UROLOGICAL ONCOLOGY

A prospective randomized EORTC intergroup phase 3 study comparing the complications of elective nephron-sparing surgery and radical nephrectomy for low-stage renal cell carcinoma
Van Poppel H, Da Pozzo L, Albrecht W, Matveev V, Bono A, Borkowski A, Marechal JM, Klotz L, Skinner E, Keane T, Claessens I, Sylvester R; European Organization for Research and Treatment of Cancer (EORTC); National Cancer Institute of Canada Clinical Trials Group (NCIC CTG); Southwest Oncology Group (SWOG); Eastern Cooperative Oncology Group (ECOG)
Department of Urology, University Hospital Gasthuisberg, Katholieke Universiteit Leuven, Leuven, Belgium
Eur Urol. 2007; 51: 1606-15

• Objectives: This study compared the complications and the cancer control of elective nephron-sparing surgery (NSS) and radical nephrectomy (RN) in patients with a small (< or = 5 cm), solitary, low-stage N0 M0 tumour suspicious for renal cell carcinoma (RCC) and a normal contralateral kidney.
• Methods: 541 patients were randomised in a prospective, multicentre, phase 3 trial to undergo NSS (n = 268) or RN (n = 273) together with a limited lymph node dissection.
• Results: This publication reports only on the complications reported for both surgical methods. The rate of perioperative blood loss < 0.5l was slightly higher after RN (96.0% vs. 87.2%) and the rate of severe haemorrhage was slightly higher after NSS (3.1% vs. 1.2%). Ten patients (4.4%), all of whom were treated with NSS, developed urinary fistulas. Pleural damage (11.5% for NSS vs. 9.3% for RN) and spleen damage (0.4% for NSS and 0.4% for RN) were observed with similar rates in both groups. Postoperative computed tomography scanning abnormalities were seen in 5.8% of NSS and 2.0% of RN patients. Reoperation for complications was necessary in 4.4% of NSS and 2.4% of RN patients.
• Conclusions: NSS for small, easily resectable, incidentally discovered RCC in the presence of a normal contralateral kidney can be performed safely with slightly higher complication rates than after RN. The oncologic results are eagerly awaited to confirm that NSS is an acceptable approach for small asymptomatic RCC.
  
  
• Editorial Comment
  This is the first report of a large randomized phase III trial on renal-sparing surgery (RSS) versus radical nephrectomy (RN) in patients with renal cancer. The trial is large enough to give meaningful results and therefore will be a standard reference in the future. In this paper, only the results of complications that have occurred are given whereas the results on oncological outcome have still to be awaited.
  In this trial, only tumors smaller than 5 cm were considered eligible for RSS as, to my opinion, the rate of complications would increase sharply in larger tumors. In this way, RSS was a safe procedure. Still, a higher complication rate (which in fact was doubled in RSS patients) was detectable with a rate of severe hemorrhage of 3.1% in RSS vs. 1.2% in RN and the occurrence of urinary fistulas in 4.4% in RSS.
  With these results in mind, we have to await the long-term data on oncological outcomes. As of now, renal-sparing surgery seems a safe procedure in elective patients with tumors < 5 cm.

Dr. Andreas Bohle
Professor of Urology
HELIOS Agnes Karll Hospital
Bad Schwartau, Germany
E-mail: boehle@urologie-bad-schwartau.de