WESTPORT, CT (Reuters Health) – Survival of patients with metastatic renal-cell cancer is significantly better when interferon therapy follows nephrectomy than when it is given alone, researchers report in The New England Journal of Medicine for December 6.
Dr. Robert C. Flanigan from Loyola University, Maywood, Illinois, and colleagues enrolled 241 patients with metastatic renal-cell cancer who were considered eligible for radical nephrectomy. Half of the patients were randomized to undergo the surgery followed by interferon alfa-2b therapy and half received interferon alfa-2b alone.
Patients who underwent nephrectomy followed by interferon alfa-2b survived a median of 11.1 months compared with 8.1 months for patients who received interferon alfa-2b therapy alone (p = 0.05), the researchers report. The difference in survival was independent of metastatic site and whether or not measurable metastatic lesions were present.
"We believe that nephrectomy in suitable patients should be an eligibility criterion in trials of new systemic agents for the treatment of metastatic renal-cell cancer. We also believe that nephrectomy followed by interferon alfa-2b therapy should be considered the standard of care in future phase III trials," Dr. Flanigan's team says.
In an accompanying editorial Dr. Ian F. Tannock from Princess Margaret Hospital, Toronto, notes that it took 7 years for Dr. Flanigan's group to accrue this small number of patients from 80 institutions.
"Randomization should ensure balance of patient-based factors between the groups, but recruitment of a small proportion of eligible patients raises questions about the applicability of the results to the overall population of patients with metastatic renal cancer," he writes.
However, the results support those of a previous European study, Dr. Tannock notes. While acknowledging that it seems illogical to remove the primary tumor in patients who already have evidence of metastasis–"closing the barn door once the horse has bolted"–he concludes that "nephrectomy can be regarded as a standard treatment in selected patients with metastatic renal cancer."
N Engl J Med 2001;345:1655-1659.
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