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    Comparison of immediate vs deferred cytoreductive nephrectomy in patients with synchronous metastatic renal cell carcinoma receiving sunitinib: The surtime randomized clinical trial
    (American Medical Association, 2019) Bex, Axel; Mulders, Peter; Jewett, Michael; Wagstaff, John; Van Thienen, Johannes V.; Blank, Christian U.; Van Velthoven, Roland; Laguna, Maria del Pilar; Wood, Lori; Van Melick, Harm H. E.; Aarts, Maureen J.; Lattouf, J. B.; Powles, Thomas; De Jong, Igle Jan; Rottey, Sylvie; Tombal, Bertrand; Marreaud, Sandrine; Collette, Sandra; Collette, Laurence; Haanen, John
    IMPORTANCE In clinical practice, patients with primary metastatic renal cell carcinoma (mRCC) have been offered cytoreductive nephrectomy (CN) followed by targeted therapy, but the optimal sequence of surgery and systemic therapy is unknown.OBJECTIVE To examine whether a period of sunitinib therapy before CN improves outcome compared with immediate CN followed by sunitinib.DESIGN, SETTING, AND PARTICIPANTS This randomized clinical trial began as a phase 3 trial on July 14, 2010, and continued until March 24, 2016, with a median follow-up of 3.3 years and a clinical cutoff date for this report of May 5, 2017. Patients with mRCC of clear cell subtype, resectable primary tumor, and 3 or fewer surgical risk factors were studied.INTERVENTIONS Immediate CN followed by sunitinib therapy vs treatment with 3 cycles of sunitinib followed by CN in the absence of progression followed by sunitinib therapy.MAIN OUTCOMES AND MEASURES Progression-free survival was the primary end point, which needed a sample size of 458 patients. Because of poor accrual, the independent data monitoring committee endorsed reporting the intention-to-treat 28-week progression-free rate (PFR) instead. Overall survival (OS), adverse events, and postoperative progression were secondary end points.RESULTS The study closed after 5.7 years with 99 patients (80 men and 19 women; mean [SD] age, 60 [8.5] years). The 28-week PFR was 42% in the immediate CN arm (n = 50) and 43% in the deferred CN arm (n = 49) (P = .61). The intention-to-treat OS hazard ratio of deferred vs immediate CN was 0.57 (95% CI, 0.34-0.95; P = .03), with a median OS of 32.4 months (95% CI, 14.5-65.3 months) in the deferred CN arm and 15.0 months (95% CI, 9.3-29.5 months) in the immediate CN arm. In the deferred CN arm, 48 of 49 patients (98%; 95% CI, 89%-100%) received sunitinib vs 40 of 50 (80%; 95% CI, 67%-89%) in the immediate arm. Systemic progression before planned CN in the deferred CN arm resulted in a per-protocol recommendation against nephrectomy in 14 patients (29%; 95% CI, 18%-43%).CONCLUSIONS AND RELEVANCE Deferred CN did not improve the 28-week PFR. With the deferred approach, more patients received sunitinib and OS results were higher. Pretreatment with sunitinib may identify patients with inherent resistance to systemic therapy before planned CN. This evidence complements recent data from randomized clinical trials to inform treatment decisions in patients with primary clear cell mRCC requiring sunitinib.
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    Comparison of immediate vs deferred cytoreductive nephrectomy in patients with synchronous metastatic renal cell carcinoma receiving sunitinib: the SURTIME randomized clinical trial (vol 5, pg 164, 2018)
    (American Medical Association, 2019) Bex, Axel; Mulders, Peter; Jewett, Michael; Wagstaff, John; Van Thienen, Johannes V.; Blank, Christian U.; Van Velthoven, Roland; Laguna, Maria del Pilar; Wood, Lori; Van Melick, Harm H. E.; Aarts, Maureen J.; Lattouf, Jean-Baptiste; Powles, Thomas; De Jong, Igle Jan; Rottey, Sylvie; Tombal, Bertrand; Marreaud, Sandrine; Collette, Sandra; Collette, Laurence; Haanen, John
    [Abstract Not Available]
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    European association of urology guidelines office rapid reaction group: An organisation-wide collaborative effort to adapt the European Association of Urology Guidelines recommendations to the coronavirus disease 2019 era
    (Elsevier, 2020) Ribal, Maria Jose; Cornford, Philip; Briganti, Alberto; Knoll, Thomas; Gravas, Stavros; Babjuk, Marek; Harding, Christopher; Breda, Alberto; Bex, Axel; Rassweiler, Jens J.; Gezen, Ali Serdar; Pini, Giovannalberto; Liatsikos, Evangelos; Giannarini, Gianluca; Mottrie, Alex; Subramaniam, Ramnath; Sofikitis, Nikolaos; Rocco, Bernardo Maria Cesare; Xie, Li-Ping; Witjes, J. Alfred; Mottet, Nicolas; Ljungberg, Boerje; Roupret, Morgan; Laguna, Maria Pilar; Salonia, Andrea; Bonkat, Gernot; Blok, Bertil F. M.; Turk, Christian; Radmayr, Christian; Kitrey, Noam David; Engeler, Daniel S.; Lumen, Nicolaas; Hakenberg, Oliver W.; Watkin, Nick; Hamid, Rizwan; Olsburgh, Jonathon; Darraugh, Julie; Shepherd, Robert; Smith, Emma-Jane; Chapple, Christopher R.; Stenzl, Arnulf; Van Poppel, Hendrik; Wirth, Manfred; Sonksen, Jens; N'Dow, James
    The coronavirus disease 2019 (COVID-19) pandemic is unlike anything seen before by modern science-based medicine. Health systems across the world are struggling to manage it. Added to this struggle are the effects of social confinement and isolation. This brings into question whether the latest guidelines are relevant in this crisis. We aim to support urologists in this difficult situation by providing tools that can facilitate decision making, and to minimise the impact and risks for both patients and health professionals delivering urological care, whenever possible. We hope that the revised recommendations will assist urologist surgeons across the globe to guide the management of urological conditions during the current COVID-19 pandemic.