Features Associated with Recurrence Beyond 5 Years After Nephrectomy and Nephron-Sparing Surgery for Renal Cell Carcinoma: Development and Internal Validation of a Risk Model (PRELANE score) to Predict Late Recurrence Based on a Large Multicenter Database (CORONA/SATURN Project)

Brookman-May, Sabine ; May, Matthias ; Shariat, Shahrokh F. ; Xylinas, Evanguelos ; Stief, Christian ; Zigeuner, Richard ; Chromecki, Thomas ; Burger, Maximilian ; Wieland, Wolf F. ; Cindolo, Luca ; Schips, Luigi ; De Cobelli, Ottavio ; Rocco, Bernardo

; De Nunzio, Cosimo

; Feciche, Bogdan ; Truss, Michael ; Gilfrich, Christian ; Pahernik, Sascha ; Hohenfellner, Markus ; Zastrow, Stefan ; Wirth, Manfred P. ; Novara, Giacomo ; Carini, Marco ; Minervini, Andrea ; Simeone, Claudio ; Antonelli, Alessandro ; Mirone, Vincenzo ; Longo, Nicola ; Simonato, Alchiede

; Carmignani, Giorgio ; Ficarra, Vincenzo

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Background: Approximately 10-20% of recurrences in patients treated with nephrectomy for renal cell carcinoma (RCC) develop beyond 5 yr after surgery (late recurrence). Objective: To determine features associated with late recurrence. Design, setting, and participants: A total of 5009 patients from a multicenter database comprising 13 107 RCC patients treated surgically had a minimum recurrence-free survival of 60 mo (median follow-up [FU]: 105 mo [range: 78-135]); at last FU, 4699 were disease free (median FU: 103 mo [range: 78-134]), and 310 patients (6.2%) experienced disease recurrence (median FU: 120 mo [range: 93-149]). Interventions: Patients underwent radical nephrectomy or nephron-sparing surgery. Outcome measurements and statistical analysis: Multivariable regression analyses identified features associated with late recurrence. Cox regression analyses evaluated the association of features with cancer-specific mortality (CSM). Results and limitations: Lymphovascular invasion (LVI) (odds ratio [OR]: 3.07; p < 0.001), Fuhrman grade 3-4 (OR: 1.60; p = 0.001), and pT stage >pT1 (OR: 2.28; p < 0.001) were significantly associated with late recurrence. Based on accordant regression coefficients, these parameters were weighted with point values (LVI: 2 points; Fuhrman grade 3-4: 1 point, pT stage >1: 2 points), and a risk score was developed for the prediction of late recurrences. The calculated values (0 points: late recurrence risk 3.1%; 1-3 points: 8.4%; 4-5 points: 22.1%) resulted in a good-, intermediate-and poor-prognosis group(area under the curve value for the model: 70%; 95% confidence interval, 67-73). Multivariable Cox regression analysis showed LVI (HR: 2.75; p < 0.001), pT stage (HR: 1.24; p < 0.001), Fuhrman grade (HR: 2.40; p < 0.001), age (HR: 1.01; p < 0.001), and gender (HR: 0.71; p = 0.027) to influence CSM significantly. Limitations are based on the multicenter and retrospective study design. Conclusions: LVI, Fuhrman grade 3/4, and a tumor stage>pT1 are independent predictors of late recurrence after at least 5 yr from surgery in patients with RCC. We developed a risk score that allows for prognostic stratification and individualized aftercare of patients with regard to counseling, follow-up scheduling, and clinical trial design. (C) 2012 European Association of Urology. Published by Elsevier B. V. All rights reserved.

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