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• W2214705573 abstract "496 Background: SORCE is a randomised double blind trial of sorafenib, given for one or three years, versus placebo for patients at moderate or high risk of disease recurrence after surgical excision of primary renal cell carcinoma (RCC). Methods: Between July 2007 and April 2013, 1,711 patients were recruited from the UK (78%), Australia, France, Belgium, Denmark, The Netherlands and Spain. We describe the presenting characteristics, staging and surgical details of the randomised population. The surgical approach was at the surgeon’s discretion. Results: Baseline information is available for 1,681 patients (98%). Median age was 59 years (range 19 to 86): 1,195 (71%) were male. Histology was conventional/clear cell in 86%. T category was pT1a (<1%), pT1b (11%), pT2 (23%), pT3a-4 (65%). 47% were at high risk of recurrence with Leibovich scores of ≥6. Surgical data are available for 1,528 patients (89%). Total (radical) nephrectomy was performed for 97% of patients with 44% having laparoscopic surgery, of which 60% had a transperitoneal approach and 10% required conversion to open surgery. Some form of lymph node dissection was performed in 25% of patients (33% of open procedures and 15% of lap. procedures). The ipsi-lateral adrenal was removed in 47% and 11% had simultaneous resection of other structures/organs. Excision of venous extension was required in 19%. Laparoscopic procedures were performed for 58% of patients with maximum tumour diameter (MTD) <10cm and 17% of those with MTD ≥ 10 cm. Intra-operative complications were reported in 6% and post-operative complications reported in 12%. Hospital stay was median (IQR) 4 days (3-5) for patients having laparoscopic procedures and 7 days (5-8) for open surgery. Hospital stay was median (IQR) 8 days (6-11) for those having post-operative complications compared to 5 days (4-7) for uncomplicated recovery. Conclusions: These data reveal the varied surgical approaches to excision of primary RCC and will inform future adjuvant trials. The use of lymph node dissection appears arbitrary and evidence of benefit from randomised controlled trials is required. Analysis of the effect of sorafenib on disease free survival is likely to be performed in 2016. Clinical trial information: ISRCTN38934710." @default.
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• W2214705573 date "2014-02-01" @default.
• W2214705573 modified "2023-09-26" @default.
• W2214705573 title "MRC SORCE trial: Analysis of patients' presenting characteristics, tumor staging, and surgical approach." @default.
• W2214705573 doi "https://doi.org/10.1200/jco.2014.32.4_suppl.496" @default.
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