic results (pT stage, final Gleason score, surgical margin status), and oncologic outcomes were assessed according to PSA recurrence-free survival (PSA-RFS). Univariate and multivariate analyses were performed using the log-rank test and the Cox proportional hazards model. RESULTS: Median follow-up was 48 months (95% CI = [45-49]). Patients with UIR had worse PSA-RFS (68.17 vs. 81.98% at 4 years, HR = 1.97, 95% CI = [1.71; 2.27], p < 0.0001) compared to those with a favorable disease. The need for adjuvant therapy was significantly greater for UIR patients (43.5 vs. 29.2%, p < 0.0001). In multivariate analysis, primary Gleason score of 4 (HR = 1.81, 95% CI = [1.55; 2.12], p < 0.0001) and PPBC ≥ 50% (HR = 1.26, 95% CI = [1.02; 1.56], p = 0.0286) were significant preoperative predictors for worse PSA-RFS. CONCLUSIONS: This study highlights the heterogeneity of NCCN intermediate-risk patients and validates (in a large RP cohort) the previously proposed subclassification for this group. This classification can significantly predict both pathologic and oncologic outcomes. This easy-to-use stratification could help physicians' decision making. Prospective study and new tools as genomic tests and novel molecular-based approaches can improve this stratification in the future for patient counseling.
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