Radical nephrectomy with and without lymph node dissection: Preliminary results of the EORTC randomized phase III protocol 30881

Objective: The authors present demographic and surgical data from a randomi zed phase III trial, instituted by the EORTC Genitourinary Group in 1988, t he aim of which was to assess whether complete lymph node dissection in con junction with radical nephrectomy for renal cell cancer is more effective t han radical nephrectomy alone. Methods: Before surgery, the renal cell carc inoma was staged and judged to be nonmetastatic and resectable. The patient s were randomized prior to surgery into those having radical nephrectomy co mbined with complete lymph node dissection or into those having radical nep hrectomy alone. Postoperatively all patients were followed until progressio n of disease or death. Results: Of the 772 randomized patients, 41 were not eligible. 383 had a complete lymph node dissection together with a radical nephrectomy. 389 had a radical nephrectomy alone. The complication rate di d not differ significantly between the two groups. A complete lymph node di ssection in 336 patients revealed absence of lymph node metastases in 325 o f them. Conclusions: The present study shows that complete lymph node disse ction does not add morbidity to the radical nephrectomy. After proper preop erative staging, the incidence of unsuspected lymph node metastases is low (3.3%). Copyright (C) 1999 S. Karger AG, Basel.