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 surgery arm.
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 interferon therapy.
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 patients.