ASCOCytoreductive nephrectomy prior to interferon-alfa-2b
(Intron A) therapy increased survival by 50% in patients with
previously untreated metastatic renal cell cancer, compared with
interferon alone, Robert Flanigan, MD, reported at the plenary
session of the 36th Annual Meeting of the American Society
of Clinical Oncology in New Orleans.
Based on this work, conducted at multiple centers and with
hundreds of patients, there should be a substantial shift toward both
surgery and the use of biologic agents in the treatment of advanced
renal cancer, said Dr. Flanigan, of Loyola University Stritch
School of Medicine, Maywood, Illinois.
This randomized Southwest Oncology Group trial enrolled 246 patients
with previously untreated metastatic renal cell cancer, 225 of whom
were eligible. The surgical group had slightly more performance
status 0 (PS 0) patients than the nonsurgical arm, but, Dr. Flanigan
said, this was balanced against a slightly increased number of
patients with measurable disease in the nonsurgery arm.
The patients treated with surgery and immunotherapy had a median
overall survival of 12.5 months vs 8.1 months for the patients
receiving immunotherapy only (P = .006).
A significant survival advantage was seen in all stratifications of
the protocol, he said. Survival for those with PS 0 increased from
12.8 months without surgery to 17.4 months with surgery. For PS 1
patients, survival increased from 4.8 to 6.9 months.
For patients with lung metastases only, survivorship improved from
10.3 months without surgery to 14.3 months with surgery. For all
other patients, the increase was from 6.3 to 10.2 months.
Among all patients, 37% of the no-surgery patients were alive at 1
year vs nearly 50% in the surgery arm. For the evaluable patients,
43% of the no-surgery patients were alive at 1 year vs 63% in the
Among the surgery patients, 80% had no surgical complications. Only
5% experienced significant surgical complications, and there was only
one surgical death. One surgical patient was unable to proceed to
Dr. Flanigan noted that the trial protocol called for interferon
dosing of 5 million IU/m² 3 days a week until progression.
This would not be considered standard aggressive immunologic
therapy, thus suggesting that with more aggressive biologic response
modification therapy or combinations, the survivorship advantage for
nephrectomy might be longer than seen in this trial, he said.
He concluded that cytoreductive nephrectomy followed by interferon
should be a treatment option, but only in selected good-risk