In an ASSURE (Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma) trial, researchers compared two different kinase inhibitors used in the setting with a placebo control arm. The trial sought to find whether removing any suspicious lymph nodes at the time of the nephrectomy might improve results. The team aimed at to wipe out any remaining micrometastatic disease and the results of the analysis are published in the Journal of Urology.
The team of researchers reviewed data on the 701 patients who were deemed high risk and underwent retroperitoneal lymphadenectomy in the trial. This included all patients whose nodes were clinically positive (cN+) and about 30% of those with clinically negative nodes (cN0).
There was no association between lymphadenectomy and overall survival, the team said. A median of three lymph nodes was removed during the procedures and that 23.4% of the total were positive upon pathologic examination (pN+).
The patients with the pN+ disease who underwent lymphadenectomy and received adjuvant sorafenib or sunitinib were the most likely to benefit from the effort to wholly remove micrometastases in affected nodes. However, overall and disease-free survival did not improve among these patients.
On the reassuring side, lymphadenectomy did not result in an increased risk for surgical complications vs nephrectomy alone. Lymphadenectomy was almost universal among the cN+ patients and not routine among the cN0 patients.
Despite its use in clinical practice, lymphadenectomy has not yet been proven to provide an oncologic benefit in the setting. The data suggesting that routine lymph node dissection does not confer a survival benefit in patients with high-risk renal cell carcinoma.
The analysis again leads us to conclude that only by performing a prospective and randomized trial of nephrectomy with and without full bilateral retroperitoneal LND will the therapeutic value of node dissection in high-risk renal cell carcinoma (RCC) be determined," Dr Russo concludes.
Removing lymph nodes may not have a therapeutic benefit, but there may be staging information from lymphadenectomy with RCC that can facilitate patient counselling and help with discussions around prognosis.
A prospective randomized clinical trial designed to evaluate the effect of lymph node removal on outcomes among patients with high-risk RCC. However, still, there is no oncologic benefit here.
Lymph node removal has oncologic benefit in other urologic cancers, where there is a stepwise progression of disease from the organ to the nodes and then metastasis. However, there is no benefit in RCC, where lymphatic involvement almost never precedes metastatic disease.
It is possible that RCC may have progressed too extensively by the time there is clinically evident lymph node enlargement and that removing nodes on the basis of size alone may be ineffective.
In fact, a European Organization for Research and Treatment of Cancer (EORTC) trial examined the treatment of RCC with and without lymphadenectomy. The trial compared patients treated with radical nephrectomy alone with patients treated with radical nephrectomy combined with lymphadenectomy. There was no difference in overall survival or progression-free survival, the researchers concluded.